Actively Recruiting
Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation
Led by Christian Cipriani · Updated on 2024-10-31
47
Participants Needed
6
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the DESC-Glove, an instrumented glove developed for sensorimotor rehabilitation in individuals recovering from a stroke, utilizing non-invasive vibrational feedback. The primary objective is to assess the technical functionality, safety, and reliability of the device during post-stroke rehabilitation, providing insights for future technical and functional improvements. The secondary objectives are: 1. To evaluate the usability and acceptability of the device in clinical rehabilitation from the perspectives of both patients and healthcare professionals; 2. To assess the short-term effects of the DESC-Glove on sensorimotor performance and manual dexterity in post-stroke individuals. To meet the second objective, researchers will compare three groups: an experimental treatment group (using the DESC-Glove during hand rehabilitation), a sham control group (using the DESC-Glove without vibration), and a conventional control group (receiving hand rehabilitation without the device).
CONDITIONS
Official Title
Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of ischemic or hemorrhagic stroke confirmed by CT or MRI
- Time from acute stroke event between 1 and 6 months
- Mild to moderate upper limb impairment with Motricity Index scores: pinch grip 219 and elbow flexion and shoulder abduction 214
You will not qualify if you...
- Severe behavioral or cognitive disorders (Montreal Cognitive Assessment 215) or decreased compliance
- Spasticity or hypertonia in affected limb with Modified Ashworth Scale > 3
- Participation in another rehabilitation trial including upper limb treatment after stroke
- Refusal to sign informed consent
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Acerenza, Italy
Not Yet Recruiting
2
Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente
Milan, Italy
Not Yet Recruiting
3
Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
Roma, Italy
Actively Recruiting
4
Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare
Salerno, Italy
Not Yet Recruiting
5
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Sant'Angelo dei Lombardi, Italy
Not Yet Recruiting
6
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Tricarico, Italy
Not Yet Recruiting
Research Team
C
Christian Cipriani, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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