Parkinson DiseaseNCT05800470
The Effects of fNIRS-based Neurofeedback Training on Balance and Gait in Parkinson's Disease
A study testing fNIRS-based neurofeedback with motor imagery, Kinesthetic motor imagery and Motor training in people with Parkinson Disease and Movement Disorder, Functional, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Movement Disorder, Functional
- What is being tested?
- fNIRS-based neurofeedback with motor imagery, Kinesthetic motor imagery and Motor training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Mar 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- cognitive impairment indicated by MMSE score < 24;
- motor imagery ability indicated by KVIQ score < 25;
- unable recognize 26 letters in the English alphabet
- 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.
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- Part 2
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang Ming Chiao Tung University
Taipei, None Selected, 112
Ray-Yau Wang, Ph.D, 88628267210, rywang@nycu.edu.tw
Ray-Yau Wang, Ph.D
About this study
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
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.
Read the 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 level of general fatigue will be measured by Traditional Chinese version of Multidimensional Fatigue Inventory (MFI-TC) in people with PD. The level of concurrent fatigue will be induced by 30-minute cognitive tasks consisting of A-X continuous performance test, 2 back and mental rotation test and will be assessed by Brunel Mood Scale (BRUMS-C) in people with PD. Independent t test will be used to compare the MI ability between PD group and healthy control group. The Pearson's correlation coefficient will be used to examine the relationships between general fatigue level (MFI) and MI ability and between concurrent fatigue level (BRUMS) and MI ability in people with PD. In Part II, people with PD will be randomly allocated to either NFB-MI, MI or MT group. Every participant will receive 12 sessions of training in four weeks. NFB-MI and MI training will consist of 20-min MI with or without neurofeedback respectively followed by 20-min of balance and gait training. In the MT group, participants will receive 40-min of balance and gait training. Outcome measures, including Mini Balance Evaluation Systems Test (Mini-BEST), Timed up-and-go test (TUG), gait performance, will be assessed at pre-, post-test, and follow-up. MI ability and fatigue will be assessed at pre-, mid-and post-test. 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.
- Conditions
- Parkinson Disease, Movement Disorder, Functional
- Being tested
- fNIRS-based neurofeedback with motor imagery, Kinesthetic motor imagery, Motor training
- Keywords
- Neurofeedback, Motor imagery, Parkinson's disease
- Medical subject headings
- Parkinson Disease, Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fNIRS-based neurofeedback with motor imageryOther
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.
Kinesthetic motor imageryOther
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.
Motor trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback combined with MI (NFB-MI) | Experimental | 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. Receives: Other: fNIRS-based neurofeedback with motor imagery; Other: Motor training |
| Motor imagery | Active comparator | 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. Receives: Other: Kinesthetic motor imagery; Other: Motor training |
| Motor training | Active comparator | 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. Receives: Other: Motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Part 1 cross-sectional assessment (day 1 of the study and day 8 for second assessment)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Part 2 pre-test and 4-week follow-up assessment (8 weeks)
Secondary outcomes (6)
Change of self-perceived fatigue from pre-test to mid-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 mid-test will be presented.
Measured: Part 2 pre-test and mid-test (2 weeks)
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.
Measured: Part 2 pre-test and post-test (4 weeks)
Change of motor imagery ability from pre-test to mid-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 mid-test will be presented.
Measured: Part 2 pre-test and mid-test (2 weeks)
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.
Measured: Part 2 pre-test and post-test (4 weeks)
Change of kinesthetic and visual imagery ability from pre-test to mid-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 mid-test will be presented.
Measured: Part 2 pre-test and mid-test (2 weeks)
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.
