INTRODUCTION AND PURPOSE
Walking is an important developmental milestone that contributes to improved outcomes across multiple developmental domains in children with developmental disability. Treadmill training has been used as a successful tool to accelerate the acquisition of walking in various diagnostic groups. Children with Down syndrome (DS) and children with cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) levels I and II have shown accelerated walking onset after intensive treadmill programs.1–3 The treadmill protocols that triggered these improvements were carried out in the children's homes during almost daily walking sessions. Infants with moderate risk for a motor disability have also been shown to increase their alternating stepping patterns after intensive home-based treadmill training following similar training parameters.4 From a clinical perspective, children with DS present with hypotonia and ligamentous laxity, whereas children at high risk for neurodevelopmental disorders and children with CP tend to have fluctuating or high muscle tone, which leads to less variable, stereotypic movements.5 Even though the damage to the central nervous system and the resulting motor manifestations are inherently different in the 2 groups, highly patterned repetitive movement on the treadmill seems to lead to improvements in both populations. In spite of encouraging evidence for this intervention, access to pediatric treadmills is lacking particularly in young children with neurodevelopmental disability who are not yet ambulating. Providing families access to pediatric treadmills outside of pediatric physical therapy (PT) clinics is simply not part of common practice.
Access to PT services and potential use of treadmill intervention is commonly limited to once per week in clinic-based settings. Early intervention services in children younger than 3 years are often provided in the child's natural environment, further limiting the exposure to treadmill equipment. Even children who show relatively mild motor involvement and have the largest potential to reach the milestone of independent walking in the first years of life receive only 1 to 2 sessions of PT intervention weekly.6 In light of the existing research on neuroplasticity in the developing brain, this dosage is likely insufficient to lead to ideal cortical reorganization that could be optimally induced by more intensive, task-specific interventions.7 Cortical plasticity and the potential to evoke changes in the maturing brain is highest in children younger than 6 years.8 To best harness this potential for experience-dependent synaptogenesis in the immature central nervous system, providing appropriate interventions that contain sensorimotor experiences with ample repetition is imperative.9 The achievement of independent walking in children with developmental disability is best realized by engaging the child in walking-related activities that provide high repetition, while allowing errors to occur during practice.10 An additional emphasis is placed on the intensive practice of motor skills at critical developmental periods during which children will best respond to a given intervention.11 Sensitive gross motor milestones that seem to predict future walking ability in CP include seated postural control, lower extremity strength, and the ability to pull into the standing position.12 In DS and other developmental disorders, similar predictors are hypothesized to play an important role, as they indicate a functional level of postural stability and strength for antigravity activities.
Findings from recent research that address therapeutic approaches in infancy and early childhood have pointed to the need for a paradigm shift to gain optimal motor outcomes.13 The shift from therapist-driven, handling-based interventions to a family-centered approach showed positive motor outcomes in 46 high-risk children. The emphasis on parent education, active engagement in motor activities by the infants, and challenging activities at the limit of the child's motor capability led to improved developmental outcomes compared with a therapist-driven paradigm.13 In contrast, in a study of 10 infants with significant motor delays who received either an individualized intensive protocol of active progressive trunk activities provided by a trained therapist or a general play-based parent-infant group that was guided by a child-life specialist, the children in the therapy group showed significant immediate and short-term improvements in functional activities when compared with the play-based group.14 The results from these studies indicate that both individualized and group-based interventions may lead to improved motor outcomes when they include a high level of intensity, child and parent engagement, and direct handling or facilitation by a skilled therapist.
An additional component of an optimal motor program for young children is the inclusion of perceptual-motor experiences. The emphasis on these experiences not only enhances motor behavior, but shapes cognitive and social development, thus leading to fewer developmental delays outside the motor realm.15 Independent locomotion in a child with a developmental disability is an important skill that aids in the development of social interaction and cognition.15 Additional clinical benefits of upright locomotion in early childhood are osteoblast formation for optimal bone mineral density later in life.16 Furthermore, the benefits of walking for obesity prevention and positive effects on the cardiopulmonary system cannot be undervalued.17–19 Finally, the vast majority of parents of young children with developmental disability rate the achievement of walking as the primary goal for their child.20
When considering these factors, the current delivery of weekly PT services should be amended by innovative, parent-friendly, ancillary, evidence-based programs that can provide a more appropriate dosage of walking training during critical developmental stages in young children. Therefore, a program was designed to provide twice-weekly free access to pediatric treadmills to families and their children at a large, child-friendly laboratory space in a university setting. The purpose of this article is to (1) describe a group-based treadmill program, titled “Supported Treadmill Exercise Program Sacramento State-Easter Seals (STEPS),” (2) examine the effects of STEPS on gross motor skills related to standing, walking, and amount of support needed for ambulation, (3) examine use of the program by families, and (4) gain insight into parent satisfaction and parent opinions regarding a group-based treadmill program.
