Clinical trial NCT06407219: Evaluating the Impacts of a Single Session of Robot Assisted Gait Training With a Trexo
Official title: Evaluating and Improving Robot Assisted Gait Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Disability
CP (Cerebral Palsy)
Developmental Disability
Keywords: Robot Assisted Gait Training
Trexo
Rehabilitation
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a randomized cross-over design, where participants will complete a training session in both the endurance mode and the strength mode of the Trexo robotic gait trainer. The session completed first will be randomized.
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Heart Rate Response to Exercise
timeFrame: Through study completion, an average of 4 weeks.
Secondary outcomes:
measure: Duration of Exercise Session
timeFrame: Through study completion, an average of 4 weeks.
measure: Total Number of Steps Taken
timeFrame: Through study completion, an average of 4 weeks.
measure: Average Number of Steps per Minute
timeFrame: Through study completion, an average of 4 weeks.
measure: Participant or Proxy Report of Rating of Perceived Exertion (RPE)
timeFrame: Through study completion, an average of 4 weeks.
measure: Brain Region Activation
timeFrame: Through study completion, an average of 4 weeks.
measure: Muscle Activation
timeFrame: Through study completion, an average of 4 weeks.
measure: Characteristics of Gait / Walking Pattern
timeFrame: Through study completion, an average of 4 weeks.
measure: Leg Muscle Spasticity
timeFrame: Through study completion, an average of 4 weeks.
measure: Physical Activity Level
timeFrame: Through study completion, an average of 4 weeks.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Elizabeth G Condliffe, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: