Effects of Intensive Training on Reocvery of Fingers Dexterity Following Stroke

NCT ID: NCT04229329

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2026-03-01

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

The patient hand will be restrained to a robotic arm AMADEO(TM) which enables the measurement and manipulation of forces at each finger individually. After appropriate calibration, the force measurements obtained from the robot will be used to move a cursor on the screen. The patient will be rewarded visually and auditory when a higher degree of finger individuation will be measured. Specifically, when the applied force of the instructed fingers hit the predefined force target and at the same, the force in the non-instructed fingers stay as low as possible

Group Type: EXPERIMENTAL

Intensive Finger Individuation Therapy

Intervention Type: COMBINATION_PRODUCT

Interactive robot-mediated treatment aimed at increased individuation done repeatedly for at least1 hour per day for 2 weeks (5 training days a week).

Control

The patient hand will be restrained to a robotic arm AMADEO(TM) which enables the measurement and manipulation of forces at each finger individually. After appropriate calibration, the force measurements obtained from the robot will be used to move a cursor on the screen. The patient will be rewarded in a way that is unrelated to the degree of individuation. In other words, a successful trial considered when the applied force of the instructed fingers hits the predefined force target regardless of the force exerted in the non-instructed fingers.

Group Type: SHAM_COMPARATOR

Intensive non-directed finger movement therapy

Intervention Type: COMBINATION_PRODUCT

Interactive robot-mediated treatment not aimed specifically at increased individuation done repeatedly for at least 1 hour per day for 2 weeks (5 training days per week)

Interventions

Intensive Finger Individuation Therapy

Interactive robot-mediated treatment aimed at increased individuation done repeatedly for at least1 hour per day for 2 weeks (5 training days a week).

Intervention Type: COMBINATION_PRODUCT

Intensive non-directed finger movement therapy

Interactive robot-mediated treatment not aimed specifically at increased individuation done repeatedly for at least 1 hour per day for 2 weeks (5 training days per week)

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technion, Israel Institute of Technology

OTHER

Sponsor Role: collaborator

Loewenstein Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nachum Soroker, MD

Head of Research, Department of Neurological Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Loewenstein Rehabilitation Center

Raanana, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Shay Ofir-Geva, M.D.

Role: CONTACT

shinofir@gmail.com

972-522204842

Silvi Frenkel-Toledo, Ph.D.

Role: CONTACT

silvft@ariel.ac.il

972-545509413

Facility Contacts

shay ofir

Role: primary

shinofir@gmail.com

972-522204842

Other Identifiers

LOE-19-19

Identifier Type: -

Identifier Source: org_study_id