Optimizing Gait Rehabilitation After Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

First-ever ischemic or haemorrhagic stroke

Able to walk independently (FAC ≥ 3)

Able to walk at least ten minutes

No full recovery of the paretic upper limb (FMA-UL < 66)

Disqualifiers

Lesions located in the cerebellum

Pre-existing neurological disorders that affect motor function (e.g., Parkinson's disease, multiple sclerosis, dementia, etc.)

Pre-existing orthopaedic disorders of the upper and/or lower limbs (e.g., shoulder prosthesis, knee prosthesis, etc.)

Inability to provide written informed consent

Trial design

Design model

Single group

Treatments tested in this trial

  • VR-feedback application

    Other intervention

    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.

Treatment groups

93 Participants
are divided into 1 treatment group
Group A: neuromechanical understanding and the role of VR feedback to improve arm swing functionalityExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of muscle synergies

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: * tibialis anterior * gastrocnemius lateralis * soleus * vastus medialis * vastus lateralis * rectus femoris * biceps femoris * gluteus medius * erector spinae * latissimus dorsi * anterior deltoid * posterior deltoid * biceps brachii * triceps brachii

Time frame
Baseline, during intervention and immediately after the intervention.
2

Weight of muscle synergies

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: * tibialis anterior * gastrocnemius lateralis * soleus * vastus medialis * vastus lateralis * rectus femoris * biceps femoris * gluteus medius * erector spinae * latissimus dorsi * anterior deltoid * posterior deltoid * biceps brachii * triceps brachii

Time frame
Baseline, during intervention and immediately after the intervention.
3

Upper and lower limb kinematics

Movements of the upper limb during walking measured by 3D kinematics.

Time frame
Baseline, during intervention and immediately after the intervention.
4

Physical Activity Enjoyment Scale (PACES)

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

Secondary outcomes

1

Fugl-Meyer assessment - Upper and lower limbs

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
2

Modified Tardieu Scale

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
3

Goniometry

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
4

10-Meter Walk Test (10MWT)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Ghent

Lead sponsor

University Ghent

Collaborator

Universiteit Antwerpen

Collaborator

University Hospital, Antwerp

Collaborator

Hasselt University

Collaborator