Measured: Part 2 pre-test and post-test (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start19 Mar 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 and MT group in people with PD.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ray-Yau Wang, National Yang Ming Chiao Tung University
- Investigators
- Ray-Yau Wang, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800470
- Sponsor's protocol ID
- NYCU112020AE
- Status last verified
- Aug 2025
- First submitted
- 22 Feb 2023
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05800470
- Acronym / sponsor ID
- NYCU112020AE
- Conditions
- Parkinson Disease, Movement Disorder, Functional
- Keywords
- Neurofeedback, Motor imagery, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 level of general fatigue will be measured by Traditional Chinese version of Multidimensional Fatigue Inventory (MFI-TC) in people with PD. The level of concurrent fatigue will be induced by 30-minute cognitive tasks consisting of A-X continuous performance test, 2 back and mental rotation test and will be assessed by Brunel Mood Scale (BRUMS-C) in people with PD. Independent t test will be used to compare the MI ability between PD group and healthy control group. The Pearson's correlation coefficient will be used to examine the relationships between general fatigue level (MFI) and MI ability and between concurrent fatigue level (BRUMS) and MI ability in people with PD. In Part II, people with PD will be randomly allocated to either NFB-MI, MI or MT group. Every participant will receive 12 sessions of training in four weeks. NFB-MI and MI training will consist of 20-min MI with or without neurofeedback respectively followed by 20-min of balance and gait training. In the MT group, participants will receive 40-min of balance and gait training. Outcome measures, including Mini Balance Evaluation Systems Test (Mini-BEST), Timed up-and-go test (TUG), gait performance, will be assessed at pre-, post-test, and follow-up. MI ability and fatigue will be assessed at pre-, mid-and post-test. 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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 and MT group in people with PD.
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback combined with MI (NFB-MI) | Experimental | Other: fNIRS-based neurofeedback with motor imagery, Other: Motor trainingParticipants 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. |
| Motor imagery | Active comparator | Other: Kinesthetic motor imagery, Other: Motor trainingParticipants 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. |
| Motor training | Active comparator | Other: Motor trainingThe 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- cognitive impairment indicated by MMSE score < 24;
- motor imagery ability indicated by KVIQ score < 25;
- unable recognize 26 letters in the English alphabet
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fNIRS-based neurofeedback with motor imageryA 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. | Other | Neurofeedback combined with MI (NFB-MI) |
| Kinesthetic motor imageryPrior 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. | Other | Motor imagery |
| Motor trainingThe 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. | Other | Motor imagery, Motor training, Neurofeedback combined with MI (NFB-MI) |
Primary outcome
Self-perceived fatigue for general fatigue level
Time frame: Part 1 cross-sectional assessment (day 1 of the study)
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
Time frame: Part 1 cross-sectional assessment (day 1 of the study and day 8 for second assessment)
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.
Kinesthetic and visual imagery ability
Time frame: Part 1 cross-sectional assessment (day 1 of the study and day 8 for second assessment)
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.
Self-perceived fatigue for concurrent fatigue level
Time frame: Part 1 cross-sectional assessment (day 8 of the study)
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.
Change of Mini Balance Evaluation Systems Test (Mini-BEST) from pre-test to post-test
Time frame: Part 2 pre-test, post-test (4 weeks)
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
Time frame: Part 2 pre-test and 4-week follow-up assessment (8 weeks)
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
Time frame: Part 2 pre-test and post-test (4 weeks)
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
Time frame: Part 2 pre-test and 4-week follow-up assessment (8 weeks)
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
Time frame: Part 2 pre-test and post-test (4 weeks)
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
Time frame: Part 2 pre-test and 4-week follow-up assessment (8 weeks)
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.
6 secondary outcomes
Change of self-perceived fatigue from pre-test to mid-test
Time frame: Part 2 pre-test and mid-test (2 weeks)
Change of self-perceived fatigue from pre-test to post-test
Time frame: Part 2 pre-test and post-test (4 weeks)
Change of motor imagery ability from pre-test to mid-test
Time frame: Part 2 pre-test and mid-test (2 weeks)
Change of motor imagery ability from pre-test to post-test
Time frame: Part 2 pre-test and post-test (4 weeks)
Change of kinesthetic and visual imagery ability from pre-test to mid-test
Time frame: Part 2 pre-test and mid-test (2 weeks)
Change of kinesthetic and visual imagery ability from pre-test to post-test
Time frame: Part 2 pre-test and post-test (4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ray-Yau Wang principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fNIRS-based neurofeedback with motor imagery, Kinesthetic motor imagery and Motor training in people with Parkinson Disease and Movement Disorder, Functional, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ray-Yau Wang (+88628267210, rywang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-perceived fatigue for general fatigue level (time frame: Part 1 cross-sectional assessment (day 1 of the study)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.