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Clinical Trials/NCT02254616
NCT02254616
Completed
Not Applicable

Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery: A Follow up Study on Brain Reorganization, Motor Performance of Upper Extremity, Daily Function, and Activity Participation

Chang Gung Memorial Hospital4 sites in 1 country24 target enrollmentAugust 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebrovascular Accident
Sponsor
Chang Gung Memorial Hospital
Enrollment
24
Locations
4
Primary Endpoint
Change scores of Motor Activity Log (MAL)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

We hypothesize that (1) the hybrid therapy will induce greater improvements on some health-related outcomes compared to other therapies; (2) such benefits will retain at 6-month follow-up; (3) better motor control and brain reorganization will be found in the hybrid therapy than the other therapies; (4) correlations will be found between brain activity and movement kinematics/health-related outcomes.

Detailed Description

Chronic stroke participants will be recruited from the Chang Gung Memorial Hospital and then were randomly assigned to 1 of the 4 groups: MT+tDCS, MT+sham tDCS, MT, and CI groups. The participants in each group receive equivalent amounts of treatment. Analysis of covariance (ANCOVA), controlling for the pretest differences, will be separately performed for each outcome measure to test the effects of different intervention groups.

Registry
clinicaltrials.gov
Start Date
August 1, 2014
End Date
October 11, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • First episode of stroke in cortical regions
  • Time since stroke more than 6 months
  • Initial motor part of UE of FMA score ranging from 24 to 52, indicating moderate to mild movement impairment
  • No severe spasticity in any joints of the affected arm (Modified Ashworth Scale ≤ 2)
  • No serious cognitive impairment (i.e., Mini Mental State Exam score≧ 24)
  • Willing to sign the informed consent form.

Exclusion Criteria

  • Aphasia that might interfere with understanding instructions
  • Visual/attention impairments that might interfere with the seeing of mirror illusion, including hemineglect/hemianopsia
  • Major health problems or poor physical conditions that might limit participation
  • Currently participation in any other research
  • Previous brain neurosurgery
  • Metallic implants within the brain.

Outcomes

Primary Outcomes

Change scores of Motor Activity Log (MAL)

Time Frame: Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks

The MAL consists of 30 structured questions to interview how the patients rate the frequency (amount of use subscale) and quality (quality of movement subscale) of movements while using their affected arm to accomplish each of the 30 daily activities. The score of each item ranges from 0 to 5, and the higher scores indicate more frequently used or higher quality of movements. The clinimetric properties of the MAL in stroke patients have been validated (Uswatte, Taub, Morris, Light, \& Thompson, 2006).

Change scores of Revised Nottingham Sensory Assessment (rNSA)

Time Frame: Baseline, and 4 weeks

The rNSA includes tactile sensation, kinesthetic sensation, and stereognosis. The rNSA is reliable measure of sensory function in stroke patients. For tactile sensation, the patient will be asked to indicate whenever he or she feels the test sensation. For kinesthetic sensations, all 3 aspects of movement will be tested: appreciation of movement, its direction and accurate joint position sense. The limb on the affected side of the body will be supported and moved by the examiner in various directions but movement is only at one joint at a time. The patients will be asked to mirror the change of movement with the other limb. For stereognosis, the object will be placed in the patient's hand for a maximum of 30 seconds. Identification is by naming, description or by pair-matching with an identical set. The object may be moved around the affected hand by the examiner. The rNSA has good intrarater and interrater reliability (Lincoln, Jackson, \& Adams, 1998).

Change scores of Fugl-Meyer Assessment (FMA)

Time Frame: Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks

The upper-extremity subscale of the FMA will be used to assess motor impairment. The 33 upper limb items measure the movement and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. They are scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully). The maximum score is 66, indicating optimal recovery. The sub-score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements. The reliability, validity, and responsiveness of the FMA in stroke patients have been shown to be good.

Change scores of Wolf Motor Function Test (WMFT)

Time Frame: Baseline, 2 weeks, and 4 weeks

The assessment requires the participant to perform 15 function-based and 2 strength-based tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds. For functional ability scoring, we used a 6-point ordinal scale where 0 indicates "does not attempt with the involved arm" and 5 indicates "arm does participate; movement appears to be normal." The clinimetrics of the WMFT has been ascertained in stroke patients (Wolf et al., 2005).

Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0)

Time Frame: Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks

The SIS 3.0 is a stroke-specific instrument of health-related quality of life. It contains 59 items measuring 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week. The reliability, validity, and responsiveness have been shown to be satisfactory in stroke patients.

Secondary Outcomes

  • Change scores of Kinematic analysis(Baseline, and 4 weeks)
  • Change scores of 10-Meter Walk Test (10MWT)(Baseline, 4 weeks)
  • Change scores of Stroop test(Baseline, and 4 weeks)
  • Change scores of Adelaide Activities Profile (AAP)(Baseline, and 4 weeks, 16 weeks, and 28 weeks)
  • Change scores of hand strength(Baseline, 2 weeks, and 4 weeks)
  • Change scores of Actigraphy(Baseline, and 4 weeks)
  • Change scores of pressure pain threshold(Baseline, and 4 weeks)

Study Sites (4)

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