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临床试验/NCT05133362
NCT05133362终止不适用

Investigating Effects of Backward Gait Training With Exoskeleton on Gait Function, Balance and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy

Alvernia University4 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2022年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
9
试验地点
4
主要终点
Changes in Berg Balance Scale

研究概览

简要总结

The proposed study aims to optimize patient outcomes and treatment intervention using a robotic exoskeleton in adults with cerebrovascular accidents (CVA, stroke) by investigating the following: AIM 1 is to investigate the effect of backward gait training with exoskeleton on motor function.

AIM 2 is to investigate the effect of backward gait training with exoskeleton on depression.

AIM 3 is to investigate the impact of social determinants of health and depression on patient adherence to physical therapy.

详细描述

Based on previous findings on backward gait training as well as the use of a wearable robotic exoskeleton in forward gait training, we hypothesize that backward gait training using exoskeleton leads to greater improvements in functional mobility, neuromuscular control and balance (AIM 1) and depression (AIM 2) in patients with stroke, when compared to standard of care, which includes forward gait training using exoskeleton. Findings from AIM 1 and 2 will provide novel evidence on the effects of backward gait training with exoskeleton in people with stroke and serve as a foundation for optimizing physical therapy protocols to improve motor functions and mental health. AIM 3 investigates the impact of social determinants of health and depression on patient adherence to physical therapy. Patient adherence (also called compliance) refers to the degree to which patients follow treatment recommendations prescribed by their health care provider.34 Even though patient adherence leads to positive treatment outcomes,35,36 it is affected by many factors, including patients' understanding of their disease and associated treatment (i.e., health literacy), social support, and depression.36-38 This experimental study employs a repeated measures design with participants randomly assigned to either a Standard Care with Ekso Group (SCG; control group, n=31) or a Standard Care with Ekso and Backward Walking Group (SCBWG; experimental group, n=31) in AIMs 1 and 2. AIMs 1 and 2 will be achieved using the group assignment as independent variables and motor function and depression as dependent variables. AIM 3 will be achieved using social determinants of health and depression as independent variables and patient adherence to physical therapy as an independent variable.

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 (Outcomes Assessor)

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

  • 18 years of age or older
  • English or Spanish speaking
  • A diagnosis first stroke (intracerebral hemorrhage or acute ischemic stroke)
  • Referred to Reading Rehabilitation Hospital Outpatient Physical Therapy Clinic (hereafter referred to as outpatient PT)

排除标准

  • Unable to follow 1-step commands
  • > 220 pounds (100 kg)
  • Height < 5'0" or > 6'4"
  • Unable to take a few steps with assistance
  • A score of > 42/56 on Berg Balance Scale (BBS)
  • Severe cardiac disease (New York Heart Association Classification IV)
  • Severe spasticity (Modified Ashworth score > 3)
  • Unstable spine or unhealed pelvic/limb fractures
  • Active heterotrophic ossification impacting lower extremity range of motion
  • Significant lower or upper extremity contractures
  • Inability to achieve neutral ankle dorsiflexion with 12° of knee flexion
  • Psychiatric or cognitive issues that could interfere with operating the exoskeleton
  • Pregnancy
  • Colostomy
  • Poor skin integrity in areas in contact with the EksoNRTM
  • Unresolved deep vein thrombosis
  • Lower limb prosthesis or amputation
  • Leg length discrepancies > 0.5 inches for upper legs, 0.75 inches for lower legs
  • ROM restrictions preventing normal, reciprocal gait
  • Inability to stand for > 60 seconds due to pain or orthostatic hypotension

结局指标

主要结局

Changes in Berg Balance Scale

时间窗: Baseline and within 1 week after the intervention

Changes from baseline static balance and fall risk at post-intervention. Berg Balance Scale ranges from 0 to 56, and a higher score indicates a better outcome (better balance and lower fall risk).

Changes in forward gait speed

时间窗: Baseline and within 1 week after the intervention

Changes from baseline forward gait speed measured by 6-Minute Walk Test at post-intervention

Changes in Functional Ambulation Category

时间窗: Baseline and within 1 week after the intervention

Changes from baseline ambulation ability at post-intervention. Functional Ambulation Category ranges from 0-5, and a higher score indicates a better outcome (greater independence in ambulation).

Changes in Patient Health Questionnaire-9

时间窗: Baseline and within 1 week after the intervention

Changes from baseline depressive symptoms at post-intervention. Patient Health Questionnaire-9 ranges from 0 to 27, and a higher score indicates a worse outcome (greater depressive symptoms).

Changes in backward gait speed

时间窗: Baseline and within 1 week after the intervention

Changes from baseline backward gait speed measured by 3-Meter Backwards Walk Test at post-intervention

Changes in reciprocal activities in antagonistic muscles measured by Electromyography

时间窗: Baseline and within 1 week after the intervention

Changes from baseline neuromuscular control of leg muscles at post-intervention. A greater reciprocity between leg antagonistic muscles indicate a better outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Soo Yeon Sun, PT, PhD

Assistant Professor

Alvernia University

研究点 (4)

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