Post Stroke SpasticityNCT03459066
Predictors Factors and Time of Onset of Spasticity and Their Relationship With the Functionality and Quality of Life.
An observational study of Post Stroke Spasticity, run by Universidad de La Frontera at 1 site in Chile.
Trial summary
Spasticity is part of the syndrome motor neuron following a Stroke. It is a clinical sign of great complexity that generates disability, limiting the function and altering the quality of life of the subjects, generating great impact on families and society. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Post Stroke Spasticity
- What is being tested?
- Institution-Group
- How many people
- 100 participants
- Where
- 1 siteChile
- Study dates
- 1 Oct 2018to 30 Oct 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It will be constituted by all the subjects with a medical diagnosis of stroke in the acute phase, attended during 2018 at the Dr. Hernán Henríquez Aravena Hospital and the Alemana Clinic.
Who may be able to join
- Have an age between 20 and 80 years, with no previous history of motor disability.
- Being hospitalized with a diagnosis of ischemic or hemorrhagic stroke in the acute period.
- Present a history with a single stroke event confirmed by Computerized Axial Tomography.
- Without severe cognitive commitment, that is, score greater than 14 on the MiniMental Abbreviated scale.
- Stable hemodynamically.
- Voluntarily accept participation in the study through the signing of informed consent, either personally or through a family member.
Who cannot join
- Present sensitive aphasia.
- Have a medical contraindication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Factors and Time of Onset of Spasticity in Post-stroke Patients and Their Relationship With the Functionality and Quality of Life.
Spasticity is part of the syndrome motor neuron following a Stroke. It is a clinical sign of great complexity that generates disability, limiting the function and altering the quality of life of the subjects, generating great impact on families and society.
Identify times and characteristics of appearance; as well as its predictive factors can support an early intervention, orienting and strengthening the work of the rehabilitation team.
Read more
Determine the times of establishment, location and factors that favor the development of spasticity in acute stage and how it influences the functionality, quality of life and emotional level of post-stroke patients in hospital facilities.
Through this proposal, it is proposed to generate a new line of research that allows the development of scientific evidence in the area of neurorehabilitation, specifically in the field of spasticity, through the identification of establishment times, affected structures and predominant patterns in the extremities; as well as determining factors that favor the development of spasticity and its impact on post-stroke functionality and quality of life.
This information will strengthen the rehabilitative process of these subjects and the actions of the rehabilitation team, supporting the identification of preventive measures and implementing effective interventions that allow achieving better motor and functional results, in search of an optimal recovery.
Read the detailed description
A correlational (non-experimental), longitudinal, prospective follow-up design will be used for descriptive and predictive purposes.
The sample will consist of 150 subjects who meet the inclusion criteria, sign the informed consent and who will be treated during the year 2018 at the Hospital and the Clinic.
The study will include three measurement times: Time 1, during the first 10 days of hospitalization (T1); Time 2, at 3 months after T1; and Time 3, at 12 months after T1.
At each time of measurement, the study variables will be evaluated by 4 professionals trained in the following instruments: the Ashworth Scale to assess spasticity; To measure global functionality, the Barthel Index will be applied and, to assess functionality of the upper extremity, the Action Research Arm scale will be used; The Quality of Life Scale for Stroke-38 will be used to assess quality of life and emotional level. In addition, in time 1 the sociodemographic and clinical characteristics of the sample will be evaluated through a clinical record prepared for this purpose.
- Conditions
- Post Stroke Spasticity
- Being tested
- Institution-Group
- Keywords
- Spasticity, Stroke, Predictors, Functionality, Quality of life
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Institution-GroupDiagnostic test
The study includes three measurement times:
- Time 1 (T1): corresponds to the first measurement, which will take place between the 3rd and 10th day of hospitalization.
- Time 2 (T2): corresponds to the second measurement, which will be carried out 3 months after the first measurement.
- Time 3 (T3): corresponds to the third measurement, which will be carried out 12 months after the first measurement.
The evaluations will be tone, functionality and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Institution-Group 8 district | Group of patients belonging to institutions of district 8. Patients will be evaluated in 3 different times with different assessment instruments for tone, functionality and quality of life. Receives: Diagnostic Test: Institution-Group | |
| Institution-Group 9 district | Group of patients belonging to institutions of district 9. Patients will be evaluated in 3 different times with different assessment instruments for tone, functionality and quality of life. Receives: Diagnostic Test: Institution-Group | |
| Institution-Group 10 district | Group of patients belonging to institutions of district 10. Patients will be evaluated in 3 different times with different assessment instruments for tone, functionality and quality of life. Receives: Diagnostic Test: Institution-Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ashworth Scale
Instrument used in the assessment of spasticity. Graduates the tone from 0 (no increase in tone) to 4 (rigid extremity in flexion or extension), it is based on the examiner manually moving a limb of the patient, in the whole of the possible joint range (in the clinical setting it is use 1 second to perform the complete joint travel) and perceive the resistance that a muscle offers when stretched.
Measured: 6 months
Action Research Arm
This Instrument was constructed to determine the functional recovery of the upper limb. It is composed of 19 items grouped in 4 subtest, including each subtest: 6 items of grip, 4 items taken, 6 items of clip, 3 items of thick movement. All the items are evaluated with a scale of 4 points from 0 to 3, where 0 represents no movement and 3 normal movement for the task.
Measured: 6 months
Barthel Index
Scale that assesses the level of patient independence with respect to performing Activity Daily Life. The values assigned to each activity depend on the time spent and help to carry it out.
The activities are valued differently, being able to assign 0, 5, 10 or 15 points. The global range can vary between 0, completely dependent, and 100 points, completely independent.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Oct 2018
- Primary completion30 Mar 2019
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Stroke SpasticityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARLETTE PATRICIA DOUSSOULIN SANHUEZA, Universidad de La Frontera
- Investigators
- Arlette Doussoulin, PhD, Principal investigator, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459066
- Sponsor's protocol ID
- Spasticity Factors
- Status last verified
- Nov 2020
- First submitted
- 2 Mar 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not decided this item.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors and Time of Onset of Spasticity in Post-stroke Patients and Their Relationship With the Functionality and Quality of Life.
- ClinicalTrials.gov ID
- NCT03459066
- Acronym / sponsor ID
- Spasticity Factors
- Conditions
- Post Stroke Spasticity
- Keywords
- Spasticity, Stroke, Predictors, Functionality, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 8 Mar 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.
Spasticity is part of the syndrome motor neuron following a Stroke. It is a clinical sign of great complexity that generates disability, limiting the function and altering the quality of life of the subjects, generating great impact on families and society.
Identify times and characteristics of appearance; as well as its predictive factors can support an early intervention, orienting and strengthening the work of the rehabilitation team.
Determine the times of establishment, location and factors that favor the development of spasticity in acute stage and how it influences the functionality, quality of life and emotional level of post-stroke patients in hospital facilities.
Through this proposal, it is proposed to generate a new line of research that allows the development of scientific evidence in the area of neurorehabilitation, specifically in the field of spasticity, through the identification of establishment times, affected structures and predominant patterns in the extremities; as well as determining factors that favor the development of spasticity and its impact on post-stroke functionality and quality of life.
This information will strengthen the rehabilitative process of these subjects and the actions of the rehabilitation team, supporting the identification of preventive measures and implementing effective interventions that allow achieving better motor and functional results, in search of an optimal recovery.
Detailed description
A correlational (non-experimental), longitudinal, prospective follow-up design will be used for descriptive and predictive purposes.
The sample will consist of 150 subjects who meet the inclusion criteria, sign the informed consent and who will be treated during the year 2018 at the Hospital and the Clinic.
The study will include three measurement times: Time 1, during the first 10 days of hospitalization (T1); Time 2, at 3 months after T1; and Time 3, at 12 months after T1.
