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Parkinson s DiseaseMI-SeRNCT07860294

Effects of Mental Imagery With Self-regulation on Daily Activities in People With Parkinson's Disease

A study testing Mental imagery with self-regulation and Exercise and health education in people with Parkinson s Disease, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn whether mental imagery combined with self-regulation can improve daily activities in people with Parkinson's disease. The main questions it aims to answer are: Does mental imagery with self-regulation improve performance in daily activities? Does it improve overall… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson s Disease
What is being tested?
Mental imagery with self-regulation and Exercise and health education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteHong Kong
Study dates
5 Oct 2026to 31 Dec 2028
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • have been diagnosed with Parkinson's disease by a neurologist according to the diagnostic criteria of the UK Parkinson's Disease Society Brain Bank, regardless of their age range;
  • have Parkinson's disease with mild-to-moderate severity determined in the 'ON' phase, with scores of 1 to 3 on the Hoehn and Yahr scale;
  • have been screened for intact attention and short-term memory functions by repeating all five words in the 'memory' question and scoring '1' (full marks) in forward order repeat in the 'read list of digits' in the 'attention' question of the Montreal Cognitive Assessment; and
  • do not have depression, as indicated by scores less than 2 on the 4-item Geriatric Depression Scale

Who cannot join

  • severe dyskinesia or severe ON-OFF motor fluctuations;
  • stereotaxic brain surgery for Parkinson's disease;
  • changes in dopamine therapy dose within 3 months before the study starts;
  • disabling comorbidities such as cognitive disorders including stroke and depression; and
  • language difficulties, unstable cardia or reparatory illness, or other medical conditions that may affect participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Karen P. Y. Liu contact

852 27665386

karen.liu@polyu.edu.hk

Hong Kong1 site, 1 recruiting
  • The Hong Kong Polytechnic University

    Hong Kong

    Karen P. Y. Liu, 852-27665386, karen.liu@polyu.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

The goal of this clinical trial is to learn whether mental imagery combined with self-regulation can improve daily activities in people with Parkinson's disease.

The main questions it aims to answer are:

  • Does mental imagery with self-regulation improve performance in daily activities?
  • Does it improve overall, cognitive, and motor function?

Researchers will compare mental imagery with self-regulation with exercise and health education to assess their effects.

Participants will:

  • Complete a six-week mental imagery and self-regulation programme, conventional learning, or exercise.
  • Complete assessments of daily activities and overall, cognitive, and motor function.
Read the detailed description

With less dopamine in the substantia nigra of the basal ganglia, People with Parkinson's Disease (PwPD) experience symptoms across a spectrum. This causes impairment of their supervisory attentional system (SAS), affecting the person's mental flexibility and ability to focus attention on movements and leading to a reliance on slow and energy-intensive action. As a result, PwPD have many restrictions not only in gait and walking but also in completing routine daily activities such as bathing and shopping.

Conventional rehabilitation, such as exercise, targets their motor issues and enhances mobility. However, exercise may not directly work on SAS impairment and non-motor symptoms and, therefore, may only produce short-term benefits. Cueing is another strategy that facilitates motor performance in PwPD by shifting attention resources to compensate for movement initiation and sequencing. Our previous systematic review and meta-analysis showed that cueing improved task performance in PwPD with a lasting effect from 1 week to 1 year. However, cueing relies on an external cue and device, which is unrealistic for daily and community living and specific to a particular task, such as walking. Generalisation to other daily activities is limited.

The use of Mental Imagery (MI) is a rehabilitation strategy that has been studied to improve function in PwPD. MI works under a cognitive mechanism that tackles the SAS impairment and improves the attentional focus required in learning movement strategies. However, conflicting results in the use of MI in PwPD have been found. When reviewing the intervention protocols of clinical trials with positive results, the intervention broke tasks into steps, engaged participants in self-awareness of their own problems, or drew attention toward task performance during mental imagery. Drawing attention toward task performance seems to work using a cognitive approach to tackle SAS impairment and improve the attentional focus required in learning movement strategies. Modification of MI intervention protocols by adding an extra component to enhance attentional focus when learning movement strategies and engaging them in understanding the motor demand based on their ability are hypothesised to be the key to guaranteeing the success of these MI intervention protocols. Self-regulation is a strategy that can offer this extra component.

