Stroke SequelaeNCT03251209
Mental Practice in Post-stroke Subjects
A study testing Physical practice, Mental practice and Videotherapy in people with Stroke Sequelae and Stroke, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
Among the limitations caused by cerebrovascular accident (CVA), the upper limb (MS) undergoes changes that limit the individual in his ability to maintain an active social life. Mental Practice (MP) consists of the internal reproduction of an event, which is repeated extensively in order to learn or improve an already… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Sequelae, Stroke
- What is being tested?
- Physical practice, Mental practice and Videotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Apr 2017to 1 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of stroke, ischemic or hemorrhagic, for more than 6 months, age above 18 years, unilateral involvement and are able to hold objects
Who cannot join
- Painful conditions that affect the ability to perform the proposed exercises, spasticity greater than 3 by the Ashworth Scale and cognitive deficits that will be evaluated by the Mini Mental State Examination (MMSE)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Health Science - Facisa/UFRN
Santa Cruz, Rio Grande do Norte, 59200000
About this study
Official title: Influence of Mental Practice on Manual Dexterity Associated Before and After Physical Practice in Patients With Stroke Sequelae
Among the limitations caused by cerebrovascular accident (CVA), the upper limb (MS) undergoes changes that limit the individual in his ability to maintain an active social life. Mental Practice (MP) consists of the internal reproduction of an event, which is repeated extensively in order to learn or improve an already known skill. The objective of the study is evaluate the effects of the physical practice associated with PM, on paretic MS. Subjects with unilateral stroke over 6 months, age> 18 years and who were able to hold objects will be selected. Subjects with painful conditions that affected exercise performance,> 3 spasticity by Ashworth, and cognitive deficit suggested by the Mini Mental State Examination will be excluded.
Read the detailed description
There are 3 study protocols. The MP protocol 1 comprise 4 steps: 1) 5 minutes of global relaxation; 2) Video therapy, being 2 minutes / task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles); 3) MP: think about the tasks assisted in the video for 5 minutes / task. 4) Physical Practice: reproduce through the motor execution, the activities assisted in the video (5 minutes / task). The MP protocol 2 was the same, changing the order: first physical practice and after MP. For the protocol 3 without PM, step 3 was suppressed, remaining the remaining steps. There were 15 sessions, 2x / week, for 1 hour. The Fugl-Meyer (FM) Scales, Ashworth Modified Scale (EMA), Functional Independence Measurement (MIF), Action Research Arm Test (ARAt), Box and block task (BBT) and Theory of mind battery (ToM) will be applied before and after the sessions, and in 3 months follow-up.
- Conditions
- Stroke Sequelae, Stroke
- Being tested
- Physical practice, Mental practice, Videotherapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical practiceOther
Physical Practice: reproduce through the motor execution (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles), the activities assisted in the video (5 minutes / task).
Mental practiceOther
Mental practice: think about the tasks watched in the videotherapy (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles) for 5 minutes / task.
VideotherapyOther
Videotherapy, being 2 minutes per task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Post-stroke participants receive the mental practice before the physical practice. The activities will be presented in a videotherapy way. Receives: Other: Physical practice; Other: Mental practice; Other: Videotherapy |
| Group 2 | Experimental | Post-stroke participants receive the mental practice after the physical practice. The activities will be presented in a videotherapy way. Receives: Other: Physical practice; Other: Mental practice; Other: Videotherapy |
| Group 3 | Active comparator | Post-stroke participants receive only physical practice. The activities will be presented in a videotherapy way. Receives: Other: Physical practice; Other: Videotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Scale
Sensory-motor impairment of upper limb
Measured: Change from baseline sensory-motor impairmente at 8 weeks and 3 months (follow-up).
surface electromyography
Short radial extensor of the carpus and superficial flexor of the fingers
Measured: change from baseline muscle activity at 8 weeks and 3 months (follow-up)
Functional independence measure (FIM)
assess the dependence of others for activities of daily living
Measured: change from baseline functional independence at 8 weeks and 3 months (follow-up)
Action Research Arm Test (ARAT)
functional test of upper limb
Measured: change from baseline dexterity at 8 weeks and 3 months (follow-up)
Box and Block test (BBT)
manual dexterity
Measured: change from baseline dexterity at 8 weeks and 3 months (follow-up)
Secondary outcomes (5)
Movement Imagery Questionnaire-Revised second version (MIQ-RS)
evaluate the ability to imagine thick movements related to the upper and include movements referring to the ADLs.
Measured: change from baseline ability to imagine at 8 weeks
Kinesthetic and Visual Imagery Questionnaire (KVIQ - 10)
assessing visual and kinesthetic motor imagery
Measured: change from baseline capacity of imagination at 8 weeks
Mini-mental State Examination
evaluation of cognition
Measured: baseline
Theory of Mind Task Battery (ToM)
evaluation of mental function
Measured: change from mental function baseline at 8 weeks
Modified ashworth scale (MAS)
evaluation of muscle tone of upper limb
Measured: change fom baseline muscle tone at 8 weeks and 3 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start20 Apr 2017
- Primary completion10 Jun 2017
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke SequelaeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta de Oliveira Cacho, Universidade Federal do Rio Grande do Norte
- Investigators
- Roberta O Cacho, PhD, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251209
- Sponsor's protocol ID
- 1.978.586/2017
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2017
- Last updated
- 16 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Mental Practice on Manual Dexterity Associated Before and After Physical Practice in Patients With Stroke Sequelae
- ClinicalTrials.gov ID
- NCT03251209
- Acronym / sponsor ID
- 1.978.586/2017
- Conditions
- Stroke Sequelae, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 10 Jun 2017 (actual)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 16 Aug 2017 (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.
