Immersive Virtual Reality During Robot-assisted Walking.

NCT03459014 | Completed

• 1 other identifier: Lokomat study with VR - I
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effect of manipulating the optic flow (OF) speed in 2 different virtual environments (VE) on active participation in healthy participants during virtual reality (VR) - enhanced robot-assisted gait(RAG). The second aim is to investigate the effect of two different VEs on active participation during RAG.

Conditions

Healthy

Keywords

Robot-Assisted Gait Training; Virtual Reality; Optic Flow; Active Participation

Outcome Measures

Primary Outcomes (9)

• Muscle activity (EMG)

  Muscle activity will be measured continuously during the 21 minutes of testing. Average muscle activity (%MVIC) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

  Every minute of the 21-minute session.

• Interaction torques left hip

  Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

  Every minute of the 21-minute session.

• Interaction torques left knee

  Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

  Every minute of the 21-minute session.

• Interaction torques right hip

  Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

  Every minute of the 21-minute session.

• Interaction torques right knee

  Interaction torques will be measured continuously during the 21 minutes of testing. Average interaction torques (Nm) between participant and device will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

  Every minute of the 21-minute session.

• Range of motion left hip

  Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

  Every minute of the 21-minute session.

• Range of motion left knee

  Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

  Every minute of the 21-minute session.

• Range of motion right hip

  Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

  Every minute of the 21-minute session.

• Range of motion right knee

  Range of motion will be measured continuously during the 21 minutes of testing. Average range of motion (°) will be measured at different time frames. Offline calculation (e.g. averages) will be performed afterwards.

  Every minute of the 21-minute session.

Study Arms (2)

Stimulus rich VE

EXPERIMENTAL

Participants will be tested during 1 RAG session in the Lokomat. Participants in the experimental group will walk in a stimulus rich VE such as walking in a park.

Other: Stimulus rich VE

Stimulus poor VE

ACTIVE COMPARATOR

Participants will be tested during 1 RAG session in the Lokomat. Participants in the control group will walk in a stimulus poor VE, such as walking through an endless hallway.

Other: Stimulus poor VE

Interventions

Stimulus rich VE OTHER

Participants will walk in the Lokomat with the VR for 21 minutes. After every 7 minutes, the speed of the OF will change (2 times the comfortable walking speed, equally to the comfortable walking speed, and 0.5 times the comfortable walking speed).

Stimulus rich VE

Stimulus poor VE OTHER

Participants will walk in the Lokomat with the VR for 21 minutes. After every 7 minutes, the speed of the OF will change (2 times the comfortable walking speed, equally to the comfortable walking speed, and 0.5 times the comfortable walking speed).

Stimulus poor VE

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy persons ≥ 55 years of age,
• Normal or corrected-to-normal vision with glasses or contact lenses,
• No locomotion impairments,
• A maximal body weight of 135 kg,
• A maximal body height of 200 cm

You may not qualify if:

• Skin lesions that cannot be protected appropriately,
• Significant lower extremity injuries during the last two years that might affect their gait,
• Any type of vestibular/visual deficiency

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Rehabilitation center TrainM

Antwerp, 2018, Belgium

Location

Study Officials

• Eric Kerckhofs, Prof. Ph.D

  Vrije Universiteit Brussel

  STUDY CHAIR

• Eva Swinnen, Prof. Ph.D

  Vrije Universiteit Brussel

  STUDY DIRECTOR

• Emma De Keersmaecker, Ph.D student

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 8, 2018
• Study Start: September 12, 2018
• Primary Completion: April 13, 2019
• Study Completion: April 13, 2019
• Last Updated: April 24, 2019

Record last verified: 2019-04

Locations

BE (1)