StrokeNCT03632499
An Algorithm for Prognosis of Upper Limb Paresis in Patients With Subacute Stroke
An observational study of Stroke and Upper Limb Hypertonia, run by University of Aarhus at 1 site in Denmark.
Trial summary
Aim study 1:Assess the accuracy of PREP2 when applied in a subacute rehabilitation setting. Aim study 2: Prediction of real life UL use. Method: A prospective cohort study. Main outcome measure study 1: Action Research Arm Test (ARAT), measuring UL motor function. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Stroke, Upper Limb Hypertonia, Physical Activity
- What is being tested?
- rehabilitation
- How many people
- 103 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jun 2018to 15 Mar 2020
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stroke in a rehabilitation setting
Who may be able to join
- First or recurrent ischemic or hemorrhagic stroke (diagnosis verified by CT or MR scan)
- New upper limp impairment; Less than 15 days post stroke
- ≥ 18 years
- Able to follow simple commands and cooperate with examinations
Who cannot join
- Subarachnoid hemorrhages
- UL motor residuals from former stroke
- Severe illness with life expectancy < 6 months
- Place of residence more than 1½ hours drive away and not reachable for follow up assessments
- Patients with contraindications for TMS are excluded from the TMS part of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: From Research to Clinical Practice. Applying an Algorithm for Prognosis of Upper Limb Paresis in Patients With Subacute Stroke
Aim study 1:Assess the accuracy of PREP2 when applied in a subacute rehabilitation setting.
Aim study 2: Prediction of real life UL use. Method: A prospective cohort study. Main outcome measure study 1: Action Research Arm Test (ARAT), measuring UL motor function.
Main outcome study 2: use ratio between affected and unaffected UL measured by accellerometer.
Secondary outcome measure: Fugl-Meyer Motor Assessment for UL (FM).
Read the detailed description
Background Accurate prediction of recovery of UL function after stroke can lead to targeted rehabilitation. The Predict Recovery Potential (PREP2) algorithm combines individual prediction of UL function with recommendations for treatment. The PREP2 algorithm is based on clinical assessment of UL paresis combined with transcranial magnetic stimulation (TMS) to examine corticospinal tract integrity. For this PhD project the PREP2 is modified to be applicable in a rehabilitation setting and the initial assessment of PREP2, the SAFE score, is carried out at day 14.
Study 1 Aim: Assess the accuracy of PREP2 when applied in a subacute rehabilitation setting.
Hypothesis: PREP2 applied at day 14 post stroke accurately predicts UL function 3 months after stroke for a minimum of 75 % of the patients.
Method: A prospective cohort study. Setting and population: The study will take place at Hammel Neurorehabilitation Centre and University Research Clinic. Ninety patients will be included.
Inclusion criteria: First or recurrent ischemic or hemorrhagic stroke (diagnosis verified by CT or MR scan); New upper limp impairment; Less than 15 days post stroke; ≥ 18 years; Able to follow simple commands and cooperate with examinations Main outcome measure: Action Research Arm Test (ARAT), measuring UL motor function.
Secondary outcome measure: Fugl-Meyer Motor and sensory Assessment for UL. Functional Independence Measure (FIM).
Examined at baseline: Pain wil be assessed with a verbal rating scale. Inferior subluxation in the glenohumoral joint. Neglect will be assessed with star cancellation test and line bisection test
Study 2 Prediction of real life UL use Hypothesis: PREP2 can be used to predict real life UL use 3 months post stroke. Patients: The entire cohort from study 1 will be included. Real life use will be assessed with accelerometers at 3 months follow up.
Main outcome: is the use ratio between affected and unaffected UL.
