Stroke
Conditions
Brief summary
aim: To examine the effect of a perturbation-based balance training on balance reaction characteristics in post stroke individuals.
Detailed description
60 stroke subjects from the neurology rehabilitation unit at Loewenstein hospital will be randomly allocated to one of two groups: 1) perturbations based balance training 2) weight shifting and gait training without external perturbations (control). Group 1 - Perturbations based balance training Subjects will complete a perturbation based balance training while standing and walking on the BalanceTutor (MediTouch). Perturbation level will be individually adjusted and progressed according to subject's abilities. Progression occurs by increasing perturbation level (increase distance, velocity and acceleration). At each practiced level subjects will be exposed to random right/left/forward/backward unannounced platform translations while standing and to right/left perturbations (in defined events in gait cycle) while walking. In order to examine adaptation to repeated perturbations, kinematic data will be collected in the first session. Group 2 - Weight shifting and gait training Subjects will complete a balance training program that includes voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill. Weight shifting toward a target will be adjusted and progressed according to subject's abilities. Progression in difficulty level will occur by increasing the distance to target without changing the base of support. At each practiced level weight shifting will be conducted to right/left/forward/backward directions. In the gait part of the session, subjects will be asked to walk at their preferred treadmill walking speed. Subjects in both groups will complete 10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes and will include practice in standing and walking. Subject's activities will be documented in each session in both groups. Furthermore, in each session subjects will be asked to rate their perceived level of challenge on a 0-10 scale. Pre- and post-intervention measurements will be conducted. A follow-up measurement will be conducted 3-6 weeks post intervention. The following measurements will be administered: 1)Compensatory balance reaction kinematic measurement: Compensatory balance reactions will be measured using the BalanceTutor (MediTouch). The BalanceTutor is a mechatronic device consisting of a computerized treadmill with a horizontal movable platform and an operator station. Measurements will be taken in two conditions: Standing. Subjects will be instructed to stand and will be exposed to random unexpected platform translations. The platform translations will be increased systematically and controlled. The increases in platform translation will be adjusted by the examiner to the subject's ability to recover from perturbations. Participants will be asked to respond in a natural manner to perturbations. Walking. Subjects will be instructed to walk comfortably (self-paced) on the treadmill, and will be exposed to random unexpected platform translations. The platform translations will be increased systematically and controlled and will be adjusted by the examiner to the subject's ability to recover from perturbations. Compensatory balance reaction characteristics (reaction time, swing time, compensatory step time, step length etc.) will be collected through a three-dimensional motion analysis system. During examination subjects will wear a loose safety harness that will prevent a fall and yet allow the execution of balance recovery reactions. In addition, clinical measures will be used: Berg Balance Scale, 6 minute walk test, 10 meter walk test, the Fugl-Meyer test for motor recovery after stroke and the ABC (Activities-specific Balance Confidence) scale. Normalized lesion data will be computed using the ABLE module within MEDx software (Medical Numerics).
Interventions
DEVICEStroke Subjects Perturbation-Based Balance Training
DEVICEStroke Subjects Weight Shifting and Gait training
Sponsors
Ben-Gurion University of the Negev
Nachum Soroker, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
RCT
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
For measurements taken while standing, post stroke subjects will meet the criteria of being able to stand independently or with supervision for at least 2 minutes. For measurements taken while walking, post stroke subjects will meet the criteria of being able to walk for at least 10 meter with supervision/independently without walking aids. * 3 weeks-6 months post stroke (hemorrhage/infarct) * First stroke * Age 25-75 years * Able to understand research instructions * Stable clinical/metabolic state
Exclusion criteria
* \- A history of neurological diseases amongst peripheral neuropathy * Significant skeletal system diseases, such as severe osteoporosis * Uncontrolled atrial fibrillation * Unstable ischemic heart disease * Significant visual deficiency * Dizziness * Pregnancy * Body weight above 135 kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Compensatory Step Execution Time | 1-5 days before the first session of intervention and 1-5 days after the last session of intervention. | Will be calculated as the time from platform perturbation to foot contact using a 3D motion analysis system. Step execution time in response to surface translations toward the non-paretic side. |
| Change in Compensatory Step Velocity | 1-3 days before the first session of intervention and 1-3 days after the last session of intervention. | will be calculated from step length and step swing time data, using a 3D motion analysis system. Step velocity in response to surface translations toward the non-paretic side. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Berg Balance Scale Score | 1-3 days before the first session of intervention and 1-3 days after the last session of intervention. | A 14-item objective measure (ordinal scale) designed to assess static balance and fall risk. Minimus score =0, Maximal score=56. Higher values represent a better outcome. |
| Change in Fall Threshold | 1-3 days before the first session of intervention and 1-3 days after the last session of intervention. | The perturbation level at which the subject lost balance and fell into the safety harness. Score on a scale (1-7). Each unit represents the perturbation intensity where the subject was unable to recover balance and fell into harness system. Higher values represent a better outcome. |
| Change in Activities-specific Balance Confidence (ABC) Scale | 1-3 days before the first session of intervention and 1-3 days after the last session of intervention. | A self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Score on a scale (0-100). Higher values represent a better outcome. |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Perturbation-based Balance Training perturbation-based balance training while standing and walking on the BalanceTutor (MediTouch).
