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

University of Calgary

Status: Enrolling

Conditions: Physical Disability; CP (Cerebral Palsy); Developmental Disability

Treatments: Device: Robot Assisted Gait Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06407219

REB21-1312

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Passive "Endurance"

Active Comparator group

Description:

Participants will complete a training session using the Trexo robotic gait trainer in the "endurance" mode with a fixed gait pattern regardless of the participant's activity.

Treatment:

Device: Robot Assisted Gait Training

Voluntary activity "Strength"

Active Comparator group

Description:

Participants will complete a training session using the Trexo robotic gait trainer in the "strength" mode where the gait pattern is impacted by the participant's activity

Treatment:

Device: Robot Assisted Gait Training