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

NCT03879070 | Completed

• 1 other identifier: GIP599
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury

Outcome Measures

Primary Outcomes (1)

• Passive range of motion of ankle dorsi-plantarflexion

  Measured with goniometer

  Change from baseline after 4 weeks of treatment

Secondary Outcomes (4)

• Ankle joint stiffness

  Change from baseline after 4 weeks of treatment

• Medical Research Council (MRC) Scale for Muscle Strength

  Change from baseline after 4 weeks of treatment

• Cerebral activation

  Change from baseline after 4 weeks of treatment

• Time-Domain Near-Infrared Spectroscopy

  Change from baseline after 4 weeks of treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• The National Research Council, Italy: collaborator
• Regione Lombardia: collaborator

Study Sites (1)

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 18, 2019
• Study Start: February 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 2, 2023

Record last verified: 2023-03

Locations

IT (1)