RecruitingPhase 1

Augmenting Ankle Plantarflexor Function in Cerebral Palsy

United States36 participantsStarted 2023-02-01

Plain-language summary

The first specific aim is to quantify improvement in ankle muscle function and functional mobility following targeted ankle resistance gait training in ambulatory children with cerebral palsy (CP). The primary hypothesis for the first aim is that targeted ankle resistance training will produce larger improvements in lower-extremity motor control, gait mechanics, and clinical measures of mobility assessed four- and twelve-weeks post intervention compared to standard physical therapy and standard gait training. The second specific aim is to determine the efficacy of adaptive ankle assistance to improve capacity and performance during sustained, high-intensity, and challenging tasks in ambulatory children with CP. The primary hypothesis for the second aim is that adaptive ankle assistance will result in significantly greater capacity and performance during the six-minute-walk-test and graded treadmill and stair stepping protocols compared to walking with ankle foot orthoses and walking with just shoes.

Who can participate

Age range

8 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ages between 8 and 21 years old, inclusive. Diagnosis of CP and a pathological gait pattern caused by ankle dysfunction. * Able to understand and follow simple directions (based on parent report, if needed) and walk at least 30 feet with or without a walking aid (Gross Motor Function Classification System (GMFCS) Level I-III). * At least 20° of passive plantar-flexion range of motion. Exclusion Criteria: * Concurrent treatment other than those assigned during the study. * A condition other than CP that would affect safe participation. * Surgical intervention within 6 months of participation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in preferred walking speed

Timeframe: Immediately after the intervention

Change in preferred walking speed

Timeframe: 2 weeks after the intervention

Change in preferred walking speed

Timeframe: 12 weeks after the intervention

Change in similarity of plantarflexor muscle activity

Timeframe: Immediately after the intervention

Change in similarity of plantarflexor muscle activity

Timeframe: 2 weeks after the intervention

Change in similarity of plantarflexor muscle activity

Timeframe: 12 weeks after the intervention

Change in 6-minute-walk-test distance

Timeframe: Immediately after the intervention

Trial details

NCT IDNCT05154253

SponsorNorthern Arizona University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-14

Contact for this trial

Zach Lerner, PhD

928-523-1787 zachary.lerner@nau.edu

View on ClinicalTrials.gov More Cerebral Palsy trials

Plain-language summary

Who can participate

Age range

8 Years – 21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in preferred walking speed

Timeframe: Immediately after the intervention

Change in preferred walking speed

Timeframe: 2 weeks after the intervention

Change in preferred walking speed

Timeframe: 12 weeks after the intervention

Change in similarity of plantarflexor muscle activity

Timeframe: Immediately after the intervention

Change in similarity of plantarflexor muscle activity

Timeframe: 2 weeks after the intervention

Change in similarity of plantarflexor muscle activity

Timeframe: 12 weeks after the intervention

Change in 6-minute-walk-test distance

Timeframe: Immediately after the intervention