Clinical trial NCT04229329: Effects of Intensive Training on Reocvery of Fingers Dexterity Following Stroke
Official title: The Effect of Intensive Training on Recovery of Fingers Dexterity Following Stroke: Behavioral, Physiological and Anatomical Predictors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Stroke
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2020-01-18
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to test whether intensive training of finger individuation during the sensitive window of the subacute phases can lead to a clinically-meaningful recovery of dexterous movement in stroke patients.


Eligibility criteria: Inclusion Criteria:

* First symptomatic ischemic or hemorrhagic stroke
* Clinically evident upper-limb motor deficit
* Understand the study aim, is able to cooperate with the task for the specified time
* Clinically stable

Exclusion Criteria:

* Other neurological or psychiatric illness which affects upper-limb motor function
* An orthopedic or rheumatologic disease that affects the ability to undergo a robotic hand therapy.
* Sensory problems that prevent the patient from reporting pain during the robotic hand therapy
* Skin breakdown or wounds located in places where the hand contacts the robot.
* Patients with C/I to TMS (history of seizures, the existence of cardiac pacer, VP shunt, spinal stimulator or any other hardware that may malfunction at the presence of strong magnetic fields) will no undergo TMS but may participate in the study
* Participation in another interventional study for upper limb rehabilitation

Primary outcomes:
measure: Change in Fugl-Meyer Assessment Score for Upper Extremity at the immediate post-intervention time
timeFrame: Change from Baseline Score at 1-3 days post-intervention
measure: Change in Fugl-Meyer Assessment Score for Upper Extermity at 1-month post-intervention
timeFrame: Change from Baseline Score at 1 month post-intervention
measure: Change in Fugl-Meyer Assessment Score for Upper Extermity at 3-month post-intervention
timeFrame: Change from Baseline Score at 3 month post-intervention
measure: Change in Individuation Index at the immediate post-intervention time
timeFrame: Change from Baseline Score at 1-3 days post-intervention
measure: Change in Individuation Index at 1-month post-intervention
timeFrame: Change from Baseline Score at 1-month post-intervention
measure: Change in Individuation Index at 3-month post-intervention
timeFrame: Change from Baseline Score at 3-month post-intervention
Secondary outcomes:
measure: Arm Research Action Test (ARAT) Score at the immediate post-intervention time
timeFrame: Change from Baseline Score at 1-3 days post-intervention
measure: Arm Research Action Test (ARAT) Score at at 1-month post-intervention
timeFrame: Change from Baseline Score at 1-month post-intervention
measure: Arm Research Action Test (ARAT) Score at at 3-month post-intervention
timeFrame: Change from Baseline Score at 3-month post-intervention
measure: Change in M1 MEP (motor evoked potentials) amplitude at immediate post-intervention time
timeFrame: Change from Baseline Score at 1-3 days post-intervention
measure: Change in M1 MEP (motor evoked potentials) amplitude at 1-month post-intervention
timeFrame: Change from Baseline Score at 1-month post-intervention
measure: Change in MEP (motor evoked potentials) amplitude at 3-months post-intervention
timeFrame: Change from Baseline Score at 3-months post-intervention
measure: Change in extent of SICI (short-interval cortical inhibition) at the immediate post-intervention time
timeFrame: Change from Baseline Score at 1-3 days post-intervention
measure: Change in extent of SICI (short-interval cortical inhibition) at 1-month post-intervention
timeFrame: Change from Baseline Score at 1-month post-intervention
measure: Change in extent of SICI (short-interval cortical inhibition) at 3-months post-intervention
timeFrame: Change from Baseline Score at 3-months post-intervention
Other outcomes:
Locations:
city: Raanana
country: Israel
facility: Loewenstein Rehabilitation Center
Study officials:
References: