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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Therapist assisted | Active Comparator | Therapist assisted locomotor training (partial body-weight supported) |
|
| Arm 2: Robot-assisted | Experimental | Robot-assisted locomotor training (partial body-weight supported) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Locomotor training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-selected Overground Walking Speed | Overground walking speed determined as rate of walking over a 10 meter distance. | 4 weeks (s/p 12 sessions of locomotor training) |
| Measure | Description | Time Frame |
|---|---|---|
| Fast Walking Speed | Fastest comfortable walking speed measured while walking overground | 4 weeks (s/p 12 training sessions) |
| Six Minute Walk | distance, in meters, walked overground over a six minute interval. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolynn Patten, PhD | North Florida/South Georgia Veterans Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Florida/South Georgia Veterans Health System | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19523207 | Result | Westlake KP, Patten C. Pilot study of Lokomat versus manual-assisted treadmill training for locomotor recovery post-stroke. J Neuroeng Rehabil. 2009 Jun 12;6:18. doi: 10.1186/1743-0003-6-18. | |
| 22446153 | Result | Spiess MR, Jaramillo JP, Behrman AL, Teraoka JK, Patten C. Unexpected recovery after robotic locomotor training at physiologic stepping speed: a single-case design. Arch Phys Med Rehabil. 2012 Aug;93(8):1476-84. doi: 10.1016/j.apmr.2012.02.030. Epub 2012 Mar 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 2: Robot-assisted | Rehabilitation got 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). |
| FG001 | Arm 1: Therapist Assisted | Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Arm 1: Therapist Assisted |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self-selected Overground Walking Speed | Overground walking speed determined as rate of walking over a 10 meter distance. | Posted | Mean | Standard Deviation | meters/s | 4 weeks (s/p 12 sessions of locomotor training) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARM2 | Rehabilitation got 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). |
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Small sample size, but consistent with intent of pilot study Inclusion criterion was >6 months post-event, allowing for large heterogeneity in chronicity Intervention was limited (12 sessions distributed over 4 weeks)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carolynn Patten | VA Brain Rehabilitation Research Center | 352.376.1611 | 4160 | patten@phhp.ufl.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
|
| 4 weeks |
| Step Length Ratio (Abs) | measure of step length symmetry, calculated as = ABS [1 - (Pstep length / NPstep length)] | 4 weeks |
| 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. | 4 weeks |
| 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. | 4 weeks |
| Berg Balance Scale | Clinical measure of balance | 4 weeks |
Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Self-selected Overground Walking speed | Mean | Standard Deviation | meters per second |
|
| Fast Walking Speed | Mean | Standard Deviation | meters per second |
|
| Six Minute Walk Test | Mean | Standard Deviation | distance walked, meters |
|
| Step-length Asymmetry | Measure is a ratio of paretic/non-paretic step length calculated as follows: = ABS[1-(paretic step length/non-paretic step length)] Values approaching 0 reveal greater symmetry. | Mean | Standard Deviation | ratio |
|
| Lower Extremity Fugl-Meyer Motor Assessment | The Fugl-Meyer Motor Assessment is a standardized clinical assessment used to determine the magnitude of motor impairment (or severity) following stroke. There are separate scales for the upper and lower extremities. Here we used the lower extremity component which has a range of 36 points. Higher scores reflect better motor status than lower scores. Importantly, there is a remarkable ceiling effect with the FMA, thus a full score of 36 points does not indicate an individual post-stroke has fully recovered. | Mean | Standard Deviation | units on a scale |
|
| Short Physical Performance Battery | The Short Physical Performance Battery measures 3 components of physical function: walking speed, strength - assessed through repeated sit-to-stand movements, and balance. The SPPB is scored over a range of 0-12 points, where 12 is the highest, or best, score. Each of the 3 components contributes 4 points to the total SPPB, although sub-scores are not typically calculated and/or interpreted. | Mean | Standard Deviation | units on a scale |
|
| Berg Balance Scale | The Berg Balance Scale is a standardized clinical assessment of balance function involving performance of 14 tasks ranging from sitting unsupported to standing on one leg with eyes closed. It is scored on a range of 0 - 56 points where 56 is the best score, which is generally equivalent to normal. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | Fast Walking Speed | Fastest comfortable walking speed measured while walking overground | Posted | Mean | Standard Deviation | meters/s | 4 weeks (s/p 12 training sessions) |
|
|
|
|
| Secondary | Six Minute Walk | distance, in meters, walked overground over a six minute interval. | Posted | Mean | Standard Deviation | meters | 4 weeks |
|
|
|
|
| Secondary | Step Length Ratio (Abs) | measure of step length symmetry, calculated as = ABS [1 - (Pstep length / NPstep length)] | Posted | Mean | Standard Deviation | ratio | 4 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
|
| Secondary | Berg Balance Scale | Clinical measure of balance | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Arm 1 | Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg) | 0 | 8 | 0 | 8 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| >.05 |
| No |
| Superiority or Other |
| Within-groups comparison of pre- vs. post-treatment effects for Robot (Lokomat) training. | Wilcoxon Signed Ranks | <.05 | No | Superiority or Other |
| >.05 |
| No |
| Superiority or Other |
| Within group comparison of pre- vs. post-treatment effects of robot training. | Wilcoxon signed ranks | >.05 | No | Superiority or Other |
| >.05 |
| No |
| Superiority or Other |
| Within group comparison of pre- vs. post-training effects of robot training. | Wilcoxon Signed Ranks | <.05 | No | Superiority or Other |
| >.05 |
| No |
| Superiority or Other |
| Within group comparison for pre- vs. post-training effects of robot training. | Wilcoxon (Mann-Whitney) | >.05 | No | Superiority or Other |
| >.05 |
| No |
| Superiority or Other |
| Within group comparison of pre- vs. post-treatment effects of robot training. | Wilcoxon Signed Ranks | <.05 | No | Superiority or Other |
| <.05 |
| No |
| Superiority or Other |
| Within group comparison of pre- vs. post-treatment effects of robot training. | Wilcoxon Signed Ranks | <.05 | No | Superiority or Other |