Robotic Knee Orthosis-assisted Walking in CP

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT06887764
Status
Recruiting
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Conditions

  • Cerebral Palsy (CP)
  • Crouch Gait

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • RKO-assisted walking in children with CP — DEVICE
    The investigators will assess walking in each of the following conditions: shod (shoes or shoes + AFO) and RKO-assisted (shoes + RKO), to achieve the following: (1) Evaluate the effect of RKO, compared to shod upon endurance in children with CP at GMFCS level II, and (2) Evaluate the effect of RKO, compared to shod, upon temporal-spatial parameters, lower limb sagittal joint kinematics, and muscle EMG in children with CP at GMFCS level II.

Study Details

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.

Key Dates

Start date
Feb 10, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Effect of a powered knee orthosis in individuals with Cerebral Palsy and Flexed-knee Gait

Primary Outcome Measure

Distance from 2MWT [ Time Frame: From enrollment until data collection is performed, 4 weeks after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021
David M Scher, MD
[email protected]
212 606-1253
Vishnu Deep Chandran, PhD
[email protected]
212-606-1215

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