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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03937700
• Other study ID #: STU00206310
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: Shirley Ryan AbilityLab
• Contact: Sara Prokup, DPT
• Phone: 312-238-1355
• Email: sprokup[@]ricres.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6-Minute Walk Test	This test measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. This test will be administered while wearing a mask to measure oxygen consumption.	Change from baseline distance ambulated at 8 weeks
Secondary	GAITRite Data Collection	The GAITRite system automates measuring temporal and spatial gait parameters via an electronic walkway connected to a computer. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet to collect gait information. The system can be laid over any flat surface. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. Patients will be asked to walk at a self-selected speed across the GAITRite electronic walkway with at least a two meter "flying start" to compensate for initial acceleration.	Change from baseline gait quality at 8 weeks
Secondary	Pediatric Balance Scale	This test is a 14-item objective measure designed to assess static balance in pediatric populations. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed. Each item is scored from 0 to 4 points. The maximum score is 56 points.	Change from baseline balance score at 8 weeks
Secondary	Selective Control Assessment of Lower Extremity (SCALE)	This clinical tool quantifies selective voluntary motor control of the lower extremities in patients with cerebral palsy.	Change from baseline selective voluntary motor control at 8 weeks
Secondary	Gross Motor Function Measure (GMFM-88) dimensions D (standing) and E (walking)	This test measures the change in gross motor function with intervention in children with cerebral palsy	Change from baseline gross motor function at 8 weeks
Secondary	Child and Adolescent Scale of Participation	This questionnaire measures the extent to which children participate in home, school, and community activities as reported by family caregivers.	Change in children's baseline participation in activities at 8 weeks
Secondary	Gillette Functional Assessment Questionnaire (FAQ)	This is a proxy-report measure that includes a ten-level classification of ambulatory function and 22 functional locomotor activities	Change in baseline report of ambulatory function at 8 weeks