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

NCT ID: NCT03937700

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2025-12-01

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

Detailed Description

Objectives:

1. To determine the use of the CPWalker rehabilitation platform, a robotic device composed by an exoskeleton linked to a walker that provides support and balance, as a gait training intervention in the pediatric cerebral palsy population.

2. To create and define detailed guidelines consisting of robotic based treatment methods for gait rehabilitation.

Hypothesis:

1. CPWalker can be used as a gait training intervention for pediatric patients with gait impairments due to cerebral palsy

2. Performing lower limb training in conjunction with active head and trunk control therapies will improve functional gait levels

3. Following 16-24 CPWalker training sessions, persons with cerebral palsy will show improvements in functional mobility when comparing pre-training measurements to post-training measurements

Procedures:

Participants will engage in an 8-week training program, consisting of 2-3 sessions per week based on the level of gait impairment. Percentage range of motion (ROM), partial body weight support (PWBS), and gait velocity are the principal parameters under variation during training.

Additionally, screening, baseline and post-training testing sessions will be conducted

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPWalker Robotic-Assisted Gait Training

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

Group Type: EXPERIMENTAL

CPWalker Robotic Exoskeleton

Intervention Type: 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

Interventions

CPWalker Robotic Exoskeleton

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Arun Jayaraman, PT, PhD

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arun Jayaraman, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00206310

Identifier Type: -

Identifier Source: org_study_id