Evaluating the Impacts of a Single Session of Robot Assisted Gait Training With a Trexo

Официальное название

Evaluating and Improving Robot Assisted Gait Training

Обзор

Early use of robotic gait trainers have shown many benefits, however why these benefits occur and how to maximize them is unknown. There are a few options for how a robotic gait trainer can be used, however, there is not much understanding of how these options impact rehabilitation and compensate for impairments. The investigators aim to evaluate the impacts of as single session of Trexo robotic gait training and the impact of different modes of the Trexo robotic gait trainer. The investigators will evaluate how the different settings impact things like physical activity, walking, brain activity, spasticity, and fatigue. Investigators will arrange for a familiarity and fitting session to start, so that study team members can fit the participant to the Trexo and so that participants can become familiar with the feeling of using the Trexo robotic gait trainer. After the initial fitting sessions, follow up sessions will be completed to evaluate different settings on the Trexo, for example in "endurance" mode (where the robot completes the movements for the participant) and in "strength" mode (where the robot requires some assistance from the participant). Investigators may also test different fitting settings, for example with and without the supportive seat in the Trexo. Only three visits are required (one fitting/familiarity session and two testing sessions), however participants and/or their families may choose to complete more testing sessions if they want to assess other aspects of the training. For example, if the first two testing sessions assessed physical activity, participants and their families may choose to return for further sessions to assess brain activity. The aim of the study is to determine how robot assisted gait training impacts rehabilitation and compensates for impairments, as well as to provide suggestions on how the robotic gait trainer might be improved or modified. This study is exploratory to find out more about how these robotic gait trainers, specifically the Trexo, impacts various aspects of rehabilitation.

Вмешательства

• Устройство Robot Assisted Gait Training
  The Trexo robotic gait trainer will be used to facilitate physical activity in people who cannot walk independently, either at all or without the use of assistive gait aids (ie. walkers or canes). Session length will be determined by the participant's perceived fatigue level (ie. the session will run until the participant feels they want to or need to stop), and will not exceed 1 hour of training time.

Первичные конечные точки

• Change in Heart Rate Response to Exercise [Срок оценки: Through study completion, an average of 4 weeks.]

Вторичные конечные точки (9)

• Duration of Exercise Session [Срок оценки: Through study completion, an average of 4 weeks.]
• Total Number of Steps Taken [Срок оценки: Through study completion, an average of 4 weeks.]
• Average Number of Steps per Minute [Срок оценки: Through study completion, an average of 4 weeks.]
• Participant or Proxy Report of Rating of Perceived Exertion (RPE) [Срок оценки: Through study completion, an average of 4 weeks.]
• Brain Region Activation [Срок оценки: Through study completion, an average of 4 weeks.]
• Muscle Activation [Срок оценки: Through study completion, an average of 4 weeks.]
• Characteristics of Gait / Walking Pattern [Срок оценки: Through study completion, an average of 4 weeks.]
• Leg Muscle Spasticity [Срок оценки: Through study completion, an average of 4 weeks.]
• Physical Activity Level [Срок оценки: Through study completion, an average of 4 weeks.]

Критерии участия

Критерии включения

• Able to fit into the Trexo robotic gait trainer (<150 lbs., <5'7").
• Has impaired ability to walk due to a neurological or muscular disorder.

Критерии исключения

• >150 lbs.
• >5'6" tall
• Medical contraindication to weight bearing (ie. recent orthopedic surgery)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Канада · 1 центр

• Alberta Children's Hospital — Calgary

Идентификаторы

NCT: NCT06407219 · REB21-1312

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