Elderly PopulationNCT05060042
Comparison of Whole Body Vibration With Bilateral Proprioceptive Training in Elderly
A study testing Whole body vibration group and Bilateral proprioceptive training in people with Elderly Population, run by Riphah International University at 2 sites in Pakistan.
Trial summary
The aim of this study is to conduct a randomized controlled trail to compare and analyze the effects of both whole body vibrator (WBV) and proprioceptive training through Tai Chi program on static and dynamic postural balance variables of the elderly population. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Elderly Population
- What is being tested?
- Whole body vibration group and Bilateral proprioceptive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Oct 2021to 31 Mar 2022
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with balance and proprioception problems
- Those having BBS score between 21-54
- Intact cognition: MMSE >25
Who cannot join
- Subjects with recent trauma or any other neurodegenerative disorder.
- Subjects with cognitive and hearing impairments
- Subjects who cannot follow my command.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Misbah Ghous
Rawalpindi, Islamabad, 46000
Pakistan General Railway Hospital
Rawalpindi, Islamabad, 46000
About this study
Official title: Comparison of Whole Body Vibration With Bilateral Proprioceptive Training in Elderly Population
The aim of this study is to conduct a randomized controlled trail to compare and analyze the effects of both whole body vibrator (WBV) and proprioceptive training through Tai Chi program on static and dynamic postural balance variables of the elderly population. The purpose of the study is to determine that whether whole body vibrator is more evident or proprioceptive training is more effective for promoting functional independency and improving balance in older adults. Hence distinguishing choices to prevent fall and advancing functional independency by using the appropriate intervention without using extreme loads.
Read the detailed description
Elderly population is defined as 'people aged 65 or above'. Aging is a complex and challenging process of physiological changes and it is associated with decline of biological functions. Increasing age is linked with impairments in visual, proprioception, vestibular systems, decline in muscular strength and control of the lower limbs, balance/postural control, and of the mobility patterns which are known to be substantial hazards for fall, and these parameters have been found to be dynamically more disabled with getting older. Among all these factors, there is obvious decline in normal functioning and balance related issues, common in elderly population due to proprioceptive function loss that is the person is unable to sense his joint position and motion which ultimately results in mobility impairments.
Therefore, researchers have been looking for new approaches that are more feasible to improve the independence and physical mobility in older individuals and over the past decade the whole body vibrator (WBV) have been seeking attention for the beneficence of the elderly population. It is a neuromuscular training modality used to improve muscle strength, power, balance, mobility, cardiorespiratory rehabilitation, improves neuromuscular and musculoskeletal functions and general health both in healthy and as well as in orthopedic patients and neurologically diseased elderly population .Bilateral proprioceptive training is also used for impaired balance, proprioception loss and decreased ROM in elderly population. Proprioceptive receptors are present in our skin, muscles, tendons and joints with the help of which we can sense position and movement of limbs and trunk, sense of force and sense of heaviness in the absence of vision. The mechanoreceptors of the proprioception cause activation of central nervous system by initiating action potential through release of stored sodium in to the cells, this afferent sensory stimuli to the central nervous system is essential for the control of body movements
- Conditions
- Elderly Population
- Being tested
- Whole body vibration group, Bilateral proprioceptive training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibration groupOther
WBV will be provided with a frequency of 6-26Hz with amplitude of 1-3mm 4-5 bouts(60 sec each) for 3 times a week
Bilateral proprioceptive trainingOther
Static balance training will be provided in first week for 3-4 times for 10 mints of single session. 3 times a week In 2nd and 3rd week dynamic balance training for 3 times with a session of 10 mints.
In 4th week progressive balance training will be done with same frequency and duration.
Tai chai exercises will be given for 20 mints 3 times a week
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration group | Experimental | WBV will be provided with a frequency of 6-26Hz with amplitude of 1-3mm 4-5 bouts(60 sec each) for 3 times a week. Receives: Other: Whole body vibration group |
| Bilateral proprioceptive training Group | Active comparator | Static balance training will be provided in first week for 3-4 times for 10 mints of single session. 3 times a week In 2nd and 3rd week dynamic balance training for 3 times with a session of 10 mints.
In 4th week progressive balance training will be done with same frequency and duration.
Tai chai exercises will be given for 20 mints 3 times a week Receives: Other: Bilateral proprioceptive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time up and go test
The assessment of functional mobility in community dwelling elderly population, is assessed precisely by a balance test called time up and go test.Time taken to complete the task is actually indicating the level of functional mobility. An elder participant taking less than 20 seconds to complete the task have been shown to be independent in ADLs. Time taken more than 30 seconds by an older subject, indicates more dependent in ADLs and requires assistive devices for ambulation.
Measured: Change from Baseline balance to 8th Weeks
Performance-Oriented Mobility Assessment (POMA):
- The Tinetti Performance Oriented Mobility Assessment (POMA) is a widely used clinical assessment tool that gives an insight into the abnormalities in balance and gait, and it has the ability to predict fall risk in elderly population.• This scale has a total maximum score of 28 in which there is 12 score of gait assessment and 16 score of balance assessment. The overall score of 25-28 indicates low fall risk, 19-24 represents moderate fall risk and <19 means there is high risk of fall in suspected elderly population. This scale has been declared has a valid and reliable tool to assess balance and gait impairments
Measured: Change from Baseline balance and gait to 8th Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 Oct 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PopulationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah ghous, MS, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060042
- Sponsor's protocol ID
- Aneela Riaz
- Status last verified
- Dec 2022
- First submitted
- 17 Sep 2021
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Whole Body Vibration With Bilateral Proprioceptive Training in Elderly Population
- ClinicalTrials.gov ID
- NCT05060042
- Acronym / sponsor ID
- Aneela Riaz
- Conditions
- Elderly Population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 28 Sep 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.
