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Introducing early active mobilisation following flexor tendon repair in the context of care in a developing country: a randomised feasibility study
Naude AB, de Klerk S
South African Journal of Occupational Therapy 2019;49:48-56
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: No; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

INTRODUCTION: Flexor tendon injuries remain one of the most difficult hand injuries to manage post-operatively. Early active mobilisation protocols are considered 'best practice' internationally but have not been well researched in the developing country context. The feasibility of such research, and use of these protocols, need to be determined by considering the potential for improved functional outcomes for patients, together with various contextual and resource challenges. PURPOSE: To explore aspects of feasibility related to the recruitment, consent and retention rates in consideration of a future definitive randomised control trail. In addition, preliminary results of an early active therapy protocol compared to an early passive therapy protocol were reported on, together with patient satisfaction and demographics. METHODS: A parallel randomised pilot trial design was used. Thirty-one participants were recruited into one of two therapy groups (active or passive). Fourteen of these participants completed their therapy and eight-week assessments including: total active motion, grip strength, the Michigan Hand Questionnaire and the Smith Hand Function Evaluation. 95% confidence intervals examined feasibility data. Non-parametric data analysis was done primarily using medians and ranges. RESULTS: Feasibility results of 37% recruitment rate, 97% consent rate and 45% retention rate, did not meet the criteria for success, deeming a trial in the present design, not feasible. DISCUSSION: Due to the dearth of research from public health clinical settings in developing countries, this study contributes rich contextual data, but the challenges discussed need to be addressed before further research will achieve success.

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