Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 45 of 580 for:    Recruiting, Not yet recruiting, Available Studies | Superior

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03632499
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief 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).


Condition or disease Intervention/treatment
Stroke Upper Limb Hypertonia Physical Activity 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation


Intervention Details:
  • Other: rehabilitation
    rehabilitation


Primary Outcome Measures :
  1. Action Research Arm test [ Time Frame: dec 2019 ]
    Upper limb function test


Secondary Outcome Measures :
  1. Fugl Meyer Motor and sensory assesment [ Time Frame: Dec 2019 ]
    Upper limb function test

  2. Accellerometry [ Time Frame: dec 2019 ]
    accellerometer



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stroke in a rehabilitation setting
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: camilla biering Lundquist, phd stud +45 78419541/ +45 30757516 camilla.lundquist@midt.rm.dk
Contact: Iris Brunner, phd Iris.Brunner@rm.dk

Locations
Layout table for location information
Denmark
Camilla Lundquist Recruiting
Hammel, Denmark, 8470
Contact: camilla Biering Lundquist, phd stud    +45 78419541/ +45 30527516    camilla.lundquist@midt.rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Layout table for investigator information
Study Chair: Iris Brunner, phd Iris.Brunner@rm.dk

Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03632499     History of Changes
Other Study ID Numbers: 63518
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms