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临床试验/NCT03602313
NCT03602313已完成不适用

Biomechanical Gait Analysis in Patients Post-Stroke

Florida Gulf Coast University0 个研究点目标入组 48 人开始时间: 2011年12月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
主要终点
Gait Speed

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Investigators were blinded to the study intervention. Data collection was performed at a separate location than the primary intervention.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Traditional Gait Training

Active Comparator

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

干预措施: Traditional Gait Training (Other)

Body Weight Support Training

Experimental

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

干预措施: Body Weight Support Gait Training (Device)

结局指标

主要结局

Gait Speed

时间窗: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.

Velocity of center of mass of the participant.

Step Length

时间窗: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.

Difference in position between the feet at heel strike, in the direction of forward motion.

Step Asymmetry

时间窗: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.

The ratio of the difference of left and right step length over the stride length.

Step Width

时间窗: Collected in one 1-hour session after the patient has completed acute rehabilitation, approximately 21 days.

Difference in position between the feet at heel strike, in the direction normal to the direction of forward motion.

次要结局

  • Length of Stay(Approximately 21 days. Determined by the study clinicians based on severity of disability and rate of progress.)
  • Gait Units(Measured at discharge, approximately 21 days)
  • Functional Independence Measure (FIM)(Admission of the FIM is completed within 72 hours of the start of a rehabilitation, and within 75 hours of discharge, approximately 21 days)

研究者

申办方类型
Other
责任方
Sponsor

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