Primary ParkinsonismNCT03439800
Effects of Motor Imagery Training on Gait and Brain Activation Pattern of Individuals With Parkinson's Disease
A study testing Mental and Physical Practice and Physical Practice in people with Primary Parkinsonism and Rehabilitation, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
INTRODUCTION: Mental practice (MP) and action observation (AO) are characterized as cognitive strategies that contribute to motor planning and learning in diverse populations. Individuals with Parkinson's Disease (PD) are recent targets, since, with disease progression, they need external strategies to aid in motor… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Primary Parkinsonism, Rehabilitation, Kinematics
- What is being tested?
- Mental and Physical Practice and Physical Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Feb 2018to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PD according to the report of a neurologist;
- Age between 50 and 75 years;
- In the moderate stage of the disease (between stages 2 and 3 of the Hoehn and Yahr Scale);
- Use of antiparkinsonian medication;
- Do not present cognitive deficits, according to the Mini Mental State Examination - MMSE. The cutoff point will be defined considering the individual's schooling (Illiterates: 18; With school instruction: 24);
- Ability to imagine motor acts in kinesthetic mode (according to the Revised Movement Imagery Questionnaire - MIQ-R). The cut-off point will be 20 for the kinesthetic modality, indicating that it is at least "a little easy to feel" the kinesthetically imagined movement;
- Have not undergone stereotaxic surgery.
Who cannot join
- Individuals with other associated neurological diseases;
- Individuals with musculoskeletal disorders, not related to the disease, but that impair gait;
- Individuals with hemodynamic instability before or during training;
- Individuals with uncorrected visual or auditory changes;
- Individuals who do not understand some stage of the training protocol.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Lorenna Santiago
Parnamirim, Rio Grande Do Norte, 59148-520
Lorenna Santiago, +5584999029083 ext. +5584999029083, lorennamms@gmail.com
Raquel Lindquist, +5584981175502 ext. +5584981175502, raquellindquist@ufrnet.br
About this study
Official title: Effects of Motor Imagery and Action Observation Training on Gait and Brain Activation Pattern of Individuals With Parkinson's Disease: Randomized Controlled Clinical Trial
INTRODUCTION: Mental practice (MP) and action observation (AO) are characterized as cognitive strategies that contribute to motor planning and learning in diverse populations. Individuals with Parkinson's Disease (PD) are recent targets, since, with disease progression, they need external strategies to aid in motor organization. However, there is still no evidence of the efficacy of MP and AO in the gait of PD. OBJECTIVES: To compare the effects of physical practice preceded by MP and AO on gait performance in individuals with Idiopathic PD (IPD). METHODS: A controlled, randomized, single-blind clinical trial with 66 individuals with IPD, aged between 50 and 75 years, without cognitive deficit and in the moderate phase of the disease will be performed. For the inclusion and characterization of the sample, the following instruments / equipment will be used: (1) Identification form (sociodemographic, clinical and anthropometric aspects); (2) Mini Mental State Examination and Montreal Cognitive Assessment (cognitive level); (3) Hoehn and Yahr Scale (level of physical disability); (4) Revised Movement Imagery Questionnaire (sharpness of the mental image); (5) Qualisys Motion Capture Systems® (gait kinematics); (6) Emotiv Epoc + (electroencephalographic activity); (7) Unified Parkinson's Disease Rating Scale - UPDRS (motor function and activities of daily living); (8) Timed Up and Go Test - TUG Test (mobility); and (9) Parkinson's Disease Questionnaire - PDQ-39 (quality of life).Participants included will be randomly assigned to two groups: experimental (n = 33), who will participate in MP + AO and physical gait practice; and control group (n = 33), who will participate only in the physical practice of gait. Both groups will be submitted to 12 training sessions (3x / week, for 4 weeks) and will be reevaluated 10 minutes, 7 days and 30 days after the last training session with respect to items (4), (5), (6) and (8) of the evaluation. Primary outcomes will be velocity, stride length and range of motion of the hip and the secondary ones will be sharpness of the mental image, electroencephalographic activity and performance in the TUG Test. The normality in the data distribution will be verified through the Shapiro-Wilk test. The "t" test and the Mann-Whitney test will be used to verify the homogeneity of the groups in the baseline. A repeated measures ANOVA will verify the interaction between the groups at the moments observed.
Read the detailed description
No additional information.
- Being tested
- Mental and Physical Practice, Physical Practice
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental and Physical PracticeOther
- Subjects will see a video of the typical gait and will attempt to analyze the sequence of the gait cycle.
- They will imagine themselves walking in the first-person perspective (kinesthetic) using the gait of the non-pathological pattern during 2 minutes.
- From the 1st to 4th session, the subjects will perform gait with corrections identified in previously in the video for 2 minutes.
- From 5th to 8th session: the subjects will do the protocol already described, however, the imagined gait will be in an environment with obstacles, also for 2 minutes. They will continue with the physical practice of the gait with obstacles.
- From 9th to final training session: both mental and physical practice of the dual task gait.
Physical PracticeOther
- Subjects will see a video about PD which does not mention physiotherapy treatments related to gait and they will explain their understanding about the theme.
- Then, the patients will make the physical gait protocol. Patients will be invited to perform the gait, in flat and firm ground with a length of 60 meters. The execution will be carried out for 10 minutes.
- From the 5th to 8th session, the subjects will do the physical practice of the gait with obstacles (which will be: going through 2 cones zigzag, going up and down 1 step, going through a narrow door, going up and down 1 ramp, going over 1 box of shoes, climbing a ramp, going down 1 step) for 2 minutes.
- From the 9th to the final training session, the subjects will do physical practice of the dual task gait.
| Study group | Role | What they receive |
|---|---|---|
| Mental and Physical Practice | Experimental | Action observation: is defined as the observation of the motor action, in this study, through a video.
Mental Practice: is defined as motor imagery training with the aim of improving the engine performance. Is the imagination of a motor action without its physical implementation.
Physical Practice: is the execution of the motor action. Receives: Other: Mental and Physical Practice |
| Physical Practice | Active comparator | Physical Practice: is the execution of the motor action. Receives: Other: Physical Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velocity
Gait velocity in meters/second evaluated with Qualisys Motion Capture System
Measured: Change from Baseline Velocity at 1 day, 7 days and 30 days after training sessions
Secondary outcomes (3)
Electroencephalographic activity
Sharpness of the mental image evaluated by the Emotiv Epoc +
Measured: Change from Baseline Electroencephalographic activity at 1 day, 7 days and 30 days after training sessions
Mobility
Performance in the Timed Up and Go Test
Measured: Change from Baseline Mobility at 1 day, 7 days and 30 days after training sessions
Stride length
Stride length during gait of the most affected lower evaluated with Qualisys Motion Capture System
Measured: change from Baseline Stride length at 1 day, 7 days and 30 days after training sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start15 Feb 2018
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary ParkinsonismStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Raquel Rodrigues Lindquist, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439800
- Sponsor's protocol ID
- CEP-UFRN 2.057.658
- Status last verified
- Feb 2019
- First submitted
- 15 Nov 2017
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nascimento IAPDS, Santiago LMM, de Souza AA, Pegado CL, Ribeiro TS, Lindquist ARR. Effects of motor imagery training of Parkinson's disease: a protocol for a randomized clinical trial. Trials. 2019 Nov 9;20(1):626. doi: 10.1186/s13063-019-3694-8.
PubMed 31706325
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Imagery and Action Observation Training on Gait and Brain Activation Pattern of Individuals With Parkinson's Disease: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03439800
- Acronym / sponsor ID
- CEP-UFRN 2.057.658
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Feb 2018 (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.
INTRODUCTION: Mental practice (MP) and action observation (AO) are characterized as cognitive strategies that contribute to motor planning and learning in diverse populations. Individuals with Parkinson's Disease (PD) are recent targets, since, with disease progression, they need external strategies to aid in motor organization. However, there is still no evidence of the efficacy of MP and AO in the gait of PD. OBJECTIVES: To compare the effects of physical practice preceded by MP and AO on gait performance in individuals with Idiopathic PD (IPD). METHODS: A controlled, randomized, single-blind clinical trial with 66 individuals with IPD, aged between 50 and 75 years, without cognitive deficit and in the moderate phase of the disease will be performed. For the inclusion and characterization of the sample, the following instruments / equipment will be used: (1) Identification form (sociodemographic, clinical and anthropometric aspects); (2) Mini Mental State Examination and Montreal Cognitive Assessment (cognitive level); (3) Hoehn and Yahr Scale (level of physical disability); (4) Revised Movement Imagery Questionnaire (sharpness of the mental image); (5) Qualisys Motion Capture Systems® (gait kinematics); (6) Emotiv Epoc + (electroencephalographic activity); (7) Unified Parkinson's Disease Rating Scale - UPDRS (motor function and activities of daily living); (8) Timed Up and Go Test - TUG Test (mobility); and (9) Parkinson's Disease Questionnaire - PDQ-39 (quality of life).Participants included will be randomly assigned to two groups: experimental (n = 33), who will participate in MP + AO and physical gait practice; and control group (n = 33), who will participate only in the physical practice of gait. Both groups will be submitted to 12 training sessions (3x / week, for 4 weeks) and will be reevaluated 10 minutes, 7 days and 30 days after the last training session with respect to items (4), (5), (6) and (8) of the evaluation. Primary outcomes will be velocity, stride length and range of motion of the hip and the secondary ones will be sharpness of the mental image, electroencephalographic activity and performance in the TUG Test. The normality in the data distribution will be verified through the Shapiro-Wilk test. The "t" test and the Mann-Whitney test will be used to verify the homogeneity of the groups in the baseline. A repeated measures ANOVA will verify the interaction between the groups at the moments observed.
