NCT03731299

Brief Summary

The aim of this systematic review was to determine the number of muscle synergies and the distribution of muscle weightings in stroke patients during gait.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

2.3 years

First QC Date

October 26, 2018

Last Update Submit

November 5, 2018

Conditions

Keywords

muscle synergiesgaitfunctional ability

Outcome Measures

Primary Outcomes (1)

  • Amount of muscle synergies derived by non-negative matrix factorization

    Spatial characteristic of muscle synergy compared to healthy adults: the amount of synergies during walking in stroke subjects, the amount of muscles in one synergie and which muscles in one synergy

    Once, in the week of inclusion

Secondary Outcomes (1)

  • Distribution of muscle synerigies derived by non-negative matrix factorization

    Once, in the week of inclusion

Study Arms (2)

Stroke

Individuals suffered from a haemorrhagic or ischaemic stroke. Diagnosis has to be confirmed on the basis of CT or MRI imaging.

Healthy adults

Healthy individuals without any neurological or orthopaedic disorder that could influence motor performance and balance

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy Volunteers: community sample Stroke: Rehabilitation Hospital RevArte, primary care clinic

You may qualify if:

  • haemorrhagic or ischaemic stroke diagnosis, confirmed on the basis of CT or MRI imaging;
  • no known history of previous stroke;
  • stroke onset within five months; 4 patients are between 18 and 85 years of age;

You may not qualify if:

  • A score of 20 or higher on the Trunk Impairment Scale which indicates normal truncal function;
  • A score lower than two on the Functional Ambulation Categories (FAC) as patients needed to be able to ambulate without physical support to ensure that gait analysis can be executed safely;
  • Not able to sit independently for 30 seconds on a stable surface;
  • They suffer from other neurological and orthopaedic disorders that could influence motor performance and balance;
  • not able to understand instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Steven Truijen, Prof.

    Universiteit Antwerpen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 26, 2018

First Posted

November 6, 2018

Study Start

April 1, 2015

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

November 6, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share