Upper Extremity Rehabilitation Training Using Brain-Machine Interface Biofeedback in Stroke Patients With Hemiplegia

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04290377

Collaborator

(none)

Enrollment

Location

Arms

33.2

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a study to evaluate the efficacy of upper extremity rehabilitation using Brain-Machine Interface (BMI) on individuals with hemiplegia due to stroke. BMI is a device that can record and analyze human brain signals (in this study Functional near-infrared spectroscopy was used) and also provide live feedback (by pneumatic glove movement) to the individual wearing it. This device hypothetically enables more accurate training by reinforcing the correctly activated brain signal repeatedly then conventional therapy.

In phase 1 study investigators will evaluate the feasibility of BMI on chronic stroke participants. 5 sessions of BMI-assisted occupational therapy (OT) will be performed and the Fugl Meyer Assessment-Upper Limb (FMA-UL) score change between the pre-treatment and post-treatment will be analyzed by paired t-test.

In phase 2 study, a randomized controlled study will be performed by randomly allocating participants to either control (OT plus OT) or experimental group (BMI-assisted OT plus OT) and the difference of FMA-UL score change between the two groups will be analyzed by Student's t-test.

Condition or Disease	Intervention/Treatment	Phase
Stroke Hemiplegia	Device: BMI-assisted motor imagery OT Other: Motor imagery OT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Phase1 (chronic stroke): with-in group (one group) multiple measurements Phase2 (subacute stroke): Randomized controlled study. Control (OT plus OT) vs Experimental (OT plus BMI-assisted OT)Phase1 (chronic stroke): with-in group (one group) multiple measurements Phase2 (subacute stroke): Randomized controlled study. Control (OT plus OT) vs Experimental (OT plus BMI-assisted OT)

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

Impossible to mask participants and care providers due to using a device that is so obvious.

Primary Purpose:

Treatment

Official Title:

A Study on the Effectiveness of Upper Extremity Rehabilitation Training Using Brain-Machine Interface Biofeedback in Stroke Patients With Hemiplegia

Actual Study Start Date :

Feb 25, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional OT + Motor Imagery OT Conventional OT (30 minutes/day) plus Motor Imagery OT (30 minutes/day) for 10 days.	Other: Motor imagery OT In Motor imagery OT, Subjects try to extend their fingers (imagine) without BMI assistance. All other setting is equal to BMI-assisted motor imagery OT.
Experimental: Conventional OT + BMI-assisted Motor Imagery OT Conventional OT (30 minutes/day) plus BMI-assisted motor imagery OT (30 minutes/day) for 10 days.	Device: BMI-assisted motor imagery OT As the goal of the intervention is to promote finger extension in participants who are unable to extend his/her finger due to stroke, the pneumatic glove provides extension assist when appropriate brain activity is present. The brain activity is obtained by Functional Near-Infrared Spectroscopy (fNIRS). Hypothetically, this will repeatedly induce brain activation that is related to finger extension.

Arm

Intervention/Treatment

Active Comparator: Conventional OT + Motor Imagery OT

Conventional OT (30 minutes/day) plus Motor Imagery OT (30 minutes/day) for 10 days.

Other: Motor imagery OT

In Motor imagery OT, Subjects try to extend their fingers (imagine) without BMI assistance. All other setting is equal to BMI-assisted motor imagery OT.

Experimental: Conventional OT + BMI-assisted Motor Imagery OT

Conventional OT (30 minutes/day) plus BMI-assisted motor imagery OT (30 minutes/day) for 10 days.

Device: BMI-assisted motor imagery OT

As the goal of the intervention is to promote finger extension in participants who are unable to extend his/her finger due to stroke, the pneumatic glove provides extension assist when appropriate brain activity is present. The brain activity is obtained by Functional Near-Infrared Spectroscopy (fNIRS). Hypothetically, this will repeatedly induce brain activation that is related to finger extension.

Outcome Measures

Primary Outcome Measures

Change of Fugl Meyer Assessment-Upper Limb (FMA-UL) Score [Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).]
Impairment measurement

Secondary Outcome Measures

Change of Finger Tapping Test Score (taps/minute) [Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3).]
The number of finger tapping on I-pad screen per 10 seconds for 1 session. Total : 3 sessions
Change of Finger Extension (Metarcapophalangeal [MCP] joint) Range of Motion (degree) [Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).]
Range of motion of 2nd finger is measured with Goniometer.
Change of Hand grasp power (lb) [Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).]
Measured with Dynamometer
Change of Brunnstrom Stage [Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).]
Observational evaluation of the stage of recovery of a stroke patient. There are six stages (1: flaccid, 2: spasticity appears, 3: pronounced spasticity, 4: start of deviation from spasticity, 5: spasticity decreased more than 4 and complex movement combinations are possible, 6: No more spasticity present, near normal to normal movement
Change of muscle strength (Medical Research Council)-Upper extremity [Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 month of T2 (T3).]
Manual measurement of muscle strength. Range from 0 to 5. When there is absolute no movement of muscle it scored as 0. When muscle activation is felt by palpation but no movement is present it is scored as 1. If full range of motion is possible with gravity removed it is scored as 2. If one can move his/her joint to full range of motion against gravity but without other resistance it is scored as 3. If one can resist mild resistance it is score as 4. If one's muscle strength is normal it is scored as 5.
Change of Box and Block Test (BBT) Score (boxes/60 second) [Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3).]
An observational measurement on manual dexterity. The observer counts the number of boxes that participant can move across the mid-line dissection board in a limited time (60 seconds).
Change of Functional near-infrared spectroscopy Connectivity [Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3).]
Near infrared spectroscopy is a tool that can measure the brain activity and subsequently analyze connectivity between each recording spot. The connectivity will be reported as an illustration or image
Change of Modified Ashworth Scale (MAS) of upper extremity [Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3).]
Measures resistance during passive muscle stretching and is used as a simple measure of spasticity. 0: No increase in muscle tone, 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension. 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved. 3: Considerable increase in muscle tone, passive movement difficult. 4: Affected part(s) rigid in flexion or extension.
Change of range of motion of finger extension (degrees) measured with Camera and marker [Baseline evaluation (T0), Evaluation after 2 weeks of therapy (T1 [immediately or 1 day after treatment termination]), Evaluation after 1 month of T1 (T2), Evaluation after 3 months of T2 (T3).]
Markers (stickers) are placed on finger joints (Proximal phalangeal joint, Distal phalangeal joint) and finger tip of the 2nd finger. The camera will recognize the marker and measure the range of 2nd finger extension.