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

Physical Disability Clinical Trial

Official title:

Evaluating and Improving Robot Assisted Gait Training

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407219
• Other study ID #: REB21-1312
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Calgary
• Contact: PONI Lab
• Phone: 4039555528
• Email: poni.lab[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Palsy
• CP (Cerebral Palsy)
• Developmental Disabilities
• Developmental Disability
• Physical Disability

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Heart Rate Response to Exercise	We will use the collected heart rate as well as an estimated maximum heart rate (208-0.7*age) to determine the heart rate reserve (estimated maximum heart rate minus measured resting heart rate). Once the heart rate reserve has been calculated, the measured heart rate throughout the session will be used to determine how much time the participant spent above 40% of their heart rate reserve.	Through study completion, an average of 4 weeks.
Secondary	Duration of Exercise Session	Total time participant spends actively using the Trexo. This is measured directly using the Trexo Robotics application.	Through study completion, an average of 4 weeks.
Secondary	Total Number of Steps Taken	Total number of steps that the participant takes in the robotic gait trainer for the duration of the session. This is measured directly in the Trexo Robotics application.	Through study completion, an average of 4 weeks.
Secondary	Average Number of Steps per Minute	Average number of steps taken per minute while actively using the Trexo. This is measured directly in the Trexo Robotics application.	Through study completion, an average of 4 weeks.
Secondary	Participant or Proxy Report of Rating of Perceived Exertion (RPE)	The participant's (or proxy, if participant is unable to communicate their RPE) perceived level of exertion for the robot assisted gait training session. This will be assessed using a rating of fatigue scale (0-10).	Through study completion, an average of 4 weeks.
Secondary	Brain Region Activation	Brain region activation will be assessed using electroencephalography (EEG) or functional near infrared spectroscopy (fNIRS). Both methods require participants to wear a cap in order to record this data. There are no contraindications to EEG or fNIRS.	Through study completion, an average of 4 weeks.
Secondary	Muscle Activation	Muscle activation will be assessed using electromyography (EMG) or mechanomyography (MMG). Both methods require surface electrodes to be placed on the skin. There are no contraindications to EMG or MMG.	Through study completion, an average of 4 weeks.
Secondary	Characteristics of Gait / Walking Pattern	Assessed using inertial measurement units (IMUs) during training sessions as well as between sessions to gather data on gait patterns outside of the robotic gait trainer. IMUs will be placed on the top of each foot of the participant (2 IMUs total).	Through study completion, an average of 4 weeks.
Secondary	Leg Muscle Spasticity	Assessed using the EMG/MMG (mentioned above) and the Biodex dynamometer. Muscles to be assessed may include: quadriceps, hamstrings, and plantarflexors. The leg will be moved passively through its range of motion while muscle activation is sensed using the sensors of the EMG/MMG system.	Through study completion, an average of 4 weeks.
Secondary	Physical Activity Level	Reported physical activity levels will be assessed using the habitual activity estimation scale (HAES) for a typical weekday as well as a typical weekend day. The HAES is a participant or proxy report of physical activity levels.	Through study completion, an average of 4 weeks.