A Pilot Study to Examine the Effect of a Powered Knee Orthosis on Crouch Gait in Cerebral Palsy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Robotic exoskeletons are becoming increasingly accepted to provide upright mobility in individuals with neurological disorders. These devices can assist in overcoming gravitational forces and reduce energy consumption. Agilik is one such device intended for children with neurological disorders. However, Agilik is relatively new, and its efficacy in children with CP is unknown. Therefore, this study aims to assess the effectiveness of Agilik as an assistive device for children with CP and crouch gait. In this pilot study, ten children with CP, GMFCS level II, and crouch gait will walk with Agilik under the supervision of a physical therapist. Assessments of walking with AFO and Agilik will evaluate the efficacy of the device. The pilot study will assess if Agilik decreases crouch and improves gait characteristics in children with CP.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 17
Healthy Volunteers: f
View:

• Diagnosed with cerebral palsy at GMFCS level II

• Exhibits crouch gait

• Between 8 to 17 years of age

• Hip flexion contracture less than 5 degrees

• Knee flexion contracture less than 20 degrees when measured in prone with hips extended

• Thigh-foot angle is between 10 degrees (internal) to 25 degrees (external) in prone

• Can walk a minimum distance of 10 meters without stopping

Locations
United States
New York
Hospital for Special Surgery
RECRUITING
New York
Contact Information
Primary
David M Scher, MD
scherd@hss.edu
212 606-1253
Backup
Vishnu Deep Chandran, PhD
chandranv@hss.edu
212-606-1215
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 10
Treatments
Experimental: Effect of a powered knee orthosis in individuals with Cerebral Palsy and Flexed-knee Gait
Related Therapeutic Areas
Sponsors
Leads: Hospital for Special Surgery, New York

This content was sourced from clinicaltrials.gov