Stroke
Conditions
Keywords
biomechanics, stroke, electromyography, Gait disability stroke, locomotor therapy, muscular weakness, reflex variability stroke
Brief summary
The overriding goal of this proposal is to identify the critical physiological and biomechanical effects of BWSTT for promoting improved locomotor function in persons with post-stroke hemiparesis.
Detailed description
In this pilot study, we tested two forms of locomotor training for gait rehabilitation in persons post-stroke: traditional locomotor training (partial body-weight support and manual assistance of therapists) vs. robotic-assisted locomotor training (partial body-weight support and robotic guidance with the Lokomat). We enrolled 16 persons with chronic (\>6 months) hemiparesis post-stroke who were randomized to traditional/manual or robotic locomotor training. All individuals received 12 sessions (thrice weekly for four weeks) of training. Each session involved 30 minutes of stepping. The complete study results are published.
Interventions
BEHAVIORALLocomotor training
This study compares two forms of Iocomotor training: 1) standard or manual - in which an individual is provided partial body weight support while walking on a treadmill with assistance of 1-3 therapists to move the legs and stabilize the trunk/pelvis and 2) robotic-guided - in which an exoskeleton robot (Lokomat) guides movement of the walking pattern. Partial body-weight support, treadmill walking and treadmill speed are consistent between the study arms.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of cerebrovascular accident * Single event * Unilateral hemiplegia * Locomotor disability * Ability to walk independently 25' on level ground (may use an assistive device \[cane or walker\]; may NOT use a brace) * Cognitive ability to follow 3-step commands
Exclusion criteria
* Unstable or uncontrolled blood pressure * Uncontrolled seizures * Severe cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-selected Overground Walking Speed | 4 weeks (s/p 12 sessions of locomotor training) | Overground walking speed determined as rate of walking over a 10 meter distance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six Minute Walk | 4 weeks | distance, in meters, walked overground over a six minute interval. |
| Step Length Ratio (Abs) | 4 weeks | measure of step length symmetry, calculated as = ABS \[1 - (Pstep length / NPstep length)\] |
| Fast Walking Speed | 4 weeks (s/p 12 training sessions) | Fastest comfortable walking speed measured while walking overground |
| Short Physical Performance Battery | 4 weeks | Standardized clinical measure of physical function involving tests of: walking speed, strength (repeated chair rise), and balance. The scale ranges from 0 - 12 points with better physical function as the score approaches 12 points and worse physical function as the score approaches 0 points. |
| Berg Balance Scale | 4 weeks | Clinical measure of balance |
| Lower Extremity Fugl-Meyer Motor Assessment | 4 weeks | Standardized clinical measure of motor impairment. The lower extremity (leg) sub-scale ranges from 0 - 35 points, where less impairment corresponds with scores approaching 35 and worse impairment corresponds with scores approaching 0. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 2: Robot-assisted Rehabilitation for Post-stroke Hemiparesis
Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support). | 8 |
| Arm 1: Therapist Assisted Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg) | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Arm 1: Therapist Assisted | Total | Arm 2: Robot-assisted |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 12 Participants | 6 Participants |
| Age, Continuous | 55.1 years STANDARD_DEVIATION 13.6 | 56.8 years STANDARD_DEVIATION 14.4 | 58.6 years STANDARD_DEVIATION 16.9 |
| Berg Balance Scale | 47 units on a scale STANDARD_DEVIATION 7 | 46.9 units on a scale STANDARD_DEVIATION 7 | 46.9 units on a scale STANDARD_DEVIATION 7.5 |
| Fast Walking Speed | 0.72 meters per second STANDARD_DEVIATION 0.37 | 0.80 meters per second STANDARD_DEVIATION 0.47 | 0.87 meters per second STANDARD_DEVIATION 0.55 |
| Gender Female | 1 Participants | 3 Participants | 2 Participants |
| Gender Male | 7 Participants | 13 Participants | 6 Participants |
| Lower Extremity Fugl-Meyer Motor Assessment | 21.4 units on a scale STANDARD_DEVIATION 5.1 | 23 units on a scale STANDARD_DEVIATION 4.5 | 23.0 units on a scale STANDARD_DEVIATION 4.3 |
| Region of Enrollment United States | 8 participants | 16 participants | 8 participants |
| Self-selected Overground Walking speed | 0.62 meters per second STANDARD_DEVIATION 0.28 | 0.62 meters per second STANDARD_DEVIATION 0.28 | 0.62 meters per second STANDARD_DEVIATION 0.31 |
| Short Physical Performance Battery | 7.8 units on a scale STANDARD_DEVIATION 3 | 7.31 units on a scale STANDARD_DEVIATION 3.1 | 6.9 units on a scale STANDARD_DEVIATION 3.4 |
| Six Minute Walk Test | 234.3 distance walked, meters STANDARD_DEVIATION 141.2 | 250.8 distance walked, meters STANDARD_DEVIATION 161.1 | 267.3 distance walked, meters STANDARD_DEVIATION 187.2 |
| Step-length Asymmetry | 0.39 ratio STANDARD_DEVIATION 0.37 | 0.45 ratio STANDARD_DEVIATION 0.48 | 0.53 ratio STANDARD_DEVIATION 0.58 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Self-selected Overground Walking Speed
Overground walking speed determined as rate of walking over a 10 meter distance.
