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Robotic Ankle Assist Device for Cerebral Palsy

Phase 1

Recruiting

Led By Ray Browning, PhD

Research Sponsored by BiOMOTUM, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 20 degrees of passive ankle plantar flexion range of motion

Age between 8-18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 minutes pre/post

Awards & highlights

Study Summary

This trial is testing a robotic device that helps with ankle movement to see if it can improve mobility for children with cerebral palsy.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed, potential risks may include discomfort from wearing the device or muscle fatigue due to new types of movement during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can move my ankle downwards at least 20 degrees.

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I am between 8 and 18 years old.

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

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I can do 5 heel raises with little help for balance.

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I have been diagnosed with cerebral palsy.

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I can walk for 6 minutes, with or without help.

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I can walk with or without limitations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of the study visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of the study visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of the study visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in lower extremity muscle activity similarity to the average unimpaired activity pattern

Change in preferred walking speed

PF activity

Secondary outcome measures

6MWT

Ankle muscle co-contraction

COT

+10 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: User testingExperimental Treatment1 Intervention

Two sessions of user-centric testing.

Group II: Therapist-guided trainingExperimental Treatment1 Intervention

Therapist-guided gait training with the RAAD.

Group III: Therapist supervised resistance trainingExperimental Treatment1 Intervention

Resistance training with the RAAD under therapist supervision.

Group IV: Parent supervised resistance trainingExperimental Treatment1 Intervention

Resistance training under parent supervision.

Group V: Assistance trainingExperimental Treatment1 Intervention

Assistance training with the RAAD

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northern Arizona UniversityOTHER

32 Previous Clinical Trials

6,674 Total Patients Enrolled

5 Trials studying Cerebral Palsy

98 Patients Enrolled for Cerebral Palsy

Gillette Children's Specialty HealthcareOTHER

30 Previous Clinical Trials

11,454 Total Patients Enrolled

13 Trials studying Cerebral Palsy

5,833 Patients Enrolled for Cerebral Palsy

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

1,964 Previous Clinical Trials

2,672,534 Total Patients Enrolled

29 Trials studying Cerebral Palsy

8,710 Patients Enrolled for Cerebral Palsy

Media Library

Robotic Ankle Assist Device (RAAD) Clinical Trial Eligibility Overview. Trial Name: NCT04516343 — Phase 1

Cerebral Palsy Research Study Groups: Assistance training, Parent supervised resistance training, Therapist-guided training, User testing, Therapist supervised resistance training

Cerebral Palsy Clinical Trial 2023: Robotic Ankle Assist Device (RAAD) Highlights & Side Effects. Trial Name: NCT04516343 — Phase 1

Robotic Ankle Assist Device (RAAD) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04516343 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the researchers investigating with this study?

"The sponsor of this clinical trial, BiOMOTUM, Inc., is measuring the primary outcome—Change in lower extremity muscle activity similarity to the average unimpaired activity pattern—over a 30-minute session. Additionally, this study will assess secondary outcomes including Ankle muscle co-contraction (defined as Number of steps with mean stance phase ankle co-contraction below pre-session baseline), Qualitative therapist assessment of session quality, participant movement, and device usability via questionnaire (defined as Qualitative therapist assessment of session quality, participant movement quality, and device usability via questionnaire), and Minimum age and function level required to"

Answered by AI

Is the age limit for this clinical trial set at 25 years or older?

"This trial is only for children aged 8-18, as that is the age range specified in the inclusion criteria."

Answered by AI

For whom is this clinical trial designed?

"This trial is for children and adolescents with cerebral palsy aged 8-18. The primary enrolment criterion is the ability to complete 5 heel raises unassisted (for balance only). Other inclusion requirements are as follows: the understanding and following of simple directions, a diagnosis of cerebral palsy, any sex, race, ethnicity or socioeconomic status, GMFCS level I, II or III, the ability to walk unassisted or with assistance for at least 6 minutes, and age between 8-18 years old. Lastly, patients must fall within the 5th - 95th percentile height/weight/BMI range for children with CP."

Answered by AI

Are there any current openings in this trial for new participants?

"The listed clinical trial on clinicaltrials.gov is recruiting patients, with the posting date being November 1st 2020 and the last edit on May 7th 2021."

Answered by AI

What are the risks associated with using RAAD devices?

"The Robotic Ankle Assist Device (RAAD) is still in early stages of testing, so it only received a score of 1 for safety."

Answered by AI

How many people are included in this experimental treatment program?

"Yes, that is accurate. This clinical trial is seeking 48 participants from 1 location and the listing on clinicaltrials.gov says it is still recruiting patients. The initial posting was on November 1st, 2020 with the most recent update being on May 7th, 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Development of a Robotic Ankle Assist Device

2020. "Development of a Robotic Ankle Assist Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04516343.

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