The Effect of Optic Flow Speed Manipulation and the Level of Immersion on the Gait Pattern in People Post-stroke

NCT04521829 | Completed

• 1 other identifier: VR study - GRAIL/HMD
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effect of manipulating the optic flow speed in the virtual environment on the gait pattern during virtual reality (VR) - enhanced treadmill walking in people post-stroke. Furthermore, the study will also investigate if the level of immersion has an effect on the rehabilitation outcomes by manipulating the optic flow speed in two different VR devices: the semi-immersive GRAIL system and the fully-immersive 'Oculus Rift S' HMD. To properly understand the results of the people with a stroke, we will also investigate the effect of manipulating the optic flow speed and the level of immersion on the gait pattern in healthy people. That way, we can investigate whether virtual reality has a different influence on the gait pattern of people with a stroke than in healthy people.

Conditions

Stroke

Keywords

virtual reality; gait; optic flow

Outcome Measures

Primary Outcomes (11)

• 3D kinematic measurements lower limb

  Kinematic data (i.e. movement amplitudes of the bilateral hip, knee and ankle joint in degrees) of the lower limbs during treadmill walking will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.

  through study completion, an average of 1 year

• 3D kinematic measurements upper limb (arm swing)

  Kinematic data (i.e. movement amplitudes of the bilateral shoulder, elbow and wrist joint in degrees) of the upper limb during treadmill walking will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz. With these data, information about the arm swing during walking will be obtained.

  through study completion, an average of 1 year

• 3D kinetic measurements lower limb

  Kinetic data (i.e. forces, moments and powers of the bilateral hip, knee and ankle joint in respectively Newton, Newton-meters and Watt) of the lower limbs during treadmill walking will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.

  through study completion, an average of 1 year

• Walking speed

  Walking speed (m/s) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.

  through study completion, an average of 1 year

• Cadence

  Cadence (steps/min) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.

  through study completion, an average of 1 year

• Step length

  Step length (cm) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.

  through study completion, an average of 1 year

• Step time

  Step time (s) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.

  through study completion, an average of 1 year

• Swing - and stance time

  Swing and stance time (s) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.

  through study completion, an average of 1 year

• Single - and double limb support period

  Single and double limb support period (% gait cycle) will be recorded continuously with the use of a 10-camera VICON Vero 1.3 system at 100 Hz.

  through study completion, an average of 1 year

• Lower limb muscles activity

  Muscle activity of the lower limb muscles (bilateral: M. rectus femoris, M. vastus lateralis, M. biceps femoris, M. tibialis anterior, M. gastrocnemius medialis) will be recorded continuously during treadmill walking with the use of surface electrodes. Signals will be recorded with the wireless EMG system Delsys Tigno (16 channels).

  through study completion, an average of 1 year

• Upper limb muscles activity

  Muscle activity of the upper limb muscles (bilateral: M. deltoideus anterior part, M. deltoideus posterior part, M. latissimus dorsi) will be recorded continuously during treadmill walking with the use of surface electrodes. Signals will be recorded with the wireless EMG system Delsys Tigno (16 channels).

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Simulator Sickness Questionnaire

  through study completion, an average of 1 year

• Igroup Presence Questionnaire

  through study completion, an average of 1 year

• Visual Analogue Scale

  through study completion, an average of 1 year

• Number of falls or stumbles

  through study completion, an average of 1 year

Study Arms (1)

VR-enhanced treadmill walking

EXPERIMENTAL

Participants will be tested during 2 sessions of VR-enhanced treadmill walking.

Other: Walking with different optic flow speeds with 2 different VR devices

Interventions

Walking with different optic flow speeds with 2 different VR devices OTHER

Participants will perform 2 sessions of VR-enhanced treadmill walking. One session with the GRAIL system (semi-immersive) and the other session with a fully immersive head-mounted display (Oculus Rift S). In both sessions, the speed of the optic flow will be manipulated: equal to, 2 times faster and 2 times slower than the participant's comfortable walking speed.

VR-enhanced treadmill walking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with stroke (as defined by the World Health Organization)
• stroke onset ≥ 3 months
• ambulatory with an impaired gait pattern (FAC-score 2, 3 or 4)
• ability to walk on a treadmill for 4x8 minutes without bodyweight support
• adult (≥ 18 years)
• ability to signal pain, fear and discomfort
• ability to give informed consent

You may not qualify if:

• other neurological deficits than stroke leading to impaired gait (e.g. Parkinson's disease, multiple sclerosis)
• comorbidities (e.g. COPD, severe 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
• ≥ 18 years of age
• normal or corrected-to-normal vision with glasses or contact lenses,
• no locomotion impairments
• having a significant lower extremity injury during the last two years that might affect their gait
• having any type of vestibular/visual deficiency

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• University Ghent: collaborator
• University Hospital, Ghent: collaborator

Study Sites (1)

Emma De Keersmaecker

Brussels, 1090, Belgium

Location

Related Publications (1)

• De Keersmaecker E, Van Bladel A, Zaccardi S, Lefeber N, Rodriguez-Guerrero C, Kerckhofs E, Jansen B, Swinnen E. Virtual reality-enhanced walking in people post-stroke: effect of optic flow speed and level of immersion on the gait biomechanics. J Neuroeng Rehabil. 2023 Sep 25;20(1):124. doi: 10.1186/s12984-023-01254-0.

  PMID: 37749566 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Walking

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Eva Swinnen, Prof. Ph.D

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 21, 2020
• Study Start: October 10, 2020
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

BE (1)