Camilla Lundquist
Hammel, 8470, Denmark
NCT Number: NCT03632499
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).
Looking for future studies?
Notify Me18 year–120 year
All sexes
Observational
Hammel, 8470, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
rehabilitation
Time frame: dec 2019
Upper limb function test
Time frame: Dec 2019
Upper limb function test
Time frame: dec 2019
accellerometer
University of Aarhus
Other
From Research to Clinical Practice. Applying an Algorithm for Prognosis of Upper Limb Paresis in Patients With Subacute Stroke
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03305731
Behavior, Behavior, Health
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT03588663
Behavior, Brain Diseases
Winchester, Hampshire, United Kingdom
View Trial DetailsNCT07276477
Behavior, Brain Diseases
Uşak, Turkey (Türkiye)
View Trial DetailsNCT06597929
Behavior, Brain Diseases
Barcelona, Catalonia, Spain
View Trial Details