Detailed description
No additional information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental and Physical Practice | Experimental | Other: Mental and Physical PracticeAction observation: is defined as the observation of the motor action, in this study, through a video. Mental Practice: is defined as motor imagery training with the aim of improving the engine performance. Is the imagination of a motor action without its physical implementation. Physical Practice: is the execution of the motor action. |
| Physical Practice | Active comparator | Other: Physical PracticePhysical Practice: is the execution of the motor action. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of PD according to the report of a neurologist;
- Age between 50 and 75 years;
- In the moderate stage of the disease (between stages 2 and 3 of the Hoehn and Yahr Scale);
- Use of antiparkinsonian medication;
- Do not present cognitive deficits, according to the Mini Mental State Examination - MMSE. The cutoff point will be defined considering the individual's schooling (Illiterates: 18; With school instruction: 24);
Key exclusion criteria (5 listed)
- Individuals with other associated neurological diseases;
- Individuals with musculoskeletal disorders, not related to the disease, but that impair gait;
- Individuals with hemodynamic instability before or during training;
- Individuals with uncorrected visual or auditory changes;
- Individuals who do not understand some stage of the training protocol.
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 |
|---|---|---|
| Mental and Physical Practice1. Subjects will see a video of the typical gait and will attempt to analyze the sequence of the gait cycle. 2. They will imagine themselves walking in the first-person perspective (kinesthetic) using the gait of the non-pathological pattern during 2 minutes. 3. From the 1st to 4th session, the subjects will perform gait with corrections identified in previously in the video for 2 minutes. 4. From 5th to 8th session: the subjects will do the protocol already described, however, the imagined gait will be in an environment with obstacles, also for 2 minutes. They will continue with the physical practice of the gait with obstacles. 5. From 9th to final training session: both mental and physical practice of the dual task gait. | Other | Mental and Physical Practice |
| Physical Practice1. Subjects will see a video about PD which does not mention physiotherapy treatments related to gait and they will explain their understanding about the theme. 2. Then, the patients will make the physical gait protocol. Patients will be invited to perform the gait, in flat and firm ground with a length of 60 meters. The execution will be carried out for 10 minutes. 3. From the 5th to 8th session, the subjects will do the physical practice of the gait with obstacles (which will be: going through 2 cones zigzag, going up and down 1 step, going through a narrow door, going up and down 1 ramp, going over 1 box of shoes, climbing a ramp, going down 1 step) for 2 minutes. 4. From the 9th to the final training session, the subjects will do physical practice of the dual task gait. | Other | Physical Practice |
Primary outcome
Velocity
Time frame: Change from Baseline Velocity at 1 day, 7 days and 30 days after training sessions
Gait velocity in meters/second evaluated with Qualisys Motion Capture System
3 secondary outcomes
Electroencephalographic activity
Time frame: Change from Baseline Electroencephalographic activity at 1 day, 7 days and 30 days after training sessions
Mobility
Time frame: Change from Baseline Mobility at 1 day, 7 days and 30 days after training sessions
Stride length
Time frame: change from Baseline Stride length at 1 day, 7 days and 30 days after training sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Derived from this study: PubMed 31706325Nascimento IAPDS, Santiago LMM, de Souza AA, Pegado CL, Ribeiro TS, Lindquist ARR. Effects of motor imagery training of Parkinson's disease: a protocol for a randomized clinical trial. Trials. 2019 Nov 9;20(1):626. doi: 10.1186/s13063-019-3694-8.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental and Physical Practice and Physical Practice in people with Primary Parkinsonism and Rehabilitation, run by Universidade Federal do Rio Grande do Norte 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 7 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: status not confirmed, as of the sponsor's last update on 6 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Velocity (time frame: Change from Baseline Velocity at 1 day, 7 days and 30 days after training sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03439800, which also lists 1 linked publication.
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 Feb 2019.