Trial Outcomes & Findings for Effect of Mirror Therapy on Lower Extremity Motor Control and Gait in Patients With Stroke (NCT NCT01574079)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

33 participants

Primary outcome timeframe

measured at admission and discharge from rehab estimated length of stay 14 days

Results posted on

2014-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	Traditional Physical Therapy The control group will receive traditional physical therapy which 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 with the addition of 15 minutes of mirror therapy consisting of lower extremity ankle dorsiflexion, knee flexion, and hip flexion. The participant will attempt to perform the 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.
Overall Study STARTED	18	15
Overall Study COMPLETED	17	13
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Traditional Physical Therapy The control group will receive traditional physical therapy which 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 with the addition of 15 minutes of mirror therapy consisting of lower extremity ankle dorsiflexion, knee flexion, and hip flexion. The participant will attempt to perform the 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.
Overall Study Physician Decision	0	2
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Traditional Physical Therapy n=18 Participants The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.	Physical Therapy Plus Mirror Therapy n=15 Participants The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	53.47 years STANDARD_DEVIATION 11.94 • n=5 Participants	48.85 years STANDARD_DEVIATION 15.53 • n=7 Participants	51.47 years STANDARD_DEVIATION 13.56 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	15 participants n=7 Participants	33 participants n=5 Participants

PRIMARY outcome

Timeframe: measured at admission and discharge from rehab estimated length of stay 14 days

Population: Thirty-three participants enrolled in the study with 3 dropping out before completion. Two of these were due to medical issues, and one was discharged unexpectedly

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.

Outcome measures

Outcome measures
Measure	Control Group n=17 Participants The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.	Treatment Group n=13 Participants The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
Functional Independence Measure - Locomotor Score FIM locomotor score on admission	1.65 outcome score Standard Deviation 1.06	1.33 outcome score Standard Deviation 0.65
Functional Independence Measure - Locomotor Score FIM locomotor score at discharge	3.82 outcome score Standard Deviation 1.38	4.25 outcome score Standard Deviation 0.62

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=17 Participants The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.	Treatment Group n=13 Participants The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
Timed Up and Go TUG on admission (in seconds)	100.69 seconds Standard Deviation 53.42	97.75 seconds Standard Deviation 47.69
Timed Up and Go TUG at discharge (in seconds)	50.6 seconds Standard Deviation 34.88	49.25 seconds Standard Deviation 15.96

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control Group n=17 Participants The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.	Treatment Group n=13 Participants The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
Stroke Rehabilitation Assessment of Movement STREAM LE admission	8.18 outcome score Standard Deviation 4.97	5.33 outcome score Standard Deviation 1.92
Stroke Rehabilitation Assessment of Movement STREAM LE discharge	12.41 outcome score Standard Deviation 5.33	8.58 outcome score Standard Deviation 2.61
Stroke Rehabilitation Assessment of Movement STREAM mobility on admission	6.29 outcome score Standard Deviation 7.65	5.92 outcome score Standard Deviation 4.42
Stroke Rehabilitation Assessment of Movement STREAM mobility at discharge	16.47 outcome score Standard Deviation 9.86	14.67 outcome score Standard Deviation 6.02

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principle investigator

University of Mississippi Medical Center

Phone: 601-984-6369

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place