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Effect of Immersive Virtual Reality Usage on Upper Extremity Function in Stroke Patients

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ClinicalTrials.gov Identifier: NCT03135418
Recruitment Status : Completed
First Posted : May 1, 2017
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Abant Izzet Baysal University

Brief Summary:

In this study we aimed to determine whether the additional rehabilitation with 3D virtual reality headsets provide any functional contribution to conventional rehabilitation techniques of upper extremity in patient with stroke.

Forty patients with stroke history no more than 2 years will be included in this study. Patients will randomly be divided into 2 groups as control and intervention. Conventional rehabilitation techniques will be applied for 4 weeks in both groups. Intervention group will receive a 3D virtual reality rehabilitation training, each lasts 45 minutes, with a special headset 3 times a week for 4 weeks in addition to conventional rehabilitation. Patients will be assessed with Fugl-Meyer, Action Research Arm Test and Functional Independence Measurement at baseline and 4 weeks after first assessment. It will be evaluated that whether 3d virtual reality rehabilitation training provides any benefit to stroke rehabilitation.


Condition or disease Intervention/treatment Phase
Stroke Rehabilitation Device: Intervention Device: Control Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients' information and contact will be obtaioned from neurologist and willing participant's gender, age and stroke onset data will be processed with a random number generator. Patients will divide into two groups as intervention and control with a normal distrubution of gender, age and stroke onset.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Both group will recevie conventional stroke rehabilitation. Intervention group will receive a Oculus Rift+Leap motion tracking supported upper extremity activities and control group will receive a sham virtual reality on focusing visual scenes without interaction.

Outcomes will be recorded by physical therapist using SPSS and groups would not be specified with letter. Statistical analysis will be conducted by another researcher who does not aware of groups given numbers on SPSS.

Primary Purpose: Treatment
Official Title: Effect of Immersive Virtual Reality Usage on Upper Extremity Function in Stroke Patients: A Prospective, Double Blinded, Randomized Controlled Clinical Trial
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : October 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Intervention
25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Oculus Rift and Leap motion will be used to create an immersive interactive environment. Modified Ashworth Scale (MAS), Functional independence scale, self-care questionnaire,Action Research Arm Test, Fugl meyer upper extremity motor evaluations will be applied just before the rehabilitation program, after the application and at the end of 6 weeks.
Device: Intervention

Patients will use virtual reality d4evice to play task oriented games like bowling, arrow shooting and home activity simulations which focuses upper extremity abduction, flexion and rotation movements. Each session will be a total of 45 minutes divided to 3 15 minute games. Sessions will held for 6 weeks each monday, wednesday and friday at same time for each patient.

In addition to the virtual reality treatment program conventional rehabilitation therapies including neurodevelopmental facilitation techniques, physiotherapy, and occupational therapy and, where necessary, speech therapy will be applied according to the needs of the patient.


Sham Comparator: Control
25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Oculus Rift a will be used to create an immersive visual environment.Patient will be watching the premade scenarios without interaction. Modified Ashworth Scale (MAS), Functional independence scale, self-care questionnaire, Action Research Arm Test, Fugl meyer upper extremity motor evaluations will be applied just before the rehabilitation program, after the application and at the end of 6 weeks.
Device: Control
The control group will be included in the virtual reality program only focusing on visual scenes without upper extremity interaction. Bobath therapy, walking exercises, upper extremity active exercises, proprioceptive neuromuscular facial techniques will be applied to the control group for 6 weeks.




Primary Outcome Measures :
  1. Fugl meyer upper extremity motor evaluations [ Time Frame: 6 weeks ]
    Evaluates and measures recovery in post-stroke hemiplegic patients. Motor Test requires Tennis ball, A small spherical shaped container, A tool to administer reflex tests, Enough space is needed for a patient to move around freely, if possible space should be a quiet


Secondary Outcome Measures :
  1. Functional independence scale [ Time Frame: 6 weeks ]
    Measures the level of a patient's disability and indicates how much assistance is needed for the individual to carry out activities of daily living

  2. Performance Assessment of Self-Care Skills (PASS) [ Time Frame: 6 weeks ]
    Purpose of PASS is to demonstrate independence, adequacy, and safety are rated on four-point scales.

  3. Action Research Arm Test (ARAT) [ Time Frame: 6 weeks ]
    Assesses upper limb functioning using observational methods. Focuses on grip, grasp and pinch motions of hand



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing to participate
  • Mini-Mental State Test score equal or above 25
  • Modified Ashworth Scale Score lover then 3

Exclusion Criteria:

  • Secondary neurological diseases
  • Recurrent strokes
  • Reduced or lost visual field on both or single eye(s)
  • Full paralysis on affected side

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135418


Locations
Turkey
Abant Izzet Baysal University
Bolu, Turkey
Sponsors and Collaborators
Abant Izzet Baysal University
Investigators
Principal Investigator: Şule Aydın Türkoğlu, M.D. Abant Izzet Baysal University
Principal Investigator: Ramazan Kurul, Ms.C Abant Izzet Baysal University
Study Director: Muhammed Nur Öğün, M.D. Abant Izzet Baysal University
Principal Investigator: Şebnem Avcı, Ph.D. Abant Izzet Baysal University

Responsible Party: Abant Izzet Baysal University
ClinicalTrials.gov Identifier: NCT03135418     History of Changes
Other Study ID Numbers: AbantIBU-Neu1
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After publication of article all outcomes will be open to others researches with an excel data sheet. Researchers can contact corresponding researcher with his contact mail and request data.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Abant Izzet Baysal University:
Virtual Reality

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases