Effectiveness of Interactive Augmented Reality and Electrical Neuromodulation System in Persons With Stroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Augmented Reality with Functional Electrical Stimulation group
Traditional physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, augmented reality, functional electrical stimulation
Eligibility Criteria
Inclusion Criteria:
- Patients present with unilateral hemiplegia caused by a first-ever stroke
- Brunnstrom stage above stage II, mental health was stable
- Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23)
Exclusion Criteria:
- Patients having other neurologic problems, which can affect balance and walking ability
- Intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation
- severe hearing or eye problem
Sites / Locations
- Taipei Medical university HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Augmented reality with functional electrical stimulation group
Traditional physiotherapy group
Arm Description
Ten participants in group A will undergo 30 minutes interactive augmented reality with functional electrical stimulation intervention and 30 minutes traditional physiotherapy per day, 3 days a week for 8 weeks.
Ten participants in group B will undergo 30 minutes treadmill and balance training as well as 30 minutes traditional conventional physiotherapy a day, 3 days a week, for 8 weeks.
Outcomes
Primary Outcome Measures
Change of Time Up Go test (TUG)
The TUG test will ask participants to stand up, walk for 3 meters, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.
Change of Berg Balance Scale (BBS)
Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. Each task was scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56.
Change of Functional magnetic resonance imaging (fMRI)
Our study will use 3 Tesla magnetic resonance imaging[GE DISCOVERY MR750w system (GE Healthcare, Milwaukee, Wisconsin)] for functional magnetic resonance imaging. Resting-state functional MRI image is an echo-planar Image (EPI) technique, using a parameter time of repetition of 2500 milliseconds, time of echo is 30 milliseconds, 43 axial slices,slice thickness is 3 mm, flip angle is 80 degrees, field of view is 192 x 192 millimeters, and vixen size is 3 x 3 x 3 millimeters. The EPI scan for 525 seconds. All subjects are asked to close their eyes and supine. our study uses the fractional amplitude of low-frequency fluctuations analysis to confirm abnormal brain function.
Secondary Outcome Measures
Change of Fugl-Meyer Assessment (FMA)-Lower extremity
Fugl-Meyer Assessment-Lower extremity is used to measure lower-limb recovery in stroke rehabilitation studies.The scale has 6 items ranging from reflex activity to voluntary motor control. Each item further comprises components, with a total of 17. Scoring is done on a 3-point ordinal scale ranges from 0 (no performance) to 2 (faultless performance). The total score range from 0 (no motor function) to 34 (good motor recovery).
Change of Modified Ashworth Scale (MAS)
Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scoring is recorded as follows:
0: No increase in muscle tone
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 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range of motion (ROM)
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
Change of Motor evoked potential (MEP)
Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex. All TMS is delivered with the participant seated upright on the chair. Both passive and active conditions, participants are instructed to relax their right leg in the seated position. TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom). To locate the optimal site, stimuli are delivered over various points along the M1. The optimal site is the location on the M1 that evoked the greatest MEP amplitude in the bilateral tibialis anterior muscles. The onset latency and onset to peak amplitude will be assessed.
Change of 10 meter walking test
Individual walks without assistance 10 meters and the time is measured. Participants will walk 10 meter at preferred walking speed and fastest speed possible, respectively.
Change of Diffusion Tensor Imaging (DTI)
Diffusion tensor imaging technique apply to Echo-Planar Image(EPI) technique, fimbriodentate vein is 192X192 mm², time of repetition/time of echo is 11000/110.6 mm, matrix is 72X72 pixels, slice thickness is 2.7 mm. Diffusion weight gradient along 60 directions at b value of 3000/mm². By observing the reduction of the degree of diffusion anisotropy, to study the recovery of motor function after stroke.
Full Information
NCT ID
NCT04003571
First Posted
June 27, 2019
Last Updated
January 28, 2023
Sponsor
Taipei Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04003571
Brief Title
Effectiveness of Interactive Augmented Reality and Electrical Neuromodulation System in Persons With Stroke
Official Title
Development of Interactive Augmented Reality and Electrical Neuromodulation System to Improve Neuroplasticity and Limbs Function in Persons With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is to investigate the effects of Augmented Reality (AR) combined with Functional Electrical Stimulation (FES) intervention on cortical excitability, brain structure, lower limbs function, balance, and spasticity in individuals with stroke. Twenty participants will be recruited in this study. They will be allocated to two group: AR and FES group (10), Traditional physiotherapy group (10).
Detailed Description
Participants will be randomized allocated to two groups: Augmented Reality and Functional Electrical Stimulation group , and traditional physiotherapy group. All participants will undergo 60 minutes per session, 3 sessions per week for 8 weeks training. Functional Magnetic Resonance Imaging (fMRI) with Diffusion Tensor Imaging (DTI), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Modified Ashworth Scale (MAS), 10 meter walking test will be assessed before and after intervention in all participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, augmented reality, functional electrical stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Augmented reality with functional electrical stimulation group
Arm Type
Experimental
Arm Description
Ten participants in group A will undergo 30 minutes interactive augmented reality with functional electrical stimulation intervention and 30 minutes traditional physiotherapy per day, 3 days a week for 8 weeks.