Self-regulation has been used widely in education to enhance learning. It involves self-monitoring and self-modification of one's behaviour. In rehabilitation, self-regulation has been shown to enhance participation in daily activities in people with stroke. Using a cognitive approach, self-regulation is an active learning strategy that helps individuals to be aware of their own ability and environment and control their own learning. Self-regulation and executive function are connected theoretically and empirically. Both involve the processes of (1) organising/prioritising; (2) focusing/sustaining; (3) regulating alertness; (4) managing frustration and emotion; (5) utilising working memory and recalling; and (6) monitoring and self-regulating action. This is achieved by the person monitoring their own performance, identifying their solutions and reflecting on their success. Apart from people with stroke, the Principal Investigator and the team also demonstrated the effective use of self-regulation in autistic children in learning school and daily activities.

Our previous studies demonstrated the effective use of MI with self-regulation in improving the daily activities in people with stroke, with 1-month carry-over effects and generalisation to untrained daily activities. Our research showed that combining MI with self-regulation could improve attention and sequencing-processing abilities and monitoring of daily activity performance by self-reflecting on successful performance in people with stroke. The cognitive processes in understanding one's abilities and deficits, analysing the demands in each step of a task, and planning and imagining performing the individual task steps will allow PwPD to process all the cognitive and motor demands as well as their own abilities in coping with these task demands.

Based on our previous research on stroke, we developed a MI with self-regulation program for PwPD (MI-SeR) with feedback from two consumer co-designed workshops with five health professionals and five PwPD and their carers and pilot-tested it on 11 patients with mild to moderate PD. The MI-SeR was shown to have satisfactory feasibility (85% completed the intervention program) and excellent acceptability, with all participants who completed the program agreeing that they would recommend it to other PwPD. After the 6-week MI-SeR, there were significant improvements in patient-rated perceived daily activities and a medium effect size as measured by the Canadian Occupational Performance Measure (p = .011, effect size = .47), and attention and mental flexibility of cognitive function, also with medium effect sizes, as measured by the Trail Making A and Trail Making B, respectively (p ≤ .05, effect size = .59; p = .022, effect size = .69).

Objectives

  1. Primary objective To investigate the effects of MI with self-regulation (MI-SeR), compared with conventional learning and exercise (control intervention), on improving patient-rated perceived performance of daily activities in PwPD.
  2. Secondary objective To assess the effects of the two interventions on daily functioning, cognitive function, and motor function in PwPD.
  3. Exploratory objective To explore whether MI-SeR is associated with changes in fNIRS-measured cortical haemodynamic responses during ADL-related MI tasks, and whether the intervention effects on daily activity performance are mediated through improvements in prefrontal executive function quantified by fNIRS-assessed cortical activity.
Being tested
Mental imagery with self-regulation, Exercise and health education
Keywords
Parkinson's disease, Daily activities, Early intervention, Mental imagery, Self-regulation
Medical subject headings
Parkinson Disease, Self-Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mental imagery with self-regulationOther

    Also called MI-SeR

    Participants will receive a 6-week program consisting of weekly 45-minute group sessions (2-4 participants per group), mental imagery training, self-regulation strategies, home practice, and telephone follow-up. Training covers important daily activities (e.g., preparing breakfast, washing dishes, making phone calls), emphasizing task analysis, problem identification, solution development and implementation.

  • Exercise and health educationOther

    Participants will receive a 6-week exercise and health education intervention, consisting of weekly 45-minute group sessions (2-4 participants per group), home practice, and telephone follow-up.

