Robot Based Gait Training Therapy for Pediatric Population With Cerebral Palsy Using the CPWalker
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- Shirley Ryan AbilityLab
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 10-Meter Walk Test
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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
Investigators
Arun Jayaraman, PT, PhD
Research Scientist
Shirley Ryan AbilityLab
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Gillette Functional Assessment Questionnaire (FAQ)(Change in baseline report of ambulatory function at 8 weeks)
- GAITRite Data Collection(Change from baseline gait quality at 8 weeks)
- Child and Adolescent Scale of Participation(Change in children's baseline participation in activities at 8 weeks)
- Selective Control Assessment of Lower Extremity (SCALE)(Change from baseline selective voluntary motor control at 8 weeks)
- Pediatric Balance Scale(Change from baseline balance score at 8 weeks)
- Gross Motor Function Measure (GMFM-88) dimensions D (standing) and E (walking)(Change from baseline gross motor function at 8 weeks)
- 6-Minute Walk Test(Change from baseline distance ambulated at 8 weeks)