The Effect of Optic Flow During Treadmill Walking on the Gait Pattern in People Post-stroke
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|ClinicalTrials.gov Identifier: NCT03898375|
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Walking with different optic flow speeds||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||VR-enhanced Walking in People Post-stroke: the Effect of Changing the Optic Flow Speed During Treadmill Walking on the Gait Pattern|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: VR-enhanced treadmill walking
Participants will be tested during 4 sessions of 20 minutes treadmill walking.
Other: Walking with different optic flow speeds
Patients will perform 4 sessions of 20 minutes treadmill walking: one control session without VR and 3 walking sessions with the VR. In each VR session, patients will walk with a different optic flow speed: the same as, faster than or slower than their walking speed.
- 3D kinematic measurements [ Time Frame: Kinematic data will be measured continuously for 20 minutes and will be expressed per gait cycle ]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.
- Spatiotemporal gait parameters [ Time Frame: Spatiotemporal gait parameters will be measured continuously for 20 minutes and will be expressed per gait cycle ]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.
- Muscle activity (EMG) [ Time Frame: Muscle activity will be measured continuously for 20 minutes and will be expressed per gait cycle ]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.
- Simulator Sickness Questionnaire (SSQ) [ Time Frame: The SSQ will be assessed twice per session (session 1 - 2 - 3 - 4): immediately before and after the participants walked for 20 minutes. ]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).
- Physical Activity Enjoyment Scale (PACES) [ Time Frame: The PACES will be assessed once per session (session 1 - 2 - 3 - 4): immediately after the participants walked for 20 minutes. ]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).
- Number of falls or stumbles [ Time Frame: 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). ]The number of falls or stumbles that patients experience will be noted in a standardized way.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898375
|Contact: Emma De Keersmaecker||003224774529 ext firstname.lastname@example.org|
|Contact: Eva Swinnen, Prof. Ph.D||003224774529 ext email@example.com|
|Vrije Universiteit Brussel||Recruiting|
|Brussel, Belgium, 1050|
|Principal Investigator:||Eva Swinnen, Prof. Ph.D||Vrije Universiteit Brussel|
|Study Chair:||Eric Kerckhofs, Prof. Ph.D||Vrije Universiteit Brussel|