Robotic Ankle Assist Device for Cerebral Palsy

Overseen By Ray Browning, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: BiOMOTUM, Inc.

Disqualifiers: Knee/ankle contractures, Recent surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a robotic ankle assist device (RAAD) designed to help people with cerebral palsy (CP) improve their walking abilities. The trial tests two types of training: one where the device assists movement and another where it adds resistance. Both methods aim to enhance mobility in everyday settings. People with CP who can walk for at least six minutes, with or without assistance, may be suitable candidates.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative device.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this robotic ankle assist device is safe for individuals with cerebral palsy?

Research shows that robotic devices like the Robotic Ankle Assist Device (RAAD) have undergone safety testing in people with cerebral palsy (CP). Previous studies have found that similar devices are generally well-tolerated by both children and adults with CP. For instance, research on devices like the ATLAS 2030 found them safe because they are designed specifically for people with mobility challenges. Another study on robotic walking training showed that adults with CP could use these devices safely over an 11-day period.

While specific safety data for the RAAD is limited, these findings suggest that robotic devices for movement assistance have a good safety record. As this trial is in its early stages, it primarily focuses on testing safety and feasibility. Researchers exercise great care and closely monitor participants to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Robotic Ankle Assist Device (RAAD) for cerebral palsy because it offers a novel approach to improving mobility. Unlike traditional therapies that rely heavily on manual physical therapy exercises, RAAD provides targeted assistance or resistance during movement, enhancing muscle training with precision. This device is used under therapist supervision, ensuring personalized adjustments to meet the specific needs of each patient. By leveraging robotics, RAAD aims to improve motor function more effectively and efficiently than conventional methods, potentially leading to better outcomes for individuals with cerebral palsy.

What evidence suggests that the Robotic Ankle Assist Device is effective for improving mobility in cerebral palsy?

Research shows that robotic exoskeletons can help children with cerebral palsy walk better. Studies on robot-assisted ankle training have demonstrated improvements in ankle movement and walking ability. A recent study on a similar device, the Anklebot, found that six weeks of training improved leg function and structure. In this trial, participants will use the Robotic Ankle Assist Device (RAAD) in different training regimens. Although researchers are still studying the RAAD, these findings suggest that using a robotic device for ankle therapy could help improve mobility in people with cerebral palsy. ^{1 6 7 8 9}

Who Is on the Research Team?

Ray Browning, PhD

Principal Investigator

BiOMOTUM, Inc.

Are You a Good Fit for This Trial?

This trial is for children aged 8-18 with cerebral palsy who can follow simple instructions and walk for at least six minutes. They should be within the typical height, weight, or BMI range for their condition and able to do some heel raises. Those with recent surgeries or other health issues that could interfere are not eligible.

Inclusion Criteria

I can move my ankle downwards at least 20 degrees.

Able to understand and follow simple directions

My height, weight, and BMI are within the typical range for children with CP.

Exclusion Criteria

I had orthopedic surgery within the last year.

Current enrollment in a conflicting research study

I don't have any health issues besides CP that would make it unsafe for me to join.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assistance Training

Participants undergo a 4-week intervention with RAAD assistance to improve mobility

4 weeks

Pre and post intervention assessments

Resistance Training

Participants undergo a 4-week intervention with RAAD resistance to improve mobility

4 weeks

Pre and post intervention assessments

Follow-up

Participants are monitored for changes in mobility outcomes post intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Robotic Ankle Assist Device (RAAD)

Trial Overview The study tests a Robotic Ankle Assist Device (RAAD) designed to improve walking speed and distance in kids with CP. It includes personal-use trials, feedback collection for product design, comparison of RAAD therapy against standard gait training, and a 4-week intervention assessing mobility improvements.

How Is the Trial Designed?

Group I: Therapist supervised resistance training Experimental Treatment 1 Intervention

Resistance training with the RAAD under therapist supervision.

Group II: Therapist supervised assistance training Experimental Treatment 1 Intervention

Assistance training with the RAAD under therapist supervision.

Who Is Running the Clinical Trial?

BiOMOTUM, Inc.

Lead Sponsor

Trials

1

Recruited

30+

Northern Arizona University

Collaborator

Trials

36

Recruited

6,300+

Gillette Children's Specialty Healthcare

Collaborator

Trials

31

Recruited

8,100+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Shirley Ryan AbilityLab

Collaborator

Trials

212

Recruited

17,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10035373/

Is robotic gait training effective for individuals with cerebral ... Tethered robotic devices that provide assistive gait training for individuals with cerebral palsy do not provide a greater benefit for improving mobility than ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04516343

Development of a Robotic Ankle Assist Device | ... Individuals with CP will participate in a 4-week assistance intervention and mobility outcomes will be quantified pre and post intervention. The second specific ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0966636222005914

Effectiveness of robotic exoskeletons for improving gait in ... Robotic exoskeletons have been developed to assist locomotion and address gait abnormalities in children with cerebral palsy (CP).

4. cell.com cell.com/heliyon/fulltext/S2405-8440(24)10349-0

The pilot study of the effect of six-week robot-assisted ankle ... This study investigated the effect of six-week ankle training using the Anklebot device to improve lower limb structural and functional impairments

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/1743-0003-10-30

Effectiveness of robot-assisted therapy on ankle rehabilitation All the selected studies showed improvements in terms of ankle performance or gait function after a period of robot-assisted ankle rehabilitation training.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11674413/

Usability and Safety of the ATLAS 2030 Robotic Gait ... The purpose of this study was to evaluate the safety and usability of the ATLAS 2030 in children with Cerebral Palsy (CP) and Spinal Muscular Atrophy (SMA).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9918396/

Safety and Feasibility of Robot-assisted Gait Training in Adults ... We hypothesize that RAGT with HAL during a 11-day therapy inpatient stay can be delivered feasible and safe in adult patients with CP. It might ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07049523

Robotic Exoskeleton Gait Training for Children With ... The goal of this clinical trial is to evaluate whether robotic-assisted gait training can improve motor function, walking capacity, joint flexibility, ...

9. mdpi.com mdpi.com/1424-8220/21/6/2087

Overground Robot-Assisted Gait Training for Pediatric ... This pilot study evaluated the effect of overground RAGT using an untethered torque-assisted exoskeletal wearable robot for children with CP.