Back to resultsThe Effects of fNIRS-based Neurofeedback Training on Balance and Gait in Parkinson's Disease
Primary Purpose
Parkinson Disease, Movement Disorder, Functional
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fNIRS-based neurofeedback with motor imagery
Kinesthetic motor imagery
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease focused on measuring Neurofeedback, Motor imagery, Parkinson's disease
Eligibility Criteria
Part 1 Additional Inclusion Criteria for PD: diagnosis of idiopathic PD by neurologist with Hoehn and Yahr stage < 4; stable medical condition; capability of walking independently without walking devices. Exclusion Criteria: cognitive impairment indicated by MMSE score < 24; history of diseases or conditions known to interfere with participating this study (e.g. epilepsy, metal implants in the brain, or deep brain stimulation); diagnosis of any other neurological disease or psychiatric disorder (e.g. stroke, anxiety disorder, or depression); using central nervous system medications other than for PD, e.g. antiepileptic drugs in recent 3 months. obtaining the Handbook of Disabilities verified by the government of local cities in Taiwan. Part 2 Inclusion Criteria: aged 40-85 y/o; diagnosis of idiopathic PD by neurologist with Hoehn and Yahr stage < 4; stable medical condition; capability of walking independently for 10 minutes, which is the time needed for imagery walking training in order to eliminate the possible influence of physical fatigue. Exclusion Criteria: cognitive impairment indicated by MMSE score < 24; history of diseases or conditions known to interfere with participating this study (e.g. epilepsy, metal implants in the brain, or deep brain stimulation); diagnosis of any other neurological disease or psychiatric disorder (e.g. stroke, anxiety disorder, or depression); using central nervous system medications other than for PD, e.g. antiepileptic drugs in recent 3 months. obtaining the Handbook of Disabilities verified by the government of local cities in Taiwan.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Neurofeedback combined with MI (NFB-MI)
Motor imagery
Arm Description
Participants in both NFB-MI and MI groups will receive a total of 12 sessions of training in 3 weeks. At the first, 4th and 8th session, NFB-MI group will receive fNIRS-based neurofeedback during MI training in lab setting. Prior to each NFB-MI session during lab visit, participants will watch a video of a person executing balance tasks and walking in different environments. The explicit instruction will be given by the researcher. One trial of MI training consists of 30 seconds of imagery tasks and 20 seconds of rest, and the trial will be repeated 12 times. The training will take approximately 10 minutes. Visual feedback with a thermometer based on the changes of HbO concentration will be displayed on the screen during NFB-MI training. In each training session, actual balance and gait tasks will be practiced for 20 min. The difficulty of the tasks will be modified individually for each participant.
Participants in both NFB-MI and MI groups will receive a total of 12 sessions of training in 3 weeks. At the first, 4th and 8th session, MI group will practice kinesthetic MI under supervision in lab setting. Prior to each NFB-MI session during lab visit, participants will watch a video of a person executing balance tasks and walking in different environments. The explicit instruction will be given by the researcher. One trial of MI training consists of 30 seconds of imagery tasks and 20 seconds of rest, and the trial will be repeated 12 times. The training will take approximately 10 minutes. In each training session, actual balance and gait tasks will be practiced for 20 min. The difficulty of the tasks will be modified individually for each participant. The researcher will ensure the safety of executing each task during lab visit. Participants will be asked to practice at home and be checked by the daily phone call.
Outcomes
Primary Outcome Measures
Self-perceived fatigue
Traditional Chinese version of Multidimensional Fatigue Inventory (MFI-TC) will be used to measure subjective perception of fatigue. MFI-TC is a 20-item self-report scale evaluating different dimensions of fatigue (general fatigue/physical fatigue, reduced activity, reduced motivation and mental fatigue). Each item is scored on a 1 (strongly agree) to 5 (strongly disagree) scale to assess how well the statement describe the participant's experience of fatigue. Ten positively phrased items (item 2, 5, 9, 10, 13, 14, 16, 17, 18, 19) were reverse-scored before adding up scores. The total score obtained simply by adding 20-item scores together (i.e., 20-100), with higher scores indicating more fatigue.