- Conditions
- Stroke, Upper Limb Hypertonia, Physical Activity
- Being tested
- rehabilitation
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitationOther
rehabilitation
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm test
Upper limb function test
Measured: dec 2019
Secondary outcomes (2)
Fugl Meyer Motor and sensory assesment
Upper limb function test
Measured: Dec 2019
Accellerometry
accellerometer
Measured: dec 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start15 Jun 2018
- Primary completion1 Oct 2019
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Iris Brunner, phd, Study chair, Iris.Brunner@rm.dk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632499
- Sponsor's protocol ID
- 63518
- Status last verified
- Mar 2018
- First submitted
- 13 Aug 2018
- Last updated
- 4 Mar 2021
- 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 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Research to Clinical Practice. Applying an Algorithm for Prognosis of Upper Limb Paresis in Patients With Subacute Stroke
- ClinicalTrials.gov ID
- NCT03632499
- Acronym / sponsor ID
- 63518
- Conditions
- Stroke, Upper Limb Hypertonia, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 15 Aug 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.
Aim study 1:Assess the accuracy of PREP2 when applied in a subacute rehabilitation setting.
Aim study 2: Prediction of real life UL use. Method: A prospective cohort study. Main outcome measure study 1: Action Research Arm Test (ARAT), measuring UL motor function.
Main outcome study 2: use ratio between affected and unaffected UL measured by accellerometer.
Secondary outcome measure: Fugl-Meyer Motor Assessment for UL (FM).
Detailed description
Background Accurate prediction of recovery of UL function after stroke can lead to targeted rehabilitation. The Predict Recovery Potential (PREP2) algorithm combines individual prediction of UL function with recommendations for treatment. The PREP2 algorithm is based on clinical assessment of UL paresis combined with transcranial magnetic stimulation (TMS) to examine corticospinal tract integrity. For this PhD project the PREP2 is modified to be applicable in a rehabilitation setting and the initial assessment of PREP2, the SAFE score, is carried out at day 14.
Study 1 Aim: Assess the accuracy of PREP2 when applied in a subacute rehabilitation setting.
Hypothesis: PREP2 applied at day 14 post stroke accurately predicts UL function 3 months after stroke for a minimum of 75 % of the patients.
Method: A prospective cohort study. Setting and population: The study will take place at Hammel Neurorehabilitation Centre and University Research Clinic. Ninety patients will be included.
Inclusion criteria: First or recurrent ischemic or hemorrhagic stroke (diagnosis verified by CT or MR scan); New upper limp impairment; Less than 15 days post stroke; ≥ 18 years; Able to follow simple commands and cooperate with examinations Main outcome measure: Action Research Arm Test (ARAT), measuring UL motor function.
Secondary outcome measure: Fugl-Meyer Motor and sensory Assessment for UL. Functional Independence Measure (FIM).
Examined at baseline: Pain wil be assessed with a verbal rating scale. Inferior subluxation in the glenohumoral joint. Neglect will be assessed with star cancellation test and line bisection test
Study 2 Prediction of real life UL use Hypothesis: PREP2 can be used to predict real life UL use 3 months post stroke. Patients: The entire cohort from study 1 will be included. Real life use will be assessed with accelerometers at 3 months follow up.
Main outcome: is the use ratio between affected and unaffected UL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke in a rehabilitation setting
Key inclusion criteria (4 listed)
- First or recurrent ischemic or hemorrhagic stroke (diagnosis verified by CT or MR scan)
- New upper limp impairment; Less than 15 days post stroke
- ≥ 18 years
- Able to follow simple commands and cooperate with examinations
Key exclusion criteria (5 listed)
- Subarachnoid hemorrhages
- UL motor residuals from former stroke
- Severe illness with life expectancy < 6 months
- Place of residence more than 1½ hours drive away and not reachable for follow up assessments
- Patients with contraindications for TMS are excluded from the TMS part of the study.
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 |
|---|---|---|
| rehabilitationrehabilitation | Other | – |
Primary outcome
Action Research Arm test
Time frame: dec 2019
Upper limb function test
2 secondary outcomes
Fugl Meyer Motor and sensory assesment
Time frame: Dec 2019
Accellerometry
Time frame: dec 2019
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 4 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Iris Brunner, phd study chair
Iris.Brunner@rm.dk
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 Stroke and Upper Limb Hypertonia, run by University of Aarhus at 1 site in Denmark.
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 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: finished, as of the sponsor's last update on 4 Mar 2021. 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 Denmark. 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?
Action Research Arm test (time frame: dec 2019). 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 4 Mar 2021.