Challenge: Progressing Upper Extremity Strengthening in a Participant With Shoulder Pain
Protocol and Participant Presentation
The LEAPS HEP is a progressive exercise program with continual progression of sitting and standing balance, and UE/LE coordination and strengthening exercises. It includes approximately 60 to 90 minutes of activity beginning with vital sign monitoring and stretching, but with the majority of the session dedicated to the exercise protocol. The protocol requires progression of exercise difficulty or the number of repetitions at each session if the participant demonstrates appropriate quality of movement. However, in this case, during sessions 12 to 30 of the HEP, J.H. regressed in her UE resistance exercises as she started to experience pain in her hemiparetic shoulder. The participant was receiving outpatient Occupational Therapy (OT) to address UE function at the time and she had recently resumed new functional activities at home such as cooking and cleaning. She reported anterior shoulder pain (5/10 on a visual analog scale) during these tasks, especially with shoulder flexion greater than 90°. Observation of her mechanics for functional reaching revealed excessive scapular elevation and glenohumeral internal rotation with thoracic kyphosis.
Physical Therapist Decision Process
In the first session in which the patient reported the pain, the LEAPS therapist used clinical expertise to analyze her current exercises and movement to consider potential contributing factors and hypothesize the underlying mechanisms. The therapist considered potential hypotheses for the shoulder pain, including biomechanical factors such as decreased scapular, thoracic and glenohumeral mobility, muscle imbalance, and fatigue. The LEAPS HEP protocol does not include addressing shoulder pain. Therefore, the LEAPS therapist recommended that the participant obtain evaluation beyond what was a part of the LEAPS protocol, and discussed the problem with J.H.'s outpatient therapists. After discussion with the outpatient therapists, the LEAPS therapist prioritized the hypothesis that the pain was perhaps due to overuse of her UE. Between LEAPS participation and her additional prescribed therapy, she completed almost daily UE exercises. UE fatigue may have contributed to the use of faulty mechanics with overhead reaching during functional activities in the evening at home.
The protocol for continual progression of strengthening exercises was difficult to apply in this case. However, the principle of quality of movement could be emphasized to assist the patient in her kinematics to prevent pain. After consultation with the local LEAPS team and the multisite group during the weekly team leader calls, the LEAPS therapist decided to discontinue resistive UE exercises but continue with active range-of-motion (AROM) exercises in pain-free range until the pain subsided. Stretching of upper trapezius and levator scapulae muscles was also added to her warm-up. During AROM exercises, the LEAPS therapist provided verbal and tactile cues for proper postural, scapulohumeral, and scapulothoracic mechanics and explained to the participant how these could be used during all reaching activities. J.H. tolerated AROM exercises without pain; the number of verbal cues for posture and scapular movement during the exercises was gradually decreased until she performed them independently. Her overall flexibility also improved and she had improved scapular depression and upward rotation with reaching.
Because of J.H.'s shoulder pain, progression through UE exercises was slowed (Table 3). She ultimately progressed to performing UE exercises against gravity and with light resistance and progressed through all other exercises and balance tasks to nearly the highest level. The participant improved in all outcomes from baseline to 12 months poststroke, including her gait speed from 0.48 m/s to 0.78 m/s, her gait endurance, and the amount of daily walking. Though J.H. did not transition to a higher functional level of walking outcome (0.4-0.8 m/s to >0.8 m/s) at 12 months, her 0.35 m/s improvement was accompanied by a 10.1-point improvement in her perception of mobility on Stroke Impact Scale (SIS) Mobility Scale,24 which exceeded the minimally clinically important difference of 4.5 in chronic stroke.25 Of interest in this case, with regard to UE function, J.H.'s SIS Hand Function, SIS activities of daily living/instrumental activities of daily living (ADL/IADL), and Fugl-Meyer (FM) UE Motor26 score all improved from baseline to 12 months poststroke (Table 2).
In this case, movement analysis of J.H.'s reaching mechanics allowed the therapist to reorient the task to teach J.H. how to avoid compensation that may have led to shoulder pain. The clinical key illustrated to solve this problem is the prioritization of kinematics and flexibility to decrease pain to drive progression of strengthening activities.
Participant 2: B.B.
Group Assignment: LTP.
