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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02917343
Other study ID # 2614
Secondary ID
Status Completed
Phase N/A
First received September 26, 2016
Last updated September 26, 2016
Start date October 2014
Est. completion date April 2015

Study information

Verified date September 2016
Source Quinnipiac University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine the effect of a combined mirror therapy and task oriented/repetitive task training on upper extremity function of persons with hemiplegia due to cerebrovascular accident or stroke.


Description:

This case series was designed to to determine the effect of a mirror therapy and repetitive task training program on the weak arm and hand functioning due to the consequences of stroke. Mirror therapy is a type of therapy mirror reflection of the stronger arm and hand helps to promote reorganization of neurons. Studies have shown that mirror therapy is an effective adjunct to regular exercise and task-oriented therapy.

To qualify for this study, participants must meet the following criteria: 1) age 21 years or more; 2) first-time stroke with onset of at least 3 months; 3) slight movement of the weaker arm or /and hand; 3) stable physical and mental health; and 4) mentally capable and competent to make health care-related decisions and carry out a home program.

Participants were required to come to Quinnipiac University - North Haven campus to undergo mirror therapy training, in 45-60 minute sessions, twice a week for one month. They were also required to complete pre-testing before and post-testing after the mirror therapy program. In addition, they were required to carry-out a home program that includes the use of a mirror box and self-selected tasks. The home program required them to exercise and practice the use of their more affected arm and hand for at least 1-2 hours a day.

Participation was strictly voluntary. Participants were informed of the minimal risks involved as well as their options to continue or withdraw from the study upon initial consent. The study did not yield physical or mental harm to the participants.


Recruitment information / eligibility

Status Completed
Enrollment 4
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- able to give consent, complete home program

- minimal arm and hand use with the paretic limb

- onset of stroke of at least 3 months

Exclusion Criteria:

- >1 stroke episode

- significant cognitive and visual perceptual deficit

- lack of social support

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
mirror therapy and repetitive task training


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Quinnipiac University

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Patient Specific Functional Scale Patient Specific Functional Scale is a measure that involves self-rating of self-selected functional tasks Change from baseline at 2 months No
Primary Change in Fugl Myer Motor Assessment Fugl-Meyer Motor Assessment is a clinical performance test of motor ability of the upper extremity Change from baseline at 2 months No
Secondary Change in Motor Activity Log The Motor Activity Log is a self-reported measure that captures the amount of arm and hand use and perception of movement quality of the impaired upper limb Change from baseline at 2 months No
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