At each time of measurement, the study variables will be evaluated by 4 professionals trained in the following instruments: the Ashworth Scale to assess spasticity; To measure global functionality, the Barthel Index will be applied and, to assess functionality of the upper extremity, the Action Research Arm scale will be used; The Quality of Life Scale for Stroke-38 will be used to assess quality of life and emotional level. In addition, in time 1 the sociodemographic and clinical characteristics of the sample will be evaluated through a clinical record prepared for this purpose.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Institution-Group 8 district | – | Diagnostic Test: Institution-GroupGroup of patients belonging to institutions of district 8. Patients will be evaluated in 3 different times with different assessment instruments for tone, functionality and quality of life. |
| Institution-Group 9 district | – | Diagnostic Test: Institution-GroupGroup of patients belonging to institutions of district 9. Patients will be evaluated in 3 different times with different assessment instruments for tone, functionality and quality of life. |
| Institution-Group 10 district | – | Diagnostic Test: Institution-GroupGroup of patients belonging to institutions of district 10. Patients will be evaluated in 3 different times with different assessment instruments for tone, functionality and quality of life. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It will be constituted by all the subjects with a medical diagnosis of stroke in the acute phase, attended during 2018 at the Dr. Hernán Henríquez Aravena Hospital and the Alemana Clinic.
Key inclusion criteria (6 listed)
- Have an age between 20 and 80 years, with no previous history of motor disability.
- Being hospitalized with a diagnosis of ischemic or hemorrhagic stroke in the acute period.
- Present a history with a single stroke event confirmed by Computerized Axial Tomography.
- Without severe cognitive commitment, that is, score greater than 14 on the MiniMental Abbreviated scale.
- Stable hemodynamically.
Key exclusion criteria (2 listed)
- Present sensitive aphasia.
- Have a medical contraindication.
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 |
|---|---|---|
| Institution-GroupThe study includes three measurement times: * Time 1 (T1): corresponds to the first measurement, which will take place between the 3rd and 10th day of hospitalization. * Time 2 (T2): corresponds to the second measurement, which will be carried out 3 months after the first measurement. * Time 3 (T3): corresponds to the third measurement, which will be carried out 12 months after the first measurement. The evaluations will be tone, functionality and quality of life. | Diagnostic test | Institution-Group 10 district, Institution-Group 8 district, Institution-Group 9 district |
Primary outcome
Ashworth Scale
Time frame: 6 months
Instrument used in the assessment of spasticity. Graduates the tone from 0 (no increase in tone) to 4 (rigid extremity in flexion or extension), it is based on the examiner manually moving a limb of the patient, in the whole of the possible joint range (in the clinical setting it is use 1 second to perform the complete joint travel) and perceive the resistance that a muscle offers when stretched.
Action Research Arm
Time frame: 6 months
This Instrument was constructed to determine the functional recovery of the upper limb. It is composed of 19 items grouped in 4 subtest, including each subtest: 6 items of grip, 4 items taken, 6 items of clip, 3 items of thick movement. All the items are evaluated with a scale of 4 points from 0 to 3, where 0 represents no movement and 3 normal movement for the task.
Barthel Index
Time frame: 6 months
Scale that assesses the level of patient independence with respect to performing Activity Daily Life. The values assigned to each activity depend on the time spent and help to carry it out. The activities are valued differently, being able to assign 0, 5, 10 or 15 points. The global range can vary between 0, completely dependent, and 100 points, completely independent.
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 3 Nov 2020.
- Individual participant dataSharing planned: Undecided. We have not decided this item.
Related trials for Post Stroke Spasticity
Not yet recruitingEarly Phase 1
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Active, not recruiting
FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity
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RecruitingPhase 2
A Pilot Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants With Post-Stroke Spasticity (The STIPS Study)
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Recruiting
ESTIM-UL: FES for Upper Limb Recovery After Stroke
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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.
Arlette Doussoulin, PhD principal investigator
Universidad de La Frontera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Stroke Spasticity, run by Universidad de La Frontera at 1 site in Chile.
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 2 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 3 Nov 2020. 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 Chile. 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?
Ashworth Scale (time frame: 6 months). The study lists 3 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 3 Nov 2020.