B.B., a 65-year-old woman, sustained a moderate stroke (NIHSS = 11) resulting in severe walking impairment (gait speed = 0.07 m/s, the use of large base quad cane and rigid ankle foot orthosis [AFO]) and severe LE motor impairment (12/34 LE FM) at baseline evaluation (Tables 1 and 2). Despite her low functional level, she met all inclusion criteria for the study. Her goals included regaining full independence for all activities and walking without an assistive device.
Challenge: Poor Lower Extremity Motor Control—Is the Participant Ready for Locomotor Training?
Protocol and Participant Presentation
The LTP protocol includes 60- to 90-minute sessions of stretching/warm-up and locomotor training on the treadmill with BWS and overground. A primary principle is to maximize weight bearing through the paretic LE with progression of speed and maintenance of correct kinematics. B.B. demonstrated decreased paretic LE stance time with excessive trunk flexion and knee hyperextension during the first session of LTP. Palpation confirmed limited antigravity muscle control with minimal activity in the paretic LE hip extensors, abductors, and plantarflexors during stance. In a clinical scenario, the PT may question the patient's readiness for locomotor training in the face of such severe motor control deficits. However, the protocol did not allow for participants to delay training or participate in therapeutic exercise to improve motor control.
Physical Therapist Decision Process
In the first phase of training, the LEAPS protocol emphasizes a goal of locomotor training for 20 minutes total on the treadmill with good kinematics at 2.0 mph. As the algorithm indicates (Figure 2), assistance and BWS are increased and speed is decreased to reach the walking time goal of 20 minutes. To address the problem of limited LE antigravity muscle control in stance, the LEAPS therapist decided to start the first sessions of training at 40% body weight support. This was the maximum BWS in the LEAPS protocol13 and the BWS at which the participant demonstrated the most optimal kinematics. The team also used clinical expertise to determine that a decrease in the speed to approximately 1.2 to 1.4 mph helped attain appropriate kinematics and allowed the participant to walk for 20 minutes. B.B. also completed gait preparatory activities in the support harness without BWS to encourage active trunk and hip extension without knee hyperextension to maximize weight bearing on the paretic LE. For example, tactile cues for trunk extension and paretic LE hip extension were provided while BB took a step with her uninvolved LE. The LEAPS therapist decided to prioritize the activation activities in an upright, weight-bearing position instead of stretching during the “warm-up” part of the locomotor training (not included in the overall gait training time). The preparatory activities are included as part of the LEAPS protocol.
Locomotor training commenced initially at slow speeds (1.2-1.4 mph) with attention to lengthening the nonparetic LE step length to increase stance time on the paretic LE while providing assistance at the hip and trunk for extension. This initially required 3 trainers (paretic limb, nonparetic limb, and hips), which progressed to 2 trainers (paretic limb and hip) over the first 12 visits once the participant had normalized kinematics and step length on the nonparetic limb (Table 4). The team progressed the amount of trainer assist concurrently with progression of the speed and BWS. As B.B. gained independent control of the hip and trunk in stance, BWS was progressively lowered over 35 sessions to a minimum of 15% (Table 4). In overground training, the LEAPS therapist used alternative assistive devices and AFOs to promote equal LE weight bearing and increased activation of the participant's paretic LE. The therapist determined that a more substantial brace (first a rigid AFO during sessions 1-24 and then articulating AFO in sessions 25-35) was indicated to provide knee and ankle control in stance during overground walking. During overground gait training, hand-held assistance in front was used to discourage the asymmetrical pattern and trunk lean induced by the assistive device. A walking pole, held in BB's nonparetic UE, was used instead of a quad cane to promote a more upright posture.
While B.B. demonstrated consistent progression of the training parameters across the sessions, progression was slow and limited by LE motor control deficits and her high Borg Rate of Perceived Exertion27 with training. By her final session, she progressed up to 30 minutes of total stepping time at 2 mph with 15% minimum body weight support and minimum assistance at the hip and paretic LE. In addition, her walking speed progressed from 0.07 m/s to 0.19 m/s. At the end of intervention, she was walking independently in the community with an articulating AFO and narrow base quad cane and had nearly tripled her average number of steps per day (547 initial steps to 1606 after intervention).