Motor imagery ability
There are two conditions for walking tasks during motor imagery: wide and narrow walkways of 15 m in length, and respectively 2 m and 35 cm in width. participants will be asked to stand upright at the starting line, and then perform imagery walking (IW) and actual walking (AW) task in a total of four sessions in the following sequence: IW-wide walkway (2m), AW-wide walkway, IW-narrow walkway (35cm), and AW-narrow walkway. Each session contains three repeated trials of walking over 15 m wide or narrow walkways. The MI ability will be indicated by the index of performance (IP) calculated by [(AW - IW/ AW) * 100]. IP closer to zero indicates better MI ability.
Kinesthetic and visual imagery ability
Kinesthetic and visual imagery questionnaire-short version (KVIQ-10) will be used to assess kinesthetic and visual imagery ability. 5 movement will be demonstrated by the assessor and mimicked by the participant. The participant will be asked to visually and kinesthetically imagine the movement without doing the movement. The clarity of the image (visual subscale) and the intensity of the sensations (kinesthetic subscale) will be scored on a five point ordinal scale. The total scores ranged from 10 to 50, and higher scores indicate better ability on kinesthetic and visual imagery.
Brain activation
The hemodynamic signals during AW and IW in all the participants will be recorded. A multichannel wearable functional near-infrared spectroscopy (fNIRS) imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) will be used to detect the cortical activity in prefrontal cortex (PFC), premotor cortex (PMC) and supplementary motor areas (SMA).
Change of Mini Balance Evaluation Systems Test (Mini-BEST) from pre-test to post-test
Mini-BEST is used to measure dynamic balance ability in four domains: anticipatory postural adjustment, reactive postural adjustments, sensory integration and dynamic gait. Mini-BEST consists of 14 items scored on a 0-2 scale, with 2 items assess right and left sides. The total scores will be 0-32, and higher scores indicate better balance ability. The scores at pre-test subtracting from the scores at post-test will be presented.
Change of Mini Balance Evaluation Systems Test (Mini-BEST) from pre-test to follow-up
Mini-BEST is used to measure dynamic balance ability in four domains: anticipatory postural adjustment, reactive postural adjustments, sensory integration and dynamic gait. Mini-BEST consists of 14 items scored on a 0-2 scale, with 2 items assess right and left sides. The total scores will be 0-32, and higher scores indicate better balance ability.The scores at pre-test subtracting from the scores at follow-up will be presented.
Change of Timed up-and-go test (TUG) from pre-test to post-test
Functional mobility will be indicated by TUG. Participants will be asked to stand up from a chair, walk at comfortable speed for 3 m, turn around and sit back on the chair. The completing duration will be measured, and the mean value across 3 trials of TUG will be documented as the final performance. The shorter completing duration indicates better mobility function. The duration at pre-test subtracting from the duration at post-test will be presented.
Change of Timed up-and-go test (TUG) from pre-test to follow-up
Functional mobility will be indicated by TUG. Participants will be asked to stand up from a chair, walk at comfortable speed for 3 m, turn around and sit back on the chair. The completing duration will be measured, and the mean value across 3 trials of TUG will be documented as the final performance. The shorter completing duration indicates better mobility function. The duration at pre-test subtracting from the duration at follow-up will be presented.
Change of gait performance from pre-test to post-test
The gait parameters will be measured by a GAITRite system (CIR system, Inc., Havertown, Pennsylvania). The GAITRite system is a 4.57 m long, 0.9 m wide straight walkway containing pressure-sensitive sensors in a 3.66 m by 0.61 m area. The participants will be instructed to walk along the walkway at their comfortable speed for 3 times. The values at pre-test subtracting from the values at post-test will be presented.
Change of gait performance from pre-test to follow-up
The gait parameters will be measured by a GAITRite system (CIR system, Inc., Havertown, Pennsylvania). The GAITRite system is a 4.57 m long, 0.9 m wide straight walkway containing pressure-sensitive sensors in a 3.66 m by 0.61 m area. The participants will be instructed to walk along the walkway at their comfortable speed for 3 times. The values at pre-test subtracting from the values at follow-up will be presented.
