Experimentation of an Ankle Mobilization Device for the Rehabilitation of Patients With Acquired Brain Injuries.

IRCCS Eugenio Medea

Status: Completed

Conditions: Acquired Brain Injury

Treatments: Device: Ankle active and passive mobilization using an Ankle mobilization device

Study type: Interventional

Funder types: Other

Identifiers

NCT03879070

GIP599

Details and patient eligibility

About

The proposed clinical investigation plan is a randomized controlled pivotal study with 2 parallel groups, has a total duration of two years. For the study, 30 pediatric patients suffering from acquired brain injury will be recruited at the Scientific institute Eugenio Medea.

The primary aim of this study is to assess the clinical benefit of using an ankle mobilization device for the rehabilitation of pediatric patients with acquired brain injuries, on its clinical performance and its risks, and on its safety.

The efficacy of the treatment will be evaluated in terms of ankle range of motion (primary outcome). The effects of the treatment on musculoskeletal plasticity will be studied using an isokinetic machine and functional magnetic resonance imaging will provide information on variations of reactivity in the motor cortical network. Ease of use, safety and usability of the device will also be evaluated.

Enrollment: 30 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Tetraplegic and hemiplegic acquired brain injury patients, within first month of injury.
• Spastic syndrome (ankle joint Modified Ashworth Scale > 1).

Exclusion criteria

• Pace maker or other contraindication to Magnetic Resonance Imaging scans.
• Other serious comorbidity.
• Behaviour and psychiatric disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Intervention group

Experimental group

Treatment:

Device: Ankle active and passive mobilization using an Ankle mobilization device

Control group

No Intervention group