The aim of this study is to conduct a randomized controlled trail to compare and analyze the effects of both whole body vibrator (WBV) and proprioceptive training through Tai Chi program on static and dynamic postural balance variables of the elderly population. The purpose of the study is to determine that whether whole body vibrator is more evident or proprioceptive training is more effective for promoting functional independency and improving balance in older adults. Hence distinguishing choices to prevent fall and advancing functional independency by using the appropriate intervention without using extreme loads.
Detailed description
Elderly population is defined as 'people aged 65 or above'. Aging is a complex and challenging process of physiological changes and it is associated with decline of biological functions. Increasing age is linked with impairments in visual, proprioception, vestibular systems, decline in muscular strength and control of the lower limbs, balance/postural control, and of the mobility patterns which are known to be substantial hazards for fall, and these parameters have been found to be dynamically more disabled with getting older. Among all these factors, there is obvious decline in normal functioning and balance related issues, common in elderly population due to proprioceptive function loss that is the person is unable to sense his joint position and motion which ultimately results in mobility impairments.
Therefore, researchers have been looking for new approaches that are more feasible to improve the independence and physical mobility in older individuals and over the past decade the whole body vibrator (WBV) have been seeking attention for the beneficence of the elderly population. It is a neuromuscular training modality used to improve muscle strength, power, balance, mobility, cardiorespiratory rehabilitation, improves neuromuscular and musculoskeletal functions and general health both in healthy and as well as in orthopedic patients and neurologically diseased elderly population .Bilateral proprioceptive training is also used for impaired balance, proprioception loss and decreased ROM in elderly population. Proprioceptive receptors are present in our skin, muscles, tendons and joints with the help of which we can sense position and movement of limbs and trunk, sense of force and sense of heaviness in the absence of vision. The mechanoreceptors of the proprioception cause activation of central nervous system by initiating action potential through release of stored sodium in to the cells, this afferent sensory stimuli to the central nervous system is essential for the control of body movements
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration group | Experimental | Other: Whole body vibration groupWBV will be provided with a frequency of 6-26Hz with amplitude of 1-3mm 4-5 bouts(60 sec each) for 3 times a week. |
| Bilateral proprioceptive training Group | Active comparator | Other: Bilateral proprioceptive trainingStatic balance training will be provided in first week for 3-4 times for 10 mints of single session. 3 times a week In 2nd and 3rd week dynamic balance training for 3 times with a session of 10 mints. In 4th week progressive balance training will be done with same frequency and duration. Tai chai exercises will be given for 20 mints 3 times a week |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with balance and proprioception problems
- Those having BBS score between 21-54
- Intact cognition: MMSE >25
Key exclusion criteria (3 listed)
- Subjects with recent trauma or any other neurodegenerative disorder.
- Subjects with cognitive and hearing impairments
- Subjects who cannot follow my command.
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 |
|---|---|---|
| Whole body vibration groupWBV will be provided with a frequency of 6-26Hz with amplitude of 1-3mm 4-5 bouts(60 sec each) for 3 times a week | Other | Whole body vibration group |
| Bilateral proprioceptive trainingStatic balance training will be provided in first week for 3-4 times for 10 mints of single session. 3 times a week In 2nd and 3rd week dynamic balance training for 3 times with a session of 10 mints. In 4th week progressive balance training will be done with same frequency and duration. Tai chai exercises will be given for 20 mints 3 times a week | Other | Bilateral proprioceptive training Group |
Primary outcome
Time up and go test
Time frame: Change from Baseline balance to 8th Weeks
The assessment of functional mobility in community dwelling elderly population, is assessed precisely by a balance test called time up and go test.Time taken to complete the task is actually indicating the level of functional mobility. An elder participant taking less than 20 seconds to complete the task have been shown to be independent in ADLs. Time taken more than 30 seconds by an older subject, indicates more dependent in ADLs and requires assistive devices for ambulation.
Performance-Oriented Mobility Assessment (POMA):
Time frame: Change from Baseline balance and gait to 8th Weeks
• The Tinetti Performance Oriented Mobility Assessment (POMA) is a widely used clinical assessment tool that gives an insight into the abnormalities in balance and gait, and it has the ability to predict fall risk in elderly population.• This scale has a total maximum score of 28 in which there is 12 score of gait assessment and 16 score of balance assessment. The overall score of 25-28 indicates low fall risk, 19-24 represents moderate fall risk and <19 means there is high risk of fall in suspected elderly population. This scale has been declared has a valid and reliable tool to assess balance and gait impairments
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 12 Dec 2022.
- 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, MS principal investigator
Riphah International University Islamabad
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration group and Bilateral proprioceptive training in people with Elderly Population, run by Riphah International University at 2 sites 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 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Time up and go test (time frame: Change from Baseline balance to 8th 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?
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 12 Dec 2022.