Stimulate One Hand to Improve Tactile Perception on the Other
Not Applicable
Recruiting
- Conditions
- Post-stroke Sensory Deficits at the Hand
- Interventions
- Procedure: Repetitive somatosensory stimulation (RSS)Procedure: Sham Repetitive somatosensory stimulation (RSS)
- Registration Number
- NCT06149325
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
The study is a comparative study, to show that the administration of RSS stimulation on one hand compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the other hand in patients with tactile acuity impairment of the hand due to stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
-
Age: 30-80 years old
- Patients with diagnosis of unilateral (both right and left) ischemic or hemorrhagic stroke
- Stroke event dates at least 3 months before the date of inclusion to the study
- Severe-to-mild sensory loss at the fingers of the hand contralateral to the stroke lesion (affected hand)
- Capacity to provide written consent
- Affiliation to a social security scheme
-
Non inclusion Criteria * :
- Sensory impairment attributable to diabetes history, peripheral vascular disease or neuropathy
- Severe speech disorder, global aphasia and/or cognitive impairment
- Multiple stroke events
- Bilateral stroke event
- History of neurological or psychiatric illness
- Other experimental procedure is forbidden during the weeks where the study is performed
- Pregnant, parturient and lactating women
- Persons deprived of their liberty
- Adult persons subject to a legal protection measure: guardianship, curatorship
- Persons in psychiatric care
- Congenital or acquired malformation/injury of the test fingers
- Impossibility to maintain hand position necessary for the tests due to severe spasticity
Exclusion Criteria
• Severe impairment of the sensibility of the index finger of the spared hand preventing the administration of the RSS
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sham Repetitive somatosensory stimulation (RSS), then RSS Sham Repetitive somatosensory stimulation (RSS) Adult patients suffering from post-stroke sensory deficits at the hand. Each participant will participate to the study on two different days, at least a week apart from each other. The length of the experimental session on these two days will be the same: 2 hours in the morning, to perform Pre-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity, and 3 hours in the afternoon, including 45 minutes of stimulation (RSS or Sham) and 2 hours of Post-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity. In total, the length of the participation of each patient will be of 10 hours, spread on two days. Repetitive somatosensory stimulation (RSS), then SHAM Sham Repetitive somatosensory stimulation (RSS) Adult patients suffering from post-stroke sensory deficits at the hand. Each participant will participate to the study on two different days, at least a week apart from each other. The length of the experimental session on these two days will be the same: 2 hours in the morning, to perform Pre-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity, and 3 hours in the afternoon, including 45 minutes of stimulation (RSS or Sham) and 2 hours of Post-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity. In total, the length of the participation of each patient will be of 10 hours, spread on two days. Repetitive somatosensory stimulation (RSS), then SHAM Repetitive somatosensory stimulation (RSS) Adult patients suffering from post-stroke sensory deficits at the hand. Each participant will participate to the study on two different days, at least a week apart from each other. The length of the experimental session on these two days will be the same: 2 hours in the morning, to perform Pre-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity, and 3 hours in the afternoon, including 45 minutes of stimulation (RSS or Sham) and 2 hours of Post-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity. In total, the length of the participation of each patient will be of 10 hours, spread on two days. Sham Repetitive somatosensory stimulation (RSS), then RSS Repetitive somatosensory stimulation (RSS) Adult patients suffering from post-stroke sensory deficits at the hand. Each participant will participate to the study on two different days, at least a week apart from each other. The length of the experimental session on these two days will be the same: 2 hours in the morning, to perform Pre-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity, and 3 hours in the afternoon, including 45 minutes of stimulation (RSS or Sham) and 2 hours of Post-evaluation of the tactile acuity, absolute detection, overall hand functionality and manual dexterity. In total, the length of the participation of each patient will be of 10 hours, spread on two days.
- Primary Outcome Measures
Name Time Method Tactile acuity : composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 45minutes of RSS Immediate after the 45 minutes of RSS To show that RSS applied for 45 minutes on the index finger of the spared hand in stroke patients suffering from sensory deficits improves their tactile sensitivity on the affected (unstimulated) hand, measured in terms of improved spatial discrimination and/or improved absolute detection.
- Secondary Outcome Measures
Name Time Method Jebsen-Taylor hand function test (JTHFT) Immediate after the 45 minutes of RSS Overall functionality of the hand, especially with regard to handling objects
Manual dexterity Pegboard test Immediate after the 45 minutes of RSS Assessment of manual dexterity of the affected unstimulated hand (as well as of the spared hand)
Trial Locations
- Locations (1)
Groupement Hospitalier du Sud - Hôpital Henry Gabrielle
🇫🇷Saint-Genis-Laval, France