Stroke Clinical Trial
Official title:
VR-enhanced Walking in People Post-stroke: the Effect of Changing the Optic Flow Speed During Treadmill Walking on the Gait Pattern
Verified date | April 2020 |
Source | Vrije Universiteit Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to investigate the onset, magnitude and duration of the effect of manipulating the optic flow on the gait pattern during Virtual Reality (VR)-enhanced treadmill walking compared to treadmill walking without VR in people post-stroke.
Status | Terminated |
Enrollment | 2 |
Est. completion date | December 14, 2019 |
Est. primary completion date | December 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - diagnosed with stroke (as defined by the World Health Organization) - stroke onset = 6 months - ambulatory with an impaired gait pattern (FAC-score 2 or 3 or 4) - ability to walk on a treadmill for 20 minutes without bodyweight support - adult (= 18 years) - a body height between 155 cm and 200 cm - ability to signal pain, fear and discomfort - ability to give informed consent Exclusion Criteria: - other neurological deficits than stroke leading to impaired gait - comorbidities (e.g. COPD, osteoporosis, cardiovascular instability) - visual and/or vestibular disorders that can interfere with the VR - uncontrolled spasticity significantly interfering with the movement of the lower extremities (Modified Ashworth Scale > 2) - acute medical illness - communicative/cognitive problems leading to the inability to understand and carry out instructions - severe unilateral spatial neglect |
Country | Name | City | State |
---|---|---|---|
Belgium | Vrije Universiteit Brussel | Brussel |
Lead Sponsor | Collaborator |
---|---|
Vrije Universiteit Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3D kinematic measurements | Kinematic data of the lower limbs (i.e. movement amplitudes of the bilateral hip, knee and ankle joint) during treadmill walking will be recorder continuously. | Kinematic data will be measured continuously for 20 minutes and will be expressed per gait cycle | |
Primary | Spatiotemporal gait parameters | Spatiotemporal gait parameters of the lower limbs (i.e. walking speed, cadence, step length and - time, swing - and stance time, single - and double limb support period) during treadmill walking will be recorded continuously. | Spatiotemporal gait parameters will be measured continuously for 20 minutes and will be expressed per gait cycle | |
Primary | Muscle activity (EMG) | Muscle activity of the lower limb muscles (bilateral: M. rectus femoris, M. vastus medialis and lateralis, M. biceps femoris, M. tibialis anterior, M. gastrocnemius medialis and lateralis) will be recorded continuously during treadmill walking with the use of surface electrodes. | Muscle activity will be measured continuously for 20 minutes and will be expressed per gait cycle | |
Secondary | Simulator Sickness Questionnaire (SSQ) | The SSQ is a widely used questionnaire to evaluate motion sickness when using VR and consist of 16 symptoms. The SSQ will be assessed twice per walking session: at the beginning and at the end of each walking session. Patients need to indicate on a 4 point likert scale how much (none = 0 / slight = 1 / moderate = 2 / severe = 3) each symptom is affecting them at that moment. The SSQ has a minimum score of 0 and a maximum score of 48. Higher scores represent a worse outcome (more side effects due to the VR). | The SSQ will be assessed twice per session (session 1 - 2 - 3 - 4): immediately before and after the participants walked for 20 minutes. | |
Secondary | Physical Activity Enjoyment Scale (PACES) | The PACES is an 18-item scale assessing enjoyment by asking participants to rate (on a scale of 1 to 7) how they felt about the physical activity they have been doing. The PACES has a minimum score of 18 points and a maximum score is 126. Higher scores represent a better outcome (they liked the activity more). | The PACES will be assessed once per session (session 1 - 2 - 3 - 4): immediately after the participants walked for 20 minutes. | |
Secondary | Number of falls or stumbles | The number of falls or stumbles that patients experience will be noted in a standardized way. | The number of falls or stumbles will be assessed continuously for 20 minutes when patients are walking on the treadmill. The number of falls will be collected for each walking session (session 1 - 2 - 3 - 4). |
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