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

Primary Purpose

Stroke, Hemiplegia

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BMI-assisted motor imagery OT
Motor imagery OT
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Neural plasticity, Brain Machine Interface, Functional near-infrared spectroscopy, Stroke, Upper extremity, Function, Recovery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subcortical stroke with hemiplegia
  • 1st stroke
  • Time since onset is less than 3 months
  • Brunnstrom stage 2,3

Exclusion Criteria:

  • Recurred stroke
  • MMSE score below 10
  • Delirium
  • Unstable medical condition
  • Pregnancy
  • Cannot sustain sitting position for 30 minutes
  • Pain that limits upper extremity exercise

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional OT + Motor Imagery OT

Conventional OT + BMI-assisted Motor Imagery OT

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change of Fugl Meyer Assessment-Upper Limb (FMA-UL) Score
Impairment measurement

Secondary Outcome Measures

Change of Finger Tapping Test Score (taps/minute)
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)
Range of motion of 2nd finger is measured with Goniometer.
Change of Hand grasp power (lb)
Measured with Dynamometer
Change of Brunnstrom Stage
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
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)
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
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
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
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.

Full Information

First Posted
February 25, 2020
Last Updated
May 4, 2022
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04290377
Brief Title
Upper Extremity Rehabilitation Training Using Brain-Machine Interface Biofeedback in Stroke Patients With Hemiplegia
Official Title
A Study on the Effectiveness of Upper Extremity Rehabilitation Training Using Brain-Machine Interface Biofeedback in Stroke Patients With Hemiplegia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia
Keywords
Neural plasticity, Brain Machine Interface, Functional near-infrared spectroscopy, Stroke, Upper extremity, Function, Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
InvestigatorOutcomes Assessor
Masking Description
Impossible to mask participants and care providers due to using a device that is so obvious.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional OT + Motor Imagery OT
Arm Type
Active Comparator
Arm Description
Conventional OT (30 minutes/day) plus Motor Imagery OT (30 minutes/day) for 10 days.
Arm Title
Conventional OT + BMI-assisted Motor Imagery OT
Arm Type
Experimental
Arm Description
Conventional OT (30 minutes/day) plus BMI-assisted motor imagery OT (30 minutes/day) for 10 days.
Intervention Type
Device
Intervention Name(s)
BMI-assisted motor imagery OT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Motor imagery OT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Fugl Meyer Assessment-Upper Limb (FMA-UL) Score
Description
Impairment measurement
Time Frame
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).
Secondary Outcome Measure Information:
Title
Change of Finger Tapping Test Score (taps/minute)
Description
The number of finger tapping on I-pad screen per 10 seconds for 1 session. Total : 3 sessions
Time Frame
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).
Title
Change of Finger Extension (Metarcapophalangeal [MCP] joint) Range of Motion (degree)
Description
Range of motion of 2nd finger is measured with Goniometer.
Time Frame
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).
Title
Change of Hand grasp power (lb)
Description
Measured with Dynamometer
Time Frame
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).
Title
Change of Brunnstrom Stage
Description
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
Time Frame
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).
Title
Change of muscle strength (Medical Research Council)-Upper extremity
Description
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.
Time Frame
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).
Title
Change of Box and Block Test (BBT) Score (boxes/60 second)
Description
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).
Time Frame
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).
Title
Change of Functional near-infrared spectroscopy Connectivity
Description
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
Time Frame
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).
Title
Change of Modified Ashworth Scale (MAS) of upper extremity
Description
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.
Time Frame
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).
Title
Change of range of motion of finger extension (degrees) measured with Camera and marker
Description
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.
Time Frame
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subcortical stroke with hemiplegia 1st stroke Time since onset is less than 3 months Brunnstrom stage 2,3 Exclusion Criteria: Recurred stroke MMSE score below 10 Delirium Unstable medical condition Pregnancy Cannot sustain sitting position for 30 minutes Pain that limits upper extremity exercise
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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