In this case, the LEAPS protocol advocated progression of training for a participant with minimal LE motor control. The clinical key to solving this problem is the benefit of interplay of training on the treadmill and overground walking to promote activation of the paretic LE, specifically prioritizing activation activities that would promote LE activation during the “warm-up” phase of the LTP protocol. In addition, the LEAPS therapist used alternative assistive devices and AFOs to promote equal LE weight bearing and hence activation of the participant's paretic LE.
We present 2 examples of common challenges in rehabilitation seen poststroke—paretic shoulder pain and poor LE motor control—and describe how these were addressed while maintaining protocol fidelity in an RCT. Both participants progressed through a structured program and improved in nearly all outcomes between baseline and 6 months poststroke. The description of decision-making and progression of the participants through the locomotor training and home exercise program provide the clinician with useful tools to translate the protocol to practice.
As described in the Knowledge to Action cycle,6 2 distinct cycles (knowledge creation and the action cycle) are critical to achieve practice change. The knowledge tools described in this study will help drive clinical change at many steps of the action cycle. For example, when a clinician is presented with a clinical decision regarding progressing a patient poststroke in locomotor training, they can better adapt the protocols from the LEAPS trial to their local context through the use of the algorithms and descriptions provided.
The usefulness of the type of knowledge tool described here is supported by recent studies of knowledge translation in health care. In a recent review, Pentland et al28 recommend that evidence that is clearly summarized and provided in a simple format is more likely to be utilized by clinicians. In addition, they suggest that including a description about how to address commonly encountered challenges in RCTs encourages clinical implementation. By applying these recommendations here to the LEAPS RCT, we hope to facilitate implementation of the LEAPS protocols into clinical practice.
As an important aspect of knowledge translation, Glasziou et al3 recommend mapping components of interventions. This involves identifying similarities to understand the effective “ingredients.” The case examples provide an opportunity to explore the common components of 2 successful protocols for improving walking recovery poststroke. Though designed to be distinct, the HEP and LTP protocols have several common elements that may have led to successful outcomes for both groups.11 First, in each case a LEAPS therapist applied a standardized protocol. Principles and decision-making algorithms derived from previously successful LTP12,22 and HEP21 intervention studies were used to guide clinical decision-making. Common themes guiding decision-making included optimizing quality of movement and maximizing the use of the involved extremity in a safe and pain-free manner. Second, intervention difficulty was systematically progressed during each session, either by progressing number of repetitions, amount of resistance, task difficulty (HEP) or BWS, assistance, speed, endurance, and adaptability (LTP). Finally, the intervention, though standardized, was individualized to each participant's clinical presentation and goals.
Strict adherence to the protocol in this multisite RCT was critical to the integrity of the results. Rigorous therapist training before starting the trial and ongoing mentoring throughout facilitated a successful merger of clinical decision-making and protocol adherence to maintain consistent implementation of the protocol across sites.
A limitation of this report is that the selection of these 2 cases reflected a consensus of trial personnel and was not empirically based. Another limitation of this study is that the LEAPS teams had the benefit of a team-based approach to clinical decision-making that is not always available to individual clinicians. Finally, a knowledge translation framework was not used as a part of the LEAPS trial implementation process, and we recognize using such a framework would have been helpful for the LEAPS therapists in developing knowledge translation tools.
To our knowledge, this is the first knowledge translation tool created through report of case examples from an RCT to explore clinical decision-making of individual participant problems. We have described decisions related to progression of training with specific participant problems in both HEP and LTP interventions. Future investigations that aim to apply the LEAPS decision-making and protocol algorithms to individual patients in clinical practice may provide further insight into the usefulness of providing case examples as a knowledge translation tool.
These case examples facilitate translation of the LEAPS RCT into practice by enhancing understanding of the protocols, their progression, and their application to individual participants. In RCTs, a standardized protocol is required to ensure intervention fidelity. However, as we have demonstrated, implementation of a standardized protocol requires clinical decision-making by which therapists accommodate individual participant presentations. These cases provide an additional important component of reporting from the LEAPS RCT, illustrating the clinical decision-making process used to implement the HEP and LTP intervention protocols. These case examples provide a knowledge translation tool to facilitate the translation of the LEAPS RCT interventions into clinical practice.
This work was supported by funding from National Institute of Neurological Disorders and Stroke and the National Center for Medical Rehabilitation Research (RO1 NS050506), trial registration: NCT0024391; and VA Rehabilitation R&D Grant B6793C.
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Locomotor training; stroke; knowledge translation; clinical decision-making
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