NCT04337411

Brief Summary

The aim of this study is to explore time-related trajectories of muscle alterations and inflammation in acute hospitalized stroke patients. Furthermore, the researchers want to gain insight in the predictive values of these time-related trajectories towards gait recovery in the acute stroke population.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 19, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

October 6, 2021

Status Verified

October 1, 2021

Enrollment Period

4.6 years

First QC Date

March 20, 2020

Last Update Submit

October 5, 2021

Conditions

Stroke

Keywords

StrokeAcuteSubacuteMuscleInflammationGaitSarcopenia

Outcome Measures

Primary Outcomes (2)

  • Functional Ambulation Categories

    The Functional Ambulation Categories (FAC) will be used to measure walking ability in patients assigned to cohort 1. The score ranges from 0-5, with a higher score reflecting towards a more independent walking ability.

    Change over time between baseline (≤ 3 days post-stroke), discharge (anticipated average of 10 days post-stroke) and 3 months follow-up

  • 6-minutes walking test

    The 6-minutes walking test (6MWT) will evaluate the walking endurance of the subjects in cohort 2. During this test we will measure the distance walked over a span of 6 minutes.

    Change over time between baseline (≤ 3 days post-stroke), discharge (anticipated average of 10 days post-stroke) and 3 months follow-up

Secondary Outcomes (12)

  • Rivermead Mobility Index

    Baseline (≤ 3 days post-stroke), discharge (anticipated average 10 days post-stroke), 3 months

  • Gait speed

    Baseline (≤ 3 days post-stroke), discharge (anticipated average 10 days post-stroke), 3 months

  • Oxygen cost

    Baseline (≤ 3 days post-stroke), discharge (anticipated average 10 days post-stroke), 3 months

  • Muscle strength

    Baseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 months

  • Grip strength

    Baseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 months

  • +7 more secondary outcomes

Study Arms (2)

Cohort 1

Non-ambulatory acute stroke survivors at admission (Functional Ambulation Categories (FAC) ≤ 2)

Other: Follow-up assessments

Cohort 2

Ambulatory acute stroke survivors at admission (Functional Ambulation Categories (FAC) ≥ 3)

Other: Follow-up assessments

Interventions

Follow-up assessmentsOTHER

Longitudinal evaluation of recovery

Cohort 1Cohort 2

Eligibility Criteria

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

Acute stroke survivors

You may qualify if:

  • Adults (≥18 years)
  • Hospitalized at the Neurology ward of UZ Brussel
  • Diagnosed with first-ever stroke (as defined by the World Health Organisation)
  • Able to provide written or verbal informed consent

You may not qualify if:

  • Other neurological or orthopaedic problems leading to impaired gait
  • Severe deficits of communication, memory or understanding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

StrokeInflammationSarcopenia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Officials

  • David Beckwée, Prof. Ph.D

    Vrije Universiteit Brussel

    STUDY CHAIR

  • Eva Swinnen, Prof. Ph.D

    Vrije Universiteit Brussel

    STUDY CHAIR

  • Lotte Cuypers, Dra.

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lotte Cuypers, Dra.

CONTACT

00324774505lotte.cuypers@vub.be

Eva Swinnen, Prof. Ph.D

CONTACT

003224774529eva.swinnen@vub.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Researcher

Study Record Dates

First Submitted

March 20, 2020

First Posted

April 7, 2020

Study Start

November 19, 2019

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

October 6, 2021

Record last verified: 2021-10

Locations

BE(1)