Cerebral PalsyNCT05726591
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
A study testing EA-KAFO in people with Cerebral Palsy and Muscular Dystrophy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: People with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Cerebral Palsy, Muscular Dystrophy, Spina Bifida
- What is being tested?
- EA-KAFO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2023to 31 Oct 2027
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated separate informed consent and assent forms for screening purposes. Upon inclusion in the protocol, provision of signed and dated informed consent and assent forms to begin participation in the study will be necessary.
- Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.
- Age 3 to 17 years old.
- Have a gait pathology involving the knee joint, from a diagnosis of cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury.
- Knee joint range of motion of at least 25 degrees in the sagittal plane (knee extension/flexion) assessed with hip extended in supine position. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.
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- Ankle joint range of motion of at least 15 degrees in the sagittal plane (dorsi-plantar flexion) with the foot in neutral alignment.
- A measured foot-thigh angle of -15 to 30 degrees in prone position.
- Able to walk at least 10 feet without stopping with or without a walking aid.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed with the robotic exoskeleton.
- A history of uncontrolled seizure in the past year.
- Pregnancy. A urine test will be performed for all participants who are able to become pregnant at the initial screening visit and in the case of a positive test, the participant will be excluded from participation. Further monitoring will rely on self-reporting of interruption in menstruation that would require re-testing for pregnancy at the next visit.
- Any acute cardiopulmonary condition which limits exercise to less than 60 minutes per session or less than 5 days per week.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: A Phase I/II Trial Evaluating Long-Term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Background:
People with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. The wearable robot offers a new form of gait training.
Read more
Objective:
To learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder.
Eligibility:
People aged 3 to 17 years with a gait disorder involving the knee joint.
Design:
Participants will be screened. They will have a physical exam. Their walking ability will be tested.
Participants will have markers taped on their body; they will walk while cameras record their movements. They will undergo other tests of their motor function and muscle strength.
The study will be split into three 12-week phases. During 1 phase, participants will continue with their standard therapy.
During another phase, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches.
During the third phase, participants may take the exoskeleton home. They will walk in the device at least 1 hour per day, 5 days per week, for 12 weeks.
Participants walking ability will be retested after each phase....
Read the detailed description
Study Description:
This randomized crossover trial will determine whether 12 weeks of overground gait training with a robotic exoskeleton outside of the clinical setting has a beneficial effect on walking ability, muscle activity, and overall gross motor function. Participants will be randomized into two groups, one that receives the exoskeleton therapy first before crossing over to continue standard therapy and one that continues standard therapy before completing the exoskeleton intervention. An in-lab training and accommodation period will be completed prior to the exoskeleton being sent home for use outside the clinical setting. We will monitor exoskeleton use during the intervention period for compliance and safety. Assessments of gait biomechanics, neuromuscular activity and functional mobility will be completed before and after the intervention and at 6 weeks post- intervention. It is hypothesized that the 12-week exoskeleton intervention outside the clinic setting will show greater improvements than the standard therapy.
Objectives:
Primary Objective: To evaluate the effectiveness of a longitudinal robotic exoskeleton gait training paradigm in improving crouch gait from CP or knee extension deficiency from SB, iSCI or MD in children, assessed as improvement in knee angle during walking before and after the intervention period.
Secondary Objectives:
To evaluate changes in muscle strength and gait speed following longitudinal intervention with robotic exoskeleton in children with crouch gait from CP or knee extension deficiency from SB, iSCI or MD. Additionally, to evaluate the primary endpoint of knee joint range of motion at multiple time points to assess for order effect and persistence of any observed effect.
Exploratory Objectives:
To assess the effect of exoskeleton dosage (i.e., time spent using the device) on the primary endpoint.
Additionally, to evaluate change in knee extensor and flexor muscle spasticity following longitudinal intervention with a robotic exoskeleton in children with crouch gait from CP or knee extension deficiency from SB, iSCI or MD. Additionally, to asses improvement in gross motor function following the same intervention. Finally, to evaluate the safety and feasibility of a community-based protocol for rehabilitation using a pediatric robotic exoskeleton.
Endpoints:
Primary Endpoint: Knee extension as assessed by peak knee angle during midstance phase of walking.
Secondary Endpoints: Change in knee extensor muscle activation and strength after exoskeleton intervention; Change in average gait speed after exoskeleton intervention; Persistence of the primary endpoint (change in knee angle) at 6 weeks post intervention; Effect of order of standard therapy and exoskeleton intervention.
Exploratory Endpoints:
Effect of exoskeleton intervention dosage on change in peak knee angle during walking; Change in knee extensor and flexor spasticity after exoskeleton intervention; Improvement in gross motor function after exoskeleton intervention; Feasibility and safety of exoskeleton use outside clinical setting assessed by participant compliance and occurrence of adverse events, respectively.
- Being tested
- EA-KAFO
- Keywords
- EEG, Muscular Dystophies, Cerebral Palsy, Knee, incomplete spinal cord injury
- Medical subject headings
- Cerebral Palsy, Muscular Dystrophies, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA-KAFODevice
This study tests a single device that contains multiple potential configurations as outlined in Table 1 of the protocol. Each participant be evaluated in multiple configurations, minimally including the baseline configuration and the motor assist condition at the knee.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 12 weeks-study intervention Receives: Device: EA-KAFO |
| Group B | No intervention | 12 weeks the control first. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effectiveness of a longitudinal exoskeleton training program in the community, as opposed to a standard regimen of therapy of the same magnitude, at improving knee extension deficiency in children with CP, SB, iSCI or MD.
The primary endpoint will be knee extension range of motion. This will be assessed using knee angle at two positions in the gait cycle: knee angle at initial contact and peak knee angle during stance
Measured: 36 Weeks
Secondary outcomes (1)
To evaluate improvement in overground walking of children with CP, SB, iSCI or MD as a function of average gait speed while walking with the robotic exoskeleton
This outcome will be measured using peak and mean activation of knee extensor and knee flexor muscles during walking.
Measured: 15 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start2 May 2023
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thomas C Bulea, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726591
- Sponsor's protocol ID
- 10001180
- Other IDs
- 001180-CC
- Status last verified
- 22 Oct 2026
- First submitted
- 11 Feb 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided: It is not yet known if there will be a plan to make IPD available
Publications
Devine TM, Alter KE, Damiano DL, Bulea TC. A randomized cross-over study protocol to evaluate long-term gait training with a pediatric robotic exoskeleton outside the clinical setting in children with movement disorders. PLoS One. 2024 Jul 8;19(7):e0304087. doi: 10.1371/journal.pone.0304087. eCollection 2024.
PubMed 38976710
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial Evaluating Long-Term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
- ClinicalTrials.gov ID
- NCT05726591
- Acronym / sponsor ID
- 10001180
- Keywords
- EEG, Muscular Dystophies, Cerebral Palsy, Knee, incomplete spinal cord injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 2 May 2023 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 14 Feb 2023 (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.
Background:
People with cerebral palsy, spina bifida, muscular dystrophy, or spinal cord injury often have muscle weakness and problems controlling how their legs move. This can affect how they walk. The NIH has designed a robotic device (exoskeleton) that can be worn on the legs while walking. The wearable robot offers a new form of gait training.
Objective:
To learn whether a robotic device worn on the legs can improve walking ability in those with a gait disorder.
Eligibility:
People aged 3 to 17 years with a gait disorder involving the knee joint.
Design:
Participants will be screened. They will have a physical exam. Their walking ability will be tested.
Participants will have markers taped on their body; they will walk while cameras record their movements. They will undergo other tests of their motor function and muscle strength.
The study will be split into three 12-week phases. During 1 phase, participants will continue with their standard therapy.
During another phase, participants will work with the exoskeleton in a lab setting. Their legs will be scanned to create an exoskeleton with a customized fit. The exoskeleton operates in different modes: in exercise mode, it applies force that makes it difficult to take steps; in assistance mode, it applies force meant to aid walking; in combination mode, it alternates between these two approaches.
During the third phase, participants may take the exoskeleton home. They will walk in the device at least 1 hour per day, 5 days per week, for 12 weeks.
Participants walking ability will be retested after each phase....
Detailed description
Study Description:
This randomized crossover trial will determine whether 12 weeks of overground gait training with a robotic exoskeleton outside of the clinical setting has a beneficial effect on walking ability, muscle activity, and overall gross motor function. Participants will be randomized into two groups, one that receives the exoskeleton therapy first before crossing over to continue standard therapy and one that continues standard therapy before completing the exoskeleton intervention. An in-lab training and accommodation period will be completed prior to the exoskeleton being sent home for use outside the clinical setting. We will monitor exoskeleton use during the intervention period for compliance and safety. Assessments of gait biomechanics, neuromuscular activity and functional mobility will be completed before and after the intervention and at 6 weeks post- intervention. It is hypothesized that the 12-week exoskeleton intervention outside the clinic setting will show greater improvements than the standard therapy.
Objectives:
Primary Objective: To evaluate the effectiveness of a longitudinal robotic exoskeleton gait training paradigm in improving crouch gait from CP or knee extension deficiency from SB, iSCI or MD in children, assessed as improvement in knee angle during walking before and after the intervention period.
Secondary Objectives:
To evaluate changes in muscle strength and gait speed following longitudinal intervention with robotic exoskeleton in children with crouch gait from CP or knee extension deficiency from SB, iSCI or MD. Additionally, to evaluate the primary endpoint of knee joint range of motion at multiple time points to assess for order effect and persistence of any observed effect.
Exploratory Objectives:
To assess the effect of exoskeleton dosage (i.e., time spent using the device) on the primary endpoint.
Additionally, to evaluate change in knee extensor and flexor muscle spasticity following longitudinal intervention with a robotic exoskeleton in children with crouch gait from CP or knee extension deficiency from SB, iSCI or MD. Additionally, to asses improvement in gross motor function following the same intervention. Finally, to evaluate the safety and feasibility of a community-based protocol for rehabilitation using a pediatric robotic exoskeleton.
Endpoints:
Primary Endpoint: Knee extension as assessed by peak knee angle during midstance phase of walking.
Secondary Endpoints: Change in knee extensor muscle activation and strength after exoskeleton intervention; Change in average gait speed after exoskeleton intervention; Persistence of the primary endpoint (change in knee angle) at 6 weeks post intervention; Effect of order of standard therapy and exoskeleton intervention.
Exploratory Endpoints:
Effect of exoskeleton intervention dosage on change in peak knee angle during walking; Change in knee extensor and flexor spasticity after exoskeleton intervention; Improvement in gross motor function after exoskeleton intervention; Feasibility and safety of exoskeleton use outside clinical setting assessed by participant compliance and occurrence of adverse events, respectively.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: EA-KAFO12 weeks-study intervention |
| Group B | No intervention | –12 weeks the control first. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated separate informed consent and assent forms for screening purposes. Upon inclusion in the protocol, provision of signed and dated informed consent and assent forms to begin participation in the study will be necessary.
- Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.
- Age 3 to 17 years old.
- Have a gait pathology involving the knee joint, from a diagnosis of cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury.
Key exclusion criteria (5 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Any neurological, musculoskeletal or cardiorespiratory injury, health condition, or diagnosis other than cerebral palsy, muscular dystrophy, spina bifida, or incomplete spinal cord injury that would affect the ability to walk as directed with the robotic exoskeleton.
- A history of uncontrolled seizure in the past year.
- Pregnancy. A urine test will be performed for all participants who are able to become pregnant at the initial screening visit and in the case of a positive test, the participant will be excluded from participation. Further monitoring will rely on self-reporting of interruption in menstruation that would require re-testing for pregnancy at the next visit.
- Any acute cardiopulmonary condition which limits exercise to less than 60 minutes per session or less than 5 days per week.
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 |
|---|---|---|
| EA-KAFOThis study tests a single device that contains multiple potential configurations as outlined in Table 1 of the protocol. Each participant be evaluated in multiple configurations, minimally including the baseline configuration and the motor assist condition at the knee. | Device | Group A |
Primary outcome
To evaluate the effectiveness of a longitudinal exoskeleton training program in the community, as opposed to a standard regimen of therapy of the same magnitude, at improving knee extension deficiency in children with CP, SB, iSCI or MD.
Time frame: 36 Weeks
The primary endpoint will be knee extension range of motion. This will be assessed using knee angle at two positions in the gait cycle: knee angle at initial contact and peak knee angle during stance
1 secondary outcome
To evaluate improvement in overground walking of children with CP, SB, iSCI or MD as a function of average gait speed while walking with the robotic exoskeleton
Time frame: 15 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 26 Oct 2026.
- Derived from this study: PubMed 38976710Devine TM, Alter KE, Damiano DL, Bulea TC. A randomized cross-over study protocol to evaluate long-term gait training with a pediatric robotic exoskeleton outside the clinical setting in children with movement disorders. PLoS One. 2024 Jul 8;19(7):e0304087. doi: 10.1371/journal.pone.0304087. eCollection 2024.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Undecided: It is not yet known if there will be a plan to make IPD available
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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.
Thomas C Bulea, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EA-KAFO in people with Cerebral Palsy and Muscular Dystrophy, run by National Institutes of Health Clinical Center (CC) 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 9 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: looking for participants now, as of the sponsor's last update on 26 Oct 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?
Contact Thomas C Bulea, Ph.D. ((301) 451-7533, buleatc@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effectiveness of a longitudinal exoskeleton training program in the community, as opposed to a standard regimen of therapy of the same magnitude, at improving knee extension deficiency in children with CP, SB, iSCI or MD. (time frame: 36 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05726591, which also lists 1 linked publication.
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 26 Oct 2026.