Effects of Intensive Training on Reocvery of Fingers Dexterity Following Stroke

NCT04229329 | Recruiting Phase 1

• 1 other identifier: LOE-19-19
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Change in Fugl-Meyer Assessment Score for Upper Extremity at the immediate post-intervention time

  A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.

  Change from Baseline Score at 1-3 days post-intervention

• Change in Fugl-Meyer Assessment Score for Upper Extermity at 1-month post-intervention

  A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.

  Change from Baseline Score at 1 month post-intervention

• Change in Fugl-Meyer Assessment Score for Upper Extermity at 3-month post-intervention

  A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.

  Change from Baseline Score at 3 month post-intervention

• Change in Individuation Index at the immediate post-intervention time

  The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.

  Change from Baseline Score at 1-3 days post-intervention

• Change in Individuation Index at 1-month post-intervention

  The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.

  Change from Baseline Score at 1-month post-intervention

• Change in Individuation Index at 3-month post-intervention

  The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.

  Change from Baseline Score at 3-month post-intervention

Secondary Outcomes (9)

• Arm Research Action Test (ARAT) Score at the immediate post-intervention time

  Change from Baseline Score at 1-3 days post-intervention

• Arm Research Action Test (ARAT) Score at at 1-month post-intervention

  Change from Baseline Score at 1-month post-intervention

• Arm Research Action Test (ARAT) Score at at 3-month post-intervention

  Change from Baseline Score at 3-month post-intervention

• Change in M1 MEP (motor evoked potentials) amplitude at immediate post-intervention time

  Change from Baseline Score at 1-3 days post-intervention

• Change in M1 MEP (motor evoked potentials) amplitude at 1-month post-intervention

  Change from Baseline Score at 1-month post-intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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

Combination Product: Intensive Finger Individuation Therapy

Control

SHAM COMPARATOR

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.

Combination Product: Intensive non-directed finger movement therapy

Interventions

Intensive Finger Individuation Therapy 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).

Intervention

Intensive non-directed finger movement therapy 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)

Control

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loewenstein Hospital: lead
• Technion, Israel Institute of Technology: collaborator

Study Sites (1)

Loewenstein Rehabilitation Center

Raanana, 43100, Israel

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Shay Ofir-Geva, M.D.

CONTACT

972-522204842; shinofir@gmail.com

Silvi Frenkel-Toledo, Ph.D.

CONTACT

972-545509413; silvft@ariel.ac.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research, Department of Neurological Rehabilitation

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 18, 2020
• Study Start: May 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: March 1, 2026
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

IL (1)