Vestibular RehabilitationNCT04771169
Vestibular Rehabilitation Verses Virtual Reality on Dizziness, Balance and Gait in Subacute Stroke
A study testing vestibular Training Group and Virtual Reality Group in people with Vestibular Rehabilitation, run by Riphah International University at 1 site in Pakistan.
Trial summary
There is paucity of literature in studying the comparative effects of Vestibular Rehabilitation and Virtual Reality. This study will determine the effects of these interventions on dizziness, balance and gait. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Vestibular Rehabilitation
- What is being tested?
- vestibular Training Group and Virtual Reality Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2021to 31 Dec 2021
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Subacute stroke patients. 1 to 6 months
- Both male and female subacute stroke patients with age 40-70 years.
- Patients with positive Head Thrust Test.
- Patients with Vestibular Disorders.
- Modified Rankin scale score 1-4
- Score >25 on MMSE
Who cannot join
- • Patients presented with neurological condition unrelated to stroke.
- Patients that cannot provide informed consent for study participation.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan General Railway Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: Comparison of Vestibular Rehabilitation With Virtual Reality on Dizziness, Balance and Gait in Subacute Stroke Patients
There is paucity of literature in studying the comparative effects of Vestibular Rehabilitation and Virtual Reality. This study will determine the effects of these interventions on dizziness, balance and gait. This study will also deduce the role of vestibular rehabilitation and Virtual reality in subacute stroke patients
Read the detailed description
Stroke is defined as rapidly developing clinical signs of focal disturbance of cerebral function that lasts more than 24 hours or leading to death. It arises from vascular causes such as cerebral infarction, intracerebral hemorrhage or subarachnoid hemorrhage. Stroke refers to any damage to the brain due to abnormality of blood supply. Stroke patients have difficulty in maintaining balance and postural control because they have asymmetric posture, abnormal body imbalance and difficulty in weight transfer.
Balance is required to maintain posture, to respond to voluntary movements and react to external perturbations. Because of the balance disorders, compensatory movements occur in stroke patients which causes them to consume more energy compared to healthy subjects and causes the development of inefficient walking pattern.
Gait function determines the degree of physical ability of post-stroke patients and their ability to perform independent mobility during activities of daily living (ADL). Stroke patients acquire compensatory abnormal walking pattern as a result of muscular weakness and inability to maintain balance.
Virtual reality rehabilitation systems provide direct sensorial feedback to which a person can respond and interact with environment. VR environments are commonly used in treating, training, and rehabilitation of stroke patients. In virtual reality rehabilitation, the patient moves and performs predetermined tasks as if he is performing the actions in reality.
According to a study conducted by Hyung Young Lee, Virtual reality-based training has been used as therapeutic intervention for functional recovery of stroke patients. It provides a variety of environments based on the requirements of patients that can be selected for recovery.
According to a study conducted by Yurong Mao, Virtual reality balance training provides more realistic proprioceptive and visual input and improves balance and gait function effectively. Virtual reality balance games can be used as an effective tool to train patients with balance dysfunction.
Literature describes Virtual Reality training is effective in improving dynamic balance control and preventing falls in subacute stroke patients. Virtual reality training provides stroke patients with planned and consistent exercises to improve balance and gait by giving visual feedback to directly adjust their wrong weight center and shift visually.
Its reported that Vestibular rehabilitation is frequently used treatment for dizziness and balance problems. Vestibular Rehabilitation is a combination of different exercise components with an aim to improve gaze stability, balance and gait and facilitate somatosensory integration. It is used in treatment of stroke patients to improve dynamic balance by acting on the vestibular system, thus facilitating recovery.
A study indicated that, the main components of vestibular rehabilitation are gaze stabilization exercises to help adapt the VOR function and balance exercises to retrain the vestibulospinal reflex function. Thus, simultaneously measuring changes in the VOR function and gait performance before and after intervention will provide valuable information for rehabilitation.
Vestibular system plays a phase dependent role in gait and is active at certain points in the gait cycle including double support, changing direction, and step termination.
VRT is patient dependent and progression of the exercises depends upon individual patient's sensorimotor, cognitive, and emotional aspects.
- Conditions
- Vestibular Rehabilitation
- Being tested
- vestibular Training Group, Virtual Reality Group
- Keywords
- Dizziness, balance, Subacute stroke
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular Training GroupOther
this Group will receive vestibular Adaptation \& Balance exercises
Virtual Reality GroupOther
This Group will receive Virtual Reality Training by using exergaming.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Training Group | Experimental | This Group will receive vestibular Adaptation and Balance exercises Receives: Other: vestibular Training Group |
| Virtual Reality Group | Active comparator | This Group will receive virtual reality training by using exergaming. Receives: Other: Virtual Reality Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and Go test (TUG):
Timed Up and Go test (TUG) is used to assess balance and mobility in patients with stroke. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
Measured: Change from Baseline mobility and balance to 8 Weeks
Dynamic Gait Index:
DGI quantifies the dynamic balance instability and is a performance based tool. It evaluates the ability of the individual to modify gait in response to changing functions during walking. Its total score is 24.
