The Novel Application of fNIRS-based Neurofeedback to Enhance Effects of Motor Imagery on Balance and Gait Performance in Individuals With Parkinson's Disease
Sponsor study identifier
interventional
93
1 country
1
Study Start
March 19, 2025
Actual (reported)Primary Completion
August 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 22, 2023
Actual (reported)April 5, 2023
Actual (reported)March 19, 2025
Actual (reported)August 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Self-perceived fatigue for general fatigue level
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.
Part 1 cross-sectional assessment (day 1 of the study)
Motor imagery ability
The walking tasks during motor imagery: walkways of 5 m in length, 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 2 sessions in the following sequence: IW- walkway (35cm), and AW- walkway. Each session contains three repeated trials of walking over 5 m 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.
Part 1 cross-sectional assessment (day 1 of the study and day 8 for second assessment)
Change of self-perceived fatigue from pre-test to mid-test
Part 2 pre-test and mid-test (2 weeks)
Change of self-perceived fatigue from pre-test to post-test
Part 2 pre-test and post-test (4 weeks)
Change of motor imagery ability from pre-test to mid-test
Part 2 pre-test and mid-test (2 weeks)
Change of motor imagery ability from pre-test to post-test
Part 2 pre-test and post-test (4 weeks)
Change of kinesthetic and visual imagery ability from pre-test to mid-test
Part 2 pre-test and mid-test (2 weeks)
Participants in both NFB-MI and MI groups will receive a total of 12 sessions of training in 4 weeks. NFB-MI group will receive fNIRS-based neurofeedback during MI training in lab. Prior to each NFB-MI session, 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. Each MI training session (consisting of 5 trials for balance and walking tasks) includes 45 seconds of imagery tasks followed by 15 seconds of rest, repeated twice. The training will take approximately 20 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 4 weeks. MI group will practice kinesthetic MI under supervision in lab setting. Participants will watch a video of a person executing balance tasks and walking in different environments before MI training. The explicit instruction will be given by the researcher. Each MI training session (consisting of 5 trials for balance and walking tasks) includes 45 seconds of imagery tasks followed by 15 seconds of rest, repeated twice. The training will take approximately 20 minutes. In each training session, actual balance and gait tasks will be practiced for 20 min after MI training. 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.
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.
Prior to each task, participants will watch a video of a person executing balance tasks and walking tasks. The balance tasks will include static and dynamic standing tasks such as sit-to-stand, tandem stance, standing on a balance board, reaching out to different directions and single leg stance. The walking tasks consists of tandem walking, crossing obstacles, sideward walking, backward walking, and turning. The participants will be asked to kinesthetically imagine movements in the first-person perspective, and the researcher will give the explicit instruction encouraging them to focus on the feeling (i.e. tactile, proprioceptive and kinesthetic sensations). Each MI session consists of 10-min of balance tasks and 10-min of walking tasks.
National Yang Ming Chiao Tung University
Taipei, None Selected, 112, Taiwan
Ray-Yau Wang
National Yang Ming Chiao Tung University
First Submitted
February 22, 2023
First Posted
April 5, 2023
Study Start
March 19, 2025
Actual (reported)Balance Exercise and Vagus Nerve Stimulation on Weight-shifting Control and Ambulation in Parkinson Disease and Anxiety
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.
Part 1 cross-sectional assessment (day 1 of the study and day 8 for second assessment)
Self-perceived fatigue for concurrent fatigue level
Chinese version of the Brunel Mood Scale (BRUMS-C) will be used to measure subjective perception of fatigue. Fatigue is a subscale of BRUMS-C consisted with 4-item. Participants indicated whether they have felt on a five-point Likert scale (0 = not at all,1 = a little, 2 = moderately, 3 = quite a bit, 4 = extremely) using the "How do you feel right now?" response timeframe. The total score obtained simply by adding 4-item scores together (i.e., 0-16), with higher scores indicating more fatigue.
Part 1 cross-sectional assessment (day 8 of the study)
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.
Part 2 pre-test, post-test (4 weeks)
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.
Part 2 pre-test and 4-week follow-up assessment (8 weeks)
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.
Part 2 pre-test and post-test (4 weeks)
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.
Part 2 pre-test and 4-week follow-up assessment (8 weeks)
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.
Part 2 pre-test and post-test (4 weeks)
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.
Part 2 pre-test and 4-week follow-up assessment (8 weeks)
The tasks for balance and gait training are similar to those during the MI training. The balance and gait training will be practiced for 20 min in MI and NFB-MI groups, and will be practiced for 40 min in MT group. The difficulty of the tasks will be modified individually for each participant. The researcher will ensure the safety.
The tasks for balance and gait training are similar to those during the MI training. The difficulty of the tasks will be modified individually for each participant. The researcher will ensure the safety.
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Primary Completion
August 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 7, 2025
Record last verified: 2025-08
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