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Feasibility, safety, and compliance in a randomized controlled trial of physical therapy for Parkinson's disease
McGinley JL, Martin C, Huxham FE, Menz HB, Danoudis M, Murphy AT, Watts JJ, Iansek R, Morris ME
Parkinson's Disease 2012 Dec 10;(795294):Epub
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

Both efficacy and clinical feasibility deserve consideration in translation of research outcomes. This study evaluated the feasibility of rehabilitation programs within the context of a large randomized controlled trial of physical therapy. Ambulant participants with Parkinson's disease (PD) (n = 210) were randomized into three groups: (1) progressive strength training (PST); (2) movement strategy training (MST); or (3) control ("life skills"). PST and MST included fall prevention education. Feasibility was evaluated in terms of safety, retention, adherence, and compliance measures. Time to first fall during the intervention phase did not differ across groups, and adverse effects were minimal. Retention was high; only eight participants withdrew during or after the intervention phase. Strong adherence (attendance > 80%) did not differ between groups (p = 0.435). Compliance in the therapy groups was high. All three programs proved feasible, suggesting they may be safely implemented for people with PD in community-based clinical practice.

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