Role of Virtual Reality in Improving Balance in Patients With Myelopathy

NCT03591497 | Completed

• 1 other identifier: IEC (BS & NS DIV)/2017-18
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Balance of the body is achieved by the coordination of three major systems, visual, vestibular and proprioceptive sensation and by the reflexive control of the limbs. In myelopathy, factors like balance and posture, range of motion, muscle strength, coordinated motor control, muscle tone and proprioception are affected. Balance and gait rehabilitation is an important goal in myelopathy. Virtual reality (VR) is a computer based technology that is used for task oriented biofeedback therapy in rehabilitation. This study was envisioned to observe the utility of VR in rehabilitation for improving balance in patients of myelopathy.

Conditions

Myelopathy; Virtual Reality

Keywords

Myelopathy; Virtual Reality; Rehabilitation; Balance

Outcome Measures

Primary Outcomes (3)

• Change in Berg Balance Scale (BBS)

  Scale is used to measure balance during functional activities. It is a 14 item scale. A 5 point scale is used for each item (0-4). "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56. Total score is obtained by adding the individual scores.

  At admission and at discharge from hospital or 24 weeks, whichever is earlier.

• Change in Tinetti performance oriented mobility assessment (POMA)

  Balance section of Tinetti Performance Oriented Mobility Assessment (Tinetti Performance Oriented Mobility Assessment has two subscales, Balance and Gait section.) Balance section has 9 items. Each item can be scored in a 3 point ordinal scale (0-2). "0" indicates the lowest level of function and "2" the highest level of function. Total Score = 16. Total score is obtained by adding the individual scores.

  At admission and at discharge from hospital or 24 weeks, whichever is earlier.

• Change in Functional reach test (forward and lateral)

  Functional reach score. It is used to measure postural stability and dynamic balance in sitting position. It has three subsections. Right lateral reach, left lateral reach and forward lateral reach. The value of each is obtained by measuring the distance in centimeter. The total score is obtained by adding the scores of the three subsections. Lower value indicates the lower level of function and higher value the higher level of function.

  At admission and at discharge from hospital or 24 weeks, whichever is earlier.

Secondary Outcomes (6)

• Difference in Berg Balance Scale (BBS) between groups

  At admission and at discharge from hospital or 24 weeks, whichever is earlier.

• Difference in Tinetti performance oriented mobility assessment (POMA) between groups

  At admission and at discharge from hospital or 24 weeks, whichever is earlier.

• Difference in Functional reach test (forward and lateral) between groups

  At admission and at discharge from hospital or 24 weeks, whichever is earlier.

• Difference in Hospital anxiety and depression scale (HADS) between groups

  At admission and at discharge from hospital or 24 weeks, whichever is earlier.

• Difference in Spinal cord independence measurement scale (SCIM) between groups

  At admission and at discharge from hospital or 24 weeks, whichever is earlier.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Instrument to be used: Software Neuro@home (semi immersive virtual reality system for neurological rehabilitation) was used. In each of the sessions, an avatar on screen that representing the patient was regulated by the patient to perform a virtual task that focused on the training of a specific body part. Programme schedule: Each session of virtual reality therapy lasted for thirty minutes. Day 0 included an orientation to the machine with five minutes of gaming. This was followed by virtual reality therapy for five days a week at the same time of the day for three consecutive weeks.

Other: Virtual Reality

Control Group

NO INTERVENTION

Virtual reality sessions were not provided.

Interventions

Virtual Reality OTHER

As described in Experimental arm description.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with myelopathy with neurological level of injury below C4.
• Both traumatic and non-traumatic myelopathy.
• Duration of illness less than 6 months.

You may not qualify if:

• Severe orthopedic or medical impairment that interfered with sitting.
• Upper limb muscle power \<3/5.
• Cognitive or visual impairment.

Sponsors & Collaborators

• National Institute of Mental Health and Neuro Sciences, India: lead

Study Sites (1)

National Institute of Mental Heath and Neurosciences

Bangalore, Karnataka, 560029, India

Location

MeSH Terms

Conditions

Spinal Cord Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective Cohort study involving cases with use of intervention. Matched control cohort subjects were selected using pre-specified matching criteria (for matching with interventional cohort) as comparison group.

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 19, 2018
• Study Start: February 1, 2018
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)