Clinical trial NCT03591497: Role of Virtual Reality in Improving Balance in Patients With Myelopathy
Official title: Role of Virtual Reality in Improving Balance in Patients With Myelopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myelopathy
Virtual Reality
Keywords: Myelopathy
Virtual Reality
Rehabilitation
Balance
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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. Static balance which determines the ability to maintain postural stability during sitting or standing is important to perform daily functional activities. Dynamic balance on the other hand is the ability to respond and adjust to a moving floor or any external stimuli or perturbation and is a requirement for successful gait performance.

In myelopathy, factors like balance and posture, range of motion, muscle strength, coordinated motor control, muscle tone and proprioception are affected. Lack of normal postural synergy and sensory motor integration of lower limbs and trunks and spatial information that regulate upright position and sitting balance leads to balance dysfunction in the population. Hence patient develops compensatory strategies. But ambulation involves the intricate coordination of leg movements, regulating upright posture and balance and adaptation to environmental changes. Hence 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. It constructs a virtual environment resembling a situation in the real world and provides multimodal sensory cues. VR ranges from non immersive to semi immersive to fully immersive, depending on the degree to which the user is isolated from the physical surroundings when interacting with the virtual environment.

In virtual reality training, participants perform functional stretching of their extremities, learn postural control of the trunk and practice weight shifting. As the level of difficulty and speed are increased for various tasks, the movement of the body's center of gravity beyond the base of support increases thus increasing the proprioceptive sensations to the joints and improves the subject's ability to adjust balance. Hence it encourages dynamic motions and functional mobility. The VR environment can be controlled and manipulated in advance to fine tune the exercises and meet individual needs. It is interactive as well as enjoyable.

Studies indicate that spinal reflex circuitry exhibits activity dependent plasticity (the capacity of the nervous system to modify its organization). Intensive task specific training is one of the most effective ways to promote neuroplasticity and develop more normalized movement patterns. VR uses this principle of neuroplasticity to promote motor relearning. Literature supports the use of VR as an effective rehabilitative tool in individuals with stroke, spinal cord injury, cerebral palsy, multiple sclerosis and other neurological disorders.

There are few studies on balance rehabilitation in myelopathy from this part of the world. Due to absence of any guidelines, identifying the most suitable type of VR system, defining the most appropriate treatment dosing, timing and intensity of training for the therapeutic application is a challenge. This study was envisioned to observe the utility of VR in rehabilitation for improving balance in patients of myelopathy.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Berg Balance Scale (BBS)
timeFrame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
measure: Change in Tinetti performance oriented mobility assessment (POMA)
timeFrame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
measure: Change in Functional reach test (forward and lateral)
timeFrame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Secondary outcomes:
measure: Difference in Berg Balance Scale (BBS) between groups
timeFrame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
measure: Difference in Tinetti performance oriented mobility assessment (POMA) between groups
timeFrame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
measure: Difference in Functional reach test (forward and lateral) between groups
timeFrame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
measure: Difference in Hospital anxiety and depression scale (HADS) between groups
timeFrame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
measure: Difference in Spinal cord independence measurement scale (SCIM) between groups
timeFrame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
measure: Difference in Walking Index for Spinal Cord Injury II (WISCI II) between groups
timeFrame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Other outcomes:
Locations:
city: Bangalore
country: India
facility: National Institute of Mental Heath and Neurosciences
state: Karnataka
Study officials:
References: