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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03632499
• Other study ID #: 63518
• Status: Completed
• Start date: June 15, 2018
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Main outcome study 2: use ratio between affected and unaffected UL measured by accellerometer.

Secondary outcome measure: Fugl-Meyer Motor Assessment for UL (FM).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 15, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Paresis
• Physical Activity
• Stroke
• Upper Limb Hypertonia

Intervention

Other:
• rehabilitation
rehabilitation

Locations

Country	Name	City	State
Denmark	Camilla Lundquist	Hammel

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Arm test	Upper limb function test	dec 2019
Secondary	Fugl Meyer Motor and sensory assesment	Upper limb function test	Dec 2019
Secondary	Accellerometry	accellerometer	dec 2019