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Robotic Device

Robotic Ankle Therapy for Cerebral Palsy

Phase 1

Recruiting

Led By Zach F Lerner, PhD

Research Sponsored by Northern Arizona University

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks after the intervention

Awards & highlights

Study Summary

This trial is testing whether targeted ankle resistance training or adaptive ankle assistance produces larger improvements in lower-extremity motor control, gait mechanics, and clinical measures of mobility for children with cerebral palsy.

Who is the study for?

This trial is for children aged 8-18 with Cerebral Palsy who have trouble walking due to ankle issues. They must be able to follow simple instructions and walk at least 30 feet, with or without help. Kids who've had other treatments or surgeries within the last 6 months can't join.Check my eligibility

What is being tested?

The study tests if special gait training with robotic ankle assistance or resistance improves walking in kids with CP better than standard therapy. It checks their muscle control and mobility after four and twelve weeks, comparing it to regular physical therapy and walking aids.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from wearing the devices, fatigue from exercise, skin irritation at contact points of orthoses or robots, and possible strain on muscles being trained differently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks after the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after the intervention for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Average muscle activity

Change in 6-minute-walk-test distance

Change in Gross Motor Function Measure-66 sec. D&E

+11 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Standard gait training (control)Experimental Treatment1 Intervention

We will conduct a randomized controlled trial (treatment vs. control) to compare functional outcomes following bilateral targeted ankle resistance training (2 visits/week for 12 weeks) vs. dose-matched standard functional gait training.

Group II: Passive brace assisted ambulationExperimental Treatment1 Intervention

We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).

Group III: No ankle aid ambulationExperimental Treatment1 Intervention

We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).

Group IV: Device resisted gait training (treatment)Experimental Treatment1 Intervention

Group V: Device assisted ambulationExperimental Treatment1 Intervention

We will compare task capacity and performance with adaptive ankle assistance vs. standard ankle foot orthoses and vs. shod (no ankle aid).

Group VI: Comparison to Standard PT (within subjects control)Experimental Treatment1 Intervention

We will use a within-subject repeated measures design to compare both gait training groups to matched standard physical therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ankle foot orthosis

2017

N/A

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gillette Children's Specialty HealthcareOTHER

30 Previous Clinical Trials

11,466 Total Patients Enrolled

13 Trials studying Cerebral Palsy

5,845 Patients Enrolled for Cerebral Palsy

University of WashingtonOTHER

1,740 Previous Clinical Trials

1,847,634 Total Patients Enrolled

10 Trials studying Cerebral Palsy

1,168 Patients Enrolled for Cerebral Palsy

Northern Arizona UniversityLead Sponsor

32 Previous Clinical Trials

6,686 Total Patients Enrolled

5 Trials studying Cerebral Palsy

110 Patients Enrolled for Cerebral Palsy

Media Library

Biomotum Spark: Robotic ankle assistance (Robotic Device) Clinical Trial Eligibility Overview. Trial Name: NCT05154253 — Phase 1

Cerebral Palsy Research Study Groups: Standard gait training (control), Device assisted ambulation, Device resisted gait training (treatment), Comparison to Standard PT (within subjects control), Passive brace assisted ambulation, No ankle aid ambulation

Cerebral Palsy Clinical Trial 2023: Biomotum Spark: Robotic ankle assistance Highlights & Side Effects. Trial Name: NCT05154253 — Phase 1

Biomotum Spark: Robotic ankle assistance (Robotic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05154253 — Phase 1

Frequently Asked Questions

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

Are participants of this trial restricted to those younger than 30 years old?

"The parameters of this trial state that applicants must be aged 8 to 18. Additionally, there are 140 studies specifically targeting minors and 26 for those beyond the retirement age."

Answered by AI

Is this experiment still recruiting participants?

"As indicated on clinicaltrials.gov, this experiment is presently recruiting participants. This research was first made available to the public on October 4th 2022 and its information was most recently updated on September 26th 2022."

Answered by AI

Who meets the criteria to be considered for enrollment in this clinical research study?

"This clinical trial seeks 36 individuals with cerebral palsy between the ages of 8 and 18. To qualify, applicants must demonstrate 20° of passive plantar-flexion range of motion, comprehend basic instructions (with parental assistance if needed), and be able to traverse at least 30 feet using a mobility aid or independently (GMFCS Level I-III)."

Answered by AI

What is the aggregate number of participants taking part in this exploration?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical experiment, listed since October 4th 2022, is currently seeking participants. There are 36 spaces open at a single site."

Answered by AI

Has Ankle foot orthosis been granted permission by the FDA?

"Our team at Power rated Ankle foot orthosis a 1 out of 3, as the trial is only in its first stage. This means that there are limited data regarding safety and efficacy available."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Augmenting Ankle Plantarflexor Function in Cerebral Palsy

2023. "Augmenting Ankle Plantarflexor Function in Cerebral Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05154253.

All > Cerebral Palsy