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Augmented-reality Based Mirror Therapy in Stroke Rehabilitation

Primary Purpose

Stroke, Rehabilitation, Technology

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Traditional occupational therapy
Mirror therapy using a mirror box
Augmented reality-based mirror therapy
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of stroke with unilateral side involved;
  • A score of Mini-mental state examination greater than 24 for proving higher mental function
  • Time of onset > 6 months before treatment begins; and
  • Premorbid right-handedness.

Exclusion Criteria:

  • Severe vision impairment;
  • Major cognitive-perceptual deficit;
  • Other brain disease.

Sites / Locations

  • National Cheng-Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Traditional occupational therapy

Mirror therapy using a mirror box

Augmented reality-based mirror therapy

Arm Description

Traditional occupational therapy delivered skill training related to daily living tasks.

Exercise of mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise using a mirror box .

Exercise of augmented reality-based mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise using an augmented reality mirror therapy system .

Outcomes

Primary Outcome Measures

Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test
Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.

Secondary Outcome Measures

Change in the result of Modified Ashworth scale (MAS)
Muscle tone is defined by the resistance of a muscle being stretched without resistance. The MAS scores were distributed across the entire scale, ranging from 0 to 4, that is convenient for the clinician use. The grading of the scale is described as below: 0) no increase in muscle tone; 1) minimal resistance at the end of the range of motion; 1+) slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the reminder (less than half) of the ROM; 2) more marked increase in tone but only after part is easily flexed; 3) considerable increase in tone; and 4) passive movement is difficult and affected part is rigid in flexion or extension.
Change in the result of Box and blocks test
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
Change in the result of Semmes-Weinstein monofilament (SWM) test
The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
Change in the result of Motor Activity Log
Semi-structured interview examine how much and how well the subject uses their more-affected arm for 30 ADLs. Score range from 0-5. Higher values represent a better outcome.

Full Information

First Posted
October 6, 2022
Last Updated
August 8, 2023
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05580744
Brief Title
Augmented-reality Based Mirror Therapy in Stroke Rehabilitation
Official Title
Effects of Augmented-reality Based Mirror Therapy on Sensorimotor Function of Upper Extremity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University 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
In the proposed study, the investigators assumed that mirror therapy combined with augmented reality technology will provide a better treatment effects than traditional mirror therapy for the patients with unilateral stroke. The aim of the study is to examine the difference in the treatment effects among the combination of task-oriented training with either augmented reality based mirror therapy, mirror therapy or traditional occupational therapy on the upper extremity function and brain activity of the stroke patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Rehabilitation, Technology, Mirror Movement Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional occupational therapy
Arm Type
Active Comparator
Arm Description
Traditional occupational therapy delivered skill training related to daily living tasks.
Arm Title
Mirror therapy using a mirror box
Arm Type
Active Comparator
Arm Description
Exercise of mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise using a mirror box .
Arm Title
Augmented reality-based mirror therapy
Arm Type
Experimental
Arm Description
Exercise of augmented reality-based mirror therapy included movements of forearm, wrist, fingers and thumb, as well as a tendon gliding exercise using an augmented reality mirror therapy system .
Intervention Type
Other
Intervention Name(s)
Traditional occupational therapy
Intervention Description
Motor training targeted to goals that are relevant to the functional needs of the patient
Intervention Type
Other
Intervention Name(s)
Mirror therapy using a mirror box
Intervention Description
Mirror therapy using a mirror box
Intervention Type
Other
Intervention Name(s)
Augmented reality-based mirror therapy
Intervention Description
Augmented reality-based mirror therapy
Primary Outcome Measure Information:
Title
Change in the result of Fugl-Meyer assessment (FMA) for motor function of upper extremity test
Description
Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.
Time Frame
baseline, 9 weeks and 21 weeks
Secondary Outcome Measure Information:
Title
Change in the result of Modified Ashworth scale (MAS)
Description
Muscle tone is defined by the resistance of a muscle being stretched without resistance. The MAS scores were distributed across the entire scale, ranging from 0 to 4, that is convenient for the clinician use. The grading of the scale is described as below: 0) no increase in muscle tone; 1) minimal resistance at the end of the range of motion; 1+) slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the reminder (less than half) of the ROM; 2) more marked increase in tone but only after part is easily flexed; 3) considerable increase in tone; and 4) passive movement is difficult and affected part is rigid in flexion or extension.
Time Frame
baseline, 9 weeks and 21 weeks
Title
Change in the result of Box and blocks test
Description
The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome.
Time Frame
baseline, 9 weeks and 21 weeks
Title
Change in the result of Semmes-Weinstein monofilament (SWM) test
Description
The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome.
Time Frame
baseline, 9 weeks and 21 weeks
Title
Change in the result of Motor Activity Log
Description
Semi-structured interview examine how much and how well the subject uses their more-affected arm for 30 ADLs. Score range from 0-5. Higher values represent a better outcome.
Time Frame
baseline, 9 weeks and 21 weeks
Other Pre-specified Outcome Measures:
Title
changes in oxygenated (HbO) and deoxygenated (Hb) hemoglobin concentrations using near infrared spectroscopy (NIRS)
Description
To investigate the activation of specific brain regions
Time Frame
baseline, 9 weeks and 21 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of stroke with unilateral side involved; A score of Mini-mental state examination greater than 24 for proving higher mental function Time of onset > 6 months before treatment begins; and Premorbid right-handedness. Exclusion Criteria: Severe vision impairment; Major cognitive-perceptual deficit; Other brain disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiu-Yun Hsu, Ph.D
Phone
886-6-2353535
Ext
2669
Email
hyhsu@mail.ncku.edu.tw
Facility Information:
Facility Name
National Cheng-Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiu-Yun Hsu, Ph.D.
Phone
886-6-2353535
Ext
2669
Email
hyhsu@mail.ncku.edu.tw

12. IPD Sharing Statement

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Augmented-reality Based Mirror Therapy in Stroke Rehabilitation

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