search
Back to results

The Effects of Mirror Therapy on Upper Extremity in Stroke Patients

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Mirror box training
mesh glove stimulation
conventional intervention
Sponsored by
Taipei Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Comparative effectiveness research, Mirror therapy, Stroke rehabilitation, Clinical evaluation, Kinematic analysis, Mesh glove, Combined therapy

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The onset duration more than 3 months
  • Demonstration of Brunnstrom stage equal to or above stage III of the affected upper extremity
  • No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
  • No serious visual and visual-perception impairments
  • No concurrent participation in other drug or rehabilitation research
  • No serious attention deficits
  • No excessive spasticity in any of the joints of the affected UL exclusion criteria

Exclusion Criteria:

  • Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
  • Excessive pain in any joint that might limit participation

Sites / Locations

  • Shuang-Ho Hospital, Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Mirror therapy

Mirror therapy + Mesh glove stimulation

Controlled intervention

Arm Description

mirror box training with or without sham mesh glove stimulation

Mirror therapy combined with mesh glove stimulation

conventional interventions

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment (FMA)
The upper-extremity subscale of the FMA contains 33 items to assess motor impairment. Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly). The sub-score of a proximal shoulder/elbow (0-42) and a distal hand/wrist (0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements.
Wolf Motor Function Test (WMFT)
The WMFT composed of 3 parts: Time, Functional ability, and Strength Includes 15 function-based tasks and 2 strength based tasks Performance time is referred to as WMFT-TIME Functional ability is referred to as WMFT-FAS Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. Examiner should test the less affected upper extremity followed by the most affected side. Uses a 6-point ordinal scale "0" = "does not attempt with the involved arm" to "5" = "arm does participate; movement appears to be normal." Maximum score is 75 Lower scores are indicative of lower functioning levels WMFT-TIME allows 120 seconds per task
Accelerometers
The accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory. Acceleration is sampled at 10 Hz and summed over a user- specified epoch. The recording epoch in this study is 2 seconds; recording capacity is approximately 72 hours. A "threshold-filter" will be applied to the raw recordings to obtain an accurate measure of the duration of arm movement.
revised Nottingham Sensory Assessment (rNSA)
The rNSA examines the sensory function of the affected arm and includes tactile sensation (0=Absent, 1=Impaired, 2=Normal), proprioception (0=Absent, 1=Appreciation of movement sense, 2=Direction of movement sense, 3=Joint position sense), and stereognosis (0=Absent, 1=Impaired, 2=Normal) subtests.

Secondary Outcome Measures

Kinematic analyses
A 7-camera motion-analysis system (VICON MX, Oxford Metrics Inc., Oxford, UK) was used. The variables of reaction time (second), movement time (second), total displacement (mm), peak velocity (mm/second), percentage of peak velocity, joint recruitments (degree), and maximum shoulder and elbow cross-correlation were collected.
Motor Activity Log (MAL)
The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale. Higher scores indicate superior amount and quality of use in affected upper extremity.
Semmes-Weinstein monofilaments
The Semmes-Weinstein monofilaments is used for measuring diminishing and returning cutaneous sensation.A nylon 'string' is specifically calibrated in stiffness to represent a baseline level of sensation that can be considered 'the line' between having neuropathy and having normal sensation.
Functional Independence Measure (FIM)
The FIM consists of 18 items grouped into 6 subscales. Each item is rated from 1 to 7 (max. score 126) based on the required level of assistance to perform the tasks.
Stroke Impact Scale version 3.0 (SIS 3.0)
The SIS is a stroke-specific instrument of health related quality of life and contains 59 items measuring 8 domains. Items are rated on a 5- point Likert scale with lower scores indicate greater difficulty in task completion during the past week. Aggregate scores, ranges from 0 to 100, are generated for each domain.
8-OHdG
Urinary 8-OHdG is a stable and integral biomarker of oxidative DNA damage.About 10 mL to 15 mL urine samples of the patients will be collected in the centrifugal tubes before and after rehabilitation interventions. The samples will be transported with dry ice under 4°C and preserved in a -80°C refrigerator before analysis. A highly sensitive and selective method, using isotope- dilution liquid chromatography with tandem mass spectrometry (LC/MS/MS), will be used to determine the urinary 8-OHdG levels.

