Cerebral PalsyNCT05378243
Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV
A study testing Robotic Gait Training and Functional Clinical Therapy in people with Cerebral Palsy, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Robotic Gait Training and Functional Clinical Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 8 Nov 2021to 31 Jul 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with a diagnosis of cerebral palsy
- GMFCS Levels III and IV
- Ages ≥2 to ≤12 years
- Ability to take steps with and/or without assistance
- Meet the Trexo Plus device size requirements
- Ability to follow instructions and signal pain, fear, or discomfort
- Ability to safely use the device at home as determined by the study team
Who cannot join
- Lower limb or orthopedic surgery within 9 months prior to enrollment
- Botulinum toxin injections within 4 months prior to enrollment
- Serial casting within 3 months prior to enrollment
- Knee flexion contracture > 20°
- Knee valgus > 40°
- Hip subluxation > 40 % migration percentage
Show all 11Show fewer
- Uncontrolled movements that prevent transfer in and/or out of device
- Weight bearing restrictions
- Uncontrolled seizures
- Skin lesions in areas where the device straps would be attached
- Significant language barrier with parents and/or caregivers Note: children with severe contractures will be unable to fit in the device and are therefore excluded from the study
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario
Anna M McCormick, MD, 613-737-7600 ext. 2831, amccormick@cheo.on.ca
Michelle Larin, MSc, 613-737-7600 ext. 4359, MLarin@cheo.on.ca
About this study
Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.
Read the detailed description
Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.
The primary objective is to assess feasibility of the study design and device tolerability. Specifically:
- Recruitment success (number screened, number eligible, number enrolled) where 80% of the recruitment target is reached.
- Attrition rates of less than 10% (i.e. ≥90% of participant's successfully complete assessments).
- Adherence for each participant: 80% of participants who complete assessments achieve the minimum target dose (i.e. approx. ≥30 hours of therapy in both study groups).
- Qualitative feedback from clinicians and patients/caregivers on device tolerability and study participation.
Secondary objectives will evaluate the distance a child can walk in two minutes using the Two Minute Walk Test (2MWT, 18) and will examine a more global impact of the use of this technology. Data collected will include quality of gait, child or proxy chosen individualized goals, hypertonicity, contractures, and bone health.
- Conditions
- Cerebral Palsy
- Being tested
- Robotic Gait Training, Functional Clinical Therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Gait TrainingDevice
Use of a walker adapted with robotic components to promote proper walking gait
Functional Clinical TherapyBehavioural
Personalized program of physical therapy targeted to improving walking gait
| Study group | Role | What they receive |
|---|---|---|
| Robotic Gait Training | Experimental | 8 weeks of therapy with the robotic gait training device 4-5 times a week for 1 hour each session Receives: Device: Robotic Gait Training |
| Functional Clinical Therapy | Experimental | 8 weeks of therapy with a custom designed therapy program for the participant's needs 4-5 times a week for 1 hour each session Receives: Behavioral: Functional Clinical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment and recruitment in this study design
Recruitment success as defined by meeting 80% of the recruitment target
Measured: 4 months
Retention in this study design
Attrition of less than 10% where 90% of participants are completing the assessments to the end of the trial
Measured: 4 months
Adherance to protocol for each participant
Participant self-reported session diaries will be assessed to determine whether participants are achieving the min target dose of 30h of therapy over each 8 week session
Measured: 4 months
Device tolerability
Participant caregivers will be interviewed for qualitative feedback on device/therapy tolerability after each 8 week session
Measured: 4 months
Secondary outcomes (11)
2 minute walk test (2mwt)
distance child is able to walk in their own walker in 2 minutes
Measured: 4 months
Edinburgh Visual Gait Score
Edinburgh Visual Gait Score is used for assessing gait quality by assessing body positions and angles of various body parts through the gait pattern using a scale of 0-2 for each individual component of the assessment. A score of 0 indicates a more physiologically normal result while a score of 2 indicates a more disordered result. The scores are totaled to provide the complete score for the patient on this assessment
Measured: 4 months
Physiological Cost Index
assessing gait efficiency by looking at the heart rate changes upon a specified exertional task. A lower physiological cost index indicates less exertion required to complete the task
Measured: 4 months
Modified Ashworth Scale
The Modified Ashworth Scale measures resistance during passive soft tissue stretching. It is ranked by body part on a scale of 0-4 with 0 being a normal tone and 4 being highly rigid in flexion or extension.
Measured: 4 months
Hypertonia Assessment Tool
Assessing dystonia, spasticity, and rigidity, or a mixed tone through a rating scale system where 0 indicates the behavior is not observed and 1 indicates the dystonic/spastic/rigid behavior is observed.
Measured: 4 months
Barry Albright Dystonia Scale
Assessing dystonia and severity of dystonia in eyes, mouth, neck, trunk, each upper extremity and each lower extremity. Scored from 0-4 where 0 is an absence of dystonia and 4 is a high degree of dystonia.
Measured: 4 months
Goal attainment scale
Attainment of self-determined goals for treatment outcomes. Goals are set with the study therapists at the outset of each treatment period and assessed using a scale of -2 to +2 where a score of 0 is the expected outcome, a negative score indicates less than expected and a positive number indicates more than expected
Measured: 4 months
Spinal Alignment and Range of Motion Measure
Range of motion throughout the body is measured from 0-4 where 0 is no limitation and 4 is a severe limitation.
Measured: 4 months
Leg Bone cortical density
peripheral Quantitative Computed Tomography (pQCT) Measures Cortical density (mg/cm2)
Measured: 4 months
Tibia volumetric bone mineral density (BMD)
peripheral Quantitative Computed Tomography (pQCT) Measures Tibia volumetric bone mineral density (BMD) (mg/cm2)
Measured: 4 months
Leg bone cortical cross-sectional area
peripheral Quantitative Computed Tomography (pQCT) Measures cortical cross-sectional area (mm2)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start8 Nov 2021
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover trial
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Brain Institute, Academic Health Science Centres
- Responsible party
- Principal investigator, Anna McCormick, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378243
- Sponsor's protocol ID
- 20200502
- Status last verified
- Aug 2023
- First submitted
- 5 May 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no intention to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV
- ClinicalTrials.gov ID
- NCT05378243
- Acronym / sponsor ID
- 20200502
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- Ontario Brain Institute, Academic Health Science Centres
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 18 May 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.
Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.
Detailed description
Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.
The primary objective is to assess feasibility of the study design and device tolerability. Specifically:
- Recruitment success (number screened, number eligible, number enrolled) where 80% of the recruitment target is reached.
- Attrition rates of less than 10% (i.e. ≥90% of participant's successfully complete assessments).
- Adherence for each participant: 80% of participants who complete assessments achieve the minimum target dose (i.e. approx. ≥30 hours of therapy in both study groups).
- Qualitative feedback from clinicians and patients/caregivers on device tolerability and study participation.
Secondary objectives will evaluate the distance a child can walk in two minutes using the Two Minute Walk Test (2MWT, 18) and will examine a more global impact of the use of this technology. Data collected will include quality of gait, child or proxy chosen individualized goals, hypertonicity, contractures, and bone health.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover trial
| Arm | Type | Receives |
|---|---|---|
| Robotic Gait Training | Experimental | Device: Robotic Gait Training8 weeks of therapy with the robotic gait training device 4-5 times a week for 1 hour each session |
| Functional Clinical Therapy | Experimental | Behavioral: Functional Clinical Therapy8 weeks of therapy with a custom designed therapy program for the participant's needs 4-5 times a week for 1 hour each session |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients with a diagnosis of cerebral palsy
- GMFCS Levels III and IV
- Ages ≥2 to ≤12 years
- Ability to take steps with and/or without assistance
- Meet the Trexo Plus device size requirements
Key exclusion criteria (11 listed)
- Lower limb or orthopedic surgery within 9 months prior to enrollment
- Botulinum toxin injections within 4 months prior to enrollment
- Serial casting within 3 months prior to enrollment
- Knee flexion contracture > 20°
- Knee valgus > 40°
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 Gait TrainingUse of a walker adapted with robotic components to promote proper walking gait | Device | Robotic Gait Training |
| Functional Clinical TherapyPersonalized program of physical therapy targeted to improving walking gait | Behavioural | Functional Clinical Therapy |
Primary outcome
Enrollment and recruitment in this study design
Time frame: 4 months
Recruitment success as defined by meeting 80% of the recruitment target
Retention in this study design
Time frame: 4 months
Attrition of less than 10% where 90% of participants are completing the assessments to the end of the trial
Adherance to protocol for each participant
Time frame: 4 months
Participant self-reported session diaries will be assessed to determine whether participants are achieving the min target dose of 30h of therapy over each 8 week session
Device tolerability
Time frame: 4 months
Participant caregivers will be interviewed for qualitative feedback on device/therapy tolerability after each 8 week session
11 secondary outcomes
2 minute walk test (2mwt)
Time frame: 4 months
Edinburgh Visual Gait Score
Time frame: 4 months
Physiological Cost Index
Time frame: 4 months
Modified Ashworth Scale
Time frame: 4 months
Hypertonia Assessment Tool
Time frame: 4 months
Barry Albright Dystonia Scale
Time frame: 4 months
Goal attainment scale
Time frame: 4 months
Spinal Alignment and Range of Motion Measure
Time frame: 4 months
Leg Bone cortical density
Time frame: 4 months
Tibia volumetric bone mineral density (BMD)
Time frame: 4 months
Leg bone cortical cross-sectional area
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: No. There is no intention to share IPD with other researchers
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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.
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 Gait Training and Functional Clinical Therapy in people with Cerebral Palsy, run by Children's Hospital of Eastern Ontario 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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 29 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Larin (6137377600 ext. 4359, MLarin@cheo.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment and recruitment in this study design (time frame: 4 months). The study lists 4 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 29 Aug 2023.