Clinical trial NCT03602313: Biomechanical Gait Analysis in Patients Post-Stroke
Official title: Biomechanical Gait Analysis in Patients Post-Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CVA (Cerebrovascular Accident)
Stroke
Keywords: Body Weight Support
Lead sponsor: Florida Gulf Coast University
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomly assigned to 1 of 2 groups for the duration of the study.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Gait Speed
timeFrame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
measure: Step Length
timeFrame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
measure: Step Width
timeFrame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
measure: Step Asymmetry
timeFrame: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.
Secondary outcomes:
measure: Gait Units
timeFrame: Measured at discharge, approximately 21 days
measure: Functional Independence Measure (FIM)
timeFrame: Admission of the FIM is completed within 72 hours of the start of a rehabilitation, and within 75 hours of discharge, approximately 21 days
measure: Length of Stay
timeFrame: Approximately 21 days. Determined by the study clinicians based on severity of disability and rate of progress.
Other outcomes:
Locations:
Study officials:
affiliation: Florida Gulf Coast University
name: Derek J Lura, PhD
role: PRINCIPAL_INVESTIGATOR
References: