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Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke

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ClinicalTrials.gov Identifier: NCT01574079
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Lisa J Barnes, University of Mississippi Medical Center

Tracking Information
First Submitted Date  ICMJE January 30, 2012
First Posted Date  ICMJE April 10, 2012
Results First Submitted Date  ICMJE June 25, 2013
Results First Posted Date  ICMJE September 11, 2014
Last Update Posted Date September 11, 2014
Study Start Date  ICMJE November 2010
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2014)
Functional Independence Measure - Locomotor Score [ Time Frame: measured at admission and discharge from rehab estimated length of stay 14 days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
Functional Independence Measure - Locomotor Score [ Time Frame: measured at admission and discharge from rehab estimated length of stay 14 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2014)
  • Timed Up and Go [ Time Frame: Measured at admission and discharge with estimated length of stay 14 days ]
    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.
  • Stroke Rehabilitation Assessment of Movement [ Time Frame: measured at admission and discharge with estimated length of stay 14 days ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
  • Timed Up and Go [ Time Frame: Measured at admission and discharge with estimated length of stay 14 days ]
  • Stroke Rehabilitation Assessment of Movement [ Time Frame: measured at admission and discharge with estimated length of stay 14 days ]
  • Upright Motor Control Test [ Time Frame: Measured at admission and discharge with estimated length of stay 14 days ]
  • Modified Ashworth Score [ Time Frame: measured at admission and discharge with estimated length of stay 14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke
Official Title  ICMJE Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke
Brief Summary Mirror therapy may be an effective intervention in increasing motor control and gait performance in patients with stroke.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • 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.
  • Other: 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.
Study Arms  ICMJE
  • Active Comparator: Traditional Physical Therapy
    The control group will receive traditional physical therapy interventions directed at neuromuscular rehabilitation.
    Intervention: Other: Traditional Physical Therapy
  • Experimental: Physical Therapy plus Mirror Therapy
    The mirror therapy will entail 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion.
    Intervention: Other: Physical Therapy plus Mirror Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2014)
33
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2012)
40
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574079
Other Study ID Numbers  ICMJE 2010-0244
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lisa J Barnes, University of Mississippi Medical Center
Study Sponsor  ICMJE University of Mississippi Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lisa J Barnes, PT DPT University of Mississippi Medical Center
Study Director: Keri H McCullough, DPT University of Mississippi Medical Center - University Rehabilitation
Study Director: Kim C Wilcox, PT MsPT PhD University of Mississippi Medical Center - Director of Neurologic Residency Program
PRS Account University of Mississippi Medical Center
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP