Acquired Brain InjuryNCT03879070
Experimentation of an Ankle Mobilization Device for the Rehabilitation of Patients With Acquired Brain Injuries.
A study testing Ankle active and passive mobilization using an Ankle mobilization device in people with Acquired Brain Injury, run by IRCCS Eugenio Medea at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Ankle active and passive mobilization using an Ankle mobilization device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2020to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Tetraplegic and hemiplegic acquired brain injury patients, within first month of injury.
- Spastic syndrome (ankle joint Modified Ashworth Scale > 1).
Who cannot join
- Pace maker or other contraindication to Magnetic Resonance Imaging scans.
- Other serious comorbidity.
- Behaviour and psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Ankle active and passive mobilization using an Ankle mobilization device
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle active and passive mobilization using an Ankle mobilization deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Device: Ankle active and passive mobilization using an Ankle mobilization device |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive range of motion of ankle dorsi-plantarflexion
Measured with goniometer
Measured: Change from baseline after 4 weeks of treatment
Secondary outcomes (4)
Ankle joint stiffness
Device: isokinetic machine
Measured: Change from baseline after 4 weeks of treatment
Medical Research Council (MRC) Scale for Muscle Strength
Scale for measuring Muscle Strength, range 0-5, higher is better.
Measured: Change from baseline after 4 weeks of treatment
Cerebral activation
functional Magnetic Resonance blood oxygenation level dependent imaging
Measured: Change from baseline after 4 weeks of treatment
Time-Domain Near-Infrared Spectroscopy
Blood oxygen saturation in muscles
Measured: Change from baseline after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Feb 2020
- Primary completion1 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- The National Research Council, Italy, Regione Lombardia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879070
- Sponsor's protocol ID
- GIP599
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2019
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimentation of an Ankle Mobilization Device for the Rehabilitation of Patients With Acquired Brain Injuries.
- ClinicalTrials.gov ID
- NCT03879070
- Acronym / sponsor ID
- GIP599
- Conditions
- Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- The National Research Council, Italy, Regione Lombardia
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Ankle active and passive mobilization using an Ankle mobilization device |
| Control group | No intervention | – |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Tetraplegic and hemiplegic acquired brain injury patients, within first month of injury.
- Spastic syndrome (ankle joint Modified Ashworth Scale > 1).
Key exclusion criteria (3 listed)
- Pace maker or other contraindication to Magnetic Resonance Imaging scans.
- Other serious comorbidity.
- Behaviour and psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle active and passive mobilization using an Ankle mobilization deviceThe 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. | Device | Intervention group |
Primary outcome
Passive range of motion of ankle dorsi-plantarflexion
Time frame: Change from baseline after 4 weeks of treatment
Measured with goniometer
4 secondary outcomes
Ankle joint stiffness
Time frame: Change from baseline after 4 weeks of treatment
Medical Research Council (MRC) Scale for Muscle Strength
Time frame: Change from baseline after 4 weeks of treatment
Cerebral activation
Time frame: Change from baseline after 4 weeks of treatment
Time-Domain Near-Infrared Spectroscopy
Time frame: Change from baseline after 4 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle active and passive mobilization using an Ankle mobilization device in people with Acquired Brain Injury, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Passive range of motion of ankle dorsi-plantarflexion (time frame: Change from baseline after 4 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.