Clinical trial NCT03937700: Robot Based Gait Training Therapy for Pediatric Population With Cerebral Palsy Using the CPWalker
Official title: Robot Based Gait Training Therapy for Pediatric Population With Cerebral Palsy Using the CPWalker
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: 10-Meter Walk Test
timeFrame: Change from baseline gait speed at 8 weeks
Secondary outcomes:
measure: 6-Minute Walk Test
timeFrame: Change from baseline distance ambulated at 8 weeks
measure: GAITRite Data Collection
timeFrame: Change from baseline gait quality at 8 weeks
measure: Pediatric Balance Scale
timeFrame: Change from baseline balance score at 8 weeks
measure: Selective Control Assessment of Lower Extremity (SCALE)
timeFrame: Change from baseline selective voluntary motor control at 8 weeks
measure: Gross Motor Function Measure (GMFM-88) dimensions D (standing) and E (walking)
timeFrame: Change from baseline gross motor function at 8 weeks
measure: Child and Adolescent Scale of Participation
timeFrame: Change in children's baseline participation in activities at 8 weeks
measure: Gillette Functional Assessment Questionnaire (FAQ)
timeFrame: Change in baseline report of ambulatory function at 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: