Robot Based Gait Training Therapy for Pediatric Population With Cerebral Palsy Using the CPWalker

NCT03937700 | Active Not Recruiting

• 1 other identifier: STU00206310
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is being conducted to determine if the CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• 10-Meter Walk Test

  This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire 10-meter distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second.

  Change from baseline gait speed at 8 weeks

Secondary Outcomes (7)

• 6-Minute Walk Test

  Change from baseline distance ambulated at 8 weeks

• GAITRite Data Collection

  Change from baseline gait quality at 8 weeks

• Pediatric Balance Scale

  Change from baseline balance score at 8 weeks

• Selective Control Assessment of Lower Extremity (SCALE)

  Change from baseline selective voluntary motor control at 8 weeks

• Gross Motor Function Measure (GMFM-88) dimensions D (standing) and E (walking)

  Change from baseline gross motor function at 8 weeks

Study Arms (1)

CPWalker Robotic-Assisted Gait Training

EXPERIMENTAL

Each subject will participate in 16-24 gait training sessions in the CPWalker over the course of 8 weeks with each session lasting up to 2 hours

Device: CPWalker Robotic Exoskeleton

Interventions

CPWalker Robotic Exoskeleton DEVICE

The CPWalker rehabilitation platform is a robotic device composed by an exoskeleton linked to a walker that provides support and balance to a child during overground training. The device is able to implement user's partial body weight support (PBWS) and allows the adaptation of exercises to the patient's capabilities by means of individual controllers for each joint, which increases the modularity of the system. Each joint of the CPWalker can operate in a range of modes with varied levels of robotic assistance or resistance

CPWalker Robotic-Assisted Gait Training

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Cerebral Palsy with spastic diplegia
• Gross Motor Function Classification System score of 2-4
• Age 11-21 at time of enrollment
• Maximum weight of 75kg
• Height range of approximately 110cm to 170cm
• Ability to understand and follow verbal cues
• Lower limb measurements meet specifications of CPWalker
• Cognition sufficient to communicate pain or discomfort and follow one step direction from the investigator

You may not qualify if:

• Any orthopedic surgeries less than 3 months prior to study enrollment or ongoing botox injections
• Severe musculoskeletal deformities affecting safe and comfortable fit into the exoskeleton as determined by the investigator. Patients may be able to wear their AFOs in the CPWalker if it allows for safe fit.
• Unhealed wounds/lesions
• Critical motor control alterations such as dystonia, choreoathetosis, or ataxia
• Aggressive or self-harming behavior
• Severe cognitive impairments that prevent a subject from being able to understand the exercises an/or interact with the study staff

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 6, 2019
• Study Start: July 1, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (1)