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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mental imagery with self-regulation

    Other intervention

    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 education

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Mental imagery with self-regulationExperimental treatment 1 intervention
Group B: Exercise and health educationActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
Pre-intervention, at the end of the 6-week intervention, and at 3 and 6 months after intervention completion

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Pre-intervention, at the end of the 6-week intervention, and at 3 and 6 months after intervention completion

Other outcomes

1

Cortical Activity (mediator)

Participants will complete a paper-and-pencil neuropsychological test and daily activity-related mental imagery tasks. During the 10-second baseline period, participants are required to sit on a chair until the task begins. During the 30-second task period, they will be instructed to complete the tests. The fNIRS recording session will be conducted in a quiet room. A 32-channel fNIRS optical topography system (NIRSport2; NIRx Medical Technologies, Berlin, Germany) will be utilised to monitor the oxygenation changes (i.e., oxy- to deoxy-hemoglobin proportion) in the cerebral cortices over the frontoparietal network (FPN), including the dorsolateral prefrontal cortex (DLPFC), ventrolateral prefrontal cortex (VLPFC), bilateral sensorimotor (SMC), bilateral premotor cortex (PMC), and bilateral supplementary motor area (SMA), throughout the Color Trails Test and daily activity-related mental imagery task paradigm.

Time frame
Pre-intervention and at the end of the 6-week intervention

Sponsors and contacts

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The Hong Kong Polytechnic University

Lead sponsor

Tung Wah Hospital

Collaborator

The University of Hong Kong-Shenzhen Hospital

Collaborator