Parkinson DiseaseNCT02118506
Effects of Mental Practice in Gait of Individuals With Parkinson Disease: Randomized Clinical Trial
A study testing Physical practice and Mental and physical practice in people with Parkinson Disease, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the effects of mental practice, associated with physical practice, on gait (cinematic parameters and mobility) in individuals with idiopathic Parkinson's disease. Read more about this study
- Who is it for?
- Ages 44 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Physical practice and Mental and physical practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2012to Sep 2013
- 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 44 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the subjects should be in use of antiparkinsonian medication,
- be between stages 2 and 3 of the Hoehn and Yahr modified scale);
- walk without any brace or aid device, independently (scores between 3 and 5 of the Functional Ambulatory Category - FAC) for at least 10 meters
- were not undergoing stereotactic surgery.
Who cannot join
- We excluded those who were unable or declined to complete the training protocol.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Norte
Natal, Rio Grande do Norte, 59078-970
About this study
Official title: Immediate Effects of Mental Practice in Gait of Individuals With Parkinson Disease: Randomized Clinical Trial
The purpose of this study is to compare the effects of mental practice, associated with physical practice, on gait (cinematic parameters and mobility) in individuals with idiopathic Parkinson's disease. It is believed that familiarity with the normal gait pattern, associated with mental practice and physical practice can trigger significant changes in spatiotemporal and angular parameters that are not observed in the group not submitted to mental practice.
- Conditions
- Parkinson Disease
- Being tested
- Physical practice, Mental and physical practice
- Keywords
- Primary Parkinsonism., Rehabilitation., Biomechanics., Neurological gait disorders.
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical practiceOther
The control group underwent familiarization of gait phases using cards with gait phases and physical gait training.
Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases. Then, they were submitted to a physical gait training. They underwent a single training session during 1 hour and 30 minutes and were reassessed 10 minutes and 1 day after the end of the session, in respect of the kinematic gait and mobility.
Mental and physical practiceOther
The experimental group underwent familiarization of gait phases using cards with gait phases, mental practice of gait and physical gait training.
Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases.
Then, they were submitted to a mental training of gait. They imagined the gait steps per 400 repetitions. While imagining, they verbalized the gait phases.
Finally, they were submitted to a physical gait training. They executed 400 steps.
They underwent a single training session during 1 hour and 30 minutes and were reassessed 10 minutes and 1 day after the end of the session, in respect of the kinematic gait and mobility.
| Study group | Role | What they receive |
|---|---|---|
| Physical practice | Active comparator | Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases.
Physical practice: is the execution of the motor action. Receives: Other: Physical practice |
| Mental and physical practice | Experimental | Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases.
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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Step length at 10 minutes and 1 day
Measured: Three observetions were done. At baseline, 10 minutes and 1 day after intervention.
Secondary outcomes (1)
Change from Baseline in Double Limb Support Time at 10 minutes and 1 day
Double Limb Support Time is the period when both feet are on the ground at the same time. The first period of double limb support begins at initial contact, and lasts, in healthy people, 10 to 12 percent of the cycle. The second period of double limb support occurs in the final 10 to 12 percent of stance phase. As the stance limb prepares to leave the ground, the opposite limb contacts the ground and accepts the body's weight. The two periods of double limb support account for 20 to 24 percent of the gait cycle's total duration. In people with Parkinson disease, this period lasts longer.
Measured: Three observetions were done. At baseline, 10 minutes and 1 day after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startDec 2012
- Primary completionSep 2013
- Study completionSep 2013
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.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
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
- Investigators
- Lorenna M. de Melo Santiago, Master, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118506
- Sponsor's protocol ID
- CEP/UFRN 275.155
- Status last verified
- Apr 2014
- First submitted
- 20 Jan 2014
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Mental Practice in Gait of Individuals With Parkinson Disease: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02118506
- Acronym / sponsor ID
- CEP/UFRN 275.155
- Conditions
- Parkinson Disease
- Keywords
- Primary Parkinsonism., Rehabilitation., Biomechanics., Neurological gait disorders.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Apr 2014 (estimated)
- 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.
The purpose of this study is to compare the effects of mental practice, associated with physical practice, on gait (cinematic parameters and mobility) in individuals with idiopathic Parkinson's disease. It is believed that familiarity with the normal gait pattern, associated with mental practice and physical practice can trigger significant changes in spatiotemporal and angular parameters that are not observed in the group not submitted to mental practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical practice | Active comparator | Other: Physical practiceFamiliarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases. Physical practice: is the execution of the motor action. |
| Mental and physical practice | Experimental | Other: Mental and physical practiceFamiliarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases. 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. |
Who may qualify
- Ages
- 44 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the subjects should be in use of antiparkinsonian medication,
- be between stages 2 and 3 of the Hoehn and Yahr modified scale);
- walk without any brace or aid device, independently (scores between 3 and 5 of the Functional Ambulatory Category - FAC) for at least 10 meters
- were not undergoing stereotactic surgery.
Key exclusion criteria (1 listed)
- We excluded those who were unable or declined to complete 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 |
|---|---|---|
| Physical practiceThe control group underwent familiarization of gait phases using cards with gait phases and physical gait training. Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases. Then, they were submitted to a physical gait training. They underwent a single training session during 1 hour and 30 minutes and were reassessed 10 minutes and 1 day after the end of the session, in respect of the kinematic gait and mobility. | Other | Physical practice |
| Mental and physical practiceThe experimental group underwent familiarization of gait phases using cards with gait phases, mental practice of gait and physical gait training. Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases. Then, they were submitted to a mental training of gait. They imagined the gait steps per 400 repetitions. While imagining, they verbalized the gait phases. Finally, they were submitted to a physical gait training. They executed 400 steps. They underwent a single training session during 1 hour and 30 minutes and were reassessed 10 minutes and 1 day after the end of the session, in respect of the kinematic gait and mobility. | Other | Mental and physical practice |
Primary outcome
Change from Baseline in Step length at 10 minutes and 1 day
Time frame: Three observetions were done. At baseline, 10 minutes and 1 day after intervention.
1 secondary outcome
Change from Baseline in Double Limb Support Time at 10 minutes and 1 day
Time frame: Three observetions were done. At baseline, 10 minutes and 1 day after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
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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.
Lorenna M. de Melo Santiago, Master principal investigator
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical practice and Mental and physical practice in people with Parkinson Disease, 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 21 Apr 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Step length at 10 minutes and 1 day (time frame: Three observetions were done. At baseline, 10 minutes and 1 day after intervention.). 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 21 Apr 2014.