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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02942875
• Other study ID #: HSEARS20140613004
• Status: Completed
• Phase: N/A
• First received: October 21, 2016
• Last updated: October 21, 2016
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Our study aims at investigating the effect of intensive mirror therapy on the motor recovery of severely impaired paretic arm at subacute stroke.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 100 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• mirror therapy
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.
• control therapy
Control group subjects undergo the same bilateral upper limbs exercise protocol without mirror

Locations

Country	Name	City	State
Hong Kong	Haven of Hope Hospital	Tseung Kwan O	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment arm score		4 weeks	No
Secondary	Wolf Motor Function Test		4 weeks	No

External Links

•   World Health Organization (2005) website