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Randomized trial of patients with cerebrovascular accident (CVA) receiving traditional and body weight supported (BWS) gait training. Participants are enrolled and randomized upon entry into acute care and gait is evaluated within 48 hours of discharge from the rehabilitation hospital. Gait analysis is used to determine which of the two groups achieved gait parameters most similar to the normal gait of an age-matched population.
Potential participants are identified upon admission to acute care post cerebrovascular accident (CVA) and screened for inclusion. Informed consent is obtained from the patient and/or designee. Demographic information is obtained from the medical record, the patient and/or designee by the clinical coordinator. The participant is randomized into traditional gait training group or body weight support (BWS) group. The participant receives the required amount of physical therapy as directed by clinicians at the acute care facility and accrediting agencies.
The traditional gait training group will receive gait training as presently performed without additional modalities. The BWS group will received BWS gait training in lieu of traditional gait training. Participants will be treated in in-patient rehabilitation for a duration as determined by the clinical team; thus, the overall duration of care may be variable between participants. Time spent in gait training activities for both groups will be tracked by both service unit and by time (minutes).
Within 48 hours of discharge from the acute care facility, the participant will be transported to a separate site for kinematic gait analysis using a marker based motion capture system.
The procedure for gait analysis is as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Gait Training | Active Comparator | The Traditional Gait Training group will receive gait training as presently performed without additional modalities. |
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| Body Weight Support Training | Experimental | The Body Weight Support group will received body weight support gait training in lieu of traditional gait training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body Weight Support Gait Training | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Speed | Velocity of center of mass of the participant. | Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days. |
| Step Length | Difference in position between the feet at heel strike, in the direction of forward motion. | Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days. |
| Step Width | Difference in position between the feet at heel strike, in the direction normal to the direction of forward motion. | Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days. |
| Step Asymmetry | The ratio of the difference of left and right step length over the stride length. | Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Gait Units | Measure of the quantity of therapy received during the duration of care. | Measured at discharge, approximately 21 days |
| Functional Independence Measure (FIM) | A 17 items survey of patient independence in 2 domains, motor and cognition. It is used as a basic indicator of patient disability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derek J Lura, PhD | Florida Gulf Coast University | Principal Investigator |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Participants were randomly assigned to 1 of 2 groups for the duration of the study.
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Investigators were blinded to the study intervention. Data collection was performed at a separate location than the primary intervention.
| Traditional Gait Training |
| Other |
|
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| Admission of the FIM is completed within 72 hours of the start of a rehabilitation, and within 75 hours of discharge, approximately 21 days |
| Length of Stay | Total duration of care at the acute rehabilitation facility. | Approximately 21 days. Determined by the study clinicians based on severity of disability and rate of progress. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |