An Algorithm for Prognosis of Upper Limb Paresis in Patients With Subacute Stroke

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).

Study Overview

• Status: Completed
• Conditions: Stroke; Physical Activity; Upper Limb Hypertonia
• Intervention / Treatment: Other: rehabilitation

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 Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• Denmark
  • Hammel, Denmark, 8470
    • Camilla Lundquist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with stroke in a rehabilitation setting

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm test	Upper limb function test	dec 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Motor and sensory assesment	Upper limb function test	Dec 2019
Accellerometry	accellerometer	dec 2019

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Study Chair: Iris Brunner, phd, Iris.Brunner@rm.dk

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2018
• Primary Completion (ACTUAL): October 1, 2019
• Study Completion (ACTUAL): March 15, 2020

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (ACTUAL): August 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: 63518

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No