Stroke SequelaeNCT05875116
Virtual Reality Versus Constraint-induced Movement on Hemiparesis in Cerebrovascular Event
A study testing Virtual reality, Modified constraint-induced movement therapy and Usual Physical and Occupational Therapy in people with Stroke Sequelae, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
The objective of this clinical trial is to measure the effect of Rehabilitation with Virtual Reality or Modified Constraint-Induced Movement Therapy on hemiparesis in patients with Cerebral Vascular Event. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Stroke Sequelae
- What is being tested?
- Virtual reality, Modified constraint-induced movement therapy and Usual Physical and Occupational Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteMexico
- Study dates
- 17 Aug 2018to 21 Aug 2024
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients between 35 and 70 years of age and with a clinically and tomographically proven diagnosis of a cerebral vascular event in the territory of the middle cerebral artery.
- Patients with hemiparesis secondary to the cerebrovascular event
- Patients with a maximum Ashworth of 2 and Brunnstrom of minimum 4
- Patients with or without aphasia
- Patients with evolution between 1 to 3 months from hospital discharge of the cerebrovascular event
- Patients with cerebrovascular event of any sex
- Patients with vascular event without cognitive deficit
- Patients who agree to participate by signing an informed consent, by them or their family member or person in charge.
Who cannot join
- Patients who develop dementia or neurological-psychomotor complications during the study.
- Patients who present a new cerebrovascular event during the investigation
- Patients who do not complete at least 90% of the program
- Patients in whom a lack of family support or secondary gain is detected.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Mexicano del Seguro Social
Mexico City, 06720
Jaime Alfredo Castellanos Romero, 55 5684 1274, jaime.castellanos@imss.gob.mx
María del Carmen Mora Rojas, 55 5684 1274, carmen.morar@imss.gob.mx
About this study
Official title: Effect of Different Therapeutic Modalities With Virtual Reality or Modified Constraint-induced Movement Therapy Compared With Usual Physical and Occupational Therapy on Motor Recovery of Paretic Limbs in Patients With Cerebrovascular Event
The objective of this clinical trial is to measure the effect of Rehabilitation with Virtual Reality or Modified Constraint-Induced Movement Therapy on hemiparesis in patients with Cerebral Vascular Event.
The question to be answered is: What is the effect of different therapeutic modalities supported by Virtual Reality or Modified Constraint-Induced Movement Therapy compared with usual Physical and Occupational Therapy on motor recovery of paretic limbs in patients with Cerebrovascular Event?
Read more
The patients will carry out activities of:
- Virtual reality or
- Movement Restriction-Induction Therapy.
The investigators will compare the changes in the functionality of the paretic hemibody with a group undergoing regular physical and occupational therapy, as well as language and treatment-related satisfaction.
Read the detailed description
Patients with diagnosis of cerebrovascular event (CVE) will be recruited upon arrival at the Medical Unit in the first appointment area; The diagnosis will be verified and an appointment will be made to the office of one of the researchers -rehabilitation specialist- (evaluator 1). During the appointment the purpose of the study will be explained and doubts will be clarified. All participants, whether accept or not, will receive the consultation that is normally provided to these patients and the information will be recorded in the medical record. If the subject does not accept, after the consultation, the appropriate management for the condition will be prescribed and a subsequent appointment will be made with another corresponding doctor to continue with the control.
If the subject agrees to participate, a clinical summary will be prepared, which will include demographic data, employment situation, the need for temporary disability for work and clinical data for the research file. The signature of the informed consent letter will also be requested. This physician 1 will assign the therapeutic modality using a table of random numbers to: Group 1. Therapy supported by virtual reality; Group 2. Modified Constraint-Induced Movement Therapy; o Group 3. Usual physical and occupational therapy. The activities corresponding to each group will be carried out during 2 sessions a week, of 1 hour each session, for 6 weeks.
