Cerebral PalsyPhase 1NCT04516343
Development of a Robotic Ankle Assist Device
A Phase 1 study testing Robotic Ankle Assist Device (RAAD) in people with Cerebral Palsy, run by BiOMOTUM, Inc. at 1 site in United States.
Trial summary
The overall objectives of this work is to establish feasibility of a robotic ankle assist device (RAAD) to improve mobility in free-living settings and to establish the RAAD as an effective tool to provide increased dose and precision of targeted ankle therapy. Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Robotic Ankle Assist Device (RAAD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 31 Aug 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of cerebral palsy. Any sex, race, ethnicity or socioeconomic status. GMFCS level I, II, or II. Ability to walk for at least 6 minutes (assisted or unassisted). Age between 8-18 years. Height/weight/BMI between the 5th - 95th percentile of children with CP.
- Able to understand and follow simple directions. Able to complete 5 heel raises with minimal assistance (balance only). At least 20 degrees of passive ankle plantar flexion range of motion.
Who cannot join
- Knee extension or ankle dorsiflexion contractures greater than 15 degrees. Health condition or diagnosis other than CP that would affect safe participation.
- Orthopedic surgery completed in the prior 12-months. Current enrollment in a conflicting research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern Arizona University
Flagstaff, Arizona, 86011
About this study
Official title: Development of a Robotic Ankle Assist Device to Improve Mobility in Individuals With Movement Disorders
The overall objectives of this work is to establish feasibility of a robotic ankle assist device (RAAD) to improve mobility in free-living settings and to establish the RAAD as an effective tool to provide increased dose and precision of targeted ankle therapy.
The first specific goal is to assess the benefits of repeated gait training with RAAD assistance. Individuals with CP will participate in a 4-week assistance intervention and mobility outcomes will be quantified pre and post intervention.
Read more
The second specific goal is to separately assess the benefits of repeated gait training with RAAD resistance. Individuals with CP will participate in a 4-week resistance intervention and mobility outcomes will be quantified pre and post intervention.
Assessed separately, it is hypothesized that both assistance and resistance training will improve mobility outcomes.
- Conditions
- Cerebral Palsy
- Being tested
- Robotic Ankle Assist Device (RAAD)
- 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 Ankle Assist Device (RAAD)Device
The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP
| Study group | Role | What they receive |
|---|---|---|
| Therapist supervised assistance training | Experimental | Assistance training with the RAAD under therapist supervision. Receives: Device: Robotic Ankle Assist Device (RAAD) |
| Therapist supervised resistance training | Experimental | Resistance training with the RAAD under therapist supervision. Receives: Device: Robotic Ankle Assist Device (RAAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Preferred Walking Speed
How fast someone prefers to walk
Measured: baseline and post intervention at 6 minutes
Secondary outcomes (6)
Change in COT
Change in Metabolic cost of transport
Measured: baseline and post intervention
Change in 6MWT
Change in Six-minute walk test, which is the total distance walked over a 6 minute period.
Measured: 6 minutes pre/post
Change in Gait Kinetics
Change in Average knee angle across stance phase measured in degrees
Measured: 6 minutes pre/post
Change in Step Length
Step length during walking
Measured: baseline and post intervention
Change in Gross Motor Function Measure Scale 66
Change in Gross motor function measure scale 66, min score = 0, max score = 66, high score is better. Unit of measure = Scores on a scale.
Measured: 20 minutes pre/post
Change in Fast Walking Speed
How fast participants prefer to walk quickly (m/s)
Measured: baseline and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start1 Nov 2020
- Primary completion15 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This study has two experiments. In experiment I, participants will be recruited to complete gait training with the RAAD under assistance mode. In experiment two, participants will be recruited to complete gait training with the RAAD under resistance mode.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- BiOMOTUM, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northern Arizona University, Gillette Children's Specialty Healthcare, Shirley Ryan AbilityLab, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Ray Browning, PhD, Principal investigator, BiOMOTUM, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516343
- Sponsor's protocol ID
- 1R44HD104328
- Status last verified
- Mar 2025
- First submitted
- 13 Aug 2020
- Last updated
- 4 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Robotic Ankle Assist Device to Improve Mobility in Individuals With Movement Disorders
- ClinicalTrials.gov ID
- NCT04516343
- Acronym / sponsor ID
- 1R44HD104328
- Conditions
- Cerebral Palsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BiOMOTUM, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Northern Arizona University, Gillette Children's Specialty Healthcare, Shirley Ryan AbilityLab, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Posted 4 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objectives of this work is to establish feasibility of a robotic ankle assist device (RAAD) to improve mobility in free-living settings and to establish the RAAD as an effective tool to provide increased dose and precision of targeted ankle therapy.
The first specific goal is to assess the benefits of repeated gait training with RAAD assistance. Individuals with CP will participate in a 4-week assistance intervention and mobility outcomes will be quantified pre and post intervention.
The second specific goal is to separately assess the benefits of repeated gait training with RAAD resistance. Individuals with CP will participate in a 4-week resistance intervention and mobility outcomes will be quantified pre and post intervention.
Assessed separately, it is hypothesized that both assistance and resistance training will improve mobility outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study has two experiments. In experiment I, participants will be recruited to complete gait training with the RAAD under assistance mode. In experiment two, participants will be recruited to complete gait training with the RAAD under resistance mode.
| Arm | Type | Receives |
|---|---|---|
| Therapist supervised assistance training | Experimental | Device: Robotic Ankle Assist Device (RAAD)Assistance training with the RAAD under therapist supervision. |
| Therapist supervised resistance training | Experimental | Device: Robotic Ankle Assist Device (RAAD)Resistance training with the RAAD under therapist supervision. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Diagnosis of cerebral palsy. Any sex, race, ethnicity or socioeconomic status. GMFCS level I, II, or II. Ability to walk for at least 6 minutes (assisted or unassisted). Age between 8-18 years. Height/weight/BMI between the 5th - 95th percentile of children with CP.
- Able to understand and follow simple directions. Able to complete 5 heel raises with minimal assistance (balance only). At least 20 degrees of passive ankle plantar flexion range of motion.
Key exclusion criteria (2 listed)
- Knee extension or ankle dorsiflexion contractures greater than 15 degrees. Health condition or diagnosis other than CP that would affect safe participation.
- Orthopedic surgery completed in the prior 12-months. Current enrollment in a conflicting research study.
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 Ankle Assist Device (RAAD)The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP | Device | Therapist supervised assistance training, Therapist supervised resistance training |
Primary outcome
Change in Preferred Walking Speed
Time frame: baseline and post intervention at 6 minutes
How fast someone prefers to walk
6 secondary outcomes
Change in COT
Time frame: baseline and post intervention
Change in 6MWT
Time frame: 6 minutes pre/post
Change in Gait Kinetics
Time frame: 6 minutes pre/post
Change in Step Length
Time frame: baseline and post intervention
Change in Gross Motor Function Measure Scale 66
Time frame: 20 minutes pre/post
Change in Fast Walking Speed
Time frame: baseline and post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ray Browning, PhD principal investigator
BiOMOTUM, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Robotic Ankle Assist Device (RAAD) in people with Cerebral Palsy, run by BiOMOTUM, Inc. 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 2 inclusion and 2 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 4 Apr 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Preferred Walking Speed (time frame: baseline and post intervention at 6 minutes). 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 4 Apr 2025.