Clinical trial NCT06887764: Robotic Knee Orthosis-assisted Walking in CP
Official title: A Pilot Study to Examine the Effect of a Powered Knee Orthosis on Crouch Gait in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crouch Gait
Cerebral Palsy (CP)
Keywords: Robotic Knee Orthosis
Crouch Gait
Flexed-knee Gait
Cerebral Palsy
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed description: Robotic knee orthosis (RKO) can assist with voluntary knee extension and potentially reduce crouch/flexed-knee gait, but the efficacy of this technology in children with CP is unknown. This study aims to assess the effectiveness of Agilik as an assistive device for children with CP. Ten children with CP, ages 8 to 17 years, and at GMFCS level II, will be recruited for this pilot study. Each child will participate in a total of four visits over four weeks duration. The first three visits will also include RKO device fitting and tuning, followed by RKO-assisted walking practice to help with device acclamation. The walking practice will last up to 30 minutes. A two-minute walk test (2MWT) will be conducted at the first visit, which will serve as a reference to assess any shift in endurance from device-tuning/practice visits. The fourth and final visit will include 2MWT and 3D motion capture of shod and RKO-assisted conditions and may take up to 3 to 4 hours.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Plantarflexion contracture, when measured in neutral foot alignment
* No other neurological, musculoskeletal, or cardiorespiratory health conditions or injuries
* The presence of any cognitive impairment that could limit the ability to understand, follow simple directions, and inform when in pain
* Inability to participate in the study because of recent orthopedic surgery (within twelve months) or botox intervention (within six months)

Primary outcomes:
measure: Distance from 2MWT
timeFrame: From enrollment until data collection is performed, 4 weeks after enrollment
measure: Step length
timeFrame: At the end of study visit for each participant, approximately 4 weeks from enrollment
measure: Single limb support time
timeFrame: At the end of study visit for each participant, approximately 4 weeks from enrollment
measure: Walking speed
timeFrame: At the end of study visit for each participant, approximately 4 weeks from enrollment
measure: Lower limb joint kinematics
timeFrame: At the end of study visit for each participant, approximately 4 weeks from enrollment
measure: Binary indicator of improvement in walking distance with RKO use
timeFrame: At the end of study visit for each participant, approximately 4 weeks from enrollment
measure: Lower limb electromyography data
timeFrame: At the end of study visit for each participant, approximately 4 weeks from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References: