Parkinson DiseaseNCT06957405
Remote Mental Practice for Freezing of Gait in Parkinson's Disease
A study testing MPPG (Mental and Physical Practice Group) and PPG (Physical Practice Group) in people with Parkinson Disease and Freezing of Gait, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This single-blind, randomized controlled trial investigates the effects of a remotely delivered intervention based on mental practice (MP) combined with physical practice (PP) on freezing of gait (FOG) severity in people with idiopathic Parkinson's disease (PD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Freezing of Gait
- What is being tested?
- MPPG (Mental and Physical Practice Group) and PPG (Physical Practice Group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Jan 2025to Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of idiopathic PD;
- Use of dopaminergic medication;
- Experiencing FOG (positive response to the first question of the New Freezing of Gait Questionnaire - NFOG-Q);
- Able to walk independently at home;
- Access to internet and video call device;
- Agree to participate in the study.
Who cannot join
- Other neurological disorders;
- Severe cardiovascular and/or respiratory alterations;
- Uncorrected visual and/or auditory alterations;
- Cognitive impairment, detectable through the Telephone Montreal Cognitive Assessment (T-MoCA, < 12);
- Inability to perform motor imageryT during the administration of the Kinesthetic and Visual Imagery Questionnaire - 20 (KVIQ-20, < 20)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo
São Paulo, São Paulo, 05508-900
Maria Elisa P Piemonte, PT, PHD, 55 11 30917451, elisapp@usp.br
Paloma R Silva, PT, 55 11 976193193, paloma.rsilva@usp.br
About this study
Official title: Effects of a Remote Mental and Physical Practice Intervention on Freezing of Gait in People With Parkinson's Disease: a Randomized Controlled Trial
This single-blind, randomized controlled trial investigates the effects of a remotely delivered intervention based on mental practice (MP) combined with physical practice (PP) on freezing of gait (FOG) severity in people with idiopathic Parkinson's disease (PD). Fifty participants will be randomly assigned to either the experimental group (MP + PP) or a control group (PP + stretching). The intervention consists of 10 video-supervised sessions over 6 weeks. Primary outcomes include the Rapid Turn Test and percentage of time spent with FOG (%FOG). Secondary outcomes include the New Freezing of Gait Questionnaire (NFOG-Q), Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Parkinson's Disease Questionnaire-39 (PDQ-39), and Telephone Montreal Cognitive Assessment (T-MoCA). The study aims to demonstrate whether MP using Dynamic Neuro-Cognitive Imagery (DNI) techniques can effectively reduce FOG severity and improve motor and cognitive function in people with PD.
Read the detailed description
This trial aims to evaluate a home-based remote intervention delivered via encrypted video calls by physiotherapists trained in both Mental Practice (MP) and Physical Practice (PP) protocols. Participants undergo 10 structured training sessions, each lasting 45-60 minutes, across six weeks. The experimental intervention consists of two blocks of first-person kinesthetic MP and two blocks of corresponding PP. The MP is guided using DNI principles, emphasizing goal-directed control, body schema reinforcement, and environmental context. Each block lasts approximately 10 minutes and focuses on gait-related challenges. Safety measures, including environmental checks and the presence of a caregiver (when applicable), are verified before each session. The control group performs the same physical practice but replaces the MP with guided seated stretching exercises. Assessments are conducted at baseline, post-intervention, and 30-day follow-up, by a blinded evaluator. The Rapid Turn Test is video-recorded and independently analyzed. A repeated measures ANOVA will be used for statistical analysis.
- Conditions
- Parkinson Disease, Freezing of Gait
- Being tested
- MPPG (Mental and Physical Practice Group), PPG (Physical Practice Group)
- Keywords
- Parkinson disease, Freezing of Gait, Mental Practice, Telerehabilitation, Dynamic Neuro-Cognitive Imagery, Motor Imagery, Gait Disorders
- Medical subject headings
- Parkinson Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPPG (Mental and Physical Practice Group)Behavioural
Also called (Mental Practice + Physical Practice)
Participants in this group will undergo 10 remote sessions over 6 weeks, each session lasting 45-60 minutes. Each session consists of: (1) two blocks of first-person kinesthetic MP, conducted while seated with eyes closed and guided using DNI principles; and (2) two blocks of corresponding PP, involving simulated gait components such as ankle mobility, postural weight shifts, and short-distance walking under real-time supervision. Each block lasts approximately 10 minutes. The MP emphasizes attentional focus, sensory detail, and task-specific goals. Sessions are conducted synchronously via video call by trained physiotherapists.
