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临床试验/NCT06478680
NCT06478680终止不适用

Comparing Effects of Conventional Neurorehabilitation With Exoskeleton With High-intensity Gait Training on Gait, Balance, and Depression Following Stroke and the Impact of Social Determinants of Health and Depression on Patients' Adherence to Physical Therapy

Alvernia University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2024年10月1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
3
试验地点
2
主要终点
Demographic Questionnaire

研究概览

简要总结

The purpose of this research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Investigators want to compare improvements in your walking function and mental health that occur after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect attendance at physical therapy sessions.

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 of stroke (intracerebral hemorrhage or acute ischemic stroke)
  • Referred to Good Shepherd Rehabilitation Outpatient Physical Therapy Clinic

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 ≥ 50/56 on Berg Balance Scale (BBS)
  • A score of ≥ 26/30 on Functional Gait Assessment (FGA)
  • Resting blood pressure >180/110 mmHg
  • Resting heart rate > 120 bpm
  • 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
  • Pregnancy
  • Colostomy
  • Poor skin integrity in areas in contact with the EksoGTTM
  • 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 > 3 minutes due to pain or orthostatic hypotension
  • Pusher syndrome
  • Cortical blindness

结局指标

主要结局

Demographic Questionnaire

时间窗: Pre-intervention

Questions include age, sex, date of birth, race/ethnicity, total income during T the past 12 months, main occupation and when was the last work, language at home, marital status, education level, and if they take any antidepressants.

Newest Vital Sign (NVS)

时间窗: Pre-intervention

The NVS is a 6-question screening tool that identifies participants' risk of low or limited health literacy (HL) based on interpreting an ice cream nutrition label.

Patient Health Questionnaire (PHQ-9)

时间窗: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

The PHQ-9 is a self-administered depression screening tool with nine items. It has been reported that the PHQ-9 is the best-performing tool for screening for post-stroke depression.

6-Minute Walk Test

时间窗: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

The 6MWT assesses participants' aerobic capacity/endurance by recording the distance (in meters) that the participants walk in 6 minutes. Assistive devices may be used and will be documented.

Borg rating scale of Perceived Exertion

时间窗: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

The Borg Rating Scale of Perceived Exertion will be measured in all participants at the completion of 6 minute walk test. It measures exertion on a scale of 0 (no exertion or resting) to 10 (pushing oneself to the max).

Multidimensional Scale of Perceived Social Support (MSPSS)

时间窗: Pre-intervention

The Multidimensional Scale of Perceived Social Support is a 12-item self-administered scale that measures social support. The total score for the MSPSS ranges from 12 to 84, with higher scores indicating higher levels of perceived social support.

Berg Balance Scale (BBS)

时间窗: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

The Berg Balance Scale is a 14-item clinician-rated measure that assesses static and balance in sitting and standing. It has a maximum score of 56 points. Each item is scored on a 5-point scale from 0 to 4, with 0 indicating the subject is unable to perform the task and 4 being the highest score.

3-Meter Backwards Walk Test (3MBWT)

时间窗: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

The 3MBWT measures the time (in seconds) it takes for a participant to walk 3 meters backward, hence assessing a backward gait speed. Backward gait speed is used to evaluate neuromuscular control, proprioception, protective reflexes, fall risk, and balance. Use of assistive devices will be documented.

10-meter Walk Test

时间窗: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

The 10mWT assesses walking speed in meters/second (m/s) over a short distance (10m). Two trials are administered at the patient's comfortable walking speed, followed by 2 trials at their fast walking speed, per Physical Therapist's instruction. The 2 trials for each speed are then averaged and the 2 gait speeds (preferred and fast) are documented in m/s. Assistive devices may be used, and will be documented.

Muscle coactivation index

时间窗: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

Muscle coactivation index will be calculated based on the EMG signals from 8 leg muscles (bilateral tibialis anterior, medial gastrocnemius, rectus femoris, medial hamstring). Surface electromyographic recordings will be conducted during forward and backward walking tests.

Functional Gait Assessment (FGA)

时间窗: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)

The FGA is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. The Functional Gait Assessment (FGA) is scored on a 4-point ordinal scale ranging from 0-3, with 0 indicating severe impairment and 3 indicating normal ambulation. The total score is calculated by summing all the items and ranges from 0-30, with lower scores indicating greater impairment.

次要结局

  • Patient compliance(After 20 interventions (~10 weeks))

研究者

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

Soo Yeon Sun, PT, PhD

Associate professor

Alvernia University

研究点 (2)

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