Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cerebral Palsy | Device: CPWalker Robotic Exoskeleton | Not Applicable |
Objectives:
Hypothesis:
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Robot Based Gait Training Therapy for Pediatric Population With Cerebral Palsy Using the CPWalker |
Actual Study Start Date : | July 1, 2019 |
Estimated Primary Completion Date : | June 1, 2024 |
Estimated Study Completion Date : | June 1, 2024 |
Arm | Intervention/treatment |
---|---|
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
|
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
|
Ages Eligible for Study: | 11 Years to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sara Prokup, DPT | 312-238-1355 | sprokup@ricres.org | |
Contact: Matt McGuire, DPT | 312-238-3457 | mmcguire@ricres.org |
United States, Illinois | |
Shirley Ryan AbilityLab | Recruiting |
Chicago, Illinois, United States, 60611 | |
Contact: Sara Prokup, DPT 312-238-1355 sprokup@ricres.org | |
Contact: Matt McGuire, DPT 312-238-3457 mmcguire@ricres.org |
Principal Investigator: | Arun Jayaraman, PT, PhD | Shirley Ryan AbilityLab |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 1, 2019 | ||||||||
First Posted Date ICMJE | May 6, 2019 | ||||||||
Last Update Posted Date | August 20, 2020 | ||||||||
Actual Study Start Date ICMJE | July 1, 2019 | ||||||||
Estimated Primary Completion Date | June 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
|
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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:
Hypothesis:
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 | Allocation: N/A 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
|
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
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Ages ICMJE | 11 Years to 21 Years (Child, Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
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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 | No | ||||||||
U.S. FDA-regulated Product |
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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 |
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PRS Account | Shirley Ryan AbilityLab | ||||||||
Verification Date | August 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |