Effects of Intensive Training on Reocvery of Fingers Dexterity Following Stroke

Stroke Clinical Trial

Official title:

The Effect of Intensive Training on Recovery of Fingers Dexterity Following Stroke: Behavioral, Physiological and Anatomical Predictors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04229329
• Other study ID #: LOE-19-19
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 1, 2021
• Est. completion date: March 1, 2026

Study information

• Verified date: September 2022
• Source: Loewenstein Hospital
• Contact: Shay Ofir-Geva, M.D.
• Phone: 972-522204842
• Email: shinofir[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 1, 2026
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Combination Product:
• 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).
• 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)

Locations

Country	Name	City	State
Israel	Loewenstein Rehabilitation Center	Raanana

Sponsors (2)

Lead Sponsor	Collaborator
Loewenstein Hospital	Technion, Israel Institute of Technology

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Arm Research Action Test (ARAT) Score at the immediate post-intervention time	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 from Baseline Score at 1-3 days post-intervention
Secondary	Arm Research Action Test (ARAT) Score at 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 from Baseline Score at 1-month post-intervention
Secondary	Arm Research Action Test (ARAT) Score at 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.	Change from Baseline Score at 3-month post-intervention
Secondary	Change in M1 MEP (motor evoked potentials) amplitude at immediate post-intervention time	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 from Baseline Score at 1-3 days post-intervention
Secondary	Change in M1 MEP (motor evoked potentials) amplitude 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 from Baseline Score at 1-month post-intervention
Secondary	Change in MEP (motor evoked potentials) amplitude 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.	Change from Baseline Score at 3-months post-intervention
Secondary	Change in extent of SICI (short-interval cortical inhibition) at the immediate post-intervention time	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 from Baseline Score at 1-3 days post-intervention
Secondary	Change in extent of SICI (short-interval cortical inhibition) 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 from Baseline Score at 1-month post-intervention
Secondary	Change in extent of SICI (short-interval cortical inhibition) 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.	Change from Baseline Score at 3-months post-intervention