Clinical trial NCT04441190: Multi-mode Stroke Rehabilitation System: Development and Validation of Clinical Efficacy
Official title: A Novel, Digital, and Interactive Multi-mode Stroke Rehabilitation System of Arm and Hand: Development and Validation of Clinical Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cerebrovascular Disorders
Central Nervous System Diseases
Keywords: stroke
multi-mode rehabilitation
action observation
mirror therapy
digital image technology
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Phase I: Multi-mode stroke rehabilitation (MSR) System Development and Usability Testing

For stroke patients

Inclusion Criteria:

* diagnosed as having a unilateral stroke;
* aged from 20 to 80 years;
* a baseline score of the Fugl-Meyer Assessment in a range of 20 to 60;
* able to follow the instructions and able to provide user feedback verbally;
* without aphasia and neglect

For therapists

Inclusion Criteria:

* holding an occupational therapist license

Phase II: Validation of Clinical Treatment Efficacy

Inclusion Criteria:

* diagnosed as having a unilateral stroke;
* at least 6 months after stroke onset;
* aged from 20 to 80 years;
* a baseline score of FMA in a range of 20 to 60;
* able to follow the study instructions;
* capable of participating in therapy and assessment sessions

Exclusion Criteria:

* global or receptive aphasia,
* severe neglect,
* major medical problems or comorbidities that have influenced upper-limb usage or caused severe pain

Primary outcomes:
measure: Change scores of Fugl-Meyer Assessment
timeFrame: baseline, 4 weeks, 2 months
measure: Change scores of Movement Imagery Questionnaire-Revised, Second Edition
timeFrame: baseline, 4 weeks, 2 months
Secondary outcomes:
measure: Change scores of Chedoke Arm and Hand Activity Inventory
timeFrame: baseline, 4 weeks, 2 months
measure: Change scores of Box and Block Test
timeFrame: baseline, 4 weeks, 2 months
measure: Change scores of Revised Nottingham Sensory Assessment
timeFrame: baseline, 4 weeks, 2 months
measure: Change scores of Barthel Index
timeFrame: baseline, 4 weeks, 2 months
measure: Change scores of Motor Activity Log
timeFrame: baseline, 4 weeks, 2 months
measure: Change scores of the health state of EQ-5D-5L
timeFrame: baseline, 4 weeks, 2 months
measure: Change scores of the visual analogue scale (VAS) of EQ-5D-5L
timeFrame: baseline, 4 weeks, 2 months
measure: Change of joint angles of OPAL wearable sensors
timeFrame: baseline, 4 weeks, 2 months
measure: Change of joint velocity of OPAL wearable sensors
timeFrame: baseline, 4 weeks, 2 months
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Hospital, Ministry of Health and Welfare
city: Taoyuan City
country: Taiwan
facility: Taoyuan Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Occupational Therapy, College of Medicine, Chang Gung University
name: Yu-Wei Hsieh, PhD
role: PRINCIPAL_INVESTIGATOR
References: