Biomechanical Gait Analysis in Patients Post-Stroke
Primary Purpose
CVA (Cerebrovascular Accident), Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Body Weight Support Gait Training
Traditional Gait Training
Sponsored by

About this trial
This is an interventional treatment trial for CVA (Cerebrovascular Accident) focused on measuring Body Weight Support
Eligibility Criteria
Inclusion Criteria:
- Current in-patient in acute care for Cerebrovascular accident (CVA),
- Unilateral CVA affecting at least the lower limb, and
- Medically stable as determined by the rehabilitation physician.
Exclusion Criteria:
- Previous (more than 1) CVA with residual lower limb deficit, and
- Any lower extremity pathology on the affected side other than the effects of the CVA.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional Gait Training
Body Weight Support Training
Arm Description
The Traditional Gait Training group will receive gait training as presently performed without additional modalities.
The Body Weight Support group will received body weight support gait training in lieu of traditional gait training.
Outcomes
Primary Outcome Measures
Gait Speed
Velocity of center of mass of the participant.
Step Length
Difference in position between the feet at heel strike, in the direction of forward motion.
Step Width
Difference in position between the feet at heel strike, in the direction normal to the direction of forward motion.
Step Asymmetry
The ratio of the difference of left and right step length over the stride length.
Secondary Outcome Measures
Gait Units
Measure of the quantity of therapy received during the duration of care.
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.
Length of Stay
Total duration of care at the acute rehabilitation facility.
Full Information
NCT ID
NCT03602313
First Posted
May 4, 2018
Last Updated
July 18, 2018
Sponsor
Florida Gulf Coast University
1. Study Identification
Unique Protocol Identification Number
NCT03602313
Brief Title
Biomechanical Gait Analysis in Patients Post-Stroke
Official Title
Biomechanical Gait Analysis in Patients Post-Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 6, 2011 (Actual)
Primary Completion Date
September 17, 2015 (Actual)
Study Completion Date
September 17, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida Gulf Coast University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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:
Investigators will place reflective markers on the following areas using non-latex adhesive tape: top of the shoulders, bony part of the pelvis on the front and back, hips, front of the thighs, outside of the knees, front of the shins, outside of the ankles, first and fifth toes, and back of each heel.
The participant will walk across the room in the gait analysis lab no more than 20 times at his/her choice of pace while the camera system records gait parameters and kinematics. He/she will be allowed to rest as needed during the data collection.
The reflective markers and adhesive tape will be removed and the participant thanked for his/her participation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CVA (Cerebrovascular Accident), Stroke
Keywords
Body Weight Support
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomly assigned to 1 of 2 groups for the duration of the study.
Masking
Investigator
Masking Description
Investigators were blinded to the study intervention. Data collection was performed at a separate location than the primary intervention.
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional Gait Training
Arm Type
Active Comparator
Arm Description
The Traditional Gait Training group will receive gait training as presently performed without additional modalities.
Arm Title
Body Weight Support Training
Arm Type
Experimental
Arm Description
The Body Weight Support group will received body weight support gait training in lieu of traditional gait training.
Intervention Type
Device
Intervention Name(s)
Body Weight Support Gait Training
Other Intervention Name(s)
BSWTT, LiteGait
Intervention Type
Other
Intervention Name(s)
Traditional Gait Training
Other Intervention Name(s)
Overground
Primary Outcome Measure Information:
Title
Gait Speed
Description
Velocity of center of mass of the participant.
Time Frame
Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Title
Step Length
Description
Difference in position between the feet at heel strike, in the direction of forward motion.
Time Frame
Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Title
Step Width
Description
Difference in position between the feet at heel strike, in the direction normal to the direction of forward motion.
Time Frame
Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Title
Step Asymmetry
Description
The ratio of the difference of left and right step length over the stride length.
Time Frame
Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Secondary Outcome Measure Information:
Title
Gait Units
Description
Measure of the quantity of therapy received during the duration of care.
Time Frame
Measured at discharge, approximately 21 days
Title
Functional Independence Measure (FIM)
Description
A 17 items survey of patient independence in 2 domains, motor and cognition. It is used as a basic indicator of patient disability.
Time Frame
Admission of the FIM is completed within 72 hours of the start of a rehabilitation, and within 75 hours of discharge, approximately 21 days
Title
Length of Stay
Description
Total duration of care at the acute rehabilitation facility.
Time Frame
Approximately 21 days. Determined by the study clinicians based on severity of disability and rate of progress.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current in-patient in acute care for Cerebrovascular accident (CVA),
Unilateral CVA affecting at least the lower limb, and
Medically stable as determined by the rehabilitation physician.
Exclusion Criteria:
Previous (more than 1) CVA with residual lower limb deficit, and
Any lower extremity pathology on the affected side other than the effects of the CVA.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek J Lura, PhD
Organizational Affiliation
Florida Gulf Coast University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Biomechanical Gait Analysis in Patients Post-Stroke
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