Acquired Brain InjuryNCT04328857
Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing
A study testing pseudoelastic orthosis 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 pivotal controlled study with two parallel groups, has a total duration of 12 months and involves the recruitment of 34 pediatric patients suffering from acquired brain injury. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- pseudoelastic orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 31 May 2023
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Quadriplegia or acquired hemiplegia.
- Age 6-20 years.
- Dystonic, dyskinetic, spastic.
- Chronic phase patients (> 1 year post event).
- Spastic syndrome with Ashworth Score (AS) for the limb of interest> 1.
- Collaborative.
Who cannot join
- Fixed limitations of the joint.
- Joint pain.
- Skin allergies.
- Behavioral and psychiatric disorders (eg, emotional problems, anxiety, panic attacks).
Trial locations and contacts
1 site in 1 country.
FAbio A Storm contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Eugenio Medea
Bosisio Parini, LC, 23842
Elena Beretta, MD, +39031877111, elena.beretta@lanostrafamiglia.it
Fabio A Storm
About this study
The proposed clinical investigation plan is a pivotal controlled study with two parallel groups, has a total duration of 12 months and involves the recruitment of 34 pediatric patients suffering from acquired brain injury.
The primary objective of the clinical study is to evaluate the improvement of joint stiffness through the use of sensorized pseudoelastic orthoses for the rehabilitation of pediatric patients with acquired brain injury.
The effectiveness of the treatment in terms of joint stiffness (primary outcome) will be assessed and the effect of the treatment will be quantified with clinical evaluation scales and instrumental measurements by means of an optoelectronic system and isokinetic machine. The tolerability and acceptability of the device will also be checked.
- Conditions
- Acquired Brain Injury
- Being tested
- pseudoelastic orthosis
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pseudoelastic orthosisDevice
The subject will be given specific physiotherapy including activities oriented to multimodal exploration and refinement of gross and fine motor skills, customized according to the functional status of the individual patient.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Upper limb rehabilitation with pseudoelastic orthosis Receives: Device: pseudoelastic orthosis |
| Control | No intervention | Upper limb rehabilitation without pseudoelastic orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Stiffness of affected upper limb joint
Quantitative measure performed by means of an isokinetic machine (Unit of measure: Nm/°). Changes in joint stiffness following the use of new customized devices during a rehabilitation treatment period. Lower stiffness is better.
Measured: After 4 weeks of treatment
Secondary outcomes (6)
Modified Ashworth Scale
Clinical scale for spasticity (5 levels), higher is worse.
Measured: After 4 weeks of treatment
Melbourne Upper Limb Assessment 2
Clinical scale for evaluating quality of upper limb movement (16 items, each assessed from 0 to 4 points). Result reported in %. Higher is better.
Measured: After 4 weeks of treatment
Quality of Upper Extremity Skills Test
Clinical scale evaluating the quality of upper extremity function (33 items, 4 domains). Minimum score 0, maximum score 100. Higher is better.
Measured: After 4 weeks of treatment
Active range of motion
Measured with goniometer in degrees.
Measured: After 4 weeks of treatment
Passive range of motion
Measured with goniometer in degrees.
Measured: After 4 weeks of treatment
Range of motion of target joint during a pointing-forward task
Measured in degrees. A kinematic analysis will be performed during a pointing-forward task using an optoelectronic system.
Measured: 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 posted31 Mar 2020
- Study start1 Oct 2020
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- CNR - ICMATE UOS di Lecco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328857
- Sponsor's protocol ID
- 686
- Status last verified
- Feb 2023
- First submitted
- 27 Feb 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing
- ClinicalTrials.gov ID
- NCT04328857
- Acronym / sponsor ID
- 686
- Conditions
- Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- CNR - ICMATE UOS di Lecco
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 31 Mar 2020 (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 pivotal controlled study with two parallel groups, has a total duration of 12 months and involves the recruitment of 34 pediatric patients suffering from acquired brain injury.
The primary objective of the clinical study is to evaluate the improvement of joint stiffness through the use of sensorized pseudoelastic orthoses for the rehabilitation of pediatric patients with acquired brain injury.
The effectiveness of the treatment in terms of joint stiffness (primary outcome) will be assessed and the effect of the treatment will be quantified with clinical evaluation scales and instrumental measurements by means of an optoelectronic system and isokinetic machine. The tolerability and acceptability of the device will also be checked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: pseudoelastic orthosisUpper limb rehabilitation with pseudoelastic orthosis |
| Control | No intervention | –Upper limb rehabilitation without pseudoelastic orthosis |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Quadriplegia or acquired hemiplegia.
- Age 6-20 years.
- Dystonic, dyskinetic, spastic.
- Chronic phase patients (> 1 year post event).
- Spastic syndrome with Ashworth Score (AS) for the limb of interest> 1.
Key exclusion criteria (4 listed)
- Fixed limitations of the joint.
- Joint pain.
- Skin allergies.
- Behavioral and psychiatric disorders (eg, emotional problems, anxiety, panic attacks).
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 |
|---|---|---|
| pseudoelastic orthosisThe subject will be given specific physiotherapy including activities oriented to multimodal exploration and refinement of gross and fine motor skills, customized according to the functional status of the individual patient. | Device | Treatment |
Primary outcome
Joint Stiffness of affected upper limb joint
Time frame: After 4 weeks of treatment
Quantitative measure performed by means of an isokinetic machine (Unit of measure: Nm/°). Changes in joint stiffness following the use of new customized devices during a rehabilitation treatment period. Lower stiffness is better.
6 secondary outcomes
Modified Ashworth Scale
Time frame: After 4 weeks of treatment
Melbourne Upper Limb Assessment 2
Time frame: After 4 weeks of treatment
Quality of Upper Extremity Skills Test
Time frame: After 4 weeks of treatment
Active range of motion
Time frame: After 4 weeks of treatment
Passive range of motion
Time frame: After 4 weeks of treatment
Range of motion of target joint during a pointing-forward task
Time frame: After 4 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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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.
FAbio A Storm contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pseudoelastic orthosis 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Beretta (031877851, elena.beretta@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint Stiffness of affected upper limb joint (time frame: 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 8 Feb 2023.