NCT02708888

Brief Summary

The aim of SWEAT² study is to further explore the effects of additional customized trunk exercises on clinical and biomechanical gait performance. Despite of the evidence demonstrating the importance of trunk control after stroke, studies about the effects of trunk rehabilitation on gait performance are inconsistent. The findings of this study might lead to new scientific insights in the importance of the trunk during gait rehabilitation in people suffering from stroke submitted to a rehabilitation hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

February 19, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

March 2, 2016

Last Update Submit

February 15, 2019

Conditions

Stroke

Keywords

TrunkBiomechanical PhenomenaGaitElectromyographyRehabilitationBalance

Outcome Measures

Primary Outcomes (1)

  • The change in Tinetti Performance Oriented Mobility Assessment

    Tinetti Test measures gait and balance on a 3-point ordinal scale ranging from 0 to 2. The maximum score of the total Tinetti is 28 points, whereby a maximum of 12 and 16 points can be obtained for gait and balance subscales.

    week 0, week 5, and week 9

Secondary Outcomes (3)

  • The change in temporal gait parameters

    week 0, week 5, and week 9

  • The change in kinematic parameters of the trunk, hip, knee, and ankle

    week 0, week 5, and week 9

  • The change is muscle activity of the trunk and lower legs during walking

    week 0, week 5, and week 9

Other Outcomes (2)

  • The change in Trunk Impairment Scale (TIS)

    week 0, week 5, and week 9

  • The change in the Barthel Index (BI)

    week 0, week 5, and week 9

Study Arms (2)

Trunk training

EXPERIMENTAL

Exercises: Core stability training

Other: Trunk training

Cognitive exercises

SHAM COMPARATOR

Exercises: The RevArte Visual Search Test (RVST) of Lafosse et al (2013) and the Visuospatial Neglect Test Battery (VNTB) of Vaes et al. (2015)

Other: Cognitive exercises

Interventions

Trunk trainingOTHER

The experimental group receives 16 hours of additional trunk training (4 days/week, 4 weeks) focusing on trunk muscle strength, coordination and selective movements executed on stable and unstable surfaces.

Trunk training
Cognitive exercisesOTHER

The control group will be receiving the same amount of repetitive cognitive exercises within arm's range to ensure no anticipatory postural adjustments of the trunk.

Cognitive exercises

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Haemorrhagic or ischaemic stroke diagnosis has to be confirmed by the consultant appointed at the rehabilitation centre on the basis of CT or MRI imaging
  • Patients with a history of first stroke
  • Stroke onset within five months
  • Patients who are able to sit independently for 30 seconds on a stable surface
  • Hospitalized in the rehabilitation hospital RevArte
  • Written informed consent

You may not qualify if:

  • A score of 20 or higher on the Trunk Impairment Scale
  • A score of 2 or lower on the Functional Ambulation Categories
  • Patients suffering from other neurological and orthopaedic disorders that could influence motor performance and balance
  • Patients not able to understand instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Hospital RevArte

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (2)

  • Van Criekinge T, Hallemans A, Herssens N, Lafosse C, Claes D, De Hertogh W, Truijen S, Saeys W. SWEAT2 Study: Effectiveness of Trunk Training on Gait and Trunk Kinematics After Stroke: A Randomized Controlled Trial. Phys Ther. 2020 Aug 31;100(9):1568-1581. doi: 10.1093/ptj/pzaa110.

    PMID: 32542356DERIVED

  • Van Criekinge T, Saeys W, Hallemans A, Vereeck L, De Hertogh W, Van de Walle P, Vaes N, Lafosse C, Truijen S. Effectiveness of additional trunk exercises on gait performance: study protocol for a randomized controlled trial. Trials. 2017 Jun 2;18(1):249. doi: 10.1186/s13063-017-1989-1.

    PMID: 28578679DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Tamaya Van Criekinge, Msc

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic assistent

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 15, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

February 19, 2019

Record last verified: 2019-02

Locations

BE(1)