Secondary Outcome Measures
Change of self-perceived fatigue from pre-test to post-test
Traditional Chinese version of Multidimensional Fatigue Inventory (MFI-TC) will be used to measure subjective perception of fatigue. MFI-TC is a 20-item self-report scale evaluating different dimensions of fatigue (general fatigue/physical fatigue, reduced activity, reduced motivation and mental fatigue). Each item is scored on a 1 (strongly agree) to 5 (strongly disagree) scale to assess how well the statement describe the participant's experience of fatigue. Ten positively phrased items (item 2, 5, 9, 10, 13, 14, 16, 17, 18, 19) were reverse-scored before adding up scores. The total score obtained simply by adding 20-item scores together (i.e., 20-100), with higher scores indicating more fatigue. The scores at pre-test subtracting from the scores at post-test will be presented.
Change of self-perceived fatigue from pre-test to follow-up
Traditional Chinese version of Multidimensional Fatigue Inventory (MFI-TC) will be used to measure subjective perception of fatigue. MFI-TC is a 20-item self-report scale evaluating different dimensions of fatigue (general fatigue/physical fatigue, reduced activity, reduced motivation and mental fatigue). Each item is scored on a 1 (strongly agree) to 5 (strongly disagree) scale to assess how well the statement describe the participant's experience of fatigue. Ten positively phrased items (item 2, 5, 9, 10, 13, 14, 16, 17, 18, 19) were reverse-scored before adding up scores. The total score obtained simply by adding 20-item scores together (i.e., 20-100), with higher scores indicating more fatigue. The scores at pre-test subtracting from the scores at follow-up will be presented.
Change of motor imagery ability from pre-test to post-test
There are two conditions for walking tasks during motor imagery: wide and narrow walkways of 15 m in length, and respectively 2 m and 35 cm in width. participants will be asked to stand upright at the starting line, and then perform imagery walking (IW) and actual walking (AW) task in a total of four sessions in the following sequence: IW-wide walkway (2m), AW-wide walkway, IW-narrow walkway (35cm), and AW-narrow walkway. Each session contains three repeated trials of walking over 15 m wide or narrow walkways. The MI ability will be indicated by the index of performance (IP) calculated by [(AW - IW/ AW) * 100]. IP closer to zero indicates better MI ability. The scores at pre-test subtracting from the scores at post-test will be presented.
Change of motor imagery ability from pre-test to follow-up
There are two conditions for walking tasks during motor imagery: wide and narrow walkways of 15 m in length, and respectively 2 m and 35 cm in width. participants will be asked to stand upright at the starting line, and then perform imagery walking (IW) and actual walking (AW) task in a total of four sessions in the following sequence: IW-wide walkway (2m), AW-wide walkway, IW-narrow walkway (35cm), and AW-narrow walkway. Each session contains three repeated trials of walking over 15 m wide or narrow walkways. The MI ability will be indicated by the index of performance (IP) calculated by [(AW - IW/ AW) * 100]. IP closer to zero indicates better MI ability. The scores at pre-test subtracting from the scores at follow-up will be presented.
Change of kinesthetic and visual imagery ability from pre-test to post-test
Kinesthetic and visual imagery questionnaire-short version (KVIQ-10) will be used to assess kinesthetic and visual imagery ability. 5 movement will be demonstrated by the assessor and mimicked by the participant. The participant will be asked to visually and kinesthetically imagine the movement without doing the movement. The clarity of the image (visual subscale) and the intensity of the sensations (kinesthetic subscale) will be scored on a five point ordinal scale. The total scores ranged from 10 to 50, and higher scores indicate better ability on kinesthetic and visual imagery. The scores at pre-test subtracting from the scores at post-test will be presented.
Change of kinesthetic and visual imagery ability from pre-test to follow-up
Kinesthetic and visual imagery questionnaire-short version (KVIQ-10) will be used to assess kinesthetic and visual imagery ability. 5 movement will be demonstrated by the assessor and mimicked by the participant. The participant will be asked to visually and kinesthetically imagine the movement without doing the movement. The clarity of the image (visual subscale) and the intensity of the sensations (kinesthetic subscale) will be scored on a five point ordinal scale. The total scores ranged from 10 to 50, and higher scores indicate better ability on kinesthetic and visual imagery. The scores at pre-test subtracting from the scores at follow-up will be presented.
Full Information
NCT ID
NCT05800470
First Posted
February 22, 2023
Last Updated
March 23, 2023
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT05800470
Brief Title
The Effects of fNIRS-based Neurofeedback Training on Balance and Gait in Parkinson's Disease
Official Title
The Novel Application of fNIRS-based Neurofeedback to Enhance Effects of Motor Imagery on Balance and Gait Performance in Individuals With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
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
A cross-sectional study (part 1) aims to investigate the influence of fatigue on the MI ability in PD compared to healthy controls. A randomized controlled trial (part 2) aims to compare the effect of fNIRS-based NFB-MI on balance and gait performance versus MI only in people with PD.
Detailed Description
To fulfill out study purposes, a cross-sectional study (Part I) and an interventional randomized controlled trial (Part II) are designed. In Part I, people with PD and the age-matched healthy controls will be recruited and perform imagery and actual walking tasks. The questionnaire for fatigue, motor imagery ability, and brain activation during walking tasks will be recorded and compared between groups using independent t test. Pearson's correlation coefficient will be used to determine the relationship between fatigue and MI ability. In Part II, people with PD will be randomly allocated to either NFB-MI or MI group. Every participant will receive 12 sessions including three lab-visit sessions and nine home-bases training sessions. Each session consists of 10 min of MI, followed by 20 min of exercise focusing on balance and gait ability. During the lab-visit sessions, participants in experimental group will receive 10 minutes of NFB-MI. Outcome measures, including Mini Balance Evaluation Systems Test (Mini-BEST), Timed up-and-go test (TUG), gait performance, MI ability and fatigue, will be assessed at pre-, post-test, and follow-up. A two-way analysis of variance (ANOVA) with repeated measure will be used to determine the time by group interaction for all the outcomes. Post hoc test with Bonferroni correction will be applied for significant interaction. Significant level for part I and part II will be set at p < 0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Movement Disorder, Functional
Keywords
Neurofeedback, Motor imagery, Parkinson's disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Part 1: A cross-sectional study aims to investigate the influence of fatigue on the MI ability in PD compared to healthy controls Part 2: A randomized controlled trial compare the effect of fNIRS-based NFB-MI on balance and gait performance versus MI only in people with PD.
Masking
Outcomes Assessor
Masking Description
Assessor will be blinded to the allocation until the last assessment (4-week follow-up).
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neurofeedback combined with MI (NFB-MI)
Arm Type
Experimental
Arm Description
Participants in both NFB-MI and MI groups will receive a total of 12 sessions of training in 3 weeks. At the first, 4th and 8th session, NFB-MI group will receive fNIRS-based neurofeedback during MI training in lab setting. Prior to each NFB-MI session during lab visit, participants will watch a video of a person executing balance tasks and walking in different environments. The explicit instruction will be given by the researcher. One trial of MI training consists of 30 seconds of imagery tasks and 20 seconds of rest, and the trial will be repeated 12 times. The training will take approximately 10 minutes. Visual feedback with a thermometer based on the changes of HbO concentration will be displayed on the screen during NFB-MI training.
In each training session, actual balance and gait tasks will be practiced for 20 min. The difficulty of the tasks will be modified individually for each participant.
Arm Title
Motor imagery
Arm Type
Active Comparator
Arm Description
Participants in both NFB-MI and MI groups will receive a total of 12 sessions of training in 3 weeks. At the first, 4th and 8th session, MI group will practice kinesthetic MI under supervision in lab setting. Prior to each NFB-MI session during lab visit, participants will watch a video of a person executing balance tasks and walking in different environments. The explicit instruction will be given by the researcher. One trial of MI training consists of 30 seconds of imagery tasks and 20 seconds of rest, and the trial will be repeated 12 times. The training will take approximately 10 minutes.
In each training session, actual balance and gait tasks will be practiced for 20 min. The difficulty of the tasks will be modified individually for each participant. The researcher will ensure the safety of executing each task during lab visit. Participants will be asked to practice at home and be checked by the daily phone call.
