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Completed

NCT Number: NCT03879070

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

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.

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Key information

Conditions

Acquired Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ankle active and passive mobilization using an Ankle mobilization device

Device

The treatment consists in 20 rehabilitation sessions, 5 times/week for 4 weeks. The device is capable of generating ankle dorsi/plantarflexion movements using two activation modes: passive and assistive. In the passive mode the device generates a movement pattern which the patient follows passively without exerting any force on the device. During the assistive mode, the device follows the active movement of the patient. During the intervention, these two modes will be alternated.

Primary outcomes

  1. Passive range of motion of ankle dorsi-plantarflexion

    Time frame: Change from baseline after 4 weeks of treatment

    Measured with goniometer

Secondary outcomes

  1. Ankle joint stiffness

    Time frame: Change from baseline after 4 weeks of treatment

    Device: isokinetic machine

  2. Medical Research Council (MRC) Scale for Muscle Strength

    Time frame: Change from baseline after 4 weeks of treatment

    Scale for measuring Muscle Strength, range 0-5, higher is better.

  3. Cerebral activation

    Time frame: Change from baseline after 4 weeks of treatment

    functional Magnetic Resonance blood oxygenation level dependent imaging

  4. Time-Domain Near-Infrared Spectroscopy

    Time frame: Change from baseline after 4 weeks of treatment

    Blood oxygen saturation in muscles

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Collaborators

  • Regione Lombardia
  • The National Research Council, Italy

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 18, 2019
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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