NCT Number: NCT07798388
Following a cerebrovascular accident (CVA, also known as a stroke), hemiparesis occurs on the side opposite to the brain injury. This can lead to problems with walking and balance, as well as with arm movements whilst walking. The arm swing serves several important functions whilst walking, such as improving your balance and energy efficiency, and a good arm swing helps to reduce the likelihood of falling if you lose your balance. That is why regaining the ability to walk independently with the best possible arm swing is a key goal during rehabilitation for people who have had a stroke. This ensures that the risk of falling is minimised and that people can resume their daily lives as effectively as possible.
The aim of this study is to gain a better understanding of the abnormalities in arm swing whilst walking in people who have had a stroke, and how we can influence them. To identify these abnormalities, we use surface electromyography, a painless technique that allows us to measure muscle activity whilst walking. To do this, we attach sensors to the muscles whose activity we wish to record.
During this study, we are measuring both people who have had a stroke and healthy adults, in order to detect the effects of a stroke on this muscle activity. The data from the healthy adults will be used to investigate whether we observe different muscle activity in people who have had a stroke.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
University Hospital Ghent (UZ Gent), Belgium, Ghent, Oost-Vlaanderen, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Stroke:
Exclusion criteria
Stroke:
Exclusion criteria
Healthy:
The VR-feedback application targets the arm swing symmetry during gait. The application provides visual real-time feedback on the amplitude and symmetry of shoulder flexion-extension movements, as well as on excessive elbow flexion.
Time frame: Baseline, during intervention and immediately after the intervention.
The number of muscle synergies needed to account for 90% variance in muscle activity measured by surface EMG during walking in stroke survivors compared to healthy controls. Following muscles will be examined:
Time frame: Baseline, during intervention and immediately after the intervention.
The number or distribution of muscle weightings within a synergy during walking in stroke survivors compared to healthy controls.
The distribution of muscle activation averages over one gait cycle measured by surface EMG of following muscles:
Time frame: Baseline, during intervention and immediately after the intervention.
Movements of the upper limb during walking measured by 3D kinematics.
Time frame: Single point of assessment immediately after the intervention
The PACES is a questionnaire on patient enjoyment of physical activity. It consists of 18 items rated on a 7-point Likert scale, with total scores ranging from 18 to 126.
Time frame: Single point of assessment immediately after the intervention
The SIM-TLX is a questionnaire to assess the workload in simulation and virtual reality. It consists of 10 items rated on a 21-point Likert scale, with total scores ranging from 21 to 210.
Time frame: Single point of assessment immediately after the intervention
A predefined list of potential adverse effects of the VR-feedback application is used to document any experienced adverse effects experienced by participants including an open section for additional unlisted effects.
Time frame: Single point of assessment immediately after the intervention
The Fugl-Meyer Assessment (FMA) evaluates motor impairment of the upper (FMA-UL) and lower (FMA-LL) extremities. The upper-limb section includes 33 items (maximum score: 66), and the lower limb section includes 17 items (maximum score: 34). Items are scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
Time frame: Single point of assessment immediately after the intervention
The Modified Tardieu Scale (MTS) measures spasticity by assessing the muscle response to passive stretch at different velocities (V1 - V3). It evaluates both the quality of muscle reaction (0 = no resistance to 5 = immovable joint) and the angle of muscle reaction. Full passive ROM (R2) is assessed at slow velocity (V1). The angle at which a catch or clonus occurs (R1) is measured during stretch at V2 (limb falling under gravity) or V3 (quick stretch). The difference (R2 - R1) reflects the dynamic component of spasticity. The muscle groups that may influence the measured muscle activity of the upper and lower limbs will be tested. These include shoulder internal rotators, shoulder extensors, elbow flexors, elbow extensors, hip abductors, hip extensors, hip flexors, knee extensors, knee flexors, and plantar flexors.
Time frame: Single point of assessment immediately after the intervention
Goniometry quantifies passive shoulder and elbow ROM. Measurements are obtained using a standard handheld goniometer, following conventional positioning and alignment procedures to ensure reliable documentation of joint mobility.
Time frame: Single point of assessment immediately after the intervention
The 10-Meter Walk Test (10MWT) assesses walking capacity. Participants walk a 10-meter distance at a comfortable pace, and the time required to cover the central 10 meters (excluding acceleration and deceleration phases) is recorded. Walking speed (m/s) is calculated as an indicator of functional ambulation.
Time frame: Single point of assessment immediately after the intervention
The Kessler Foundation Neglect Assessment Process (KF-NAP) assesses the presence and severity of unilateral neglect during observations of the patient's behavior. It consists of 10 items, each scored from 0 to 3 (0 = no neglect, 1 = mild, with midline crossing only after attention to the right side, 2 = moderate, with clear and consistent left side omissions, and 3 = severe). Total scores range from 0 (indicating no neglect) to 30 (indicating severe neglect). Items 9 and 10, which involve eating tasks, will not be assessed because they cannot be performed in the laboratory setting. The final KF-NAP score will therefore be calculated by averaging the scores of the 8 assessed items and scaling the result to a 0-30 range using the following formula: (sum score / number of scored categories) x 10.
Contact information is provided by the study sponsor or research team.
University Hospital, Ghent
Other
Optimizing Gait Rehabilitation After Stroke: Neuromechanical Understanding and the Role of VR Feedback to Improve Arm Swing Functionality
Acronym: NMC
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