Cerebrovascular Accident, Stroke
Conditions
Keywords
Stroke, Rehabilitation, Robotics
Brief summary
This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait.
Detailed description
The hypothesis of this study is that chronic stroke survivors, more than one year post-stroke, with a motor problems in the lower extremity will be able to walk and move the affected leg better after 30 treatments with a new robotic therapy device, the AMES device. The device rotates the ankle while vibrators stimulate the tendons attached to muscles that move the ankle. Testing will be done before, during and after the treatments to determine response to the therapy.
Interventions
DEVICEAssisted movement and enhanced sensation
Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.
Sponsors
AMES Technology
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* At least 12 months post-stroke * Cognitively and behaviorally capable of complying with the regimen * Functioning proprioception * Less than 50% of normal strength in the affected ankle, but able to stand with or without assistive devices
Exclusion criteria
* Fractures of treated limb resulting in loss of range of motion * Spinal cord injury * Deep vein thrombosis * Peripheral nerve injury or neuropathy in the limb affected with motor disability * Osteoarthritis limiting range of motion * Skin condition not tolerant of device * Progressive neurodegenerative disorder * Uncontrolled seizure disorder * Botox treatment within the last 5 months * Baclofen pump
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment of the Lower Extremity | Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up | Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed 10-Meter Walk | Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up | Gait Assessment - Time |
| Stroke Impact Scale | Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up | The Stroke Impact Scale is a self-assessment questionnaire concerning activities of daily living. There are 8 sub-scales, each of which is summed as a raw score (range of 0-100) and then transformed as follows: Transformed Scale=\[(Actual raw score-lowest possible raw score)/Possible raw score range\]x100. Thus, the maximum possible score for the entire measure is 800. A higher score indicates a higher level of functioning. |
| Spasticity (Modified Ashworth) Scale | Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up | Measure of the total Ashworth scoring for increased muscle tone in the ankle flexors, ankle extensors, knee flexors, and knee extensors in the affected leg of stroke subjects. The scale range is from 0-5, with higher levels representing more exaggerated tone. |
| Strength Test | First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10) | Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions). |
| Active Motion Test | First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10) | Tracking task. Active joint position control between dorsiflexion/plantarflexion (change-score from average of first 3 training sessions and last 3 training sessions). The score is based on the amount of time that the participant is able to position the joint in a 3 deg-wide target zone presented on a video screen. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test Group Device: Assisted movement and enhanced sensation
Assisted movement and enhanced sensation: Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.
Assisted movement and enhanced sensation: Thirty treatment sessions on the AMES device, each session 30 minutes of cyclic rotation of the ankle with tendon vibration. Testing before, during, and after treatments to evaluate response to treatments. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Test Group |
|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 2 |
| Gender Female | 1 Participants |
| Gender Male | 1 Participants |
| Region of Enrollment United States | 2 participants |
| Time since stroke | 113.5 Months STANDARD_DEVIATION 85.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Fugl-Meyer Assessment of the Lower Extremity
Gold standard for motor impairment in individuals with stroke. A scale measuring tone, range-of-motion and synergies of the lower limb with a range of 0-34, higher scores referring to improved motor ability. The assessment includes 7 subscales, the scores of which are summed to arrive at a total score.
Time frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Group | Fugl-Meyer Assessment of the Lower Extremity | Baseline | 21.0 units on a scale | Standard Deviation 1 |
| Test Group | Fugl-Meyer Assessment of the Lower Extremity | Post-treatment | 19.5 units on a scale | Standard Deviation 0.5 |
| Test Group | Fugl-Meyer Assessment of the Lower Extremity | 3 Month Follow-up | 21 units on a scale | Standard Deviation 1 |
Secondary
Active Motion Test
Tracking task. Active joint position control between dorsiflexion/plantarflexion (change-score from average of first 3 training sessions and last 3 training sessions). The score is based on the amount of time that the participant is able to position the joint in a 3 deg-wide target zone presented on a video screen.
Time frame: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Group | Active Motion Test | 5.8 Seconds | Standard Deviation 0.2 |
Secondary
Spasticity (Modified Ashworth) Scale
Measure of the total Ashworth scoring for increased muscle tone in the ankle flexors, ankle extensors, knee flexors, and knee extensors in the affected leg of stroke subjects. The scale range is from 0-5, with higher levels representing more exaggerated tone.
Time frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Group | Spasticity (Modified Ashworth) Scale | Baseline | 2.0 units on a scale | Standard Deviation 2 |
| Test Group | Spasticity (Modified Ashworth) Scale | Post-treatment | 0.5 units on a scale | Standard Deviation 0.5 |
| Test Group | Spasticity (Modified Ashworth) Scale | 3 Month Follow-up | 2.0 units on a scale | Standard Deviation 1 |
Secondary
Strength Test
Measurement of ankle dorsiflexion/plantarflexion isometric strength (change-score from average of first 3 training sessions and last 3 training sessions).
Time frame: First 3 training sessions (week 1-2); Last 3 training sessions (week 9-10)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Group | Strength Test | Dorsiflexion | 33.7 Newton meters | Standard Deviation 41.4 |
| Test Group | Strength Test | Plantarflexion | 31.5 Newton meters | Standard Deviation 8.8 |
Secondary
Stroke Impact Scale
The Stroke Impact Scale is a self-assessment questionnaire concerning activities of daily living. There are 8 sub-scales, each of which is summed as a raw score (range of 0-100) and then transformed as follows: Transformed Scale=\[(Actual raw score-lowest possible raw score)/Possible raw score range\]x100. Thus, the maximum possible score for the entire measure is 800. A higher score indicates a higher level of functioning.
Time frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Group | Stroke Impact Scale | Post-treatment | 258 units on a scale | Standard Deviation 4 |
| Test Group | Stroke Impact Scale | Baseline | 234.5 units on a scale | Standard Deviation 9.5 |
| Test Group | Stroke Impact Scale | 3 Month Follow-up | 251.5 units on a scale | Standard Deviation 1.5 |
Secondary
Timed 10-Meter Walk
Gait Assessment - Time
Time frame: Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Group | Timed 10-Meter Walk | Baseline | 12.465 seconds | Standard Deviation 0.055 |
| Test Group | Timed 10-Meter Walk | Post-treatment | 13.66 seconds | Standard Deviation 0.34 |
| Test Group | Timed 10-Meter Walk | 3 Month Follow-up | 13.27 seconds | Standard Deviation 0.11 |