Robotic Walking for Children Who Cannot Walk

Cerebral Palsy Clinical Trial

— RoWaCaWa  

Official title:

Robotic Walking for Children Who Cannot Walk

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05473676
• Other study ID #: REB21-1166
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 4, 2022
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A common problem among children with nervous system disorders is difficulty walking on their own. This has impacts beyond mobility including short and long-term health conditions associated with physical inactivity and different developmental experiences as a result of the mobility impairments. A robotic trainer can both provide rehabilitation and be an assistive device to help compensate for difficulties. Figuring out how to prescribe it is critical to improve daily life for children with significant disabilities. Preliminary use of robotic trainers have shown many benefits, such as better head control and improved independence in transfers, which greatly increases ability to live independently. Additionally, vital functions that are frequently impaired in those with less physical activity, such as sleep and bowel habits, seem to improve. Finally, these children enjoy using them. This project aims to determine who is most likely to benefit from training with a robotic trainer and investigate key details about the dose of training that is needed. Families that are already using or hope to use robotic training need this data to help improve their access to the intervention. Clinicians need this systematic approach to building evidence to ensure a future multi-centre randomized control trial is well designed. This study is needed to help improve the lives of those who live with significant disabilities. The objective is to evaluate the feasibility and impacts of delivering robotic gait training at home. Integral in this study is capturing the user perspectives. This will both provide preliminary evidence-based advice to potential users, their families, and clinicians as well as provide key metrics to design a definitive multi-centre randomized control trial. The investigators will provide robotic gait trainers, specifically Trexo robotic gait trainers, to participants and their families to use in their home communities for 12 weeks to evaluate the feasibility and impacts of intensive robotic gait training in people who cannot walk independently. Assessments will be completed throughout the duration of study, including before, during, and after the training intervention, with the goal of evaluating a wide range of feasibility considerations and impacts from robotic training.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

Inclusion Criteria:

• At least 4 years of age
• Unable to walk independently due to pediatric onset, non-progressive central nervous system disorder or injury (ie. cerebral palsy or acquired brain injury)
• Able to fit into Trexo robotic gait trainer (both leg length and weight)
• Able to fulfill training requirements throughout training period (5 days/week for at least 30 minutes each session)
• Able to comply with study procedures (assessments, training)

Exclusion Criteria:

• Medical condition or recent surgery requiring lower extremity immobilization or weight-bearing restrictions (ie. fracture, unstable hip subluxation).
• Medical condition requiring a physical activity restriction (ie. unstable arrhythmia).
• Pain or symptomatic hypotension while standing.
• Contracture such that the Trexo robotic gait trainer does not result in forward movement.
• Current involvement in a potentially confounding intervention (determined on a case-by-case basis).

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Palsy
• Mobility Limitation
• Spina Bifida
• Spinal Cord Injuries
• Spinal Dysraphism
• Wounds and Injuries

Intervention

Device:
• Robotic Training Period
Participants will engage in robot assisted gait training on at least 5 days/week for at least 30 minutes each day, for a total period of 12 weeks.

Locations

Country	Name	City	State
Canada	Pediatric Onset of Neuromotor Impairments Lab, 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	Training Time	Time spent in the trainer each session, total time spent in the trainer (weekly, monthly).	Assessed throughout the 12 weeks (Week 5 through Week 16) robotic training period.
Primary	Training Frequency	Frequency of training sessions (days/week).	Assessed throughout the 12 week (Week 5 through Week 16) robotic training period.
Primary	Canadian Occupational Performance Measures (COPM)	Structured questions and rating scales to determine problem areas and goals for training. Identified problems are scored on a 10 point scale, 1 being not able to complete the task at all.	Assessed at enrollment (Week 0), before Robotic Gait Training period (~Week 4), following Robotic Gait Training period (~Week 16), and at 3-months post-training (~Week 28).
Primary	Goal Attainment Scaling	Rating of success in achieving an outcome or desired goal (identified using the COPM), where 0 = the expected level of achievement, -2 = much less achieved than expected, and +2 = much more achieved than expected.	Assessed at enrollment (Week 0), before Robotic Gait Training period (~Week 4), following Robotic Gait Training period (~Week 16), and at 3-months post-training (~Week 28).
Primary	Early Clinical Assessment of Balance (ECAB)	Clinical balance assessment to determine participant's balance capabilities.	Assessed monthly from time of enrollment through 3-months post-training.
Secondary	Number of Participants Enrolled and Completed	Assessment of number of participants that start the study and how many are able to complete the study.	Assessed throughout the study duration, an average of 7-9 months depending on time of enrollment..
Secondary	Caregiver Priorities & Child Health Index of Life with Disabilities (CP-CHILD)	Qualitative assessment of impacts of robotic gait training on participants and families.	Assessed before (~Week 4) and after (~Week 16) robotic gait training.
Secondary	EQ-5D-Y (Youth)	Qualitative assessment of impacts of robotic gait training on participants and families.	Assessed before (~Week 4) and after (~Week 16) robotic gait training.
Secondary	CarerQOL	Qualitative assessment of impacts of robotic gait training on participants and families.	Assessed before (~Week 4) and after (~Week 16) robotic gait training.
Secondary	Focus Groups	Semi-structured interviews with participants and families and/or caregivers. Themes will include independence in daily function and feedback on training with the device.	Assessed before (~Week 4) and after (~Week 16) robotic gait training.
Secondary	Head Control While Walking	Head angle from vertical will be measured to determine if head control is impacted by training.	Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28)..
Secondary	Seated Limits of Stability	Forward, backward, and side to side leaning will be assessed to evaluate trunk strength and control.	Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).
Secondary	Ramp & Hold	Evaluation of stiffness and involuntary muscle activity, recorded using electromyography (EMG) or mechanomyography (MMG).	Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).
Secondary	Voluntary Muscle Activity	Evaluation of voluntary muscle contractions. Recorded using EMG or MMG.	Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).
Secondary	Modified Tardieu Scale	Clinician movement of joint to determine range of motion and angle of catch at the joint. Joint neutral is defined as 0 degrees, where any range beyond neutral is recorded in "+" degrees and any range not reaching neutral is recorded in "-" degrees.	Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
Secondary	Habitual Activity Estimation Scale (HAES)	Participant or proxy report of estimated physical activity during a typical weekday and week-end day. Participants or proxy report a percentage of time spent inactive, somewhat inactive, somewhat active, and active on a typical weekday and week-end day.	Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
Secondary	PROMIS Sleep Disturbance Questionnaire	Participant or proxy report of sleep disturbances. Participants or a proxy will rate different sleep scenarios on a 5 point scale, 1 being Never and 5 being Always.	Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
Secondary	Heart Rate Reserve	Week-long assessment measuring heart rate, tracked using Actigraph wearable sensor worn on chest and wrist.	Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
Secondary	Distance Walked	Week-long assessment measuring heart rate, tracked using inertial measurement units (IMUs) worn on feet.	Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
Secondary	Sleep Duration	Week-long assessment measuring heart rate, tracked using Actigraph wearable sensor worn on chest and wrist.	Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
Secondary	Bowel Function	Week-long assessment measuring frequency and quality of bowel movements as well as any interventions used to facilitate bowel movements, for example medications. Tracked using participant or proxy reports in a daily diary provided by study team.	Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28