Intervention Type
Other
Intervention Name(s)
fNIRS-based neurofeedback with motor imagery
Intervention Description
A multichannel wearable fNIRS (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) will be used to detect the cortical activity in SMA. The HbO concentration will be processed and displayed as a visual feedback during MI training.
Intervention Type
Other
Intervention Name(s)
Kinesthetic motor imagery
Intervention Description
Participants will be asked to practice MI with kinesthetic strategy in the first-person perspective for balance and gait tasks in 10 mins. After the MI training, they will receive 20-min balance and gait training, the same as in experimental group.
Primary Outcome Measure Information:
Title
Self-perceived fatigue
Description
Traditional Chinese version of Multidimensional Fatigue Inventory (MFI-TC) will be used to measure subjective perception of fatigue. MFI-TC is a 20-item self-report scale evaluating different dimensions of fatigue (general fatigue/physical fatigue, reduced activity, reduced motivation and mental fatigue). Each item is scored on a 1 (strongly agree) to 5 (strongly disagree) scale to assess how well the statement describe the participant's experience of fatigue. Ten positively phrased items (item 2, 5, 9, 10, 13, 14, 16, 17, 18, 19) were reverse-scored before adding up scores. The total score obtained simply by adding 20-item scores together (i.e., 20-100), with higher scores indicating more fatigue.
Time Frame
Part 1 cross-sectional assessment (day 1)
Title
Motor imagery ability
Description
There are two conditions for walking tasks during motor imagery: wide and narrow walkways of 15 m in length, and respectively 2 m and 35 cm in width. participants will be asked to stand upright at the starting line, and then perform imagery walking (IW) and actual walking (AW) task in a total of four sessions in the following sequence: IW-wide walkway (2m), AW-wide walkway, IW-narrow walkway (35cm), and AW-narrow walkway. Each session contains three repeated trials of walking over 15 m wide or narrow walkways. The MI ability will be indicated by the index of performance (IP) calculated by [(AW - IW/ AW) * 100]. IP closer to zero indicates better MI ability.
Time Frame
Part 1 cross-sectional assessment (day 1)
Title
Kinesthetic and visual imagery ability
Description
Kinesthetic and visual imagery questionnaire-short version (KVIQ-10) will be used to assess kinesthetic and visual imagery ability. 5 movement will be demonstrated by the assessor and mimicked by the participant. The participant will be asked to visually and kinesthetically imagine the movement without doing the movement. The clarity of the image (visual subscale) and the intensity of the sensations (kinesthetic subscale) will be scored on a five point ordinal scale. The total scores ranged from 10 to 50, and higher scores indicate better ability on kinesthetic and visual imagery.
Time Frame
Part 1 cross-sectional assessment (day 1)
Title
Brain activation
Description
The hemodynamic signals during AW and IW in all the participants will be recorded. A multichannel wearable functional near-infrared spectroscopy (fNIRS) imaging system (NIRSport2, NIRx Medical Technologies LLC, Glen Head, NY, USA) will be used to detect the cortical activity in prefrontal cortex (PFC), premotor cortex (PMC) and supplementary motor areas (SMA).
Time Frame
Part 1 cross-sectional assessment (day 1)
Title
Change of Mini Balance Evaluation Systems Test (Mini-BEST) from pre-test to post-test
Description
Mini-BEST is used to measure dynamic balance ability in four domains: anticipatory postural adjustment, reactive postural adjustments, sensory integration and dynamic gait. Mini-BEST consists of 14 items scored on a 0-2 scale, with 2 items assess right and left sides. The total scores will be 0-32, and higher scores indicate better balance ability. The scores at pre-test subtracting from the scores at post-test will be presented.
Time Frame
Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks)
Title
Change of Mini Balance Evaluation Systems Test (Mini-BEST) from pre-test to follow-up
Description
Mini-BEST is used to measure dynamic balance ability in four domains: anticipatory postural adjustment, reactive postural adjustments, sensory integration and dynamic gait. Mini-BEST consists of 14 items scored on a 0-2 scale, with 2 items assess right and left sides. The total scores will be 0-32, and higher scores indicate better balance ability.The scores at pre-test subtracting from the scores at follow-up will be presented.
