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Stroke Walking Explained After Trunk Training (SWEAT²)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Trunk training
Cognitive exercises
Sponsored by
Universiteit Antwerpen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Trunk, Biomechanical Phenomena, Gait, Electromyography, Rehabilitation, Balance

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Rehabilitation Hospital RevArte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Trunk training

Cognitive exercises

Arm Description

Exercises: Core stability training

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The change in temporal gait parameters
The following temporal gait parameters will be investigated: stride length (m), step length (m), and step width (m). These parameters examine the difference in distance.
The change in kinematic parameters of the trunk, hip, knee, and ankle
The following kinematic parameters will be assessed: mean angle during stance (°), mean angle during swing (°), minimum angle during stance (°), maximal angle during stance (°), minimal angle during swing (°), maximal angle during swing (°), angle at foot strike (°), angle at foot off (°), range of motion (°). These parameters examine the difference in joint angles.
The change is muscle activity of the trunk and lower legs during walking
Muscle activity of the trunk and lower limbs will be registered by means of surface EMG. The amplitude and timing of muscle contractions will be assessed.

Full Information

First Posted
March 2, 2016
Last Updated
February 15, 2019
Sponsor
Universiteit Antwerpen
Collaborators
Rehabilitation Hospital RevArte
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1. Study Identification

Unique Protocol Identification Number
NCT02708888
Brief Title
Stroke Walking Explained After Trunk Training
Acronym
SWEAT²
Official Title
Effectiveness of Additional Trunk Exercises on Gait Performance: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiteit Antwerpen
Collaborators
Rehabilitation Hospital RevArte

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Objective: To examine the effects of additional trunk exercises on gait performance via clinical and biomechanical assessments in patients receiving inpatient rehabilitation after stroke. Design: The design of this study is an assessor-blinded randomized controlled trial. Prior to evaluation, participants will be randomly allocated to either the experimental or control group by means of concealed envelopes. The number of patients required for this study was calculated a priori to ensure sufficient statistical power. Analysis showed that a sample size of 30 patients in each group was necessary to detect a difference (ES1) with 80 % using a two-tailed hypothesis (with significance of p=0.05). Intervention: All patients will receive a multidisciplinary conventional stroke rehabilitation program provided by the rehabilitation staff. The control group will receive a series of cognitive exercises focusing on aspects of memory (visual, auditory, and working memory), attention (sustained attention and selective attention), and executive functioning (planning and problem-solving). The additional training of the trunk training group focuses on trunk muscle strength, coordination and selective movements. The training program will consist of task-specific movements of the upper and lower part of the trunk both in supine and sitting position on stable and unstable surfaces (physio balls). The following trunk exercises will be performed: bridging, reaching, lower/upper trunk rotations, lower/upper trunk lateral flexion, upper/lower trunk flexion, ... Outcome measures: Tinetti Test Gait parameters recorded during 3D-Full body gait analysis: Gait analysis was performed at the M²OCEAN movement analysis laboratory (Multidisciplinary Motor Centre Antwerp, University of Antwerp, Antwerp, Edegem). VICON analysis system (©Vicon Motion Systems Ltd., London, UK) which is the golden standard for 3D motion analysis. Eight infrared automated cameras (Vicon T10 cameras, 100 fps, 1 Megapixel) measured the 3D coordinates of reflective motion trackers. Two video cameras recorded the walking pattern of the participants in the sagittal and frontal plane. In addition, initial contact and toe off were measured based on the ankle trajectories of the reflective markers together with 3 AMTI type OR 6-7 force plates (1000 fps, 46x50x8 cm) and 1 AccuGait® (1000 fps) force plate recordings. Subsequently, the movement analysis lab is equipped with a 16 channel telemetric wireless electromyographic (EMG) system (Arion Zerowire) which measures muscle activity. Recordings where analysed using the Vicon Nexus 1.8.5. software. Step time parameters and gait kinematics were filtered (Butterworth filter) and further processed in Matlab® (The MathWorks, Inc., Natick, Massachusetts, U.S.A.). Trunk Impairment Scale, Barthel Index Follow-up. One month post intervention patients will be again subjected to clinical and biomechanical assessment to measure the sustainability of trunk exercises over time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Trunk, Biomechanical Phenomena, Gait, Electromyography, Rehabilitation, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trunk training
Arm Type
Experimental
Arm Description
Exercises: Core stability training
Arm Title
Cognitive exercises
Arm Type
Sham Comparator
Arm Description
Exercises: The RevArte Visual Search Test (RVST) of Lafosse et al (2013) and the Visuospatial Neglect Test Battery (VNTB) of Vaes et al. (2015)
Intervention Type
Other
Intervention Name(s)
Trunk training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in Tinetti Performance Oriented Mobility Assessment
Description
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.
Time Frame
week 0, week 5, and week 9
Secondary Outcome Measure Information:
Title
The change in temporal gait parameters
Description
The following temporal gait parameters will be investigated: stride length (m), step length (m), and step width (m). These parameters examine the difference in distance.
Time Frame
week 0, week 5, and week 9
Title
The change in kinematic parameters of the trunk, hip, knee, and ankle
Description
The following kinematic parameters will be assessed: mean angle during stance (°), mean angle during swing (°), minimum angle during stance (°), maximal angle during stance (°), minimal angle during swing (°), maximal angle during swing (°), angle at foot strike (°), angle at foot off (°), range of motion (°). These parameters examine the difference in joint angles.
Time Frame
week 0, week 5, and week 9
Title
The change is muscle activity of the trunk and lower legs during walking
Description
Muscle activity of the trunk and lower limbs will be registered by means of surface EMG. The amplitude and timing of muscle contractions will be assessed.
Time Frame
week 0, week 5, and week 9
Other Pre-specified Outcome Measures:
Title
The change in Trunk Impairment Scale (TIS)
Description
The TIS consists of 3 subscales of static, dynamic sitting balance and trunk coordination. TIS scores range from a minimum of 0 to a maximum of 23, subscales score up to 7, 10 and 6 points, respectively. A higher score indicates better truncal function. The static sitting balance subscale evaluates whether a person can sit independently and remain seated with legs crossed. The dynamic sitting balance subscale assesses the ability to actively shorten each side of the trunk, initiated from either the shoulder or pelvic girdle. The trunk coordination subscale tests the ability to rotate the shoulder girdle and the pelvic girdle.
Time Frame
week 0, week 5, and week 9
Title
The change in the Barthel Index (BI)
Description
The BI is an index assessing the independency of a patient's performance concerning the activities of daily living. The maximum score of the BI gives a score on 100 with increments of five points to assess is if the patient is fully dependent, independent, or needs some help regarding ten topics: feeding, bathing, grooming, dressing, toilet use, bowel and bladder continence, transferring, mobility, and stair climbing
Time Frame
week 0, week 5, and week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamaya Van Criekinge, Msc
Organizational Affiliation
Universiteit Antwerpen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Hospital RevArte
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32542356
Citation
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.
Results Reference
derived
PubMed Identifier
28578679
Citation
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.
Results Reference
derived

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Stroke Walking Explained After Trunk Training

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