Study groups in NCT07860294
Study groupRoleWhat they receive
Mental imagery with self-regulationExperimentalParticipants will receive mental imagery training, self-regulation strategies. Training covers important daily activities (e.g., preparing breakfast, washing dishes, making phone calls), emphasizing task analysis, problem identification, solution development and implementation.
Receives: Other: Mental imagery with self-regulation
Exercise and health educationActive comparatorParticipants will receive exercise, including gross and fine motor exercises, and health education.
Receives: Other: Exercise and health education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Canadian Occupational Performance Measure

    The Canadian Occupational Performance Measure is a standardised client-centred outcome measure that assesses an individual's performance in daily activities (Law et al., 2005). This sensitive instrument focuses on participants' perceptions of their functioning and improvements in daily activities.

    Measured: Pre-intervention, at the end of the 6-week intervention, and at 3 and 6 months after intervention completion

Secondary outcomes (7)
  1. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale

    The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale assesses the non-motor and motor experiences of daily living and motor complications in People with Parkinson's Disease.

    Measured: Pre-intervention, at the end of the 6-week intervention, and at 3 and 6 months after intervention completion

  2. Kinesthetic and Visual Imagery Questionnaire-10

    The Kinesthetic and Visual Imagery Questionnaire-10 will be used to assess motor imagery ability. It evaluates two dimensions of motor imagery: the clarity of visual imagery and the intensity of kinesthetic sensations associated with imagined movements. Participants first physically perform each movement and then imagine performing the same movement from a first-person perspective.

    Measured: Pre-intervention, at the end of the 6-week intervention, and at 3 and 6 months after intervention completion

  3. Color Trails Test

    The Color Trails Test assesses a person's executive functioning and is considered a sensitive test for detecting different types of brain damage in PwPD (D'Elia et al., 1989). CTT1 evaluates a person's visual scanning, sequencing, and processing speed; and CTT2 adds an alternating sequence component and is sensitive to executive functions such as mental flexibility and divided attention.

    Measured: Pre-intervention, at the end of the 6-week intervention, and at 3 and 6 months after intervention completion

  4. Stroop Color and Word Test

    The Stroop Color and Word Test assesses a person's mental flexibility - the ability to inhibit an automatic response and to establish and maintain a new, nonhabitual response based on environmental constraints.

    Measured: Pre-intervention, at the end of the 6-week intervention, and at 3 and 6 months after intervention completion

  5. Timed Up and Go test

    The Timed Up and Go test is a standardised test that records the time taken by an individual to stand up from an armchair, walk 3 metres, turn and walk back at their usual speed, and sit on the chair again.

    Measured: Pre-intervention, at the end of the 6-week intervention, and at 3 and 6 months after intervention completion

  6. 10-Meter Walk Test

    The 10-Meter Walk Test is recommended to measure gait speed in people with Parkinson's disease and is proven to be a reliable and valid measure. Gait speed is measured in metres per second over the middle 6 metres.

    Measured: Pre-intervention, at the end of the 6-week intervention, and at 3 and 6 months after intervention completion

  7. European Quality of Life, Five Dimensions, Five Levels

    The European Quality of Life, Five Dimensions, Five Levels instrument assesses five domains: mobility, self-care, usual activity, pain, and anxiety. Participants are asked to rate their self-perceived level of the five domains on a five-level scale of severity.

    Measured: Pre-intervention, at the end of the 6-week intervention, and at 3 and 6 months after intervention completion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2026
  2. Study start5 Oct 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07860294
Sponsor's protocol ID
Hongkongpu_MI_SeR for PD
Acronym
MI-SeR
Status last verified
Sep 2026
First submitted
30 Sep 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Because of data privacy, IPD will not be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Mental imagery with self-regulation and Exercise and health education in people with Parkinson s Disease, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

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 5 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 6 Oct 2026. 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 Hong Kong. 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 Karen P. Y. Liu (852 27665386, karen.liu@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Canadian Occupational Performance Measure (time frame: Pre-intervention, at the end of the 6-week intervention, and at 3 and 6 months after intervention completion). 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 6 Oct 2026.

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