An appointment will be made to be assessed by the second rehabilitation specialist (evaluator 2), who will remain blind to the treatment, and will measure the functionality of the thoracic and pelvic limbs with the different scales (Fugl-Meyer, Motor Index and Fine Clamp Test), including muscle tone, trophism, arcs of mobility, functionality of the limbs, as well as of the hand, coordination, balance and sensory aspects. These scales will be applied before (initial assessment -A.I.-), during (intermediate assessment -Int.A.- week 3, session 6) and after (final assessment -F.A. - week 6, session 12) of the different rehabilitation programs. During the same times, the Boston Aphasia Intensity scale and the Intrinsic Motivation Inventory will be applied by a neuropsychologist blinded to the treatment, for the evaluation of language and satisfaction, respectively.
- Conditions
- Stroke Sequelae
- Being tested
- Virtual reality, Modified constraint-induced movement therapy, Usual Physical and Occupational Therapy
- Keywords
- Constraint-induced movement therapy, Hemiparesis, Neurorehabilitation, Satisfaction, Stroke, Virtual Reality
- Medical subject headings
- Paresis, Personal Satisfaction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityBehavioural
The activities will be carried out with the Virtual Reality team, for 1 hour, twice a week, for 12 sessions (6 weeks). It will be indicated to repeat the activities at home, on similar equipment and with the same or similar software, at least 1 hour a day, at least 3 days a week.
Modified constraint-induced movement therapyBehavioural
Physical and occupational therapy activities will be carried out with the paretic upper limb, while the patient has the healthy upper limb "attached to the chest", for 1 hour, twice a week, for 12 sessions (6 weeks). It will be indicated to repeat the activities at home, 1 hour a day, at least 3 days a week. In addition, the participant will perform activities of daily living with the "free" paretic arm and the "fixed" healthy arm, for 5 hours a day.
Usual Physical and Occupational TherapyBehavioural
The physical and occupational therapy activities that are usually practiced in the Medical Unit will be carried out for 1 hour, twice a week, for 12 sessions (6 weeks). It will be indicated to repeat the activities at home, for 1 hour a day, at least 3 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Group I: virtual reality activities | Experimental | The patient will practice the corresponding activities of the software indicated in the virtual reality equipment. Receives: Behavioral: Virtual reality |
| Group II: Modified Constraint-Induced Movement Therapy | Experimental | Patients will have the "healthy" upper limb fixed to the thorax with a sling and a horizontal shoulder immobilizer; The participants will practice physical and occupational therapy activities with the paretic upper limb. Receives: Behavioral: Modified constraint-induced movement therapy |
| Group III: Usual Physical and Occupational Therapy | Active comparator | The participants will practice physical and occupational therapy activities that are usually provided in the Medical Unit, without any restrictions on the upper extremities. Receives: Behavioral: Usual Physical and Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality and disability of the paretic hemibody due to evento vascular cerebral (CVE) to the 3 weeks of treatment.
The motor functionality and disability of the paretic hemibody will be evaluated with Fugl-Meyer scale, it comprises 5 dominions y 113 total items that are scored on a 3 point ordinal scale (0= cannot perform, 1=perform partially, 2= perform fully).
The individual scores are summed and the assessment can show a minimum value of 0 and a maximum value of 226 points, including 66 points for the upper extremity and 34 points for the lower extremity.
A higher score represents better functionality of the hemibody (less disability).
Measured: Fugl-Meyer scale will be administered at week 3 of follow-up (just after completing 6 rehabilitation sessions).
Functionality and disability of the paretic hemibody due to cerebro vascular event (CVE) to the 6 weeks of treatment.
The change in motor functionality and disability of the paretic hemibody will be evaluated with Fugl-Meyer scale, with 5 dominions y 113 total items that are scored on a 3 point ordinal scale (0= cannot perform, 1=perform partially, 2= perform fully).
The individual scores are summed and the assessment can show a minimum value of 0 and a maximum value of 226 points, including 66 points for the upper extremity and 34 points for the lower extremity.
Changes to higher score represents better functionality of the hemibody (less disability).
Measured: The Fugl-Meyer scale will be administered at week 6 of follow-up (just after completing the 12 rehabilitation sessions).
