RECRUITING

Robotic Knee Orthosis-assisted Walking in CP

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-10
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06887764

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with cerebral palsy at GMFCS level II
  2. * Exhibits crouch gait
  3. * Between 8 to 17 years of age
  4. * Hip flexion contracture less than 5 degrees
  5. * Knee flexion contracture less than 20 degrees when measured in prone with hips extended
  6. * Thigh-foot angle is between 10 degrees (internal) to 25 degrees (external) in prone
  7. * Can walk a minimum distance of 10 meters without stopping
  1. * Plantarflexion contracture, when measured in neutral foot alignment
  2. * No other neurological, musculoskeletal, or cardiorespiratory health conditions or injuries
  3. * The presence of any cognitive impairment that could limit the ability to understand, follow simple directions, and inform when in pain
  4. * Inability to participate in the study because of recent orthopedic surgery (within twelve months) or botox intervention (within six months)

Contacts and Locations

Study Contact

David M Scher, MD
CONTACT
212 606-1253
scherd@hss.edu
Vishnu Deep Chandran, PhD
CONTACT
212-606-1215
chandranv@hss.edu

Study Locations (Sites)

Hospital for Special Surgery
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Hospital for Special Surgery, New York

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-10
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-02-10
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Robotic Knee Orthosis
  • Crouch Gait
  • Flexed-knee Gait
  • Cerebral Palsy

Additional Relevant MeSH Terms

  • Crouch Gait
  • Cerebral Palsy (CP)