Effects of Intensive Training on Reocvery of Fingers Dexterity Following Stroke

Phase 1

Recruiting

• Conditions: Stroke

• Registration Number: NCT04229329
• Lead Sponsor: Loewenstein Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-31
• Study First Submitted QC: 2020-01-12
• Study First Posted: 2020-01-18
• Study Start: 2021-05-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-17
• Last Update Posted: 2022-09-21
• Primary Completion: 2024-05-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Fugl-Meyer Assessment Score for Upper Extremity at the immediate post-intervention time	Change from Baseline Score at 1-3 days 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 in Fugl-Meyer Assessment Score for Upper Extermity at 3-month post-intervention	Change from Baseline Score 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 in Individuation Index at 1-month post-intervention	Change from Baseline Score 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 in Fugl-Meyer Assessment Score for Upper Extermity at 1-month post-intervention	Change from Baseline Score 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 in Individuation Index at 3-month post-intervention	Change from Baseline Score 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 in Individuation Index at the immediate post-intervention time	Change from Baseline Score at 1-3 days 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.

Secondary Outcome Measures

Name	Time	Method
Arm Research Action Test (ARAT) Score at the immediate post-intervention time	Change from Baseline Score at 1-3 days post-intervention	Time and quality of performance of 19 items mimicking activity of daily living, are measured. Tange: 0 - 57. Higher values correlate with better motor control.
Change in M1 MEP (motor evoked potentials) amplitude at immediate post-intervention time	Change from Baseline Score at 1-3 days post-intervention	Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Change in M1 MEP (motor evoked potentials) amplitude at 1-month post-intervention	Change from Baseline Score at 1-month post-intervention	Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Change in MEP (motor evoked potentials) amplitude at 3-months post-intervention	Change from Baseline Score at 3-months post-intervention	Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Arm Research Action Test (ARAT) Score at at 3-month post-intervention	Change from Baseline Score at 3-month post-intervention	Time and quality of performance of 19 items mimicking activity of daily living, are measured. Range: 0 - 57. Higher values correlate with better motor control.
Arm Research Action Test (ARAT) Score at at 1-month post-intervention	Change from Baseline Score at 1-month post-intervention	Time and quality of performance of 19 items mimicking activity of daily living, are measured. Range: 0 - 57. Higher values correlate with better motor control.
Change in extent of SICI (short-interval cortical inhibition) at the immediate post-intervention time	Change from Baseline Score at 1-3 days post-intervention	Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.
Change in extent of SICI (short-interval cortical inhibition) at 1-month post-intervention	Change from Baseline Score at 1-month post-intervention	Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.
Change in extent of SICI (short-interval cortical inhibition) at 3-months post-intervention	Change from Baseline Score at 3-months post-intervention	Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.

Trial Locations

Locations (1)

Loewenstein Rehabilitation Center; 🇮🇱 Raanana, Israel