Independency of patient with hemiparesis secondary to cerebro vascular event (CVE) to the 3 weeks of treatment.
The motor functionality and independency of patient with paretic hemibody will be evaluated with motor index scale, it comprises 3 dominions and 5 items (two for upper limb, one to hand -grip-, and two to lower limb). In each domain can be obtained a minimum value of 0 and a maximum value of 33 points, and 1 point is added to the sum of all of them for the total qualification.
A higher qualification represents a better ability to carry out activities of daily human life (greater independency).
Measured: Motor Index scale will be administered at week 3 of follow-up (just after completing 6 therapy sessions).
Independency of patient with hemiparesis secondary to cerebro vascular event (CVE) to the 6 weeks of treatment.
The motor functionality and independency of patient with paretic hemibody will be evaluated with motor index scale, it comprises 3 dominions and 5 items (two for upper limb, one to hand -grip-, and two to lower limb). In each domain can be obtained a minimum value of 0 and a maximum value of 33 points, and 1 point is added to the sum of all of them for the total qualification.
Changes to higher qualification represents a better ability to carry out activities of daily human life (greater independency).
Measured: The Motor Index scale will be administered at week 6 of follow-up (just after completing the 12 therapy sessions).
Realization of the fine clamp of the plegia hand due to cerebro vascular event (CVE) to the 3 weeks of treatment.
The realization of grip of the plegia hand will be evaluated with the fine clamp test, it comprises three action for cubes take of size different (score: 0- inability to take the cube, 1- Grab with your whole hand, 2- Radial clamp or 3 finger clamp and 3- Forefinger thumb clamp). The total qualification has a minimum value of 0 and a maximum value of 9 points.
A higher score represents a better performance of the clamp between the index finger and thumb of the paralyzed hand.
Measured: Fine clamp test will be administered at week 3 of follow-up (just after completing 6 therapy sessions).
Realization of fine clamp of the plegia hand due to cerebro vascular event (CVE) to the 6 weeks of treatment.
The realization of grip of the plegia hand will be evaluated with the fine clamp test, it comprises three action for cubes take of size different (score: 0- inability to take the cube, 1- Grab with your whole hand, 2- Radial clamp or 3 finger clamp, and 3- Forefinger thumb clamp). The total qualification has a minimum value of 0 and a maximum value of 9 points.
A higher score represents a better performance of the clamp between the index finger and thumb of the paralyzed hand.
Measured: Fine clamp test will be administered at week 6 of follow-up (just after completing 12 therapy sessions).
Secondary outcomes (4)
Level of aphasy to the 3 weeks of treatment.
The quality of language will be evaluated with the Boston Aphasia Intensity scale in patients after cerebro vascular event (CVE).
In the Boston Aphasia Intensity scale the result has a minimum value of 0 and a maximum value of 5 points.
A higher score represents a better language quality (less aphasy).
Measured: Boston Aphasia Intensity scale will be administered at week 3 of follow-up (just after completing 6 rehabilitation sessions).
Level of aphasy to the 6 weeks of treatment.
The quality of language will be evaluated with the Boston Aphasia Intensity scale in patients after cerebro vascular event (CVE).
In the Boston Aphasia Intensity scale the result has a minimum value of 0 and a maximum value of 5 points.
A higher score represents a better language quality (less aphasy).
Measured: Boston Aphasia Intensity scale will be administered at week 6 of follow-up (just after completing 12rehabilitation sessions).
Level of patient satisfaction with treatment to the 3 weeks of treatment.
The satisfaction reported by the patient with the treatment received will be evaluated, with the Intrinsic Motivation inventory.
In the Intrinsic Motivation inventory the result has a minimum value of 22 and a maximum value of 154 points. Score: from 1 (no satisfaction) to 7 (maximum satisfaction).
A higher score represents a best level of satisfaction
Measured: Intrinsic Motivation inventory will be administered at week 3 of follow-up (just after completing 6 rehabilitation sessions).
Level of patient satisfaction with treatment to the 6 weeks of treatment.
