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

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a robotic device that helps move the ankle to improve walking. It targets children with Cerebral Palsy who have difficulty walking. The device either helps the ankle push off the ground or provides resistance to strengthen muscles. Researchers hope this will help children walk faster and farther. The use of robotic devices for ankle rehabilitation in children with cerebral palsy has been explored in various studies, showing potential benefits in improving ankle mobility and walking ability.

Research Team

Ray Browning, PhD

Principal Investigator

BiOMOTUM, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+