Arm Title
Traditional physiotherapy group
Arm Type
Active Comparator
Arm Description
Ten participants in group B will undergo 30 minutes treadmill and balance training as well as 30 minutes traditional conventional physiotherapy a day, 3 days a week, for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Augmented Reality with Functional Electrical Stimulation group
Intervention Description
Experimental group contains 30 minutes augmented reality combined with functional electrical stimulation training, and 30 minutes traditional physiotherapy. Augmented reality includes treadmill and balance exercise. Functional electrical stimulation applies on tibialis anterior muscle. Traditional physiotherapy includes rolling, sitting, standing, overground walking, facilitation of the paretic limbs, and so on.
Intervention Type
Behavioral
Intervention Name(s)
Traditional physiotherapy
Intervention Description
Traditional physiotherapy includes treadmill and balance training for 30 minutes as well as rolling, sitting, standing, overground walking, facilitation of the paretic limbs for another 30 minutes .
Primary Outcome Measure Information:
Title
Change of Time Up Go test (TUG)
Description
The TUG test will ask participants to stand up, walk for 3 meters, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Title
Change of Berg Balance Scale (BBS)
Description
Participants performed a series of 14 functional balance tasks, including maintaining a quiet stance, sitting-to-standing, shifting weight and reaching, turning in place, standing on one leg, and maintaining a tandem stance. Each task was scored on a 5-point ordinal scale (from 0 to 4). A score of 0 denotes the inability of the participant to perform the task, and a score of 4 denotes that the participant can complete the task based on a preset criterion. The highest possible score is 56.
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Title
Change of Functional magnetic resonance imaging (fMRI)
Description
Our study will use 3 Tesla magnetic resonance imaging[GE DISCOVERY MR750w system (GE Healthcare, Milwaukee, Wisconsin)] for functional magnetic resonance imaging. Resting-state functional MRI image is an echo-planar Image (EPI) technique, using a parameter time of repetition of 2500 milliseconds, time of echo is 30 milliseconds, 43 axial slices,slice thickness is 3 mm, flip angle is 80 degrees, field of view is 192 x 192 millimeters, and vixen size is 3 x 3 x 3 millimeters. The EPI scan for 525 seconds. All subjects are asked to close their eyes and supine. our study uses the fractional amplitude of low-frequency fluctuations analysis to confirm abnormal brain function.
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Secondary Outcome Measure Information:
Title
Change of Fugl-Meyer Assessment (FMA)-Lower extremity
Description
Fugl-Meyer Assessment-Lower extremity is used to measure lower-limb recovery in stroke rehabilitation studies.The scale has 6 items ranging from reflex activity to voluntary motor control. Each item further comprises components, with a total of 17. Scoring is done on a 3-point ordinal scale ranges from 0 (no performance) to 2 (faultless performance). The total score range from 0 (no motor function) to 34 (good motor recovery).
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Title
Change of Modified Ashworth Scale (MAS)
Description
Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Scoring is recorded as follows:
0: No increase in muscle tone
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 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the Range of motion (ROM)
More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Title
Change of Motor evoked potential (MEP)
Description
Motor evoked potential (MEP) is recorded from tibialis anterior muscles following direct transcranial magnetic stimulation (TMS) of motor cortex. All TMS is delivered with the participant seated upright on the chair. Both passive and active conditions, participants are instructed to relax their right leg in the seated position. TMS is delivered over the motor cortex (M1) using a concave double cone coil (Magstim Co., United Kingdom) attached to a BiStim magnetic stimulator (Magstim Co., United Kingdom). To locate the optimal site, stimuli are delivered over various points along the M1. The optimal site is the location on the M1 that evoked the greatest MEP amplitude in the bilateral tibialis anterior muscles. The onset latency and onset to peak amplitude will be assessed.
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Title
Change of 10 meter walking test
Description
Individual walks without assistance 10 meters and the time is measured. Participants will walk 10 meter at preferred walking speed and fastest speed possible, respectively.
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
Title
Change of Diffusion Tensor Imaging (DTI)
Description
Diffusion tensor imaging technique apply to Echo-Planar Image(EPI) technique, fimbriodentate vein is 192X192 mm², time of repetition/time of echo is 11000/110.6 mm, matrix is 72X72 pixels, slice thickness is 2.7 mm. Diffusion weight gradient along 60 directions at b value of 3000/mm². By observing the reduction of the degree of diffusion anisotropy, to study the recovery of motor function after stroke.
Time Frame
Measurement before and after intervention ( week 0 and at the end of week 8) in both groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients present with unilateral hemiplegia caused by a first-ever stroke
Brunnstrom stage above stage II, mental health was stable
Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23)
Exclusion Criteria:
Patients having other neurologic problems, which can affect balance and walking ability
Intake of drugs or other medical condition that can affect function or can't tolerate rehabilitation
severe hearing or eye problem
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chien-Hung Lai, MD PhD
Phone
886-2-27372181
Ext
3538
Email
chlai@tmu.edu.tw
Facility Information:
Facility Name
Taipei Medical university Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chien-Hung Lai, MD PhD
12. IPD Sharing Statement
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Effectiveness of Interactive Augmented Reality and Electrical Neuromodulation System in Persons With Stroke
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