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临床试验/NCT07405450
NCT07405450招募中不适用

Clinical Impacts of Structured Robotic Gait Training Programs

University of Calgary1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年11月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Number of Sessions Attended

研究概览

简要总结

Background and Rationale:

Walking impairments impacts the 2-3/1000 children who have cerebral palsy1,2, and others unable to walk due to other central nervous system disorders such as a traumatic brain injury. The impacts of this and related impairment impact all aspects of life. The lifelong costs of these is staggering in terms of dollars (over $1 million/child) and health adjusted life years (~half compared to typically developing populations despite only slightly shorter lifespans). Yet there are currently no effective interventions to treat the fundamental balance impairment that underlie these problems4,5. Early use of robotic gait trainers have shown many benefits6,7, however access to these trainers is limited due to cost, availability, and ease of use within the home. Currently, there are a few options for an overground robotic gait trainer supported by the stability of a walker. The Trexo, is an option designed for use at home or in a community settings, but barriers to access mean that access to this therapy is out of reach for many people who may see benefits.

Research Questions and Objectives:

The aim of this study is to (a) evaluate the feasibility of a clinical robotic gait training program and (b) evaluate the effectiveness of these types of programs in achieving patient, family, and therapist goals. The study will examine adherence to a structured training program to determine if training with a robotic gait trainer in a hospital setting is feasible for the entire length of the designed training program. Goals will be set, a re-evaluation of these goals will be completed following the training program to determine whether or not the clinical program of robotic gait training was successful in helping patients reach the goals set out at the beginning of the program.

详细描述

Background and Rationale:

Walking impairments impacts the 2-3/1000 children who have cerebral palsy1,2, and others unable to walk due to other central nervous system disorders such as a traumatic brain injury. The impacts of this and related impairment impact all aspects of life. The lifelong costs of these is staggering in terms of dollars (over $1 million/child) and health adjusted life years (~half compared to typically developing populations despite only slightly shorter lifespans). Yet there are currently no effective interventions to treat the fundamental balance impairment that underlie these problems4,5. Early use of robotic gait trainers have shown many benefits6,7, however access to these trainers is limited due to cost, availability, and ease of use within the home. Currently, there are a few options for an overground robotic gait trainer supported by the stability of a walker. The Trexo, is an option designed for use at home or in a community settings, but barriers to access mean that access to this therapy is out of reach for many people who may see benefits.

Research Questions and Objectives:

The aim of this study is to (a) evaluate the feasibility of a clinical robotic gait training program and (b) evaluate the effectiveness of these types of programs in achieving patient, family, and therapist goals. The study will examine adherence to a structured training program to determine if training with a robotic gait trainer in a hospital setting is feasible for the entire length of the designed training program. Goals will be set, a re-evaluation of these goals will be completed following the training program to determine whether or not the clinical program of robotic gait training was successful in helping patients reach the goals set out at the beginning of the program.

Methods:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • able to fit into Trexo robotic gait trainer (both leg length and weight); height of <~5'6", weight <150 lbs.)
  • able to fulfill training requirements throughout training period
  • able to comply with study procedures (assessments, training)

排除标准

  • those with contraindications to training with a robotic gait trainer (ie. medical condition or recent surgery requiring lower extremity immobilization or weight-bearing restriction (ie. fracture, unstable hip subluxation), medical condition requiring a physical activity restriction (ie. unstable arrythmia), pain or symptomatic hypotension while standing, contracture such that the Trexo Robotic Gait Training does not result in forward movement)
  • those involved in a potentially confounding intervention (will be discussed case-by-case to determine risk of impacting the study results).

研究组 & 干预措施

Clinical Impacts of Structured Robotic Gait Training Programs

Experimental

All participants will participate in this arm involving 8 weeks of training 2-3 days/week

干预措施: Clinical Impacts of Structured Robotic Gait Training Programs (Device)

结局指标

主要结局

Number of Sessions Attended

时间窗: Approximately 8 weeks

Evaluate the feasibility of using a robotic gait trainer in an out-patient setting by tracking the number of sessions attended by the participants.

Number of Sessions Missed

时间窗: Approximately 8 weeks

Evaluate the feasibility of using a robotic gait trainer in an out-patient setting by tracking the number of sessions missed by the participants.

Length of Session

时间窗: Approximately 8 weeks

Evaluate the feasibility of using a robotic gait trainer in an out-patient setting by tracking the length of each training session.

Number of steps per session

时间窗: Approximately 8 weeks

Evaluate the feasibility of using a robotic gait trainer in an out-patient setting by tracking the number of steps taken by participants in each session.

Clinician time per session

时间窗: Approximately 8 weeks per participant enrolled.

Evaluate the feasibility of using a robotic gait trainer in an out-patient setting by tracking the amount of time it takes clinicians to setup, run, and teardown for each training session

次要结局

  • Canadian Occupational Performance Measure (COPM)(Approximately 8 weeks)
  • Goal Attainment Scaling (GAS)(Approximately 8 weeks)

研究者

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

Elizabeth Condliffe, PhD MD

Assistant Professor

University of Calgary

研究点 (1)

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