Measured: Change from Baseline gait and balance to 8 Weeks
Secondary outcomes (1)
Dizziness Handicap Inventory
The Dizziness Handicap Inventory measures the self-perceived level of handicap associated with the symptom of dizziness. Its total score is 100
Measured: Change from Baseline dizziness and balance to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Vestibular RehabilitationStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, MSNMPT, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771169
- Sponsor's protocol ID
- REC/00830 Vishal Sana
- Status last verified
- Jan 2022
- First submitted
- 24 Feb 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chavez LM, Huang SS, MacDonald I, Lin JG, Lee YC, Chen YH. Mechanisms of Acupuncture Therapy in Ischemic Stroke Rehabilitation: A Literature Review of Basic Studies. Int J Mol Sci. 2017 Oct 28;18(11):2270. doi: 10.3390/ijms18112270.
PubMed 29143805Chung EJ, Kim JH, Lee BH. The effects of core stabilization exercise on dynamic balance and gait function in stroke patients. J Phys Ther Sci. 2013 Jul;25(7):803-6. doi: 10.1589/jpts.25.803. Epub 2013 Aug 20.
PubMed 24259857Osoba MY, Rao AK, Agrawal SK, Lalwani AK. Balance and gait in the elderly: A contemporary review. Laryngoscope Investig Otolaryngol. 2019 Feb 4;4(1):143-153. doi: 10.1002/lio2.252. eCollection 2019 Feb.
PubMed 30828632Yom C, Cho HY, Lee B. Effects of virtual reality-based ankle exercise on the dynamic balance, muscle tone, and gait of stroke patients. J Phys Ther Sci. 2015 Mar;27(3):845-9. doi: 10.1589/jpts.27.845. Epub 2015 Mar 31.
PubMed 25931744Kim WI, Choi YK, Lee JH, Park YH. The effect of muscle facilitation using kinesio taping on walking and balance of stroke patients. J Phys Ther Sci. 2014 Nov;26(11):1831-4. doi: 10.1589/jpts.26.1831. Epub 2014 Nov 13.
PubMed 25435710Lee MM, Shin DC, Song CH. Canoe game-based virtual reality training to improve trunk postural stability, balance, and upper limb motor function in subacute stroke patients: a randomized controlled pilot study. J Phys Ther Sci. 2016 Jul;28(7):2019-24. doi: 10.1589/jpts.28.2019. Epub 2016 Jul 29.
PubMed 27512255
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vestibular Rehabilitation With Virtual Reality on Dizziness, Balance and Gait in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT04771169
- Acronym / sponsor ID
- REC/00830 Vishal Sana
- Conditions
- Vestibular Rehabilitation
- Keywords
- Dizziness, balance, Subacute stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 25 Feb 2021 (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.
There is paucity of literature in studying the comparative effects of Vestibular Rehabilitation and Virtual Reality. This study will determine the effects of these interventions on dizziness, balance and gait. This study will also deduce the role of vestibular rehabilitation and Virtual reality in subacute stroke patients
Detailed description
Stroke is defined as rapidly developing clinical signs of focal disturbance of cerebral function that lasts more than 24 hours or leading to death. It arises from vascular causes such as cerebral infarction, intracerebral hemorrhage or subarachnoid hemorrhage. Stroke refers to any damage to the brain due to abnormality of blood supply. Stroke patients have difficulty in maintaining balance and postural control because they have asymmetric posture, abnormal body imbalance and difficulty in weight transfer.
Balance is required to maintain posture, to respond to voluntary movements and react to external perturbations. Because of the balance disorders, compensatory movements occur in stroke patients which causes them to consume more energy compared to healthy subjects and causes the development of inefficient walking pattern.
Gait function determines the degree of physical ability of post-stroke patients and their ability to perform independent mobility during activities of daily living (ADL). Stroke patients acquire compensatory abnormal walking pattern as a result of muscular weakness and inability to maintain balance.
Virtual reality rehabilitation systems provide direct sensorial feedback to which a person can respond and interact with environment. VR environments are commonly used in treating, training, and rehabilitation of stroke patients. In virtual reality rehabilitation, the patient moves and performs predetermined tasks as if he is performing the actions in reality.
According to a study conducted by Hyung Young Lee, Virtual reality-based training has been used as therapeutic intervention for functional recovery of stroke patients. It provides a variety of environments based on the requirements of patients that can be selected for recovery.
According to a study conducted by Yurong Mao, Virtual reality balance training provides more realistic proprioceptive and visual input and improves balance and gait function effectively. Virtual reality balance games can be used as an effective tool to train patients with balance dysfunction.
