Feasibility study of a randomized controlled trial protocol to examine clinical effectiveness of shoulder strapping in acute stroke patients

Objective: The majority of stroke patients experience upper limb motor impairment and reduced ability to perform basic activities. Shoulder strapping has been reported as a beneficial adjunct to rehabilitation therapies but has not been rigorously trialled. This study tested the feasibility of recruitment, intervention and outcome assessment protocols for future trial of the clinical effectiveness of shoulder strapping. Design and setting: Feasibility study using a randomized controlled trial in an East London stroke service. Subjects: Fourteen acute stroke patients with mild to moderate upper limb hemiparesis were recruited between October 2004 and July 2005. Intervention: Five strapping methods and criteria for use were identified from the literature. Shoulder strapping applied for one month in addition to routine rehabilitation was compared to routine rehabilitation only. Main measures: The Motor Assessment Scale, Fugl Meyer Scale - Arm section and the Nine Hole Peg Test were measured at baseline and 1, 2, 3 and 5 weeks later. The Stroke-specific Quality of Life questionnaire was delivered at 6 and 12 weeks post stroke. Results: Useful findings were demonstrated in relation to the feasibility of all elements of the protocol. Motor Assessment Scale findings showed a small-moderate (0.27) effect size for the strapping intervention used as an adjunct to routine rehabilitation compared to routine rehabilitation alone. Sample size calculation indicated 312 participants would be adequate to test a null hypothesis of nil benefit additional to routine rehabilitation. Conclusion: Findings supported the value of pilot-testing, and enabled revision of the study protocol for future definitive trial.