Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation
Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation After Stroke (DESC-Glove)
Christian Cipriani
47 participants
Oct 21, 2024
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria3
- Diagnosis of ischemic or hemorrhagic stroke confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI);
- Time from the acute event between 1 and 6 months;
- Mild to moderate impairment of the upper limb, assessed using the Motricity Index (item score for "pinch grip" ≥ 19 and scores for "elbow flexion" and "shoulder abduction" ≥ 14).
Exclusion Criteria4
- Severe behavioral and cognitive disorders (Montreal Cognitive Assessment (MoCA) ≤ 15 ) and/or decreased compliance;
- Spasticity or hypertonia (Modified Ashworth Scale (MAS) > 3) in the affected limb;
- Concurrent participation in a rehabilitation trial that includes treatment training for the upper limb following a stroke;
- Refusal to sign informed consent.
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Interventions
Rehabilitation treatment for the upper limb using the DESC-Glove device. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20-minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. During each session, patients will wear the DESC-Glove on the affected hand, receiving vibratory stimuli that are synchronized with the exercises being performed.
Rehabilitation treatment for the upper limb using the DESC-Glove device. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20-minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. During each session, patients will wear the DESC-Glove on the affected hand, but will not receive any vibratory stimuli.
Traditional rehabilitation treatment for the upper limb. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20- minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. The DESC- Glove will not be used during this treatment.
Locations(6)
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NCT06649968