Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions
NCT ID: NCT03349138
Last Updated: 2017-11-24
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2015-01-01
2017-08-31
Brief Summary
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Detailed Description
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Robotic hand mobilization achieves grasp rehabilitation by providing passive mobilization of the affected limb if the subject does not react to the designed task.
Functional electrical stimulation achieves grasp rehabilitation by inducing localized muscle contraction, that is by providing an electrical field able to stimulate both sensory afferent pathways and lower motor neurons in the targeted volume.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* conventional treatment (27 treatments)
* functional electrical stimulation (27 treatments)
* robotic glove ( 27 treatments )
* robotic glove and electrical stimulation ( each session uses one device, half of the sessions uses the robotic glove, half the functional electrical stimulation )
TREATMENT
NONE
Study Groups
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Conventional Therapy
27 sessions, 3 sessions per week for a total of 9 weeks. Each session lasts about 90 minutes and consists of different standard motor training modalities typically used in the rehabilitation of the arm after stroke. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.
Conventional Therapy
Robotic Glove
Robotic Glove \& Conventional Therapy 27 sessions, 3 sessions per week for a total of 9 weeks. Each session consists of 30-minute training with the robotic glove system plus 60 minutes of conventional therapy. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.
Robotic Glove
Electrical Stimulation
Electrical Stimulation \& Conventional Therapy 27 sessions, 3 sessions per week for a total of 9 weeks. Each session consists of 30-minute training with the electrical stimulation system plus 60 minutes of conventional therapy. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.
Electrical Stimulation
Electrical Stimulation and Robotic Glove
Electrical Stimulation \& Robotic Glove \& Conventional Therapy 27 sessions, 3 sessions per week for a total of 9 weeks. Each session consists of 30-minute training with the electrical stimulation system plus 60 minutes of conventional therapy or 30-minute training with the robotic glove system plus 60 minutes of conventional therapy. Half of the sessions are allocated to the electrical stimulation system, and half are allocated to the robotic glove system. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.
Robotic Glove
Electrical Stimulation
Interventions
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Conventional Therapy
Robotic Glove
Electrical Stimulation
Eligibility Criteria
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Inclusion Criteria
* Patients who have suffered one or more strokes with major unilateral functional impairment
* Hemiplegic, left and right unilateral lesion
* Chronic phase of stroke at least six months before study enrollment
* Level of impairment: hand and/or arm
* No left handed
* Mini-Mental State Examination \> 20
Exclusion Criteria
* Pain due to Spasticity evaluated using Modified Ashworth Scale (\>=3)
* Previous history of major neurological or psychiatric disorders
* allergy to electrodes
18 Years
85 Years
ALL
No
Sponsors
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Ecole Polytechnique Fédérale de Lausanne
OTHER
Villa Beretta Rehabilitation Center
OTHER
Responsible Party
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Dr. Franco Molteni
Clinical Director
Principal Investigators
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Franco Molteni, MD
Role: PRINCIPAL_INVESTIGATOR
Villa Beretta Rehabilitation Center
Locations
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Villa Beretta Rehabilitation Center
Costa Masnaga, Lecco, Italy
Countries
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References
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Crema A, Bassolino M, Guanziroli E, Colombo M, Blanke O, Serino A, Micera S, Molteni F. Neuromuscular electrical stimulation restores upper limb sensory-motor functions and body representations in chronic stroke survivors. Med. 2022 Jan 14;3(1):58-74.e10. doi: 10.1016/j.medj.2021.12.001. Epub 2022 Jan 7.
Other Identifiers
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INCOGNITO
Identifier Type: -
Identifier Source: org_study_id