An Algorithm for Prognosis of Upper Limb Paresis in Patients With Subacute Stroke
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|ClinicalTrials.gov Identifier: NCT03632499|
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : August 17, 2018
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).
|Condition or disease||Intervention/treatment|
|Stroke Upper Limb Hypertonia Physical Activity||Other: rehabilitation|
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 Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||From Research to Clinical Practice. Applying an Algorithm for Prognosis of Upper Limb Paresis in Patients With Subacute Stroke|
|Actual Study Start Date :||June 15, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
- Other: rehabilitation
- Action Research Arm test [ Time Frame: dec 2019 ]Upper limb function test
- Fugl Meyer Motor and sensory assesment [ Time Frame: Dec 2019 ]Upper limb function test
- Accellerometry [ Time Frame: dec 2019 ]accellerometer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03632499
|Contact: camilla biering Lundquist, phd stud||+45 78419541/ +45 email@example.com|
|Contact: Iris Brunner, phd||Iris.Brunner@rm.dk|
|Hammel, Denmark, 8470|
|Contact: camilla Biering Lundquist, phd stud +45 78419541/ +45 30527516 firstname.lastname@example.org|
|Study Chair:||Iris Brunner, phd||Iris.Brunner@rm.dk|