Among the limitations caused by cerebrovascular accident (CVA), the upper limb (MS) undergoes changes that limit the individual in his ability to maintain an active social life. Mental Practice (MP) consists of the internal reproduction of an event, which is repeated extensively in order to learn or improve an already known skill. The objective of the study is evaluate the effects of the physical practice associated with PM, on paretic MS. Subjects with unilateral stroke over 6 months, age> 18 years and who were able to hold objects will be selected. Subjects with painful conditions that affected exercise performance,> 3 spasticity by Ashworth, and cognitive deficit suggested by the Mini Mental State Examination will be excluded.
Detailed description
There are 3 study protocols. The MP protocol 1 comprise 4 steps: 1) 5 minutes of global relaxation; 2) Video therapy, being 2 minutes / task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles); 3) MP: think about the tasks assisted in the video for 5 minutes / task. 4) Physical Practice: reproduce through the motor execution, the activities assisted in the video (5 minutes / task). The MP protocol 2 was the same, changing the order: first physical practice and after MP. For the protocol 3 without PM, step 3 was suppressed, remaining the remaining steps. There were 15 sessions, 2x / week, for 1 hour. The Fugl-Meyer (FM) Scales, Ashworth Modified Scale (EMA), Functional Independence Measurement (MIF), Action Research Arm Test (ARAt), Box and block task (BBT) and Theory of mind battery (ToM) will be applied before and after the sessions, and in 3 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Physical practice, Other: Mental practice, Other: VideotherapyPost-stroke participants receive the mental practice before the physical practice. The activities will be presented in a videotherapy way. |
| Group 2 | Experimental | Other: Physical practice, Other: Mental practice, Other: VideotherapyPost-stroke participants receive the mental practice after the physical practice. The activities will be presented in a videotherapy way. |
| Group 3 | Active comparator | Other: Physical practice, Other: VideotherapyPost-stroke participants receive only physical practice. The activities will be presented in a videotherapy way. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of stroke, ischemic or hemorrhagic, for more than 6 months, age above 18 years, unilateral involvement and are able to hold objects
Key exclusion criteria (1 listed)
- Painful conditions that affect the ability to perform the proposed exercises, spasticity greater than 3 by the Ashworth Scale and cognitive deficits that will be evaluated by the Mini Mental State Examination (MMSE)
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 practicePhysical Practice: reproduce through the motor execution (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles), the activities assisted in the video (5 minutes / task). | Other | Group 1, Group 2, Group 3 |
| Mental practiceMental practice: think about the tasks watched in the videotherapy (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles) for 5 minutes / task. | Other | Group 1, Group 2 |
| VideotherapyVideotherapy, being 2 minutes per task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles) | Other | Group 1, Group 2, Group 3 |
Primary outcome
Fugl-Meyer Scale
Time frame: Change from baseline sensory-motor impairmente at 8 weeks and 3 months (follow-up).
Sensory-motor impairment of upper limb
surface electromyography
Time frame: change from baseline muscle activity at 8 weeks and 3 months (follow-up)
Short radial extensor of the carpus and superficial flexor of the fingers
Functional independence measure (FIM)
Time frame: change from baseline functional independence at 8 weeks and 3 months (follow-up)
assess the dependence of others for activities of daily living
Action Research Arm Test (ARAT)
Time frame: change from baseline dexterity at 8 weeks and 3 months (follow-up)
functional test of upper limb
Box and Block test (BBT)
Time frame: change from baseline dexterity at 8 weeks and 3 months (follow-up)
manual dexterity
5 secondary outcomes
Movement Imagery Questionnaire-Revised second version (MIQ-RS)
Time frame: change from baseline ability to imagine at 8 weeks
Kinesthetic and Visual Imagery Questionnaire (KVIQ - 10)
Time frame: change from baseline capacity of imagination at 8 weeks
Mini-mental State Examination
Time frame: baseline
Theory of Mind Task Battery (ToM)
Time frame: change from mental function baseline at 8 weeks
Modified ashworth scale (MAS)
Time frame: change fom baseline muscle tone at 8 weeks and 3 months (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Roberta O Cacho, PhD 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, Mental practice and Videotherapy in people with Stroke Sequelae and Stroke, 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 1 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: status not confirmed, as of the sponsor's last update on 16 Aug 2017. 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?
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?
Fugl-Meyer Scale (time frame: Change from baseline sensory-motor impairmente at 8 weeks and 3 months (follow-up).). The study lists 5 primary outcomes in all. 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 16 Aug 2017; AzTrials last refreshed its copy on 27 Oct 2026.