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

NCT03135418 | Completed DMC

• 1 other identifier: AbantIBU-Neu1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Rehabilitation

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Fugl meyer upper extremity motor evaluations

  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

  6 weeks

Secondary Outcomes (3)

• Functional independence scale

  6 weeks

• Performance Assessment of Self-Care Skills (PASS)

  6 weeks

• Action Research Arm Test (ARAT)

  6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

Intervention DEVICE

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.

Intervention

Control DEVICE

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.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Şule Aydın Türkoğlu, M.D.

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

• Ramazan Kurul, Ms.C

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

• Muhammed Nur Öğün, M.D.

  Abant Izzet Baysal University

  STUDY DIRECTOR

• Şebnem Avcı, Ph.D.

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: May 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 6, 2017
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

TU (1)