Cerebral Palsy (CP)
Conditions
Keywords
exoskeleton device, powered orthosis, cerebral palsy, crouch gait, home use
Brief summary
The goal of this clinical trial is to learn if a two month training with the Agilik powered orthosis improves the knee extension or the endurance in pediatric patients with Cerebral palsy and a crouch gait. It will also learn about the safety of Agilik. The main questions it aims to answer are: Does the Agilik powered orthosis increase the value of the knee extension during walking? What medical problems do participants have when using the Agilik powered orthosis? Researchers will compare a group of patients using the Agilik powered exoskeleton with a group of patients treated with standard therapy. Participants will: Use Agilik at home or perform standard therapy for 2 months Visit the clinic at the beginning of the study, after 3 months and after 1 additional month.
Interventions
DEVICEPowered orthosis
Home rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home.
Sponsors
IRCCS Eugenio Medea
IRCCS Fondazione Stella Maris
Fondazione Don Carlo Gnocchi Onlus
IRCCS National Neurological Institute "C. Mondino" Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of CP and a crouch gait * Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination. * Body weight between 20 and 125 Kg * Knee flexion retraction assessed in supine position by less than 10°. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study. * Subjects must not have had a tibio-tarsal arthrodesis. In addition, they must have at least 5° of passive dorsi-flexion of the ankle. * Able to walk at least 3 m without stopping, with or without a walking aid. * Able to understand and follow simple directions based on parent report and physician observation during historical and physical examination. * GMFCS level I, II and III * MAS score ≤ 2
Exclusion criteria
* Any severe neurological, musculoskeletal and/or cardiorespiratory involvement preventing the ability to walk; * A history of uncontrolled seizure in the past year * Severe spasticity * Hip and/or knee flexion contracture of more than 20°
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endurance | Baseline, 3 months and 4 months | Distance walked during a 6-minutes walking test (6MWT) |
| Knee extension in mid stance (KEMS) | Baseline, 3 months and 4 months | Anti-gravity knee extension in mid stance measured with quantitative gait analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurements of the Joint range of motions (ROMs) and muscle lengths | Baseline, 3 months and 4 months | Joint Range of motions and muscle lengths as measured by therapists |
| Level of spasticity in the lower limbs | Baseline, 3 months and 4 months | Assessed with the Modified Ashworth scale (MAS) |
| Walking speed | Baseline, 3 months and 4 months | Assessed with the 10-meter walking test (10mWT) |
| Postural and motor abilities | Baseline, 3 months and 4 months | Assessed with the Gross Motor Function Measure-88 (GMFM-88) |
| Gait pattern | Baseline, 3 months and 4 months | Assessed with overground 3D gait analysis with electromyography (EMG) data acquisition |
| Self-perception of performance in everyday living | Baseline, 3 months and 4 months | Assessed with the Canadian Occupational Performance Measure (COPM) |
| Static balance | Baseline, 3 months and 4 months | Assessed with Centre of Pressure (COP) detection using the force platforms of the gait analysis. |
| Usability and acceptability of the powered orthosis | After the treatment only in the intervention group | Assessed with the System Usability Scale (SUS) and the Technology Acceptance Method 3 (TAM-3) |
| Behavioural engagement | After the treatment only in the intervention group | Assessed with semi-structured interviews |
Countries
Italy
Contacts
CONTACTEmilia Biffi, PhD
CONTACTCristina Maghini, MD
Outcome results
None listed