NCT04441190

Multi-mode Stroke Rehabilitation System: Development and Validation of Clinical Efficacy

A Novel, Digital, and Interactive Multi-mode Stroke Rehabilitation System of Arm and Hand: Development and Validation of Clinical Efficacy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The specific study aims will be: 1. To develop the novel, digital, and interactive MSR system of arm and hand with integrated digital action observation therapy (AOT) and mirror therapy (MT). 2. To pilot usability testing for examining the feasibility of this new MSR system from the users' experiences and feedback. 3. To examine the treatment effects of digital AOT, digital MT and a control intervention in patients with stroke by conducting a randomized controlled trial. 4. To identify who will be the possible good responders to digital AOT and MT based on their baseline motor function and mental imagery abilities.

Detailed description

Phase I: Multi-mode stroke rehabilitation (MSR) System Development \& Usability Testing Ten patients with stroke and 4 certified occupational therapists were recruited in this phase I study. During the pilot testing, each stroke patient will try to use each training mode of digital AOT and MT by the assistance of the therapist. At the end of the pilot testing, the patients and the therapists will be asked to complete the System Usability Scale and a self-designed questionnaire to assess the user experience and perspective about this new MSR system and their view of its suitability for stroke patients. Phase II: Validation of Clinical Treatment Efficacy This three-arm, single-blind, randomized controlled trial will investigate the treatment effects among the 3 groups of digital AOT, digital MT, and dose-matched control intervention. An estimated 60 patients with stroke will be recruited to participate in this phase II study. Each participant will receive a total of 15 training sessions (60 minutes per session) for 3 to 4 weeks. Clinical outcome measures will be conducted at baseline, immediately after treatment (the fourth week), and at 1 month follow-up after treatment.

Conditions

• Stroke
• Cerebrovascular Disorders
• Central Nervous System Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Digital Action Observation Therapy (Digital AOT)	The participants will be asked to observe videos and then practice what the participants observed.
BEHAVIORAL	Digital Mirror Therapy (Digital MT)	The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible.
BEHAVIORAL	Conventional Occupational Therapy	The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements.

Timeline

• Start date: 2020-08-03
• Primary completion: 2021-05-11
• Completion: 2021-07-31
• First posted: 2020-06-22
• Last updated: 2021-11-26

Locations

2 sites across 1 country: Taiwan