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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01574079
Other study ID # 2010-0244
Secondary ID
Status Completed
Phase N/A
First received January 30, 2012
Last updated September 4, 2014
Start date November 2010
Est. completion date November 2012

Study information

Verified date September 2014
Source University of Mississippi Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Mirror therapy may be an effective intervention in increasing motor control and gait performance in patients with stroke.


Description:

Using a mirrored image of the uninvolved extremity superimposed upon the involved extremity during exercise may facilitate improved motor control in patients after stroke.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- lower extremity Brunnstrom stage 2,

- lower extremity modified ashworth < 3,

- has the ability to follow 3-step command in English,

- has only unilateral involvement.

Exclusion Criteria:

- lower extremity Brunnstrom stage 1,

- lower extremity modified ashworth 3 or higher,

- history of prior stroke,

- Passive Range of Motion limitation of hip and or knee flexion < 90,

- has visual deficits which prevent participation.

Study Design

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


Related Conditions & MeSH terms


Intervention

Other:
Traditional Physical Therapy
Traditional physical therapy includes, but is not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
Physical Therapy plus Mirror Therapy
The treatment group will receive traditional physical therapy intervention as described in the control group with the addition of mirror therapy. The participant will attempt to perform the flexion exercises with both lower extremities. The patient will be blinded to the affected lower extremity with a mirror, and will be looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performs the activities.

Locations

Country Name City State
United States University of Mississippi Medical Center - University Rehabilitation Jackson Mississippi

Sponsors (1)

Lead Sponsor Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional Independence Measure - Locomotor Score The Functional Independence Measure (FIM)assesses level of disability and measures progress toward independence with rehabilitational intervention. The tool consists of 18 items. Only the the locomotor score was used to assess gait ability in this study. The locomotor score ranges from 1 - 7 with a higher score indicating a higher level of functional independence. measured at admission and discharge from rehab estimated length of stay 14 days Yes
Secondary Timed Up and Go The Timed Up and Go (TUG) is used to assess balance and gait, and to estimate fall risks in patients with deficits. The participant rises from a seated position in a chair, walks 3 meters, turns around, returns to the chair, and sits down. The test is measured in seconds, with a lower number indicating a higher level of independence and the least risk for falls. Measured at admission and discharge with estimated length of stay 14 days Yes
Secondary Stroke Rehabilitation Assessment of Movement The Stroke Rehabilitation Assessment of Movement (STREAM)is designed to measure mobility and motor ability after stroke. There are three subscales with 10 items each assessing the upper extremity, lower extremity, and basic mobility. Only the lower extremity and basic mobility items were used in this study. The lower extremity scores ranged from 0 - 18 with higher scores indicating a higher level of motor control. The basic mobility scores ranged from 0 - 30 with high numbers indicating a higher level of functional mobility. measured at admission and discharge with estimated length of stay 14 days No
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