Cerebral PalsyNCT03937700
Robot Based Gait Training Therapy for Pediatric Population With Cerebral Palsy Using the CPWalker
A study testing CPWalker Robotic Exoskeleton in people with Cerebral Palsy, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
This trial is being conducted to determine if the CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy Read more about this study
- Who is it for?
- Ages 11 to 21 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- CPWalker Robotic Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Cerebral Palsy with spastic diplegia
- Gross Motor Function Classification System score of 2-4
- Age 11-21 at time of enrollment
- Maximum weight of 75kg
- Height range of approximately 110cm to 170cm
- Ability to understand and follow verbal cues
- Lower limb measurements meet specifications of CPWalker
- Cognition sufficient to communicate pain or discomfort and follow one step direction from the investigator
Who cannot join
- Any orthopedic surgeries less than 3 months prior to study enrollment or ongoing botox injections
- Severe musculoskeletal deformities affecting safe and comfortable fit into the exoskeleton as determined by the investigator. Patients may be able to wear their AFOs in the CPWalker if it allows for safe fit.
- Unhealed wounds/lesions
- Critical motor control alterations such as dystonia, choreoathetosis, or ataxia
- Aggressive or self-harming behavior
- Severe cognitive impairments that prevent a subject from being able to understand the exercises an/or interact with the study staff
Trial locations and contacts
1 site in 1 country.
About this study
This trial is being conducted to determine if the CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy
Read the detailed description
Objectives:
- To determine the use of the CPWalker rehabilitation platform, a robotic device composed by an exoskeleton linked to a walker that provides support and balance, as a gait training intervention in the pediatric cerebral palsy population.
- To create and define detailed guidelines consisting of robotic based treatment methods for gait rehabilitation.
Hypothesis:
- CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy
- Performing lower limb training in conjunction with active head and trunk control therapies will improve functional gait levels
- Following 16-24 CPWalker training sessions, persons with cerebral palsy will show improvements in functional mobility when comparing pre-training measurements to post-training measurements
Procedures:
Participants will engage in an 8-week training program, consisting of 2-3 sessions per week based on the level of gait impairment. Percentage range of motion (ROM), partial body weight support (PWBS), and gait velocity are the principal parameters under variation during training.
Additionally, screening, baseline and post-training testing sessions will be conducted
- Conditions
- Cerebral Palsy
- Being tested
- CPWalker Robotic Exoskeleton
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPWalker Robotic ExoskeletonDevice
The CPWalker rehabilitation platform is a robotic device composed by an exoskeleton linked to a walker that provides support and balance to a child during overground training. The device is able to implement user's partial body weight support (PBWS) and allows the adaptation of exercises to the patient's capabilities by means of individual controllers for each joint, which increases the modularity of the system. Each joint of the CPWalker can operate in a range of modes with varied levels of robotic assistance or resistance
| Study group | Role | What they receive |
|---|---|---|
| CPWalker Robotic-Assisted Gait Training | Experimental | Each subject will participate in 16-24 gait training sessions in the CPWalker over the course of 8 weeks with each session lasting up to 2 hours Receives: Device: CPWalker Robotic Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-Meter Walk Test
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire 10-meter distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second.
Measured: Change from baseline gait speed at 8 weeks
Secondary outcomes (7)
6-Minute Walk Test
This test measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption.
Measured: Change from baseline distance ambulated at 8 weeks
GAITRite Data Collection
The GAITRite system automates measuring temporal and spatial gait parameters via an electronic walkway connected to a computer. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet to collect gait information. The system can be laid over any flat surface. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. Patients will be asked to walk at a self-selected speed across the GAITRite electronic walkway with at least a two meter "flying start" to compensate for initial acceleration.
Measured: Change from baseline gait quality at 8 weeks
Pediatric Balance Scale
This test is a 14-item objective measure designed to assess static balance in pediatric populations. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points.
Measured: Change from baseline balance score at 8 weeks
Selective Control Assessment of Lower Extremity (SCALE)
This clinical tool quantifies selective voluntary motor control of the lower extremities in patients with cerebral palsy.
Measured: Change from baseline selective voluntary motor control at 8 weeks
Gross Motor Function Measure (GMFM-88) dimensions D (standing) and E (walking)
This test measures the change in gross motor function with intervention in children with cerebral palsy
Measured: Change from baseline gross motor function at 8 weeks
Child and Adolescent Scale of Participation
This questionnaire measures the extent to which children participate in home, school, and community activities as reported by family caregivers.
Measured: Change in children's baseline participation in activities at 8 weeks
Gillette Functional Assessment Questionnaire (FAQ)
This is a proxy-report measure that includes a ten-level classification of ambulatory function and 22 functional locomotor activities
Measured: Change in baseline report of ambulatory function at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Jul 2019
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937700
- Sponsor's protocol ID
- STU00206310
- Status last verified
- May 2026
- First submitted
- 1 May 2019
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot Based Gait Training Therapy for Pediatric Population With Cerebral Palsy Using the CPWalker
- ClinicalTrials.gov ID
- NCT03937700
- Acronym / sponsor ID
- STU00206310
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 May 2019 (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.
This trial is being conducted to determine if the CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy
Detailed description
Objectives:
- To determine the use of the CPWalker rehabilitation platform, a robotic device composed by an exoskeleton linked to a walker that provides support and balance, as a gait training intervention in the pediatric cerebral palsy population.
- To create and define detailed guidelines consisting of robotic based treatment methods for gait rehabilitation.
Hypothesis:
- CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy
- Performing lower limb training in conjunction with active head and trunk control therapies will improve functional gait levels
- Following 16-24 CPWalker training sessions, persons with cerebral palsy will show improvements in functional mobility when comparing pre-training measurements to post-training measurements
Procedures:
Participants will engage in an 8-week training program, consisting of 2-3 sessions per week based on the level of gait impairment. Percentage range of motion (ROM), partial body weight support (PWBS), and gait velocity are the principal parameters under variation during training.
Additionally, screening, baseline and post-training testing sessions will be conducted
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPWalker Robotic-Assisted Gait Training | Experimental | Device: CPWalker Robotic ExoskeletonEach subject will participate in 16-24 gait training sessions in the CPWalker over the course of 8 weeks with each session lasting up to 2 hours |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Diagnosis of Cerebral Palsy with spastic diplegia
- Gross Motor Function Classification System score of 2-4
- Age 11-21 at time of enrollment
- Maximum weight of 75kg
- Height range of approximately 110cm to 170cm
Key exclusion criteria (6 listed)
- Any orthopedic surgeries less than 3 months prior to study enrollment or ongoing botox injections
- Severe musculoskeletal deformities affecting safe and comfortable fit into the exoskeleton as determined by the investigator. Patients may be able to wear their AFOs in the CPWalker if it allows for safe fit.
- Unhealed wounds/lesions
- Critical motor control alterations such as dystonia, choreoathetosis, or ataxia
- Aggressive or self-harming behavior
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 |
|---|---|---|
| CPWalker Robotic ExoskeletonThe CPWalker rehabilitation platform is a robotic device composed by an exoskeleton linked to a walker that provides support and balance to a child during overground training. The device is able to implement user's partial body weight support (PBWS) and allows the adaptation of exercises to the patient's capabilities by means of individual controllers for each joint, which increases the modularity of the system. Each joint of the CPWalker can operate in a range of modes with varied levels of robotic assistance or resistance | Device | CPWalker Robotic-Assisted Gait Training |
Primary outcome
10-Meter Walk Test
Time frame: Change from baseline gait speed at 8 weeks
This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire 10-meter distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second.
7 secondary outcomes
6-Minute Walk Test
Time frame: Change from baseline distance ambulated at 8 weeks
GAITRite Data Collection
Time frame: Change from baseline gait quality at 8 weeks
Pediatric Balance Scale
Time frame: Change from baseline balance score at 8 weeks
Selective Control Assessment of Lower Extremity (SCALE)
Time frame: Change from baseline selective voluntary motor control at 8 weeks
Gross Motor Function Measure (GMFM-88) dimensions D (standing) and E (walking)
Time frame: Change from baseline gross motor function at 8 weeks
Child and Adolescent Scale of Participation
Time frame: Change in children's baseline participation in activities at 8 weeks
Gillette Functional Assessment Questionnaire (FAQ)
Time frame: Change in baseline report of ambulatory function at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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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.
Arun Jayaraman, PT, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPWalker Robotic Exoskeleton in people with Cerebral Palsy, run by Shirley Ryan AbilityLab at 1 site in United States.
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 8 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
10-Meter Walk Test (time frame: Change from baseline gait speed at 8 weeks). 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 11 May 2026.