JMIR Publications

ABSTRACT

Background:

Motor impairment is a common consequence of stroke, significantly impacting patients' daily functioning and quality of life. More than 80% of stroke survivors experience Upper Extremity (UE) motor impairments, which severely impact their ability to carry out daily living activities. To enhance UE functional recovery after stroke, combining motor rehabilitation techniques like Constraint-Induced Movement Therapy (CIMT) with sensorimotor stimulation methods such as Neuromuscular Electrical Stimulation (NMES) may be beneficial. This combined approach could potentially activate a broader range of brain regions, leading to improved motor control. However, evidence for the effectiveness of these interventions when combined is still lacking.

Objective:

This randomized controlled trial (RCT) study aims to determine the effectiveness of CIMT combined with NMES, CIMT alone, and conventional therapy in rehabilitating UE function in chronic stroke survivors.

Methods:

This assessor-blinded, clustered RCT will compare three intervention groups: two experimental groups (CIMT combined with NMES group and CIMT group) and one control group (conventional therapy). Forty-two participants will be recruited and randomly assigned to one of the three groups. Participants in the CIMT group will undergo six shaping practice tasks (50 repetitions for each task, totalling 300 repetitions per session). The CIMT combined with the NMES group will perform tasks similar to those carried out by the CIMT group, and a bio-feedback electrical stimulator for NMES will also be given. Whereas, the group that receives conventional neurodevelopmental therapy will act as a control group. All groups will receive 1 session/day of therapy for 3 consecutive days a week for 4 weeks. A blinded assessor using standardized tests will measure the interventions' outcomes, including UE motor function, motor impairment, perceived motor function, and upper limb self-efficacy. All data will be analyzed descriptively, presenting the mean and standard deviation. In inferential tests, a two-way mixed ANOVA will be conducted to evaluate the effects of the interventions and compare them between and within groups.

Results:

Funding for this study was provided by the Research and Ethics Committee of Universiti Kebangsaan Malaysia starting in November 2023. Between January and May 2023, we developed the initial ethics proposal and recruited research staff. Research ethics applications were submitted to RECUKM from May to November 2023. We anticipate publishing the study results in September 2025.

Conclusions:

This trial will provide insights into the effectiveness of CIMT combined with NMES, CIMT alone, and conventional therapy for UE rehabilitation in stroke survivors. Findings will be published in a peer-reviewed journal, and any updates based on emerging evidence will be provided. Any changes to the study methods will be documented in the final publication. Clinical Trial: Australian New Zealand Clinical Trials Registry: ACTRN12624000564550.