The satisfaction reported by the patient with the treatment received will be evaluated, with the Intrinsic Motivation inventory.
In the Intrinsic Motivation inventory the result has a minimum value of 22 and a maximum value of 154 points. Score: from 1 (no satisfaction) to 7 (maximum satisfaction).
A higher score represents a best level of satisfaction
Measured: Intrinsic Motivation inventory will be administered at week 6 of follow-up (just after completing 12 rehabilitation sessions).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start17 Aug 2018
- Primary completion21 Aug 2024
- Study completion21 Aug 2024 (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
- Model description
- Clinical Trial Randomized Single Blind
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, María del Carmen Rojas-Sosa, Coordinación de Investigación en Salud, Mexico
- Investigators
- María del Carmen Rojas-Sosa, Doctorado, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875116
- Sponsor's protocol ID
- R 2016 3702 44
- Status last verified
- Aug 2024
- First submitted
- 3 May 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Therapeutic Modalities With Virtual Reality or Modified Constraint-induced Movement Therapy Compared With Usual Physical and Occupational Therapy on Motor Recovery of Paretic Limbs in Patients With Cerebrovascular Event
- ClinicalTrials.gov ID
- NCT05875116
- Acronym / sponsor ID
- R 2016 3702 44
- Conditions
- Stroke Sequelae
- Keywords
- Constraint-induced movement therapy, Hemiparesis, Neurorehabilitation, Satisfaction, Stroke, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 21 Aug 2024 (estimated)
- First posted
- 25 May 2023 (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.
The objective of this clinical trial is to measure the effect of Rehabilitation with Virtual Reality or Modified Constraint-Induced Movement Therapy on hemiparesis in patients with Cerebral Vascular Event.
The question to be answered is: What is the effect of different therapeutic modalities supported by Virtual Reality or Modified Constraint-Induced Movement Therapy compared with usual Physical and Occupational Therapy on motor recovery of paretic limbs in patients with Cerebrovascular Event?
The patients will carry out activities of:
- Virtual reality or
- Movement Restriction-Induction Therapy.
The investigators will compare the changes in the functionality of the paretic hemibody with a group undergoing regular physical and occupational therapy, as well as language and treatment-related satisfaction.
Detailed description
Patients with diagnosis of cerebrovascular event (CVE) will be recruited upon arrival at the Medical Unit in the first appointment area; The diagnosis will be verified and an appointment will be made to the office of one of the researchers -rehabilitation specialist- (evaluator 1). During the appointment the purpose of the study will be explained and doubts will be clarified. All participants, whether accept or not, will receive the consultation that is normally provided to these patients and the information will be recorded in the medical record. If the subject does not accept, after the consultation, the appropriate management for the condition will be prescribed and a subsequent appointment will be made with another corresponding doctor to continue with the control.
If the subject agrees to participate, a clinical summary will be prepared, which will include demographic data, employment situation, the need for temporary disability for work and clinical data for the research file. The signature of the informed consent letter will also be requested. This physician 1 will assign the therapeutic modality using a table of random numbers to: Group 1. Therapy supported by virtual reality; Group 2. Modified Constraint-Induced Movement Therapy; o Group 3. Usual physical and occupational therapy. The activities corresponding to each group will be carried out during 2 sessions a week, of 1 hour each session, for 6 weeks.
