Stroke Gait Rehabilitation
Conditions
Brief summary
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.
Interventions
OTHERVR-feedback application
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.
Sponsors
University Hospital, Ghent
University Ghent
Universiteit Antwerpen
University Hospital, Antwerp
Hasselt University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Stroke: * 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) * Able to follow simple instructions during the assessment
Exclusion criteria
Stroke: * 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 * Inability to understand instructions (AbilityQ: verbal \< 3/4 and VAS \< 3/3)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of muscle synergies | 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: * 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 |
| Weight of muscle synergies | 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: * 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 |
| Upper and lower limb kinematics | Baseline, during intervention and immediately after the intervention. | Movements of the upper limb during walking measured by 3D kinematics. |
| Physical Activity Enjoyment Scale (PACES) | 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. |
| Simulation Task Load Index (SIM-TLX) | 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. |
| List of potential adverse effects | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer assessment - Upper and lower limbs | 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). |
| Modified Tardieu Scale | 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. |
| Goniometry | 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. |
| 10-Meter Walk Test (10MWT) | 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. |
| Kessler Foundation Neglect Assessment Process (KF-NAP) | 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. |
Countries
Belgium
Contacts
CONTACTGitte Van Cleemput
Outcome results
None listed