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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average muscle activity
Change in 6-minute-walk-test distance
Change in Gross Motor Function Measure-66 sec. D&E
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
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 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
~130

Find a Location

Who is running the clinical trial?

University of WashingtonOTHER
1,831 Previous Clinical Trials
1,907,533 Total Patients Enrolled
10 Trials studying Cerebral Palsy
1,169 Patients Enrolled for Cerebral Palsy
Gillette Children's Specialty HealthcareOTHER
30 Previous Clinical Trials
8,035 Total Patients Enrolled
13 Trials studying Cerebral Palsy
2,414 Patients Enrolled for Cerebral Palsy
Northern Arizona UniversityLead Sponsor
33 Previous Clinical Trials
6,529 Total Patients Enrolled
5 Trials studying Cerebral Palsy
92 Patients Enrolled for Cerebral Palsy
Zach F Lerner, PhDPrincipal InvestigatorNorthern Arizona University

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
~15 spots leftby May 2026
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