This was a retroactive analysis of data systematically collected during STEPS in the fall of 2013 and spring of 2014. The program was accepted by the Institutional Review Board of the California State University, Sacramento. The retroactive data analysis was approved by the same review board after completion of STEPS. Parents of participating children signed a waiver and release of liability at program onset. The program was offered free of charge for a duration of 14 weeks in the fall of 2013 and an additional 14 weeks in the spring of 2014. All families enrolled in the program voluntarily. No incentives were offered for program participation. The parent or caregiver was required to be present during all treadmill sessions and was encouraged to actively engage in the program by motivating the child during the treadmill sessions. All children were tested at study entry and at the completion of the 14-week program. Testing was conducted by a Pediatric Certified Specialist (PCS) with the assistance of Doctor of Physical Therapy (DPT) students who were supervised and trained in test administration.
Participants in this study were a convenience sample of 12 children with neurodevelopmental disabilities referred to STEPS by their treating physical therapists. The children had a mean age of 30.4 months (standard deviation [SD], 7.9). All children had developmental delay that warranted PT intervention through an early intervention or preschool program. All children received direct PT intervention, with the vast majority receiving PT once per week (Table 1). Diagnoses included CP (n = 4), genetic syndrome (n = 5), infantile spasms (n = 1), temporal lobe astrocytoma (n = 1), and cytomegalovirus (n = 1). Of the 12 children, 6 showed hypertonia or fluctuating tone and 6 presented with hypotonia. Program inclusion criteria were (a) age less than 60 months; (b) weight less than 60 lb (weight limitation for safe treadmill use); (c) ability to sit for at least 30 seconds unsupported to demonstrate presence of postural control in the upright position; (d) ability to take 5 to 7 steps when fully supported by an adult to demonstrate sign of readiness for intervention; and (e) referral to STEPS by the treating therapist who continued regular treatment with the child.
Exclusion criteria included (a) presence of uncontrolled seizures; (b) Botox injection or other spasticity-reducing medications in the past 6 months; (c) a history of orthopedic surgery; and (d) any medical condition that precluded the child from engaging in walking activities or customary PT interventions. Both the inclusion and exclusion criteria were based on parameters used in previous studies and were based on the perceived readiness of the child for the treadmill intervention.2,3,12,21
Before participation in STEPS, 7 children engaged in some ambulation with a push-toy (n = 3), reverse walker (n = 2), or gait trainer (n = 2) with supervision in their homes, but mainly crept on hands and knees. The remaining 5 children used creeping as their only means of locomotion for household distances and were transported by the parent for longer distances. These children were able to take a few steps when held by their hands or around the trunk by a parent, but did not use an assistive device for ambulation. All children were able to pull to stand on furniture and showed an interest in the upright position.
The children were of several ethnicities, with white being the most prominent (n = 6), followed by Hispanic (n = 3), Asian (n = 2), and black (n = 1). This ethnic distribution closely mirrored the population in the county in which the program was administered.22 Socioeconomic backgrounds also varied. Seven children were male and 5 were female (Table 1).
The children were tested for all outcome measures at program onset in week 1 and at the end of the program. All outcome measures used represented the Activity level of the International Classification of Functioning, Disability and Health (ICF) model.23 Because of the young age of the children and the activity-based focus of the program, measures of the Body Function and Structures and Participation components of the ICF model were not felt to be as salient. The Gross Motor Function Measure-88 Dimensions D and E (GMFM-88 Dim D/E) was used to measure changes related to developmental skills in upright mobility. The Functional Mobility Scale (FMS) was used to document the children's customary mode of transportation in the home and community. The timed 10-m walk test (10MWT) was used to examine changes in gait speed. To gain a parent/caretaker perspective on the children's mobility, the Pediatric Evaluation of Disability Inventory Caregiver Mobility Scale (PEDI) was administered.
The GMFM-88 has been validated for children with CP and DS.24 To gain insight about the children's changes in standing and walking activity, Dimensions D and E of the GMFM-88 were used. Dimension D examines skills related to standing and Dimension E measures skills related to walking, running, and jumping. Because of the absence of diagnosis-specific outcome measures for some of the rare conditions or genetic syndromes, the GMFM-88 was thought to best reflect skills related to standing and walking, and was therefore also used for children who fell outside these 2 diagnostic groups.
