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

Not Applicable

Completed

• Conditions: Acquired Brain Injury

• Registration Number: NCT03879070
• Lead Sponsor: IRCCS Eugenio Medea

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-13
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-18
• Study Start: 2020-02-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-02-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-01
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Passive range of motion of ankle dorsi-plantarflexion	Change from baseline after 4 weeks of treatment	Measured with goniometer

Secondary Outcome Measures

Name	Time	Method
Time-Domain Near-Infrared Spectroscopy	Change from baseline after 4 weeks of treatment	Blood oxygen saturation in muscles
Ankle joint stiffness	Change from baseline after 4 weeks of treatment	Device: isokinetic machine
Cerebral activation	Change from baseline after 4 weeks of treatment	functional Magnetic Resonance blood oxygenation level dependent imaging
Medical Research Council (MRC) Scale for Muscle Strength	Change from baseline after 4 weeks of treatment	Scale for measuring Muscle Strength, range 0-5, higher is better.

Trial Locations

Locations (1)

IRCCS E. Medea; 🇮🇹 Bosisio Parini, Lecco, Italy