Time frame: 4 weeks (s/p 12 sessions of locomotor training)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 2: Robot-assisted | Self-selected Overground Walking Speed | 0.72 meters/s | Standard Deviation 0.38 |
| Arm 1: Therapist Assisted | Self-selected Overground Walking Speed | 0.65 meters/s | Standard Deviation 0.29 |
Comparison: Between group comparison of Robot (Lokomat) vs. Manual (therapist-assisted) training.p-value: 0.72Wilcoxon (Mann-Whitney)
Comparison: Within group test for change pre- vs. post-training due to Robot (Lokomat) training.p-value: <0.05Wilcoxon Signed Ranks
Comparison: Within group test for change pre- vs. post-training due to Manual (Therapist Assisted) training.p-value: >0.05Wilcoxon Signed Ranks
Secondary
Berg Balance Scale
Clinical measure of balance
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 2: Robot-assisted | Berg Balance Scale | 48.3 units on a scale | Standard Deviation 6.8 |
| Arm 1: Therapist Assisted | Berg Balance Scale | 51.0 units on a scale | Standard Deviation 5.4 |
Comparison: Between groups comparison of robot vs. manual training.p-value: >0.05Wilcoxon (Mann-Whitney)
Comparison: Within group comparison of pre- vs. post-training effects of manual training.p-value: <0.05Wilcoxon Signed Ranks
Comparison: Within group comparison of pre- vs. post-treatment effects of robot training.p-value: <0.05Wilcoxon Signed Ranks
Secondary
Fast Walking Speed
Fastest comfortable walking speed measured while walking overground
Time frame: 4 weeks (s/p 12 training sessions)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 2: Robot-assisted | Fast Walking Speed | 0.96 meters/s | Standard Deviation 0.66 |
| Arm 1: Therapist Assisted | Fast Walking Speed | 0.70 meters/s | Standard Deviation 0.33 |
Comparison: Between-groups comparison of Robot vs. Manual training.p-value: >0.05Wilcoxon (Mann-Whitney)
Comparison: Within groups comparison (pre- vs. post-treatment) due to Manual (therapist-assisted) treatment.p-value: >0.05Wilcoxon Signed Ranks
Comparison: Within-groups comparison of pre- vs. post-treatment effects for Robot (Lokomat) training.p-value: <0.05Wilcoxon Signed Ranks
Secondary
Lower Extremity Fugl-Meyer Motor Assessment
Standardized clinical measure of motor impairment. The lower extremity (leg) sub-scale ranges from 0 - 35 points, where less impairment corresponds with scores approaching 35 and worse impairment corresponds with scores approaching 0.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 2: Robot-assisted | Lower Extremity Fugl-Meyer Motor Assessment | 25.6 units on a scale | Standard Deviation 5 |
| Arm 1: Therapist Assisted | Lower Extremity Fugl-Meyer Motor Assessment | 22.4 units on a scale | Standard Deviation 5.2 |
Comparison: Between groups comparison of robot vs. manual training.p-value: >0.05Wilcoxon (Mann-Whitney)
Comparison: Within groups comparison for pre- vs. post-training effects of manual training.p-value: >0.05Wilcoxon (Mann-Whitney)
Comparison: Within group comparison for pre- vs. post-training effects of robot training.p-value: >0.05Wilcoxon (Mann-Whitney)
Secondary
Short Physical Performance Battery
Standardized clinical measure of physical function involving tests of: walking speed, strength (repeated chair rise), and balance. The scale ranges from 0 - 12 points with better physical function as the score approaches 12 points and worse physical function as the score approaches 0 points.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 2: Robot-assisted | Short Physical Performance Battery | 7.9 units on a scale | Standard Deviation 3.2 |
| Arm 1: Therapist Assisted | Short Physical Performance Battery | 8.5 units on a scale | Standard Deviation 3.1 |
Comparison: Between groups comparison of robot vs. manual training.p-value: >0.05Wilcoxon (Mann-Whitney)
Comparison: Within group comparison of pre- vs. post-training effects of manual training.p-value: >0.05Wilcoxon Signed Ranks
Comparison: Within group comparison of pre- vs. post-treatment effects of robot training.p-value: <0.05Wilcoxon Signed Ranks
Secondary
Six Minute Walk
distance, in meters, walked overground over a six minute interval.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 2: Robot-assisted | Six Minute Walk | 278.1 meters | Standard Deviation 176.5 |
| Arm 1: Therapist Assisted | Six Minute Walk | 212.4 meters | Standard Deviation 113.5 |
Comparison: Between-groups comparison of robot vs. manual training.p-value: >0.05Wilcoxon (Mann-Whitney)
Comparison: Within group comparison of pre- vs. post-treatment effects for manual training.p-value: >0.05Wilcoxon Signed Ranks
Comparison: Within group comparison of pre- vs. post-treatment effects of robot training.p-value: >0.05Wilcoxon signed ranks
Secondary
Step Length Ratio (Abs)
measure of step length symmetry, calculated as = ABS \[1 - (Pstep length / NPstep length)\]
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 2: Robot-assisted | Step Length Ratio (Abs) | 0.37 ratio | Standard Deviation 0.46 |
| Arm 1: Therapist Assisted | Step Length Ratio (Abs) | 0.34 ratio | Standard Deviation 0.35 |
Comparison: Between groups comparison of effects of robot vs. manual training.p-value: >0.05Wilcoxon (Mann-Whitney)
Comparison: Within groups comparison of pre- vs. post-treatment effects of manual training.p-value: >0.05Wilcoxon Signed Ranks
Comparison: Within group comparison of pre- vs. post-training effects of robot training.p-value: <0.05Wilcoxon Signed Ranks