Cerebral PalsyRoWaCaWaNCT05473676
Robotic Walking for Children Who Cannot Walk
A study testing Robotic Training Period in people with Cerebral Palsy and Mobility Limitation, run by University of Calgary at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Cerebral Palsy, Mobility Limitation, Brain Injuries
- What is being tested?
- Robotic Training Period
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2022to 28 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pediatric Onset of Neuromotor Impairments Lab, Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
About this study
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.
- Being tested
- Robotic Training Period
- Keywords
- Robot Assisted Gait Training, Trexo, Rehabilitation, Robotic Training, Assisted Walking
- Medical subject headings
- Cerebral Palsy, Mobility Limitation, Brain Injuries, Spinal Cord Injuries, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Training PeriodDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Training Period | Experimental | 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. Receives: Device: Robotic Training Period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Training Time
Time spent in the trainer each session, total time spent in the trainer (weekly, monthly).
Measured: Assessed throughout the 12 weeks (Week 5 through Week 16) robotic training period.
Training Frequency
Frequency of training sessions (days/week).
Measured: Assessed throughout the 12 week (Week 5 through Week 16) robotic training period.
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.
Measured: 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).
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.
Measured: 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).
Early Clinical Assessment of Balance (ECAB)
Clinical balance assessment to determine participant's balance capabilities.
Measured: Assessed monthly from time of enrollment through 3-months post-training.
Secondary outcomes (16)
Number of Participants Enrolled and Completed
Assessment of number of participants that start the study and how many are able to complete the study.
Measured: Assessed throughout the study duration, an average of 7-9 months depending on time of enrollment..
Caregiver Priorities & Child Health Index of Life with Disabilities (CP-CHILD)
Qualitative assessment of impacts of robotic gait training on participants and families.
Measured: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
EQ-5D-Y (Youth)
Qualitative assessment of impacts of robotic gait training on participants and families.
Measured: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
CarerQOL
Qualitative assessment of impacts of robotic gait training on participants and families.
Measured: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
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.
Measured: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
Head Control While Walking
Head angle from vertical will be measured to determine if head control is impacted by training.
Measured: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28)..
Seated Limits of Stability
Forward, backward, and side to side leaning will be assessed to evaluate trunk strength and control.
Measured: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).
Ramp & Hold
Evaluation of stiffness and involuntary muscle activity, recorded using electromyography (EMG) or mechanomyography (MMG).
Measured: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).
Voluntary Muscle Activity
Evaluation of voluntary muscle contractions. Recorded using EMG or MMG.
Measured: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).
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.
Measured: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
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.
Measured: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
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.
Measured: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
Heart Rate Reserve
Week-long assessment measuring heart rate, tracked using Actigraph wearable sensor worn on chest and wrist.
Measured: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
Distance Walked
Week-long assessment measuring heart rate, tracked using inertial measurement units (IMUs) worn on feet.
Measured: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
Sleep Duration
Week-long assessment measuring heart rate, tracked using Actigraph wearable sensor worn on chest and wrist.
Measured: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
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.
Measured: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start4 Jul 2022
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will proceed through the same study timeline from the time of enrollment.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Condliffe, PhD MD, University of Calgary
- Investigators
- Elizabeth G Condliffe, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473676
- Sponsor's protocol ID
- REB21-1166
- Acronym
- RoWaCaWa
- Status last verified
- May 2024
- First submitted
- 22 Apr 2022
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is an Open Science plan to share de-identified IPD. All data collected in this study will be de-identified and added to a robotic training database. Access by other researchers must be requested, and agree to a Terms of Use agreement before access is granted.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Walking for Children Who Cannot Walk
- ClinicalTrials.gov ID
- NCT05473676
- Acronym / sponsor ID
- RoWaCaWa / REB21-1166
- Keywords
- Robot Assisted Gait Training, Trexo, Rehabilitation, Robotic Training, Assisted Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will proceed through the same study timeline from the time of enrollment.
| Arm | Type | Receives |
|---|---|---|
| Robotic Training Period | Experimental | Device: Robotic Training PeriodParticipants 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. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Training PeriodParticipants 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. | Device | Robotic Training Period |
Primary outcome
Training Time
Time frame: Assessed throughout the 12 weeks (Week 5 through Week 16) robotic training period.
Time spent in the trainer each session, total time spent in the trainer (weekly, monthly).
Training Frequency
Time frame: Assessed throughout the 12 week (Week 5 through Week 16) robotic training period.
Frequency of training sessions (days/week).
Canadian Occupational Performance Measures (COPM)
Time frame: 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).
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.
Goal Attainment Scaling
Time frame: 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).
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.
Early Clinical Assessment of Balance (ECAB)
Time frame: Assessed monthly from time of enrollment through 3-months post-training.
Clinical balance assessment to determine participant's balance capabilities.
16 secondary outcomes
Number of Participants Enrolled and Completed
Time frame: Assessed throughout the study duration, an average of 7-9 months depending on time of enrollment..
Caregiver Priorities & Child Health Index of Life with Disabilities (CP-CHILD)
Time frame: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
EQ-5D-Y (Youth)
Time frame: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
CarerQOL
Time frame: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
Focus Groups
Time frame: Assessed before (~Week 4) and after (~Week 16) robotic gait training.
Head Control While Walking
Time frame: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28)..
Seated Limits of Stability
Time frame: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).
Ramp & Hold
Time frame: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).
Voluntary Muscle Activity
Time frame: Assessed at enrollment (Week 0), before Robotic Training Period (~Week 4), after Robotic Training Period (~Week 16), and 3-months post-training (~Week 28).
Modified Tardieu Scale
Time frame: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
Habitual Activity Estimation Scale (HAES)
Time frame: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
PROMIS Sleep Disturbance Questionnaire
Time frame: Assessed monthly from time of enrollment (Week 0) through to 3-months post-training (~Week 28).
Heart Rate Reserve
Time frame: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
Distance Walked
Time frame: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
Sleep Duration
Time frame: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
Bowel Function
Time frame: Assessed continually for 1 week at Week 0, ~Week 4, ~Week 5-8 (once), ~Week 12-16 (once), ~Week 17, and ~Week 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: Yes. There is an Open Science plan to share de-identified IPD. All data collected in this study will be de-identified and added to a robotic training database. Access by other researchers must be requested, and agree to a Terms of Use agreement before access is granted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth G Condliffe, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Training Period in people with Cerebral Palsy and Mobility Limitation, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training Time (time frame: Assessed throughout the 12 weeks (Week 5 through Week 16) robotic training period.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.