Biomechanical Gait Analysis in Patients Post-Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke; CVA (Cerebrovascular Accident)
• Intervention / Treatment: Other: Traditional Gait Training; Device: Body Weight Support Gait Training

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:

1. 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.
2. 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.
3. The reflective markers and adhesive tape will be removed and the participant thanked for his/her participation.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Traditional Gait Training; The Traditional Gait Training group will receive gait training as presently performed without additional modalities.	Other: Traditional Gait Training; Other Names: Overground
EXPERIMENTAL: Body Weight Support Training; The Body Weight Support group will received body weight support gait training in lieu of traditional gait training.	Device: Body Weight Support Gait Training; Other Names: BSWTT, LiteGait

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Florida Gulf Coast University
• Investigators: Principal Investigator: Derek J Lura, PhD, Florida Gulf Coast University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2011
• Primary Completion (ACTUAL): September 17, 2015
• Study Completion (ACTUAL): September 17, 2015

Study Registration Dates

• First Submitted: May 4, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Body Weight Support
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2011-40 (Other Identifier: AP HM)

Drug and device information, study documents

• 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