MyelopathyNCT03591497
Role of Virtual Reality in Improving Balance in Patients With Myelopathy
A study testing Virtual Reality in people with Myelopathy and Virtual Reality, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Myelopathy, Virtual Reality
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2018to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with myelopathy with neurological level of injury below C4.
- Both traumatic and non-traumatic myelopathy.
- Duration of illness less than 6 months.
Who cannot join
- Severe orthopedic or medical impairment that interfered with sitting.
- Upper limb muscle power <3/5.
- Cognitive or visual impairment.
Trial locations and contacts
1 site in 1 country.
India1 site
National Institute of Mental Heath and Neurosciences
Bangalore, Karnataka, 560029
About this study
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.
Read the 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.
- Conditions
- Myelopathy, Virtual Reality
- Being tested
- Virtual Reality
- Keywords
- Myelopathy, Virtual Reality, Rehabilitation, Balance
- Medical subject headings
- Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
As described in Experimental arm description.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual Reality |
| Control Group | No intervention | Virtual reality sessions were not provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Secondary outcomes (6)
Difference in Berg Balance Scale (BBS) between groups
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.
Measured: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Difference in Tinetti performance oriented mobility assessment (POMA) between groups
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.
Measured: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Difference in Functional reach test (forward and lateral) between groups
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.
Measured: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Difference in Hospital anxiety and depression scale (HADS) between groups
Hospital anxiety and depression scale. It is a self-assessment scale used to detect anxiety and depression of patients under investigation and treatment in a hospital setting. There are 7 items for anxiety and 7 items for depression. A 4 point scale (0-3) is used for each. "0" indicates a negative response and "3" the highest positive response. The total score is the sum of the anxiety and depression scores. 0-7= non case, 8-10= borderline case, 11+= case.
Measured: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Difference in Spinal cord independence measurement scale (SCIM) between groups
This scale assesses the independence of a spinal cord injury patient in key areas of self-care, respiration and mobility. There are 4 items in 'Self-care', 4 items in 'Respiration and Sphincter management', and 9 items in 'Mobility'. Score of each section is obtained by adding the individual item scores. Total score is 100 obtained from adding the scores of the 3 sections.
Measured: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Difference in Walking Index for Spinal Cord Injury II (WISCI II) between groups
The Walking Index for Spinal Cord Injury. It corporates the extent and nature of assistance requires for walking in spinal cord injury patients. It is an ordinal scale consisting of 21 levels from "0" being unable to walk with all possible support to "20" being "able to walk with no assistive device, brace or support". The score corresponding to the person's ambulatory status is taken.
Measured: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Feb 2018
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhritiman Chakrabarti, National Institute of Mental Health and Neuro Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591497
- Sponsor's protocol ID
- IEC (BS & NS DIV)/2017-18
- Status last verified
- Jul 2018
- First submitted
- 20 Jun 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Virtual Reality in Improving Balance in Patients With Myelopathy
- ClinicalTrials.gov ID
- NCT03591497
- Acronym / sponsor ID
- IEC (BS & NS DIV)/2017-18
- Conditions
- Myelopathy, Virtual Reality
- Keywords
- Myelopathy, Virtual Reality, Rehabilitation, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Virtual RealityInstrument 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. |
| Control Group | No intervention | –Virtual reality sessions were not provided. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with myelopathy with neurological level of injury below C4.
- Both traumatic and non-traumatic myelopathy.
- Duration of illness less than 6 months.
Key exclusion criteria (3 listed)
- Severe orthopedic or medical impairment that interfered with sitting.
- Upper limb muscle power <3/5.
- Cognitive or visual impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityAs described in Experimental arm description. | Other | Intervention Group |
Primary outcome
Change in Berg Balance Scale (BBS)
Time frame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
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.
Change in Tinetti performance oriented mobility assessment (POMA)
Time frame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
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.
Change in Functional reach test (forward and lateral)
Time frame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
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.
6 secondary outcomes
Difference in Berg Balance Scale (BBS) between groups
Time frame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Difference in Tinetti performance oriented mobility assessment (POMA) between groups
Time frame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Difference in Functional reach test (forward and lateral) between groups
Time frame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Difference in Hospital anxiety and depression scale (HADS) between groups
Time frame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Difference in Spinal cord independence measurement scale (SCIM) between groups
Time frame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Difference in Walking Index for Spinal Cord Injury II (WISCI II) between groups
Time frame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Myelopathy
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Myelopathy and Virtual Reality, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Berg Balance Scale (BBS) (time frame: At admission and at discharge from hospital or 24 weeks, whichever is earlier.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.