An appointment will be made to be assessed by the second rehabilitation specialist (evaluator 2), who will remain blind to the treatment, and will measure the functionality of the thoracic and pelvic limbs with the different scales (Fugl-Meyer, Motor Index and Fine Clamp Test), including muscle tone, trophism, arcs of mobility, functionality of the limbs, as well as of the hand, coordination, balance and sensory aspects. These scales will be applied before (initial assessment -A.I.-), during (intermediate assessment -Int.A.- week 3, session 6) and after (final assessment -F.A. - week 6, session 12) of the different rehabilitation programs. During the same times, the Boston Aphasia Intensity scale and the Intrinsic Motivation Inventory will be applied by a neuropsychologist blinded to the treatment, for the evaluation of language and satisfaction, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Clinical Trial Randomized Single Blind
| Arm | Type | Receives |
|---|---|---|
| Group I: virtual reality activities | Experimental | Behavioral: Virtual realityThe patient will practice the corresponding activities of the software indicated in the virtual reality equipment. |
| Group II: Modified Constraint-Induced Movement Therapy | Experimental | Behavioral: Modified constraint-induced movement therapyPatients will have the "healthy" upper limb fixed to the thorax with a sling and a horizontal shoulder immobilizer; The participants will practice physical and occupational therapy activities with the paretic upper limb. |
| Group III: Usual Physical and Occupational Therapy | Active comparator | Behavioral: Usual Physical and Occupational TherapyThe participants will practice physical and occupational therapy activities that are usually provided in the Medical Unit, without any restrictions on the upper extremities. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult patients between 35 and 70 years of age and with a clinically and tomographically proven diagnosis of a cerebral vascular event in the territory of the middle cerebral artery.
- Patients with hemiparesis secondary to the cerebrovascular event
- Patients with a maximum Ashworth of 2 and Brunnstrom of minimum 4
- Patients with or without aphasia
- Patients with evolution between 1 to 3 months from hospital discharge of the cerebrovascular event
Key exclusion criteria (4 listed)
- Patients who develop dementia or neurological-psychomotor complications during the study.
- Patients who present a new cerebrovascular event during the investigation
- Patients who do not complete at least 90% of the program
- Patients in whom a lack of family support or secondary gain is detected.
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 |
|---|---|---|
| Virtual realityThe activities will be carried out with the Virtual Reality team, for 1 hour, twice a week, for 12 sessions (6 weeks). It will be indicated to repeat the activities at home, on similar equipment and with the same or similar software, at least 1 hour a day, at least 3 days a week. | Behavioural | Group I: virtual reality activities |
| Modified constraint-induced movement therapyPhysical and occupational therapy activities will be carried out with the paretic upper limb, while the patient has the healthy upper limb "attached to the chest", for 1 hour, twice a week, for 12 sessions (6 weeks). It will be indicated to repeat the activities at home, 1 hour a day, at least 3 days a week. In addition, the participant will perform activities of daily living with the "free" paretic arm and the "fixed" healthy arm, for 5 hours a day. | Behavioural | Group II: Modified Constraint-Induced Movement Therapy |
| Usual Physical and Occupational TherapyThe physical and occupational therapy activities that are usually practiced in the Medical Unit will be carried out for 1 hour, twice a week, for 12 sessions (6 weeks). It will be indicated to repeat the activities at home, for 1 hour a day, at least 3 days a week. | Behavioural | Group III: Usual Physical and Occupational Therapy |
Primary outcome
Functionality and disability of the paretic hemibody due to evento vascular cerebral (CVE) to the 3 weeks of treatment.
Time frame: Fugl-Meyer scale will be administered at week 3 of follow-up (just after completing 6 rehabilitation sessions).
The motor functionality and disability of the paretic hemibody will be evaluated with Fugl-Meyer scale, it comprises 5 dominions y 113 total items that are scored on a 3 point ordinal scale (0= cannot perform, 1=perform partially, 2= perform fully). The individual scores are summed and the assessment can show a minimum value of 0 and a maximum value of 226 points, including 66 points for the upper extremity and 34 points for the lower extremity. A higher score represents better functionality of the hemibody (less disability).
Functionality and disability of the paretic hemibody due to cerebro vascular event (CVE) to the 6 weeks of treatment.
Time frame: The Fugl-Meyer scale will be administered at week 6 of follow-up (just after completing the 12 rehabilitation sessions).
The change in motor functionality and disability of the paretic hemibody will be evaluated with Fugl-Meyer scale, with 5 dominions y 113 total items that are scored on a 3 point ordinal scale (0= cannot perform, 1=perform partially, 2= perform fully). The individual scores are summed and the assessment can show a minimum value of 0 and a maximum value of 226 points, including 66 points for the upper extremity and 34 points for the lower extremity. Changes to higher score represents better functionality of the hemibody (less disability).
Independency of patient with hemiparesis secondary to cerebro vascular event (CVE) to the 3 weeks of treatment.
Time frame: Motor Index scale will be administered at week 3 of follow-up (just after completing 6 therapy sessions).
The motor functionality and independency of patient with paretic hemibody will be evaluated with motor index scale, it comprises 3 dominions and 5 items (two for upper limb, one to hand -grip-, and two to lower limb). In each domain can be obtained a minimum value of 0 and a maximum value of 33 points, and 1 point is added to the sum of all of them for the total qualification. A higher qualification represents a better ability to carry out activities of daily human life (greater independency).
Independency of patient with hemiparesis secondary to cerebro vascular event (CVE) to the 6 weeks of treatment.
Time frame: The Motor Index scale will be administered at week 6 of follow-up (just after completing the 12 therapy sessions).
The motor functionality and independency of patient with paretic hemibody will be evaluated with motor index scale, it comprises 3 dominions and 5 items (two for upper limb, one to hand -grip-, and two to lower limb). In each domain can be obtained a minimum value of 0 and a maximum value of 33 points, and 1 point is added to the sum of all of them for the total qualification. Changes to higher qualification represents a better ability to carry out activities of daily human life (greater independency).
Realization of the fine clamp of the plegia hand due to cerebro vascular event (CVE) to the 3 weeks of treatment.
Time frame: Fine clamp test will be administered at week 3 of follow-up (just after completing 6 therapy sessions).
The realization of grip of the plegia hand will be evaluated with the fine clamp test, it comprises three action for cubes take of size different (score: 0- inability to take the cube, 1- Grab with your whole hand, 2- Radial clamp or 3 finger clamp and 3- Forefinger thumb clamp). The total qualification has a minimum value of 0 and a maximum value of 9 points. A higher score represents a better performance of the clamp between the index finger and thumb of the paralyzed hand.
Realization of fine clamp of the plegia hand due to cerebro vascular event (CVE) to the 6 weeks of treatment.
Time frame: Fine clamp test will be administered at week 6 of follow-up (just after completing 12 therapy sessions).
The realization of grip of the plegia hand will be evaluated with the fine clamp test, it comprises three action for cubes take of size different (score: 0- inability to take the cube, 1- Grab with your whole hand, 2- Radial clamp or 3 finger clamp, and 3- Forefinger thumb clamp). The total qualification has a minimum value of 0 and a maximum value of 9 points. A higher score represents a better performance of the clamp between the index finger and thumb of the paralyzed hand.
4 secondary outcomes
Level of aphasy to the 3 weeks of treatment.
Time frame: Boston Aphasia Intensity scale will be administered at week 3 of follow-up (just after completing 6 rehabilitation sessions).
Level of aphasy to the 6 weeks of treatment.
Time frame: Boston Aphasia Intensity scale will be administered at week 6 of follow-up (just after completing 12rehabilitation sessions).
Level of patient satisfaction with treatment to the 3 weeks of treatment.
Time frame: Intrinsic Motivation inventory will be administered at week 3 of follow-up (just after completing 6 rehabilitation sessions).
Level of patient satisfaction with treatment to the 6 weeks of treatment.
Time frame: Intrinsic Motivation inventory will be administered at week 6 of follow-up (just after completing 12 rehabilitation sessions).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- 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.
María del Carmen Rojas-Sosa, Doctorado principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality, Modified constraint-induced movement therapy and Usual Physical and Occupational Therapy in people with Stroke Sequelae, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 8 inclusion and 4 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 23 Aug 2024. 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 Mexico. 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?
Contact Juan Garduño-Espinosa, Doctorado (55 5228 9917 ext. 4314, juan.gardunoe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionality and disability of the paretic hemibody due to evento vascular cerebral (CVE) to the 3 weeks of treatment. (time frame: Fugl-Meyer scale will be administered at week 3 of follow-up (just after completing 6 rehabilitation sessions).). The study lists 6 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 23 Aug 2024.