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 range8 Years – 21 Years

SexALL

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.

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

Change in 6-minute-walk-test distance

Timeframe: 2 weeks 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 range8 Years – 21 Years

SexALL

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

Change in 6-minute-walk-test distance

Timeframe: 2 weeks after the intervention