The Effect of Optic Flow During Treadmill Walking on the Gait Pattern in People Post-stroke

NCT03898375 | Terminated

• 1 other identifier: VR study I - optic flow
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Virtual reality; optic flow; gait

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Simulator Sickness Questionnaire (SSQ)

  The SSQ will be assessed twice per session (session 1 - 2 - 3 - 4): immediately before and after the participants walked for 20 minutes.

• Physical Activity Enjoyment Scale (PACES)

  The PACES will be assessed once per session (session 1 - 2 - 3 - 4): immediately after the participants walked for 20 minutes.

• Number of falls or stumbles

  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).

Study Arms (1)

VR-enhanced treadmill walking

EXPERIMENTAL

Participants will be tested during 4 sessions of 20 minutes treadmill walking.

Other: Walking with different optic flow speeds

Interventions

Walking with different optic flow speeds OTHER

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.

VR-enhanced treadmill walking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1050, Belgium

Location

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

• Eric Kerckhofs, Prof. Ph.D

  Vrije Universiteit Brussel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Researcher

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 2, 2019
• Study Start: November 25, 2019
• Primary Completion: December 14, 2019
• Study Completion: December 14, 2019
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

BE (1)