Stroke Walking Explained After Trunk Training

NCT ID: NCT02708888

Last Updated: 2019-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-08-31

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:

1. Tinetti Test

2. 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.).

3. 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Trunk training

Exercises: Core stability training

Group Type: EXPERIMENTAL

Trunk training

Intervention Type: OTHER

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.

Cognitive exercises

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

Group Type: SHAM_COMPARATOR

Cognitive exercises

Intervention Type: OTHER

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.

Interventions

Trunk training

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

Cognitive exercises

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rehabilitation Hospital RevArte

UNKNOWN

Sponsor Role: collaborator

Universiteit Antwerpen

OTHER

Sponsor Role: lead

Responsible Party

Tamaya Van Criekinge

Academic assistent

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamaya Van Criekinge, Msc

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

Rehabilitation Hospital RevArte

Edegem, Antwerp, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 32542356 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28578679 (View on PubMed)

Other Identifiers

TVC-1

Identifier Type: -

Identifier Source: org_study_id