Phase 1 Completed N=31 Treatment

Development of a Robotic Ankle Assist Device

Cerebral Palsy

Source: ClinicalTrials.gov NCT04516343 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcomePrimary: Change in Preferred Walking Speed — 0.09; 0.13 m/s

Summary

The overall objectives of this work is to establish feasibility of a robotic ankle assist device (RAAD) to improve mobility in free-living settings and to establish the RAAD as an effective tool to provide increased dose and precision of targeted ankle therapy. The first specific goal is to assess the benefits of repeated gait training with RAAD assistance. Individuals with CP will participate in a 4-week assistance intervention and mobility outcomes will be quantified pre and post intervention. The second specific goal is to separately assess the benefits of repeated gait training with RAAD resistance. Individuals with CP will participate in a 4-week resistance intervention and mobility outcomes will be quantified pre and post intervention. Assessed separately, it is hypothesized that both assistance and resistance training will improve mobility outcomes.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Preferred Walking Speed	0.09; 0.13	—
SECONDARY Change in COT	-0.06; -0.01	—
SECONDARY Change in 6MWT	46; 48.4	—
SECONDARY Change in Gait Kinetics	-1.62; -2.00	—
SECONDARY Change in Step Length	0.082; 0.072	—
SECONDARY Change in Gross Motor Function Measure Scale 66	1.43; 1.56	—
SECONDARY Change in Fast Walking Speed	0.06; 0.18	—

Eligibility Criteria

Inclusion Criteria

Diagnosis of cerebral palsy. Any sex, race, ethnicity or socioeconomic status. GMFCS level I, II, or II. Ability to walk for at least 6 minutes (assisted or unassisted). Age between 8-18 years. Height/weight/BMI between the 5th - 95th percentile of children with CP.

Able to understand and follow simple directions. Able to complete 5 heel raises with minimal assistance (balance only). At least 20 degrees of passive ankle plantar flexion range of motion.

Exclusion Criteria

Knee extension or ankle dorsiflexion contractures greater than 15 degrees. Health condition or diagnosis other than CP that would affect safe participation.

Orthopedic surgery completed in the prior 12-months. Current enrollment in a conflicting research study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04516343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.