Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000056247) titled 'Integrating behavioral medicine with physiotherapy to improve treatment adherence and performance: a mixed-method randomized controlled trial for physical rehabilitation of stroke patients' on June 30.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - The Hong Kong Polytechnic University

Condition: Condition - Stroke Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To assess the feasibility and acceptability of an integrated home-based functional electrical stimulation (FES) and a behavioral implementation intention intervention (III) for improving physical function among stroke patients with physical function limitations in Hong Kong; To evaluate the efficacy of the combined intervention and compare it with the efficacy of a home-based FES intervention alone and the efficacy of usual care (the control treatment) in terms of improving physical function of stroke patients (e.g., walking speed and mobility index) Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention group 1: Home-based functional electrical stimulation (FES) intervention will require participants to walk daily for at least 1 hour using a commercial FES device for 2 consecutive months. The study device is a battery-operated single-channel electrical stimulator approved by the US Food and Drug Administration for treating foot drop. The participants will first receive training in the set-up, fitting, and safe use of the device. Once the participants can walk safely and consistently with supervision, they will be given an FES device for use in ongoing gait practice at home and in the community. Interventions/Control_2 - Intervention group 2: Combined intervention (Home-based FES intervention + III) will receive behavioral implementation intention intervention (III) in addition to the FES intervention. A volitional help sheet will be used to help participants make specific action and coping plans, with two telephone follow-up calls.

Eligibility: Age-lower limit - Not applicable Age-upper limit - 18 years-old >= Gender - Male and Female Key inclusion criteria - The eligibility criteria for participation include: (1) aged 18 years or older, (2) having a post-stroke period of 6 to 60 months, (3) exhibiting impaired ankle voluntary movement with muscle strength of dorsiflexion less than grade 4, (4) being able to walk for 6 minutes with or without walking aids, (5) being able to communicate effectively and provide informed consent. Key exclusion criteria - The exclusion criteria will be (1) currently participating in other rehabilitative projects; (2) a serious medical condition preventing study procedures (consent and assessment); (3) severe pain in the lower limbs and back; (4) contraindications to doing physical exercise; (5) contraindications to FES use (e.g., skin problems or recently open wound in the affected leg, or any electric or metallic implants). Target Size - 51

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2024 Year 01 Month 01 Day Date of IRB - 2023 Year 10 Month 01 Day Anticipated trial start date - 2024 Year 11 Month 25 Day Last follow-up date - 2025 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064126

Disclaimer: Curated by HT Syndication.