Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke
This study is currently recruiting participants.
Verified February 2013 by Chang Gung Memorial Hospital
Sponsor:
Chang Gung Memorial Hospital
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01655160
First received: July 30, 2012
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms of mirror therapy and its effects on physiological markers.
| Condition | Intervention |
|---|---|
|
Cerebrovascular Accident |
Behavioral: MT with low-intensity group (MT-LI) Behavioral: MT with moderate-intensity group Behavioral: Mirror therapy with high intensity group Behavioral: Control intervention group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke: Outcomes in Brain and Movement Reorganization, Sensorimotor and Daily Functions, and Measures of Physiological Markers. |
Resource links provided by NLM:
Further study details as provided by Chang Gung Memorial Hospital:
Primary Outcome Measures:
- Fugl-Meyer Assessment (FMA) [ Time Frame: Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks ] [ Designated as safety issue: No ]The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.
- Action Research Arm Test (ARAT) [ Time Frame: Baseline, change of ARAT at 2 weeks, and change of ARAT at 4 weeks ] [ Designated as safety issue: No ]ARAT will be used to assess the motor function of UE. A total of 19 items are to test the movement of grasp, grip, pinch, and gross motor, with a scale of 0-3 for each item (maximal of 57).
- Motor Activity Log (MAL) [ Time Frame: Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks ] [ Designated as safety issue: No ]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 better performance.
- ABILHAND Questionnaire [ Time Frame: Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks ] [ Designated as safety issue: No ]ABILHAND questionnaire is an inventory of 56 manual activities that uses a 3-point ordinal scale to measure subjectively perceived difficulty in performing everyday bimanual activity.
- Adelaide Activities Profile (AAP) [ Time Frame: Baseline, change of AAP at 2 weeks, and change of AAP at 4 weeks ] [ Designated as safety issue: No ]AAP will be applied to indicate the level of participation in household and community activities. This profile includes 21 activities in the four areas: domestic chores, household maintenance, service to others, and social activities.
Secondary Outcome Measures:
- Functional magnetic resonance imaging (fMRI) [ Time Frame: Baseline and change of fMRI at 4 weeks ] [ Designated as safety issue: No ]uses the blood oxygenation level-dependent (BOLD) response to evaluate the brain reorganization after intervention.
- Physiological marker measures [ Time Frame: Baseline and change from baseline in physiological marker measures at 4 weeks ] [ Designated as safety issue: No ]measure inflammatory markers, oxidative stress markers, and erythrocyte deformability.
| Estimated Enrollment: | 128 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: mirror therapy treatment
Three groups will be involved in this part of the whole project:MT with low-intensity group (MT-LI), MT with moderate-intensity group (MT-MI), MT with high-intensity group (MT-HI)
|
Behavioral: MT with low-intensity group (MT-LI)
The MT-LI group will receive a 30-minute MT per session followed by a 30-minute functional training.
Other Name: MT-LI
Behavioral: MT with moderate-intensity group
The MT-MI group will receive a 60-minute MT per session followed by a 30-minute functional training.
Other Name: MT-MI
Behavioral: Mirror therapy with high intensity group
The MT-HI group will receive a 90-minute MT per session followed by a 30-minute functional training
Other Name: MT-HI
|
|
Active Comparator: control intervention group
The part of this project will involve 1 treatment groups:control intervention group (CI)
|
Behavioral: Control intervention group
The CI group will carry out a 30-minute conventional stroke rehabilitation training per session followed by a 30-minute functional training.
Other Name: CI
|
Detailed Description:
This trial is to examine whether (1) the immediate effects of treatment intensity in MT would occur on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in MT on functionality can persist for six months after treatment finished; and (3) the MT could result in cortical/movement reorganization as well as the changes in physiological markers.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- first episode of stroke in cortical regions
- time since stroke less than 3 months
- initial motor part of UE of FMA score ranging from 24 to 52
- no serious cognitive impairment
Exclusion Criteria:
- aphasia
- visual impairments
- major health problems or poor physical conditions
- currently participation in any other
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655160
Contacts
| Contact: Ching-yi Wu, ScD | +886-3-211-8800 ext 5761 | cywu@mail.cgu.edu.tw |
Locations
| Taiwan | |
| Chang Gung Memorial Hospital | Recruiting |
| Kwei-shan, Toayuan county, Taiwan | |
| Contact: Chia-ling Chen, MD/PhD 886-3-3281200 ext 8148 | |
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Investigators
| Principal Investigator: | Ching-yi Wu, ScD | Chang Gung University |
More Information
No publications provided
| Responsible Party: | Chang Gung Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01655160 History of Changes |
| Other Study ID Numbers: | 100-4548B |
| Study First Received: | July 30, 2012 |
| Last Updated: | February 27, 2013 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Chang Gung Memorial Hospital:
|
Stroke rehabilitation Mirror therapy Functional performance |
Kinematic analysis Functional magnetic resonance image Motor recovery |
Additional relevant MeSH terms:
|
Cerebral Infarction Stroke Brain Infarction Brain Ischemia Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013