Challenges in Conducting a Randomized Controlled Trial of a More Practicable Constraint-Induced Movement Therapy for Upper Limb Motor Function After Stroke

Abstract

Carrying out a randomized controlled trial can be very challenging as there may be some difficulties that can be encountered. Some of the difficulties are participants’ recruitment, participants’ randomization, and ensuring compliance with the protocol. Participants’ recruitment was very difficult possibly because of the tight inclusion criteria used, and from the lesson learned, it is advisable researchers report what they have, or in some cases, if need be, they can adjust the inclusion criteria a little bit to accommodate more participants. For the randomization, a modified simple random sampling method had to be used as the participants came consecutively. What was done was four therapists who were blinded to the aim of the study were randomly selected using folded opaque papers marked with letters A to D. The therapists represent one group each. Thereafter, a study assistant wrote numbers representing the study sample size on pieces of opaque papers, folded them, and mixed them several times in a small bowl. He then asked each therapist representing a particular group to pick equivalent amount of the pieces of papers. Compliance was also difficult because the participants had to do the tasks sometimes at home on their own under the supervision of their caregivers. However, to get around it, this was what was used: Occasional telephone calls (every 3 days) and a log book (daily record) were used to monitor compliance with the protocol. Therefore, carrying out research in the real world requires out-of-the-box thinking.

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