Clinical trial NCT02708888: Stroke Walking Explained After Trunk Training
Official title: Effectiveness of Additional Trunk Exercises on Gait Performance: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Trunk
Biomechanical Phenomena
Gait
Electromyography
Rehabilitation
Balance
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Rehabilitation Hospital RevArte
First posted: 2016-03-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The change in Tinetti Performance Oriented Mobility Assessment
timeFrame: week 0, week 5, and week 9
Secondary outcomes:
measure: The change in temporal gait parameters
timeFrame: week 0, week 5, and week 9
measure: The change in kinematic parameters of the trunk, hip, knee, and ankle
timeFrame: week 0, week 5, and week 9
measure: The change is muscle activity of the trunk and lower legs during walking
timeFrame: week 0, week 5, and week 9
Other outcomes:
measure: The change in Trunk Impairment Scale (TIS)
timeFrame: week 0, week 5, and week 9
measure: The change in the Barthel Index (BI)
timeFrame: week 0, week 5, and week 9
Locations:
city: Edegem
country: Belgium
facility: Rehabilitation Hospital RevArte
state: Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Tamaya Van Criekinge, Msc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.