10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.
BalanceTutor | 18 |
| Weight Shifting and Gait Training Balance and gait training without external perturbations. Voluntary weight shifting while standing on a computerized posturography (NeuroCom) and walking on a treadmill.
10-12 training sessions, 4-5 per week for 3 weeks. Each session will last 30 minutes.
posturograph | 16 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | foot pain | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Perturbation-based Balance Training | Weight Shifting and Gait Training | Total |
|---|---|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 8.7 | 60.4 years STANDARD_DEVIATION 10.1 | 61.4 years STANDARD_DEVIATION 9.2 |
| Days post stroke | 40.6 days STANDARD_DEVIATION 17 | 43.7 days STANDARD_DEVIATION 19.7 | 42.0 days STANDARD_DEVIATION 18.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 16 |
| other Total, other adverse events | 1 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 |
Outcome results
Primary
Change in Compensatory Step Execution Time
Will be calculated as the time from platform perturbation to foot contact using a 3D motion analysis system. Step execution time in response to surface translations toward the non-paretic side.
Time frame: 1-5 days before the first session of intervention and 1-5 days after the last session of intervention.
Population: Analysis was conducted for step responses at perturbation level 3, since step responses were not frequently induced at low perturbation intensities and most subjects were not able to recover balance loss at higher perturbation intensities. Data represent subjects who reached intensity 3 without a fall in previous intensities (n=13 and n=8).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perturbation-based Balance Training | Change in Compensatory Step Execution Time | -119.7 msec | Standard Deviation 236.6 |
| Weight Shifting and Gait Training | Change in Compensatory Step Execution Time | -4.2 msec | Standard Deviation 44.4 |
Primary
Change in Compensatory Step Velocity
will be calculated from step length and step swing time data, using a 3D motion analysis system. Step velocity in response to surface translations toward the non-paretic side.
Time frame: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.
Population: Analysis was conducted for step responses at perturbation level 3, since step responses were not frequently induced at low perturbation intensities and most subjects were not able to recover balance loss at higher perturbation intensities. Data represent subjects who reached intensity 3 without a fall in previous intensities (n=13 and n=8).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perturbation-based Balance Training | Change in Compensatory Step Velocity | 0.05 m/sec | Standard Deviation 0.2 |
| Weight Shifting and Gait Training | Change in Compensatory Step Velocity | -0.05 m/sec | Standard Deviation 0.08 |
Secondary
Change in Activities-specific Balance Confidence (ABC) Scale
A self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Score on a scale (0-100). Higher values represent a better outcome.
Time frame: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perturbation-based Balance Training | Change in Activities-specific Balance Confidence (ABC) Scale | 17.9 score on a scale | Standard Deviation 16.01 |
| Weight Shifting and Gait Training | Change in Activities-specific Balance Confidence (ABC) Scale | 4.1 score on a scale | Standard Deviation 9.23 |
Secondary
Change in Berg Balance Scale Score
A 14-item objective measure (ordinal scale) designed to assess static balance and fall risk. Minimus score =0, Maximal score=56. Higher values represent a better outcome.
Time frame: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perturbation-based Balance Training | Change in Berg Balance Scale Score | 5.7 units on a scale 0-56. | Standard Deviation 3.9 |
| Weight Shifting and Gait Training | Change in Berg Balance Scale Score | 5.8 units on a scale 0-56. | Standard Deviation 5.6 |
Secondary
Change in Fall Threshold
The perturbation level at which the subject lost balance and fell into the safety harness. Score on a scale (1-7). Each unit represents the perturbation intensity where the subject was unable to recover balance and fell into harness system. Higher values represent a better outcome.
Time frame: 1-3 days before the first session of intervention and 1-3 days after the last session of intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Perturbation-based Balance Training | Change in Fall Threshold | 1.93 score on a scale | Standard Deviation 1.6 |
| Weight Shifting and Gait Training | Change in Fall Threshold | 1.12 score on a scale | Standard Deviation 1.8 |