Stroke
Conditions
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.
Interventions
OTHERTraditional 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.
OTHERPhysical 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.
Sponsors
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Independence Measure - Locomotor Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Traditional Physical Therapy 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. | 18 |
| Physical Therapy Plus Mirror Therapy 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. | 15 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 0 | 2 |
Baseline characteristics
| Characteristic | Physical Therapy Plus Mirror Therapy | Traditional Physical Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 15 Participants | 28 Participants |
| Age, Continuous | 48.85 years STANDARD_DEVIATION 15.53 | 53.47 years STANDARD_DEVIATION 11.94 | 51.47 years STANDARD_DEVIATION 13.56 |
| Region of Enrollment United States | 15 participants | 18 participants | 33 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 15 |
| serious Total, serious adverse events | 0 / 18 | 0 / 15 |
Outcome results
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Functional Independence Measure - Locomotor Score | FIM locomotor score on admission | 1.65 outcome score | Standard Deviation 1.06 |
| Control Group | Functional Independence Measure - Locomotor Score | FIM locomotor score at discharge | 3.82 outcome score | Standard Deviation 1.38 |
| Treatment Group | Functional Independence Measure - Locomotor Score | FIM locomotor score on admission | 1.33 outcome score | Standard Deviation 0.65 |
| Treatment Group | Functional Independence Measure - Locomotor Score | FIM locomotor score at discharge | 4.25 outcome score | Standard Deviation 0.62 |
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.
Time frame: measured at admission and discharge with estimated length of stay 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Stroke Rehabilitation Assessment of Movement | STREAM LE admission | 8.18 outcome score | Standard Deviation 4.97 |
| Control Group | Stroke Rehabilitation Assessment of Movement | STREAM LE discharge | 12.41 outcome score | Standard Deviation 5.33 |
| Control Group | Stroke Rehabilitation Assessment of Movement | STREAM mobility on admission | 6.29 outcome score | Standard Deviation 7.65 |
| Control Group | Stroke Rehabilitation Assessment of Movement | STREAM mobility at discharge | 16.47 outcome score | Standard Deviation 9.86 |
| Treatment Group | Stroke Rehabilitation Assessment of Movement | STREAM mobility at discharge | 14.67 outcome score | Standard Deviation 6.02 |
| Treatment Group | Stroke Rehabilitation Assessment of Movement | STREAM LE admission | 5.33 outcome score | Standard Deviation 1.92 |
| Treatment Group | Stroke Rehabilitation Assessment of Movement | STREAM mobility on admission | 5.92 outcome score | Standard Deviation 4.42 |
| Treatment Group | Stroke Rehabilitation Assessment of Movement | STREAM LE discharge | 8.58 outcome score | Standard Deviation 2.61 |
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.
Time frame: Measured at admission and discharge with estimated length of stay 14 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Timed Up and Go | TUG on admission (in seconds) | 100.69 seconds | Standard Deviation 53.42 |
| Control Group | Timed Up and Go | TUG at discharge (in seconds) | 50.6 seconds | Standard Deviation 34.88 |
| Treatment Group | Timed Up and Go | TUG on admission (in seconds) | 97.75 seconds | Standard Deviation 47.69 |
| Treatment Group | Timed Up and Go | TUG at discharge (in seconds) | 49.25 seconds | Standard Deviation 15.96 |