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

Cerebrovascular Accident Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655160
• Other study ID #: 100-4548B
• Status: Completed
• Phase: N/A
• First received: July 30, 2012
• Last updated: June 4, 2015
• Start date: August 2012
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

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.
• MT with moderate-intensity group
The MT-MI group will receive a 60-minute MT per session followed by a 30-minute functional training.
• 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
• 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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kwei-shan	Toayuan county

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment (FMA)	The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.	Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks	No
Primary	Action Research Arm Test (ARAT)	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).	Baseline, change of ARAT at 2 weeks, and change of ARAT at 4 weeks	No
Primary	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 better performance.	Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks	No
Primary	ABILHAND Questionnaire	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.	Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks	No
Primary	Adelaide Activities Profile (AAP)	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.	Baseline, change of AAP at 2 weeks, and change of AAP at 4 weeks	No
Secondary	Functional magnetic resonance imaging (fMRI)	uses the blood oxygenation level-dependent (BOLD) response to evaluate the brain reorganization after intervention.	Baseline and change of fMRI at 4 weeks	No
Secondary	Physiological marker measures	measure inflammatory markers, oxidative stress markers, and erythrocyte deformability.	Baseline and change from baseline in physiological marker measures at 4 weeks	No