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

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ClinicalTrials.gov Identifier: NCT03937700
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab

Tracking Information
First Submitted Date  ICMJE May 1, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date May 6, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
10-Meter Walk Test [ Time Frame: Change from baseline gait speed at 8 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • 6-Minute Walk Test [ Time Frame: Change from baseline distance ambulated at 8 weeks ]
    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.
  • GAITRite Data Collection [ Time Frame: Change from baseline gait quality at 8 weeks ]
    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.
  • Pediatric Balance Scale [ Time Frame: Change from baseline balance score at 8 weeks ]
    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.
  • Selective Control Assessment of Lower Extremity (SCALE) [ Time Frame: Change from baseline selective voluntary motor control at 8 weeks ]
    This clinical tool quantifies selective voluntary motor control of the lower extremities in patients with cerebral palsy.
  • Gross Motor Function Measure (GMFM-88) dimensions D (standing) and E (walking) [ Time Frame: Change from baseline gross motor function at 8 weeks ]
    This test measures the change in gross motor function with intervention in children with cerebral palsy
  • Child and Adolescent Scale of Participation [ Time Frame: Change in children's baseline participation in activities at 8 weeks ]
    This questionnaire measures the extent to which children participate in home, school, and community activities as reported by family caregivers.
  • Gillette Functional Assessment Questionnaire (FAQ) [ Time Frame: Change in baseline report of ambulatory function at 8 weeks ]
    This is a proxy-report measure that includes a ten-level classification of ambulatory function and 22 functional locomotor activities
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Robot Based Gait Training Therapy for Pediatric Population With Cerebral Palsy Using the CPWalker
Official Title  ICMJE Robot Based Gait Training Therapy for Pediatric Population With Cerebral Palsy Using the CPWalker
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: 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
Intervention: Device: CPWalker Robotic Exoskeleton
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 2, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2024
Estimated Primary Completion Date June 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sara Prokup, DPT 312-238-1355 sprokup@ricres.org
Contact: Matt McGuire, DPT 312-238-3457 mmcguire@ricres.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03937700
Other Study ID Numbers  ICMJE STU00206310
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
Study Sponsor  ICMJE Shirley Ryan AbilityLab
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arun Jayaraman, PT, PhD Shirley Ryan AbilityLab
PRS Account Shirley Ryan AbilityLab
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP