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Completed

NCT Number: NCT03632499

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).

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Camilla Lundquist

Hammel, 8470, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • 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.

Treatment and study plan

rehabilitation

Other

rehabilitation

Primary outcomes

  1. Action Research Arm test

    Time frame: dec 2019

    Upper limb function test

Secondary outcomes

  1. Fugl Meyer Motor and sensory assesment

    Time frame: Dec 2019

    Upper limb function test

  2. Accellerometry

    Time frame: dec 2019

    accellerometer

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

From Research to Clinical Practice. Applying an Algorithm for Prognosis of Upper Limb Paresis in Patients With Subacute Stroke

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 15, 2018
Registry last updated
Mar 4, 2021

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.

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