Full Information

First Posted
July 27, 2012
Last Updated
November 3, 2015
Sponsor
Taipei Medical University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01656876
Brief Title
The Effects of Mirror Therapy on Upper Extremity in Stroke Patients
Official Title
The Effects of Mirror Therapy on Upper Extremity in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people with stroke.
Detailed Description
55% to 75% of people after stroke have a paretic arm that causes motor impairment. Among novel rehabilitation interventions, MT was found to be beneficial and comparatively low-cost. MT reduced motor impairment possibly in part of recruiting the premotor cortex or balancing the neural activation within the primary motor cortex toward the affected hemisphere. However, the benefits in certain aspects of outcomes are under debate. Another treatment, MG, can be used to normalize muscle tone, suppress muscle spasticity, enhance residual volitional activity of hand and arm, or even increasing walking speed. In addition, providing MG stimulation might result in plastic changes in the primary motor cortex, and induced a long-lasting modulated effect on motor cortical excitability. The possible mechanism of brain plasticity underlying MG is collective with the mechanism behind the MT. Adding MG to MT might augment the cortical reorganization. In sum, combining MT with MG may supplement the disadvantage or uncertain effects of MT and broaden the benefited outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Comparative effectiveness research, Mirror therapy, Stroke rehabilitation, Clinical evaluation, Kinematic analysis, Mesh glove, Combined therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror therapy
Arm Type
Experimental
Arm Description
mirror box training with or without sham mesh glove stimulation
Arm Title
Mirror therapy + Mesh glove stimulation
Arm Type
Experimental
Arm Description
Mirror therapy combined with mesh glove stimulation
Arm Title
Controlled intervention
Arm Type
Active Comparator
Arm Description
conventional interventions
Intervention Type
Behavioral
Intervention Name(s)
Mirror box training
Other Intervention Name(s)
MT
Intervention Description
This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.
Intervention Type
Other
Intervention Name(s)
mesh glove stimulation
Other Intervention Name(s)
MG
Intervention Description
The MG is a two-channel electrical stimulator providing synchronous or reciprocal sensory stimulation with variant amplitudes.
Intervention Type
Behavioral
Intervention Name(s)
conventional intervention
Other Intervention Name(s)
CI
Intervention Description
Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment (FMA)
Description
The upper-extremity subscale of the FMA contains 33 items to assess motor impairment. Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly). The sub-score of a proximal shoulder/elbow (0-42) and a distal hand/wrist (0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements.
Time Frame
Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
Title
Wolf Motor Function Test (WMFT)
Description
The WMFT composed of 3 parts: Time, Functional ability, and Strength Includes 15 function-based tasks and 2 strength based tasks Performance time is referred to as WMFT-TIME Functional ability is referred to as WMFT-FAS Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. Examiner should test the less affected upper extremity followed by the most affected side. Uses a 6-point ordinal scale "0" = "does not attempt with the involved arm" to "5" = "arm does participate; movement appears to be normal." Maximum score is 75 Lower scores are indicative of lower functioning levels WMFT-TIME allows 120 seconds per task
Time Frame
Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
Title
Accelerometers
Description
The accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory. Acceleration is sampled at 10 Hz and summed over a user- specified epoch. The recording epoch in this study is 2 seconds; recording capacity is approximately 72 hours. A "threshold-filter" will be applied to the raw recordings to obtain an accurate measure of the duration of arm movement.
Time Frame
Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
Title
revised Nottingham Sensory Assessment (rNSA)
Description
The rNSA examines the sensory function of the affected arm and includes tactile sensation (0=Absent, 1=Impaired, 2=Normal), proprioception (0=Absent, 1=Appreciation of movement sense, 2=Direction of movement sense, 3=Joint position sense), and stereognosis (0=Absent, 1=Impaired, 2=Normal) subtests.
Time Frame
Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
Secondary Outcome Measure Information:
Title
Kinematic analyses
Description
A 7-camera motion-analysis system (VICON MX, Oxford Metrics Inc., Oxford, UK) was used. The variables of reaction time (second), movement time (second), total displacement (mm), peak velocity (mm/second), percentage of peak velocity, joint recruitments (degree), and maximum shoulder and elbow cross-correlation were collected.
Time Frame
Baseline, change from baseline in kinematic parameters at 4 weeks
Title
Motor Activity Log (MAL)
Description
The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale. Higher scores indicate superior amount and quality of use in affected upper extremity.
Time Frame
Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
Title
Semmes-Weinstein monofilaments
Description
The Semmes-Weinstein monofilaments is used for measuring diminishing and returning cutaneous sensation.A nylon 'string' is specifically calibrated in stiffness to represent a baseline level of sensation that can be considered 'the line' between having neuropathy and having normal sensation.
Time Frame
Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
Title
Functional Independence Measure (FIM)
Description
The FIM consists of 18 items grouped into 6 subscales. Each item is rated from 1 to 7 (max. score 126) based on the required level of assistance to perform the tasks.
Time Frame
Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
Title
Stroke Impact Scale version 3.0 (SIS 3.0)
Description
The SIS is a stroke-specific instrument of health related quality of life and contains 59 items measuring 8 domains. Items are rated on a 5- point Likert scale with lower scores indicate greater difficulty in task completion during the past week. Aggregate scores, ranges from 0 to 100, are generated for each domain.
Time Frame
Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
Title
8-OHdG
Description
Urinary 8-OHdG is a stable and integral biomarker of oxidative DNA damage.About 10 mL to 15 mL urine samples of the patients will be collected in the centrifugal tubes before and after rehabilitation interventions. The samples will be transported with dry ice under 4°C and preserved in a -80°C refrigerator before analysis. A highly sensitive and selective method, using isotope- dilution liquid chromatography with tandem mass spectrometry (LC/MS/MS), will be used to determine the urinary 8-OHdG levels.
Time Frame
Baseline, change from baseline in 8-OHDG at 4 weeks, change from baseline in 8-OHDG at 16 weeks, change from baseline in 8-OHDG at 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The onset duration more than 3 months Demonstration of Brunnstrom stage equal to or above stage III of the affected upper extremity No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam) No serious visual and visual-perception impairments No concurrent participation in other drug or rehabilitation research No serious attention deficits No excessive spasticity in any of the joints of the affected UL exclusion criteria Exclusion Criteria: Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation Excessive pain in any joint that might limit participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsan-hon Liou, PhD
Organizational Affiliation
Shuang-Ho Hospital, Taipei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ching-yi Wu, ScD
Organizational Affiliation
Department of Occupational Therapy, College of Medicine, Chang Gung University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keh-chung Lin, ScD
Organizational Affiliation
School of Occupational Therapy, College of Medicine, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shuang-Ho Hospital, Taipei Medical University
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

The Effects of Mirror Therapy on Upper Extremity in Stroke Patients

We'll reach out to this number within 24 hrs