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临床试验/NCT04238260
NCT04238260已完成不适用

Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

University of British Columbia2 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2021年4月25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
306
试验地点
2
主要终点
Six-minute walk Test

研究概览

简要总结

The aim of this study is to assess the effect of implementing best practices into current stroke rehabilitation physical therapy on walking outcomes. Participants will also be provided an activity monitor to help them track and target their walking practice to determine if this can improve walking ability.

详细描述

This multi-site study will have each site start in usual care with participants consented to collecting outcome measures. The twelve inpatient stroke units include: Kelowna General Hospital, Nanaimo Regional General Hospital, Glenrose Rehabilitation Hospital, Saskatoon City Hospital, Wascana Rehabilitation Centre, Joseph Brant Hospital, Bruyère Hospital, Freeport Grand River Hospital, CIUSSS-de-l'Estrie-CHUS Centre de réadaptation de l'Estrie, Centre interdisciplinaire de recherche en réadaptation et intégration sociale, Dr. Everett Chalmers Regional Hospital, and Queen Elizabeth Hospital. Each site will randomly switch over to Enhanced Usual Care (best practice implementation) where all physical therapists at the site will be educated on delivery of best practice for locomotor retraining. The specific therapy activities are at the discretion of the physical therapist; however, physical therapists must work towards thirty minutes of weight-bearing/stepping activity at greater than forty percent heart rate reserve. Participants will continue to be consented to collecting outcome measures. Additionally, participants will be given and trained to use activity watches to monitor their own progress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Assessors at each site will be blinded to intervention. Site study coordinators will be unblinded.

入排标准

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

入选标准

  • Admitted by inpatient or day stroke rehabilitation
  • Improved walking is a rehabilitation goal
  • Within 12 weeks post hemorrhagic or ischemic CVA with hemiparesis (confirmed by medical chart or motor assessment)
  • Able to ambulate at least 5 steps. May use assistive and/or orthotic device and maximum one person assist
  • Overground walking speed slower than normal
  • Able to understand and follow directions
  • Greater than or equal to 19 years of age
  • Medically stable

排除标准

  • Pre-stroke health included a serious gait disorder or disease that affected ambulation (musculoskeletal conditions, amputation, surgery/arthroplasty in the last 6 months, etc.)
  • Pre-stroke health included a neurological condition (such as Parkinson's disease or Multiple Sclerosis) or other serious medical condition (active cancer, uncontrolled diabetes)
  • Excessive pain in the body/joint preventing participation in an exercise intervention
  • Participating in an experimental drug field study
  • Participating in another formal exercise rehabilitation clinical trial
  • Expected to receive <2 weeks daily in-/out- patient rehabilitation

研究组 & 干预措施

Usual Physical Therapy Care

Active Comparator

Physical Therapists continue usual care

干预措施: Physical Therapy Usual Care (Behavioral)

Enhanced Physical Therapy Usual Care

Experimental

Best practice implemented

干预措施: Enhancing Physical Therapy Usual Care (Behavioral)

结局指标

主要结局

Six-minute walk Test

时间窗: 4 weeks

This test measures distance a participant can walk in 6 minutes.

次要结局

  • Blood pressure(4 weeks & 12 months post-stroke)
  • Six-minute walk test(12 months post-stroke)
  • Short performance physical battery(4 weeks & 12 months post-stroke)
  • Modified Rankin Scale (mRS)(4 weeks & 12 months post-stroke)
  • Euro-QOL 5D-5L(4 weeks & 12 months post-stroke)
  • Physical Activity Scale for the Elderly (PASE)(12 months post-stroke)
  • Step activity monitor(12 months post stroke)
  • Montreal Cognitive Assessment(4 weeks & 12 months post-stroke)
  • Patient Health Questionnaire-9 (PHQ-9)(4 weeks & 12 months post-stroke)

研究者

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

Janice Eng

Professor

University of British Columbia

研究点 (2)

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