Biomechanical Gait Analysis in Patients Post-Stroke

NCT ID: NCT03602313

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-06
• Study Completion Date: 2015-09-17

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:

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.

Conditions

CVA (Cerebrovascular Accident); Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional Gait Training

The Traditional Gait Training group will receive gait training as presently performed without additional modalities.

Group Type: ACTIVE_COMPARATOR

Traditional Gait Training

Intervention Type: OTHER

Body Weight Support Training

The Body Weight Support group will received body weight support gait training in lieu of traditional gait training.

Group Type: EXPERIMENTAL

Body Weight Support Gait Training

Intervention Type: DEVICE

Interventions

Body Weight Support Gait Training

Intervention Type: DEVICE

Traditional Gait Training

Intervention Type: OTHER

Other Intervention Names

BSWTT, LiteGait; Overground

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida Gulf Coast University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Derek J Lura, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida Gulf Coast University

Other Identifiers

2011-40

Identifier Type: -

Identifier Source: org_study_id