Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke
|ClinicalTrials.gov Identifier: NCT01655160|
Recruitment Status : Completed
First Posted : August 1, 2012
Last Update Posted : June 8, 2015
|Condition or disease||Intervention/treatment|
|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 (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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.|
|Study Start Date :||August 2012|
|Primary Completion Date :||March 2015|
|Study Completion Date :||March 2015|
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-LIBehavioral: 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-MIBehavioral: 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
- Fugl-Meyer Assessment (FMA) [ Time Frame: Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks ]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 ]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 ]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 ]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 ]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.
- Functional magnetic resonance imaging (fMRI) [ Time Frame: Baseline and change of fMRI at 4 weeks ]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 ]measure inflammatory markers, oxidative stress markers, and erythrocyte deformability.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655160
|Chang Gung Memorial Hospital|
|Kwei-shan, Toayuan county, Taiwan|
|Principal Investigator:||Ching-yi Wu, ScD||Chang Gung University|