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

Shirley Ryan AbilityLab

Status: Active, not recruiting

Conditions: Cerebral Palsy

Treatments: Device: CPWalker Robotic Exoskeleton

Study type: Interventional

Funder types: Other

Identifiers

NCT03937700

STU00206310

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 11 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

CPWalker Robotic-Assisted Gait Training

Experimental group

Description:

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

Treatment:

Device: CPWalker Robotic Exoskeleton