The Effects of Mirror Therapy on Upper Extremity in Stroke Patients

NCT01656876 | Completed

• 1 other identifier: CRC-09-10-08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people with stroke.

Conditions

Cerebrovascular Accident

Keywords

Comparative effectiveness research; Mirror therapy; Stroke rehabilitation; Clinical evaluation; Kinematic analysis; Mesh glove; Combined therapy

Outcome Measures

Primary Outcomes (4)

• Fugl-Meyer Assessment (FMA)

  The upper-extremity subscale of the FMA contains 33 items to assess motor impairment. Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly). The sub-score of a proximal shoulder/elbow (0-42) and a distal hand/wrist (0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements.

  Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks

• Wolf Motor Function Test (WMFT)

  * The WMFT composed of 3 parts: Time, Functional ability, and Strength * Includes 15 function-based tasks and 2 strength based tasks * Performance time is referred to as WMFT-TIME * Functional ability is referred to as WMFT-FAS * Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks. * Examiner should test the less affected upper extremity followed by the most affected side. * Uses a 6-point ordinal scale * "0" = "does not attempt with the involved arm" to * "5" = "arm does participate; movement appears to be normal." * Maximum score is 75 * Lower scores are indicative of lower functioning levels * WMFT-TIME allows 120 seconds per task

  Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks

• Accelerometers

  The accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory. Acceleration is sampled at 10 Hz and summed over a user- specified epoch. The recording epoch in this study is 2 seconds; recording capacity is approximately 72 hours. A "threshold-filter" will be applied to the raw recordings to obtain an accurate measure of the duration of arm movement.

  Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks

• revised Nottingham Sensory Assessment (rNSA)

  The rNSA examines the sensory function of the affected arm and includes tactile sensation (0=Absent, 1=Impaired, 2=Normal), proprioception (0=Absent, 1=Appreciation of movement sense, 2=Direction of movement sense, 3=Joint position sense), and stereognosis (0=Absent, 1=Impaired, 2=Normal) subtests.

  Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks

Secondary Outcomes (6)

• Kinematic analyses

  Baseline, change from baseline in kinematic parameters at 4 weeks

• Motor Activity Log (MAL)

  Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks

• Semmes-Weinstein monofilaments

  Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks

• Functional Independence Measure (FIM)

  Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks

• Stroke Impact Scale version 3.0 (SIS 3.0)

  Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks

Study Arms (3)

Mirror therapy

EXPERIMENTAL

mirror box training with or without sham mesh glove stimulation

Behavioral: Mirror box training

Mirror therapy + Mesh glove stimulation

EXPERIMENTAL

Mirror therapy combined with mesh glove stimulation

Behavioral: Mirror box training; Other: mesh glove stimulation

Controlled intervention

ACTIVE COMPARATOR

conventional interventions

Behavioral: conventional intervention

Interventions

Mirror box training BEHAVIORAL

This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.

Also known as: MT

Mirror therapy; Mirror therapy + Mesh glove stimulation

mesh glove stimulation OTHER

The MG is a two-channel electrical stimulator providing synchronous or reciprocal sensory stimulation with variant amplitudes.

Also known as: MG

Mirror therapy + Mesh glove stimulation

conventional intervention BEHAVIORAL

Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach

Also known as: CI

Controlled intervention

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The onset duration more than 3 months
• Demonstration of Brunnstrom stage equal to or above stage III of the affected upper extremity
• No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
• No serious visual and visual-perception impairments
• No concurrent participation in other drug or rehabilitation research
• No serious attention deficits

You may not qualify if:

• Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
• Excessive pain in any joint that might limit participation

Sponsors & Collaborators

• Taipei Medical University Hospital: lead

Study Sites (1)

Shuang-Ho Hospital, Taipei Medical University

New Taipei City, 23561, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Tsan-hon Liou, PhD

  Shuang-Ho Hospital, Taipei Medical University

  PRINCIPAL INVESTIGATOR

• Ching-yi Wu, ScD

  Department of Occupational Therapy, College of Medicine, Chang Gung University

  PRINCIPAL INVESTIGATOR

• Keh-chung Lin, ScD

  School of Occupational Therapy, College of Medicine, National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: August 3, 2012
• Study Start: September 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 5, 2015

Record last verified: 2012-11

Locations

TW (1)