Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke

Not Applicable

Completed

• Conditions: Cerebrovascular Accident

• Registration Number: NCT01655160
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms of mirror therapy and its effects on physiological markers.

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.

Study Timeline

• Study First Submitted: 2012-07-30
• Study First Submitted QC: 2012-07-31
• Study Start: 2012-08
• Study First Posted: 2012-08-01
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-04
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	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)	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	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)	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.
Fugl-Meyer Assessment (FMA)	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.

Secondary Outcome Measures

Name	Time	Method
Functional magnetic resonance imaging (fMRI)	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	Baseline and change from baseline in physiological marker measures at 4 weeks	measure inflammatory markers, oxidative stress markers, and erythrocyte deformability.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Kwei-shan, Toayuan county, Taiwan

Chang Gung Memorial Hospital

🇨🇳Kwei-shan, Toayuan county, Taiwan