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

Acquired Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879070
• Other study ID #: GIP599
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2023
• Source: IRCCS Eugenio Medea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Wounds and Injuries

Intervention

Device:
• Ankle active and passive mobilization using an Ankle mobilization 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.

Locations

Country	Name	City	State
Italy	IRCCS E. Medea	Bosisio Parini	Lecco

Sponsors (3)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea	National Research Council of Italy, Regione Lombardia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Passive range of motion of ankle dorsi-plantarflexion	Measured with goniometer	Change from baseline after 4 weeks of treatment
Secondary	Ankle joint stiffness	Device: isokinetic machine	Change from baseline after 4 weeks of treatment
Secondary	Medical Research Council (MRC) Scale for Muscle Strength	Scale for measuring Muscle Strength, range 0-5, higher is better.	Change from baseline after 4 weeks of treatment
Secondary	Cerebral activation	functional Magnetic Resonance blood oxygenation level dependent imaging	Change from baseline after 4 weeks of treatment
Secondary	Time-Domain Near-Infrared Spectroscopy	Blood oxygen saturation in muscles	Change from baseline after 4 weeks of treatment