PPG (Physical Practice Group)Behavioural
Also called (Physical Practice + Stretching)
Participants in the control group will receive 10 remote sessions over 6 weeks, each session lasting 45-60 minutes. Each session consists of the same PP as the experimental group but replaces motor imagery with two 10-minute seated stretching block, focusing on the upper limbs and trunk. The PP follows the same structure and duration as in the experimental group. All sessions are delivered remotely via live video by physiotherapists trained in both protocols. Volume, frequency, and interaction levels are matched between groups to ensure equivalence.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (EG) | Experimental | In the Experimental Group (EG), the intervention will consist of 10 remote sessions, each including two blocks of Mental Practice (MP) and two blocks of corresponding Physical Practice (PP), focuses on gait-related challenges. Receives: Behavioral: MPPG (Mental and Physical Practice Group) |
| Control Group (CG) | Active comparator | In the Control Group (CG), the intervention will consist of 10 remote sessions, each including two blocks of seated upper-limb stretching exercises followed by two blocks of Physical Practice (PP), with the same structure and duration as in the Experimental Group (EG). Receives: Behavioral: PPG (Physical Practice Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid Turns Test
A provocative freezing test. The individuals will be instructed to spin around their own axis repeatedly, in both directions, at high speed. A Percentage of time with FOG (%FOG) will be performed based on video recordings of Rapid Turns Test to measure the actual severity of freezing, calculated using the formula (total duration of FOG during the test * 100) / total duration of the test.
Measured: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (Follow-up).
Secondary outcomes (4)
New Freezing of Gait Questionnaire (NFOG-Q)
A self reported questionnaire that assesses the clinical aspects of FOG and the impact on quality of life. The total scores range from 0 to 28, with higher scores indicating greater severity impact of FOG.
Measured: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (Follow-up).
Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
It is a widely recognized scale used to evaluate and track the progression of Parkinson's Disease (PD). The scale includes 42 items, categorized into four sections: Part I (non-motor aspects of daily living), Part II (motor aspects of daily living), Part III (motor evaluation), and Part IV (motor complications). Scores range from 0 to 4, with lower scores indicating better functional status. In Part II, the evaluator asks the questions, and the responses are based on the individual's self-reported motor performance in daily activities.
Measured: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention .
Parkinson Disease Questionnaire - 39 (PDQ-39)
A questionnaire consisting of 39 questions distributed across eight domains (mobility - ten items; activities of daily living - six items; emotional well being - six items; social support - three items; physical discomfort - three items; stigma - four items; and communication - three items). Each item can be answered with one of five predetermined responses (never, rarely, sometimes, frequently, and always). The score for each item ranges from 0 to 4, with the total score ranging from 0 to 100, where the lowest score reflects better quality of life.
Measured: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (follow-up).
Telephone Montreal Cognitive Assessment (T-MoCA)
The instrument evaluates six cognitive domains, including naming, memory, attention, language, abstraction, and orientation. The scale does not require the use of paper, pencil or visual stimuli and has a total score of 22 points, with higher scores indicating normal cognitive performance.
Measured: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start25 Jan 2025
- Primary completionAug 2025 (estimated)
- Study completionJan 2028 (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 University of Sao Paulo General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-blind, randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957405
- Sponsor's protocol ID
- PM-DP NeuroMat
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 27 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 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Remote Mental and Physical Practice Intervention on Freezing of Gait in People With Parkinson's Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06957405
- Acronym / sponsor ID
- PM-DP NeuroMat
- Conditions
- Parkinson Disease, Freezing of Gait
- Keywords
- Parkinson disease, Freezing of Gait, Mental Practice, Telerehabilitation, Dynamic Neuro-Cognitive Imagery, Motor Imagery, Gait Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 4 May 2025 (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.
This single-blind, randomized controlled trial investigates the effects of a remotely delivered intervention based on mental practice (MP) combined with physical practice (PP) on freezing of gait (FOG) severity in people with idiopathic Parkinson's disease (PD). Fifty participants will be randomly assigned to either the experimental group (MP + PP) or a control group (PP + stretching). The intervention consists of 10 video-supervised sessions over 6 weeks. Primary outcomes include the Rapid Turn Test and percentage of time spent with FOG (%FOG). Secondary outcomes include the New Freezing of Gait Questionnaire (NFOG-Q), Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Parkinson's Disease Questionnaire-39 (PDQ-39), and Telephone Montreal Cognitive Assessment (T-MoCA). The study aims to demonstrate whether MP using Dynamic Neuro-Cognitive Imagery (DNI) techniques can effectively reduce FOG severity and improve motor and cognitive function in people with PD.