Literature describes Virtual Reality training is effective in improving dynamic balance control and preventing falls in subacute stroke patients. Virtual reality training provides stroke patients with planned and consistent exercises to improve balance and gait by giving visual feedback to directly adjust their wrong weight center and shift visually.
Its reported that Vestibular rehabilitation is frequently used treatment for dizziness and balance problems. Vestibular Rehabilitation is a combination of different exercise components with an aim to improve gaze stability, balance and gait and facilitate somatosensory integration. It is used in treatment of stroke patients to improve dynamic balance by acting on the vestibular system, thus facilitating recovery.
A study indicated that, the main components of vestibular rehabilitation are gaze stabilization exercises to help adapt the VOR function and balance exercises to retrain the vestibulospinal reflex function. Thus, simultaneously measuring changes in the VOR function and gait performance before and after intervention will provide valuable information for rehabilitation.
Vestibular system plays a phase dependent role in gait and is active at certain points in the gait cycle including double support, changing direction, and step termination.
VRT is patient dependent and progression of the exercises depends upon individual patient's sensorimotor, cognitive, and emotional aspects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Training Group | Experimental | Other: vestibular Training GroupThis Group will receive vestibular Adaptation and Balance exercises |
| Virtual Reality Group | Active comparator | Other: Virtual Reality GroupThis Group will receive virtual reality training by using exergaming. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Subacute stroke patients. 1 to 6 months
Key exclusion criteria (2 listed)
- • Patients presented with neurological condition unrelated to stroke.
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 |
|---|---|---|
| vestibular Training Groupthis Group will receive vestibular Adaptation \& Balance exercises | Other | Vestibular Training Group |
| Virtual Reality GroupThis Group will receive Virtual Reality Training by using exergaming. | Other | Virtual Reality Group |
Primary outcome
Timed up and Go test (TUG):
Time frame: Change from Baseline mobility and balance to 8 Weeks
Timed Up and Go test (TUG) is used to assess balance and mobility in patients with stroke. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
Dynamic Gait Index:
Time frame: Change from Baseline gait and balance to 8 Weeks
DGI quantifies the dynamic balance instability and is a performance based tool. It evaluates the ability of the individual to modify gait in response to changing functions during walking. Its total score is 24.
1 secondary outcome
Dizziness Handicap Inventory
Time frame: Change from Baseline dizziness and balance to 8 Weeks
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 9 Feb 2022.
- Background: PubMed 29143805Chavez LM, Huang SS, MacDonald I, Lin JG, Lee YC, Chen YH. Mechanisms of Acupuncture Therapy in Ischemic Stroke Rehabilitation: A Literature Review of Basic Studies. Int J Mol Sci. 2017 Oct 28;18(11):2270. doi: 10.3390/ijms18112270.
- Background: PubMed 24259857Chung EJ, Kim JH, Lee BH. The effects of core stabilization exercise on dynamic balance and gait function in stroke patients. J Phys Ther Sci. 2013 Jul;25(7):803-6. doi: 10.1589/jpts.25.803. Epub 2013 Aug 20.
- Background: PubMed 30828632Osoba MY, Rao AK, Agrawal SK, Lalwani AK. Balance and gait in the elderly: A contemporary review. Laryngoscope Investig Otolaryngol. 2019 Feb 4;4(1):143-153. doi: 10.1002/lio2.252. eCollection 2019 Feb.
- Background: PubMed 25931744Yom C, Cho HY, Lee B. Effects of virtual reality-based ankle exercise on the dynamic balance, muscle tone, and gait of stroke patients. J Phys Ther Sci. 2015 Mar;27(3):845-9. doi: 10.1589/jpts.27.845. Epub 2015 Mar 31.
- Background: PubMed 25435710Kim WI, Choi YK, Lee JH, Park YH. The effect of muscle facilitation using kinesio taping on walking and balance of stroke patients. J Phys Ther Sci. 2014 Nov;26(11):1831-4. doi: 10.1589/jpts.26.1831. Epub 2014 Nov 13.
- Background: PubMed 27512255Lee MM, Shin DC, Song CH. Canoe game-based virtual reality training to improve trunk postural stability, balance, and upper limb motor function in subacute stroke patients: a randomized controlled pilot study. J Phys Ther Sci. 2016 Jul;28(7):2019-24. doi: 10.1589/jpts.28.2019. Epub 2016 Jul 29.
- Individual participant dataSharing planned: No
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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.
Misbah Ghous, MSNMPT principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vestibular Training Group and Virtual Reality Group in people with Vestibular Rehabilitation, run by Riphah International University at 1 site in Pakistan.
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 6 inclusion and 2 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 9 Feb 2022. 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 Pakistan. 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?
Timed up and Go test (TUG): (time frame: Change from Baseline mobility and balance to 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771169, which also lists 6 linked publications.
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 9 Feb 2022.