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

Primary Purpose

Stroke, Cerebrovascular Disorders, Central Nervous System Diseases

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Digital Action Observation Therapy (Digital AOT)
Digital Mirror Therapy (Digital MT)
Conventional Occupational Therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring stroke, multi-mode rehabilitation, action observation, mirror therapy, digital image technology

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Hospital, Ministry of Health and Welfare
  • Taoyuan Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Digital Action Observation Therapy (Digital AOT)

Digital Mirror Therapy (Digital MT)

Conventional Occupational Therapy

Arm Description

The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.

The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.

The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.

Outcomes

Primary Outcome Measures

Change scores of Fugl-Meyer Assessment
The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.
Change scores of Movement Imagery Questionnaire-Revised, Second Edition
The Movement Imagery Questionnaire-Revised, Second Edition is a 14-item questionnaire with sound reliability and validity to evaluate the ability of motion imagination in patients with stroke.

Secondary Outcome Measures

Change scores of Chedoke Arm and Hand Activity Inventory
The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to assess the independence of stroke patients to perform activities of daily living with an affected upper limb.
Change scores of Box and Block Test
The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients.
Change scores of Revised Nottingham Sensory Assessment
The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to assess sensory function in patients with stroke.
Change scores of Barthel Index
The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence.
Change scores of Motor Activity Log
The Motor Activity Log is a semi-structured interview with good psychometric properties to assess the level of use of affected upper limb in 30 main activities of daily living.
Change scores of the health state of EQ-5D-5L
The questionnaire of EQ-5D-5L contains 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and uses a 5-point Likert scale scored from 1 (no problem) to 5 (unable to/extreme problems); whereas, the numerical description of 5 dimensions represents the health state.
Change scores of the visual analogue scale (VAS) of EQ-5D-5L
The VAS of EQ-5D-5L scores will be scored from 0 to 100, with a higher score indicating better overall current health.
Change of joint angles of OPAL wearable sensors
The OPAL wearable sensors is used to objectively record the movements of an affected upper limb in patients with stroke in real time, such as joint angles. Joint angles of the shoulder, elbow, and wrist will be calculated.
Change of joint velocity of OPAL wearable sensors
The OPAL wearable sensors is used to objectively record the movements of an affected upper limb in patients with stroke in real time, such as joint velocity. The angular velocity of shoulder, elbow, and wrist will be also collected.

Full Information

First Posted
June 16, 2020
Last Updated
November 23, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04441190
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The specific study aims will be: To develop the novel, digital, and interactive MSR system of arm and hand with integrated digital action observation therapy (AOT) and mirror therapy (MT). To pilot usability testing for examining the feasibility of this new MSR system from the users' experiences and feedback. To examine the treatment effects of digital AOT, digital MT and a control intervention in patients with stroke by conducting a randomized controlled trial. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Disorders, Central Nervous System Diseases
Keywords
stroke, multi-mode rehabilitation, action observation, mirror therapy, digital image technology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital Action Observation Therapy (Digital AOT)
Arm Type
Experimental
Arm Description
The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.
Arm Title
Digital Mirror Therapy (Digital MT)
Arm Type
Experimental
Arm Description
The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.
Arm Title
Conventional Occupational Therapy
Arm Type
Active Comparator
Arm Description
The common categories of motor actions and tasks will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-limb functional tasks.
Intervention Type
Behavioral
Intervention Name(s)
Digital Action Observation Therapy (Digital AOT)
Intervention Description
The participants will be asked to observe videos and then practice what the participants observed.
Intervention Type
Behavioral
Intervention Name(s)
Digital Mirror Therapy (Digital MT)
Intervention Description
The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Occupational Therapy
Intervention Description
The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements.
Primary Outcome Measure Information:
Title
Change scores of Fugl-Meyer Assessment
Description
The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.
Time Frame
baseline, 4 weeks, 2 months
Title
Change scores of Movement Imagery Questionnaire-Revised, Second Edition
Description
The Movement Imagery Questionnaire-Revised, Second Edition is a 14-item questionnaire with sound reliability and validity to evaluate the ability of motion imagination in patients with stroke.
Time Frame
baseline, 4 weeks, 2 months
Secondary Outcome Measure Information:
Title
Change scores of Chedoke Arm and Hand Activity Inventory
Description
The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to assess the independence of stroke patients to perform activities of daily living with an affected upper limb.
Time Frame
baseline, 4 weeks, 2 months
Title
Change scores of Box and Block Test
Description
The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients.
Time Frame
baseline, 4 weeks, 2 months
Title
Change scores of Revised Nottingham Sensory Assessment
Description
The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to assess sensory function in patients with stroke.
Time Frame
baseline, 4 weeks, 2 months
Title
Change scores of Barthel Index
Description
The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence.
Time Frame
baseline, 4 weeks, 2 months
Title
Change scores of Motor Activity Log
Description
The Motor Activity Log is a semi-structured interview with good psychometric properties to assess the level of use of affected upper limb in 30 main activities of daily living.
Time Frame
baseline, 4 weeks, 2 months
Title
Change scores of the health state of EQ-5D-5L
Description
The questionnaire of EQ-5D-5L contains 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and uses a 5-point Likert scale scored from 1 (no problem) to 5 (unable to/extreme problems); whereas, the numerical description of 5 dimensions represents the health state.
Time Frame
baseline, 4 weeks, 2 months
Title
Change scores of the visual analogue scale (VAS) of EQ-5D-5L
Description
The VAS of EQ-5D-5L scores will be scored from 0 to 100, with a higher score indicating better overall current health.
Time Frame
baseline, 4 weeks, 2 months
Title
Change of joint angles of OPAL wearable sensors
Description
The OPAL wearable sensors is used to objectively record the movements of an affected upper limb in patients with stroke in real time, such as joint angles. Joint angles of the shoulder, elbow, and wrist will be calculated.
Time Frame
baseline, 4 weeks, 2 months
Title
Change of joint velocity of OPAL wearable sensors
Description
The OPAL wearable sensors is used to objectively record the movements of an affected upper limb in patients with stroke in real time, such as joint velocity. The angular velocity of shoulder, elbow, and wrist will be also collected.
Time Frame
baseline, 4 weeks, 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Wei Hsieh, PhD
Organizational Affiliation
Department of Occupational Therapy, College of Medicine, Chang Gung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Hospital, Ministry of Health and Welfare
City
New Taipei City
ZIP/Postal Code
24213
Country
Taiwan
Facility Name
Taoyuan Chang Gung Memorial Hospital
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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