NCT03632499

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

August 13, 2018

Last Update Submit

March 3, 2021

Conditions

StrokeUpper Limb HypertoniaPhysical Activity

Outcome Measures

Primary Outcomes (1)

  • Action Research Arm test

    Upper limb function test

    dec 2019

Secondary Outcomes (2)

  • Fugl Meyer Motor and sensory assesment

    Dec 2019

  • Accellerometry

    dec 2019

Interventions

rehabilitationOTHER

rehabilitation

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stroke in a rehabilitation setting

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Camilla Lundquist

Hammel, 8470, Denmark

Location

MeSH Terms

Conditions

StrokeMotor Activity

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Iris Brunner, phd

    Iris.Brunner@rm.dk

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 15, 2018

Study Start

June 15, 2018

Primary Completion

October 1, 2019

Study Completion

March 15, 2020

Last Updated

March 4, 2021

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)