NCT01574079

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 11, 2014

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

January 30, 2012

Results QC Date

June 25, 2013

Last Update Submit

September 4, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Timed Up and Go

    Measured at admission and discharge with estimated length of stay 14 days

  • Stroke Rehabilitation Assessment of Movement

    measured at admission and discharge with estimated length of stay 14 days

Study Arms (2)

Traditional Physical Therapy

ACTIVE COMPARATOR

The control group will receive traditional physical therapy interventions directed at neuromuscular rehabilitation.

Other: Traditional Physical Therapy

Physical Therapy plus Mirror Therapy

EXPERIMENTAL

The mirror therapy will entail 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion.

Other: Physical Therapy plus Mirror Therapy

Interventions

Traditional physical therapy includes, but is not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.

Traditional Physical 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.

Physical Therapy plus Mirror Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • lower extremity Brunnstrom stage 2,
  • lower extremity modified ashworth \< 3,
  • has the ability to follow 3-step command in English,
  • has only unilateral involvement.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Mississippi Medical Center - University Rehabilitation

Jackson, Mississippi, 39216, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy ModalitiesMirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Results Point of Contact

Title
Principle investigator
Organization
University of Mississippi Medical Center

Study Officials

  • Lisa J Barnes, PT DPT

    University of Mississippi Medical Center

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 30, 2012

First Posted

April 10, 2012

Study Start

November 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

September 11, 2014

Results First Posted

September 11, 2014

Record last verified: 2014-09

Locations