The FMS was developed for children with CP and has been found to reliably evaluate the amount of support needed for walking even when administered via parent interview.25 The FMS is designed to rate a child's walking ability over household (5 m), classroom (50 m), and community (500 m) distances. Children were rated on a Likert scale from 1 to 6, with 1 being the lowest ranking (uses wheelchair) and 6 being the highest ranking (independent on all surfaces). According to FMS instructions, an additional ranking of C (crawling) was used for household distances. Because of the children's young age, the FMS was only used to rate household and classroom distances, because children in this age group are unlikely to ambulate a 500-m community distance.
The timed 10MWT has shown to be most reliable in young children when they are encouraged to walk at a fast speed rather than a self-selected speed.26 The children in this study were thus encouraged to engage in their fastest walking speed. This was achieved by holding a motivational toy in front of them, or by being motivated by their parent. The 10MWT was conducted by providing the necessary amount of support required for assisted ambulation with the children who were initially unable to take steps with a gait trainer or walker. This support included holding the child's hands or providing trunk support. The minimal detectable change for this test was established in a group of older children with CP,26 and was used to report results. Because of the young age of the children and the fact that they were all just beginning to ambulate, a test of walking endurance was not performed.26
The PEDI is a valid and reliable tool that provides an assessment of a child's functional performance.27 The Caregiver Mobility Scale of the PEDI was used to assess the parents' perception of the degree of independence their child exhibits during functional mobility tasks. The PEDI has established scores for the minimal clinically important difference, but because only a subsection of the PEDI was used, it was not included when reporting the results.28 Program use was recorded on a daily attendance data sheet for each child.
Parent satisfaction surveys assessed 4 domains: information/application process (4 questions), facility/equipment (2 questions), time commitment (2 questions), overall program satisfaction (1 question). The questions were rated on a 4-point scale (strongly disagree, disagree, agree, strongly agree). Written comments were solicited for all areas.
All children were scheduled to participate twice weekly in a group-based treadmill exercise program. A large laboratory space at a university that was decorated with child-friendly motif was outfitted with 4 pediatric treadmills (Carlin's Creations, http://www.carlinscreations.com). The treadmills had handle bars, nonresettable minute timers, and a speed dial. Available treadmill speeds ranged from 0.05 to 0.6 m/s. After a brief period of free play with age-appropriate toys, the children were placed on the treadmills. One DPT student, under the supervision of a PCS, sat behind the child and provided support at the pelvis as needed and to prevent the child from falling. A second person, either a DPT student or a parent, sat in front of the child and operated the treadmill. A computer tablet was placed on a tablet stand in front of the treadmill, and the children watched a child-friendly program selected by the parents during the walking activity. If the child did not enjoy watching a movie, other forms of motivation such as blowing bubbles, singing songs, and other toys were used. The treadmill and motivational activities were started simultaneously. The treadmill was stopped when the child dragged his or her feet for more than 3 seconds or refused to continue walking. At that time, all motivational activities were stopped and the child was able to briefly sit on an adult's lap before being encouraged to continue walking. This approach had been successfully used in a previous study by the author to keep the young children engaged in the walking process.2 The child walked at the fastest possible speed during which the child needed the least amount of support. The speed from the previous session was used as a benchmark for each new session and was adjusted on the basis of individual ability. The child was encouraged to walk for as many minutes as possible. If the child was uncooperative on a given day, over ground walking activities or floor plays were interspersed and treadmill training was attempted again. Parents were in charge of determining when their child should receive a break or discontinue the session. Several progressions were implemented once the child walked without support at the pelvis. At that point, in addition to increasing the speed, the child was encouraged to point at things, thus letting go of 1 handle bar. If a child relied more on the handle bars than necessary, they were removed and a table with toys was placed in front of the child during the treadmill walk to reduce the amount of holding on the handle bars. If a child walked easily with support from only a table top or 1 handle bar, the treadmill was placed at an incline of 15%. After the treadmill walk, the child was encouraged to rest and play on the floor for 5 to 10 minutes. The children were scheduled for the program for about 30 to 45 minutes during each session. Because of the limited availability of treadmills, 3 groups of 4 children were scheduled each day. However, because of the young age of the children, flexibility was allowed in the schedule and there was some overlap of the groups on all days. Figure 1 shows a typical scene of several children walking during STEPS.
Statistical analysis was conducted using Prism version 6.02. Nonparametric data between pretest and posttest were analyzed with the Wilcoxon matched-pairs signed rank test for the GMFM-88, PEDI, and FMS. The paired t test was conducted for the timed 10MWT because of the parametric nature of the data. The alpha level of significance was set at .05. Parent satisfaction data were presented on the basis of survey results.
Statistically significant improvements were found between pre- and post-tests in the GMFM-88 Dimension D (P = .0005) and Dimension E (P = .001), indicating a positive change over time in skills related to standing and walking (Figures 2 and 3). Improvements in walking ability were further evidenced by significant improvements in FMS scores over 5 (P = .039) and 50 (P = .039) m. Overall, 4 children achieved independent walking without assistive device, 4 without previous upright mobility achieved independent walking with a reverse walker, 1 continued to use a gait trainer, and 3 continued independent walking with a reverse walker at a faster pace. These results held true for both the 5- and 50-m distances.
No statistically significant improvements were seen in the 10MWT (P = .1). However, the children changed walking conditions from pre- to posttest. At pre-test, the children were supported as needed over the distance of 10 m, with handheld support provided for 3 of the children. At posttest, all children manipulated their own walking device or walked independently. Of the 12 children, 9 improved their walking speed and 3 decreased their walking speed. Of the 9 children who showed improvement in their walking speed, 5 exceeded the minimal detectable change.26 Of the 3 children who decreased in walking speed, 2 went from walking with support at the hands or trunk to independent walking with a walker. One child with significant lower extremity spasticity continued to walk at a nonfunctional speed with a gait trainer (Figure 4).
Statistically significant improvements were made in the PEDI Caregiver Mobility Scale (P = .001). Nine children improved, and 3 maintained their PEDI scores as reported by the caregivers.
The children attended an average of 77% of their scheduled appointments. The main stated reasons for missed sessions were illness or conflicting medical appointments. The children walked on the treadmills for a mean duration of 27.3 min/wk. The duration of the treadmill walks increased steadily over the course of the program, with an average duration of 17.4 (SD, 9.9) min/wk in week 1 to 37.3 (SD, 16.2) by week 7 and 29.7 (SD 18.1) min/wk in week 13. In addition to increased walking duration, the average treadmill speed also increased. In week 1, the mean treadmill speed was 0.18 (SD, 0.07) m/s, and increased to 0.25 (SD, 0.09) m/s in week 7 and 0.29 (SD, 0.06) m/s by week 13.
Parent surveys at the end of the program revealed high satisfaction rates in all areas. When expressed numerically (1 = strongly disagree to 4 = strongly agree), questions about general information and the application process received a mean rating of 3.89; satisfaction with the facility and equipment received a rating of 3.96; questions about the time commitment by parents were rated 3.83 and overall program satisfaction received the highest mean score of 4.0. When questioned how many times a week the families would like to attend such a program if it was available, 8 families indicated that they would like to attend a minimum of 3 times a week or more. Three of the families found the twice weekly offering sufficient and 1 family indicated that a once weekly offering was their preference.
To our knowledge, this is the first study to evaluate the effects of a group-based treadmill program, in which the treadmill intervention was individualized to each child's specific capability. Our results illustrate that a group-based treadmill training program for young children with developmental disability who are not yet ambulating could successfully be implemented and serve as a useful adjunct to weekly PT sessions. The children showed improved motor outcomes related to functional walking skills, and parents reported an increase in mobility skills. This reported independence in mobility skills reflects a decreased burden on the caregiver because caregivers are the main providers of transportation for young children with disabilities. Furthermore, parent satisfaction with the community program was high and the majority of parents reported that they would prefer more than twice weekly offerings. Attendance of the program was consistent with a low perceived parental burden, and the administration of evidence-based walking parameters was successfully implemented on the basis of existing literature. Both children with low and increased or fluctuating tone benefited from the intervention. When considering the children's walking ability and muscle tone, children with hypotonia tended to make more gains, with 3 of the 6 children achieving independent walking. Only 1 child from the hypertonic group achieved walking without an assistive device.
Other studies have examined the effects of treadmill training in children with CP and DS who are not yet ambulating, but the treadmill training was offered either in a clinical setting or home-based setting.1–3 To our knowledge, this study is the first to examine the effects of a group-based treadmill program. A similar dosage of treadmill training that was offered 3 times per week for 4 weeks led to significant improvements in GMFM Dimensions D and E and PEDI scores in 6 children with CP ages 2.5 to 3.9 years.3 In a quasi-randomized controlled trial of 12 children with CP (mean age, 22 months), GMFCS levels I and II who were not yet ambulating, children in the treadmill group received high dosage of home-based intervention carried out twice daily, 6 days per week for 6 weeks by the parents.2 Treadmill speed was individualized for each child and upwardly adjusted each week. The children in the intervention group made significant improvements in the GMFM Dimensions D and E and the PEDI, but also showed additional improvements in their walking speed. These results indicate that a higher dosage might be required to positively influence walking speed than the dosage provided by the STEPS program. Similarly, in a randomized controlled trial, 30 children with DS received either low-intensity or high-intensity home-based treadmill intervention 5 times a week until walking onset.1 Children in the low-intensity group walked for 8 minutes per day, 5 times per week at a constant speed of 0.18 m/s. The children in the high-intensity group were challenged both by increasing the belt speed on an individual basis, ranging from 0.18 to 0.22 m/s, and by the addition of ankle weights. The high-intensity group achieved most motor milestones earlier than the low-intensity group. The treadmill speeds in our study were adjusted according to the child's ability and set at a challenging pace for each child during each session. In light of our results and those of others, individualized walking speeds that challenge the child at his or her limit appear to bring about more optimal results than a preset treadmill speed.
Little is known about the effects of group-based versus individual motor programs in young children with developmental delay. The majority of studies that used a group-based format have been conducted in older children with CP. A functional, intensive goal-directed, individualized, group-based program was offered 5 times a week for 3 weeks to 22 children with various degrees of CP ages 3 to 9 years of age.29 Significant improvements in GMFM and PEDI scores were found at the end of the program, and the program was well-received by the children and their parents. Other studies used a group-based design for strength training in children with CP. A circuit training program for children (ages 4 to 8 years) with CP who were ambulating was offered for 1 hour twice weekly in a school-based setting.30 Exercises included closed chain strength training and an unspecified dosage of treadmill walking.30 The authors reported significant improvements in functional strength and in the 10MWT. A 6-week group-based task-based strengthening program that reported the effects of upper versus lower extremity strengthening led to significant improvements in children with CP ages 6 to 14 years.31 Overall, the group-based environment was reported to have a motivating effect as well as being cost-effective, feasible, and enjoyable for these preschool and school-aged children.29–31
Although the effect of the group-based nature of the program could not be directly measured, beneficial aspects were observed by parents and researchers. The children showed curiosity about each other, frequently looked and smiled at one another, interacted while walking on adjacent treadmills by sharing toys, and sometimes encouraged each other verbally. The comments from the parent survey after completion of STEPS support the notion that a group-based format was perceived as valuable by families for their children. Some of the comments from the parent survey spoke directly to the motivating environment. Most other comments expressed gratitude and a perceived helpfulness of the program. Some parents expressed additional appreciation for being allowed to bring the participant's sibling/s (Table 2).
Overall, no negative comments were made and no child dropped out of the program during the 14-week duration. Given the twice weekly commitment, which involved up to 30 minutes of travel in a major metropolitan area by the parents, this was an additional indicator of the program being perceived as valuable to the families. However, some children missed some sessions because of illness and conflicting medical appointments, which is not unusual in young children with developmental delay.
The positive results from this study have to be viewed in context. Even though the children were not yet walking, all had good walking potential with or without an assistive device on the basis of their mild to moderate level of impairment. Without a control group, knowing how much of the progress was due to maturation and regularly scheduled PT, and how much was triggered by the treadmill training itself is impossible.
All families were able to provide transportation for their children and allow the time to attend the program. These families might represent a highly motivated subsample of the population who could afford the time commitment. Furthermore, the high parent satisfaction scores might have been influenced by the fact that the program was offered at no charge to the families.
The outcome measures used in this study to document changes in the child were limited to the activity component of the ICF, and little information was gathered whether the increases in functional ambulation influenced the children's overall participation.
Future studies should explore the most optimal dosage for treadmill training and compare home-based with group-based treadmill programs to measure their effects on motor skills and to evaluate child and family engagement, family support, and motivation.
A group-based treadmill training program offered twice weekly for 14 weeks resulted in improvements in skills related to standing and walking, a decrease of amount of support needed for walking, and an increase in independence in mobility in children with developmental delay who are not yet ambulating. Group-based treadmill programs might provide a fun, therapeutic, and cost-effective adjunct to regular PT intervention when treadmills for the home are not available.
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Keywords:Copyright © 2016 Academy of Pediatric Physical Therapy of the American Physical Therapy Association
body weight; child development/physiology child; exercise movement techniques/instrumentation; exercise movement techniques/methods; humans; locomotion/physiology; motor skills disorders/prevention and control; motor skills disorders/rehabilitation; motor skills/physiology; preschool