Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing
NCT ID: NCT04328857
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
34 participants
INTERVENTIONAL
2020-10-01
2023-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Upper limb rehabilitation with pseudoelastic orthosis
pseudoelastic orthosis
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.
Control
Upper limb rehabilitation without pseudoelastic orthosis
No interventions assigned to this group
Interventions
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pseudoelastic orthosis
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.
Eligibility Criteria
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Inclusion Criteria
2. Age 6-20 years.
3. Dystonic, dyskinetic, spastic.
4. Chronic phase patients (\> 1 year post event).
5. Spastic syndrome with Ashworth Score (AS) for the limb of interest\> 1.
6. Collaborative.
Exclusion Criteria
2. Joint pain.
3. Skin allergies.
4. Behavioral and psychiatric disorders (eg, emotional problems, anxiety, panic attacks).
6 Years
20 Years
ALL
No
Sponsors
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CNR - ICMATE UOS di Lecco
UNKNOWN
IRCCS Eugenio Medea
OTHER
Responsible Party
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Locations
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IRCCS Eugenio Medea
Bosisio Parini, LC, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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686
Identifier Type: -
Identifier Source: org_study_id
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