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Motor Recovery of the Severely Impaired Paretic Upper Limb After Mirror Therapy in Sub-acute Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
mirror therapy
control therapy
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring upper limb, mirror therapy, rehabilitation, subacute

Eligibility Criteria

35 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 35 years or older
  • first stroke within the first month after stroke onset;
  • has upper limb paresis contralateral to the side of cerebral hemisphere with stroke;
  • Presence of active movements (at least flicker of movement in gravity free position, but not able to accomplish full range of motion against gravity) at any one joint of shoulder, elbow and hand of hemiplegic arm, and Motricity Index less than 47.
  • Able to follow instructions

Exclusion Criteria:

  • has visual impairment not correctable by corrective lens;
  • has cognitive impairment (Mini-Mental State Examination score < 22/30)
  • has comprehension or expression aphasia;
  • Presence of visuospatial neglect
  • has premorbid neurological or musculoskeletal conditions that affect movements in the upper limbs

Sites / Locations

  • Haven of Hope Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mirror therapy group

Control therapy group

Arm Description

MT group subjects will attend training sessions of bilateral upper limb exercise daily in the presence of the mirror.

Control group subjects will undergo the same training sessions of bilateral upper limb exercise daily without mirror.

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment arm score

Secondary Outcome Measures

Wolf Motor Function Test

Full Information

First Posted
October 21, 2016
Last Updated
October 21, 2016
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02942875
Brief Title
Motor Recovery of the Severely Impaired Paretic Upper Limb After Mirror Therapy in Sub-acute Stroke
Official Title
Motor Recovery of the Severely Impaired Paretic Upper Limb After Mirror Therapy in Sub-acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Our study aims at investigating the effect of intensive mirror therapy on the motor recovery of severely impaired paretic arm at subacute stroke.
Detailed Description
It was reported that upper limb hemiparesis happened in 80% of stroke patients and only 20% regained full arm function 6 months post stroke. The paretic upper arm accounted for 50% of the variance in functional limitation after stroke. Early and intensive upper limb intervention can promote motor recovery of paretic arm and is associated with better upper limb functional outcomes on 6 month post stroke. Mirror therapy (MT) is one of the potential approach in enhancing motor recovery of paretic arm after stroke. However, the effect of intensive MT on the motor recovery of severely impaired paretic arm after stroke has not been investigated. Knowledge on the effect of intensive MT on motor recovery can enhance formulation of effective and efficiency treatment protocol in stroke rehabilitation. Therefore, our study aims at investigating the effect of intensive MT on the motor recovery of severely impaired paretic arm of patients at subacute phase of stroke. Stroke patients admitted to Haven of Hope Hospital will be screened according to inclusion and exclusion criteria. Eligible subjects will consent and be randomized into two groups: MT group- subjects will have daily two 30-min sessions of standardized bilateral upper limbs exercise with presence of mirror, 5 days per week for 4 consecutive weeks. During MT, a mirror is placed in the patient's mid-sagittal plane, with the reflecting surface facing the non-paretic upper limb so that the reflected image of this non-paretic limb would be perceived as the paretic upper limb. Subjects are instructed to watch at the movements of the reflected image of the non-paretic limbs and at the same time, the paretic upper limb should imitate the observed movements and be synchronized with those of the good side. Standardized bilateral upper limbs exercise (4 sets of 30 repetitions of shoulder, elbow, wrist and fingers movements) will be carried out within 30 min per session. Control group subjects will receive same daily two sessions of standardized bilateral upper limbs exercise without mirror, 5 days per week for 4 consecutive weeks. Motor functions of paretic arm of subjects measured by Fugl-Meyer Assessment (motor domain) and Wolf Motor Function Test will be assessed by independent assessor who is blinded to the group allocation of subjects before and after the 4-week intervention. Baseline comparison between the two groups was tested with independent t-test and the difference among and between groups after intervention will be tested by repeated measures ANOVA with level of significant at 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
upper limb, mirror therapy, rehabilitation, subacute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror therapy group
Arm Type
Experimental
Arm Description
MT group subjects will attend training sessions of bilateral upper limb exercise daily in the presence of the mirror.
Arm Title
Control therapy group
Arm Type
Active Comparator
Arm Description
Control group subjects will undergo the same training sessions of bilateral upper limb exercise daily without mirror.
Intervention Type
Other
Intervention Name(s)
mirror therapy
Intervention Description
During MT, subjects will sit in front of a table on which a mirror will be placed vertically in the space ipsilateral to the paretic upper limb with its reflective surface facing the unaffected upper limb. The subjects are required to look at the mirror to observe the reflective image of the unaffected arm from shoulder to the hand, while it is performing certain designated movements. At the same time, the affected arm will be required to follow the unaffected arm to practice the same movements. The upper limbs movements during the 30-min MT session are open and close of grasp; wrist flexion and extension; forearm supination and pronation; elbow flexion and extension; shoulder flexion and extension. A total of 120 repetitions for each action will be practiced.
Intervention Type
Other
Intervention Name(s)
control therapy
Intervention Description
Control group subjects undergo the same bilateral upper limbs exercise protocol without mirror
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment arm score
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 35 years or older first stroke within the first month after stroke onset; has upper limb paresis contralateral to the side of cerebral hemisphere with stroke; Presence of active movements (at least flicker of movement in gravity free position, but not able to accomplish full range of motion against gravity) at any one joint of shoulder, elbow and hand of hemiplegic arm, and Motricity Index less than 47. Able to follow instructions Exclusion Criteria: has visual impairment not correctable by corrective lens; has cognitive impairment (Mini-Mental State Examination score < 22/30) has comprehension or expression aphasia; Presence of visuospatial neglect has premorbid neurological or musculoskeletal conditions that affect movements in the upper limbs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wing Chiu Chan, MSc
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haven of Hope Hospital
City
Tseung Kwan O
State/Province
Kowloon
ZIP/Postal Code
0
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
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Motor Recovery of the Severely Impaired Paretic Upper Limb After Mirror Therapy in Sub-acute Stroke

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