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

NCT01655160 | Completed

• 1 other identifier: 100-4548B
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Keywords

Stroke rehabilitation; Mirror therapy; Functional performance; Kinematic analysis; Functional magnetic resonance image; Motor recovery

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (2)

• Functional magnetic resonance imaging (fMRI)

  Baseline and change of fMRI at 4 weeks

• Physiological marker measures

  Baseline and change from baseline in physiological marker measures at 4 weeks

Study Arms (2)

mirror therapy treatment

EXPERIMENTAL

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); Behavioral: MT with moderate-intensity group; Behavioral: Mirror therapy with high intensity group

control intervention group

ACTIVE COMPARATOR

The part of this project will involve 1 treatment groups:control intervention group (CI)

Behavioral: Control intervention group

Interventions

MT with low-intensity group (MT-LI) BEHAVIORAL

The MT-LI group will receive a 30-minute MT per session followed by a 30-minute functional training.

Also known as: MT-LI

mirror therapy treatment

MT with moderate-intensity group BEHAVIORAL

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

Also known as: MT-MI

mirror therapy treatment

Mirror therapy with high intensity group BEHAVIORAL

The MT-HI group will receive a 90-minute MT per session followed by a 30-minute functional training

Also known as: MT-HI

mirror therapy treatment

Control intervention group BEHAVIORAL

The CI group will carry out a 30-minute conventional stroke rehabilitation training per session followed by a 30-minute functional training.

Also known as: CI

control intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• aphasia
• visual impairments
• major health problems or poor physical conditions
• currently participation in any other

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Kwei-shan, Toayuan County, Taiwan

Location

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Ching-yi Wu, ScD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 1, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

TW (1)