Detailed description
This trial aims to evaluate a home-based remote intervention delivered via encrypted video calls by physiotherapists trained in both Mental Practice (MP) and Physical Practice (PP) protocols. Participants undergo 10 structured training sessions, each lasting 45-60 minutes, across six weeks. The experimental intervention consists of two blocks of first-person kinesthetic MP and two blocks of corresponding PP. The MP is guided using DNI principles, emphasizing goal-directed control, body schema reinforcement, and environmental context. Each block lasts approximately 10 minutes and focuses on gait-related challenges. Safety measures, including environmental checks and the presence of a caregiver (when applicable), are verified before each session. The control group performs the same physical practice but replaces the MP with guided seated stretching exercises. Assessments are conducted at baseline, post-intervention, and 30-day follow-up, by a blinded evaluator. The Rapid Turn Test is video-recorded and independently analyzed. A repeated measures ANOVA will be used for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-blind, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) | Experimental | Behavioral: MPPG (Mental and Physical Practice Group)In the Experimental Group (EG), the intervention will consist of 10 remote sessions, each including two blocks of Mental Practice (MP) and two blocks of corresponding Physical Practice (PP), focuses on gait-related challenges. |
| Control Group (CG) | Active comparator | Behavioral: PPG (Physical Practice Group)In the Control Group (CG), the intervention will consist of 10 remote sessions, each including two blocks of seated upper-limb stretching exercises followed by two blocks of Physical Practice (PP), with the same structure and duration as in the Experimental Group (EG). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of idiopathic PD;
- Use of dopaminergic medication;
- Experiencing FOG (positive response to the first question of the New Freezing of Gait Questionnaire - NFOG-Q);
- Able to walk independently at home;
- Access to internet and video call device;
Key exclusion criteria (5 listed)
- Other neurological disorders;
- Severe cardiovascular and/or respiratory alterations;
- Uncorrected visual and/or auditory alterations;
- Cognitive impairment, detectable through the Telephone Montreal Cognitive Assessment (T-MoCA, < 12);
- Inability to perform motor imageryT during the administration of the Kinesthetic and Visual Imagery Questionnaire - 20 (KVIQ-20, < 20)
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 |
|---|---|---|
| MPPG (Mental and Physical Practice Group)Also: (Mental Practice + Physical Practice)Participants in this group will undergo 10 remote sessions over 6 weeks, each session lasting 45-60 minutes. Each session consists of: (1) two blocks of first-person kinesthetic MP, conducted while seated with eyes closed and guided using DNI principles; and (2) two blocks of corresponding PP, involving simulated gait components such as ankle mobility, postural weight shifts, and short-distance walking under real-time supervision. Each block lasts approximately 10 minutes. The MP emphasizes attentional focus, sensory detail, and task-specific goals. Sessions are conducted synchronously via video call by trained physiotherapists. | Behavioural | Experimental Group (EG) |
| PPG (Physical Practice Group)Also: (Physical Practice + Stretching)Participants in the control group will receive 10 remote sessions over 6 weeks, each session lasting 45-60 minutes. Each session consists of the same PP as the experimental group but replaces motor imagery with two 10-minute seated stretching block, focusing on the upper limbs and trunk. The PP follows the same structure and duration as in the experimental group. All sessions are delivered remotely via live video by physiotherapists trained in both protocols. Volume, frequency, and interaction levels are matched between groups to ensure equivalence. | Behavioural | Control Group (CG) |
Primary outcome
Rapid Turns Test
Time frame: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (Follow-up).
A provocative freezing test. The individuals will be instructed to spin around their own axis repeatedly, in both directions, at high speed. A Percentage of time with FOG (%FOG) will be performed based on video recordings of Rapid Turns Test to measure the actual severity of freezing, calculated using the formula (total duration of FOG during the test * 100) / total duration of the test.
4 secondary outcomes
New Freezing of Gait Questionnaire (NFOG-Q)
Time frame: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (Follow-up).
Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II
Time frame: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention .
Parkinson Disease Questionnaire - 39 (PDQ-39)
Time frame: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (follow-up).
Telephone Montreal Cognitive Assessment (T-MoCA)
Time frame: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (follow-up).
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 27 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPPG (Mental and Physical Practice Group) and PPG (Physical Practice Group) in people with Parkinson Disease and Freezing of Gait, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 6 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 27 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 Brazil. 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 Maria Elisa P Piemonte, PT, PHD (55 11 30917451, elisapp@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid Turns Test (time frame: Change from Baseline to immediately Post-intervention, and then at 30 days post-intervention (Follow-up).). 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 27 Aug 2025.