Time Frame
Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks)
Title
Change of Timed up-and-go test (TUG) from pre-test to post-test
Description
Functional mobility will be indicated by TUG. Participants will be asked to stand up from a chair, walk at comfortable speed for 3 m, turn around and sit back on the chair. The completing duration will be measured, and the mean value across 3 trials of TUG will be documented as the final performance. The shorter completing duration indicates better mobility function. The duration at pre-test subtracting from the duration at post-test will be presented.
Time Frame
Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks)
Title
Change of Timed up-and-go test (TUG) from pre-test to follow-up
Description
Functional mobility will be indicated by TUG. Participants will be asked to stand up from a chair, walk at comfortable speed for 3 m, turn around and sit back on the chair. The completing duration will be measured, and the mean value across 3 trials of TUG will be documented as the final performance. The shorter completing duration indicates better mobility function. The duration at pre-test subtracting from the duration at follow-up will be presented.
Time Frame
Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks)
Title
Change of gait performance from pre-test to post-test
Description
The gait parameters will be measured by a GAITRite system (CIR system, Inc., Havertown, Pennsylvania). The GAITRite system is a 4.57 m long, 0.9 m wide straight walkway containing pressure-sensitive sensors in a 3.66 m by 0.61 m area. The participants will be instructed to walk along the walkway at their comfortable speed for 3 times. The values at pre-test subtracting from the values at post-test will be presented.
Time Frame
Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks)
Title
Change of gait performance from pre-test to follow-up
Description
The gait parameters will be measured by a GAITRite system (CIR system, Inc., Havertown, Pennsylvania). The GAITRite system is a 4.57 m long, 0.9 m wide straight walkway containing pressure-sensitive sensors in a 3.66 m by 0.61 m area. The participants will be instructed to walk along the walkway at their comfortable speed for 3 times. The values at pre-test subtracting from the values at follow-up will be presented.
Time Frame
Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks)
Secondary Outcome Measure Information:
Title
Change of self-perceived fatigue from pre-test to post-test
Description
Traditional Chinese version of Multidimensional Fatigue Inventory (MFI-TC) will be used to measure subjective perception of fatigue. MFI-TC is a 20-item self-report scale evaluating different dimensions of fatigue (general fatigue/physical fatigue, reduced activity, reduced motivation and mental fatigue). Each item is scored on a 1 (strongly agree) to 5 (strongly disagree) scale to assess how well the statement describe the participant's experience of fatigue. Ten positively phrased items (item 2, 5, 9, 10, 13, 14, 16, 17, 18, 19) were reverse-scored before adding up scores. The total score obtained simply by adding 20-item scores together (i.e., 20-100), with higher scores indicating more fatigue. The scores at pre-test subtracting from the scores at post-test will be presented.
Time Frame
Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks)
Title
Change of self-perceived fatigue from pre-test to follow-up
Description
Traditional Chinese version of Multidimensional Fatigue Inventory (MFI-TC) will be used to measure subjective perception of fatigue. MFI-TC is a 20-item self-report scale evaluating different dimensions of fatigue (general fatigue/physical fatigue, reduced activity, reduced motivation and mental fatigue). Each item is scored on a 1 (strongly agree) to 5 (strongly disagree) scale to assess how well the statement describe the participant's experience of fatigue. Ten positively phrased items (item 2, 5, 9, 10, 13, 14, 16, 17, 18, 19) were reverse-scored before adding up scores. The total score obtained simply by adding 20-item scores together (i.e., 20-100), with higher scores indicating more fatigue. The scores at pre-test subtracting from the scores at follow-up will be presented.
Time Frame
Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks)
Title
Change of motor imagery ability from pre-test to post-test
Description
There are two conditions for walking tasks during motor imagery: wide and narrow walkways of 15 m in length, and respectively 2 m and 35 cm in width. participants will be asked to stand upright at the starting line, and then perform imagery walking (IW) and actual walking (AW) task in a total of four sessions in the following sequence: IW-wide walkway (2m), AW-wide walkway, IW-narrow walkway (35cm), and AW-narrow walkway. Each session contains three repeated trials of walking over 15 m wide or narrow walkways. The MI ability will be indicated by the index of performance (IP) calculated by [(AW - IW/ AW) * 100]. IP closer to zero indicates better MI ability. The scores at pre-test subtracting from the scores at post-test will be presented.
Time Frame
Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks)
Title
Change of motor imagery ability from pre-test to follow-up
Description
There are two conditions for walking tasks during motor imagery: wide and narrow walkways of 15 m in length, and respectively 2 m and 35 cm in width. participants will be asked to stand upright at the starting line, and then perform imagery walking (IW) and actual walking (AW) task in a total of four sessions in the following sequence: IW-wide walkway (2m), AW-wide walkway, IW-narrow walkway (35cm), and AW-narrow walkway. Each session contains three repeated trials of walking over 15 m wide or narrow walkways. The MI ability will be indicated by the index of performance (IP) calculated by [(AW - IW/ AW) * 100]. IP closer to zero indicates better MI ability. The scores at pre-test subtracting from the scores at follow-up will be presented.
Time Frame
Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks)
Title
Change of kinesthetic and visual imagery ability from pre-test to post-test
Description
Kinesthetic and visual imagery questionnaire-short version (KVIQ-10) will be used to assess kinesthetic and visual imagery ability. 5 movement will be demonstrated by the assessor and mimicked by the participant. The participant will be asked to visually and kinesthetically imagine the movement without doing the movement. The clarity of the image (visual subscale) and the intensity of the sensations (kinesthetic subscale) will be scored on a five point ordinal scale. The total scores ranged from 10 to 50, and higher scores indicate better ability on kinesthetic and visual imagery. The scores at pre-test subtracting from the scores at post-test will be presented.
Time Frame
Part 2 pre-test (in the week before the intervention starts) and post-test (3 weeks)
Title
Change of kinesthetic and visual imagery ability from pre-test to follow-up
Description
Kinesthetic and visual imagery questionnaire-short version (KVIQ-10) will be used to assess kinesthetic and visual imagery ability. 5 movement will be demonstrated by the assessor and mimicked by the participant. The participant will be asked to visually and kinesthetically imagine the movement without doing the movement. The clarity of the image (visual subscale) and the intensity of the sensations (kinesthetic subscale) will be scored on a five point ordinal scale. The total scores ranged from 10 to 50, and higher scores indicate better ability on kinesthetic and visual imagery. The scores at pre-test subtracting from the scores at follow-up will be presented.
Time Frame
Part 2 pre-test (in the week before the intervention starts) and 4-week follow-up assessment (7 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Part 1
Additional Inclusion Criteria for PD:
diagnosis of idiopathic PD by neurologist with Hoehn and Yahr stage < 4;
stable medical condition;
capability of walking independently without walking devices.
Exclusion Criteria:
cognitive impairment indicated by MMSE score < 24;
history of diseases or conditions known to interfere with participating this study (e.g. epilepsy, metal implants in the brain, or deep brain stimulation);
diagnosis of any other neurological disease or psychiatric disorder (e.g. stroke, anxiety disorder, or depression);
using central nervous system medications other than for PD, e.g. antiepileptic drugs in recent 3 months.
obtaining the Handbook of Disabilities verified by the government of local cities in Taiwan.
Part 2
Inclusion Criteria:
aged 40-85 y/o;
diagnosis of idiopathic PD by neurologist with Hoehn and Yahr stage < 4;
stable medical condition;
capability of walking independently for 10 minutes, which is the time needed for imagery walking training in order to eliminate the possible influence of physical fatigue.
Exclusion Criteria:
cognitive impairment indicated by MMSE score < 24;
history of diseases or conditions known to interfere with participating this study (e.g. epilepsy, metal implants in the brain, or deep brain stimulation);
diagnosis of any other neurological disease or psychiatric disorder (e.g. stroke, anxiety disorder, or depression);
using central nervous system medications other than for PD, e.g. antiepileptic drugs in recent 3 months.
obtaining the Handbook of Disabilities verified by the government of local cities in Taiwan.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ray-Yau Wang
Phone
+88628267210
Email
rywang@nycu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray-Yau Wang
Organizational Affiliation
National Yang Ming Chiao Tung University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Effects of fNIRS-based Neurofeedback Training on Balance and Gait in Parkinson's Disease
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