Proprioception, Postural BalanceNCT05644847
Effects of Whole Body Vibration Training on Lumbar Proprioception and Postural Stability in Healthy Adults
A study testing Whole Body Vibration Training and Core Stability Training in people with Proprioception, Postural Balance, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Spinal proprioception is integral for maintaining trunk stability during the performance of both static and dynamic tasks. Proprioceptive feedback contributes towards joint position sense and postural stability. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Proprioception, Postural Balance
- What is being tested?
- Whole Body Vibration Training and Core Stability Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2022to 30 Jan 2023
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy young adults aged 18-25 years
- Both males and females willing to participate in the study
- No participation in a regular exercise or physical activity program
- Subjects with fall risk score (FRS) > 1.5 on Biodex balance system
Who cannot join
- Individuals suffering from any acute or chronic co-morbidities of musculoskeletal, neurologic, cardiovascular or systemic origin
- Subjects with history of low back pain or any vestibular disorders, inner ear infections, or hearing loss, which could affect balance and proprioception
- Pregnant females
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Fauji Foundation Hospital Department of Rehabilitation
Rawalpindi, Punjab Province
Dr Naureen Tassadaq, MBBS,FCPS., 03009182210(PA Dr Naureen)
About this study
Spinal proprioception is integral for maintaining trunk stability during the performance of both static and dynamic tasks. Proprioceptive feedback contributes towards joint position sense and postural stability. Several treatment approaches are available for improving proprioception, one such modality is whole body vibration. The evidence supporting the effectiveness of WBV in improving postural stability is scarce. Moreover, the population of interest for this study is healthy adults because this age group is often neglected in the research related to balance and postural stability however incidence of falls in this age group is high as per latest evidence. The aim of this study is to compare the effect of whole-body vibration along with core stability training versus core stability training alone on lumbar proprioception and postural stability in healthy adults.
Read the detailed description
Stability of the lumbar spine is required for static and dynamic functioning in daily life activities. Spinal proprioception is one of the major feedback mechanisms which contribute to spine positioning and trunk stability. Sense of proprioception is processed by the central nervous system based on the afferent information received by mechanoreceptors located in muscle spindles, Golgi tendon organs, and joint capsules. Proprioceptive feedback contributes toward joint position sense which is integral for trunk control, postural stability, and balance. Defective proprioceptive feedback can impair normal coordinated trunk motion which, in turn, can lead to decreased stability and a higher risk of musculoskeletal injury.
Several treatment approaches are available that aim to improve proprioception such as balance board, taping, bracing, manual therapy techniques, etc. However, with recent technological advancements, newer treatment modalities have been introduced that aim to improve joint position sense. One such modality is whole body vibration where the individual is exposed to mechanical vibrations through a device or a vibrating platform. It requires the individual to perform exercises on a platform vibrating between 1-50 Hz. The effects of WBV are currently being studied in the field of rehabilitation. Past research has established the neurophysiological basis of whole-body vibration on proprioception. Studies have demonstrated that training via WBV causes a continuous proprioceptive stimulation which enhances neuromuscular receptivity of the muscle spindle and helps improve muscle function. Existing literature has established the effectiveness of WBV to improve muscle strength, endurance, and power, moreover, it is also suitable for individuals who cannot perform strenuous exercise. However, there is conflicting evidence on the role of WBV on postural stability, and needs further exploration. Core strengthening is already a part of treatment regimens focused on improving trunk stability, and is backed by a vast literature. The current study is focused on comparing the effects of WBV along with core strengthening protocol verse core stability training alone in adults. If WBV is found effective, it can help in providing training protocols using WBV for improving muscle activation among untrained and enhancing performance among trained sports personnel. The main objective of this study is to compare the effect of whole-body vibration along with core stability training versus core stability training alone on lumbar joint position sense error and postural stability in healthy adults. For the purpose of this study, 42 participants meeting the inclusion criteria will be recruited. After baseline assessment participants will be randomly allocated to two groups i.e. Whole-Body Vibration along with core training and core stability training alone. Participants will receive 12 treatment sessions over the course of four weeks after which post treatment assessment of outcome measures will be carried out.
- Conditions
- Proprioception, Postural Balance
- Being tested
- Whole Body Vibration Training, Core Stability Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Body Vibration TrainingOther
WBV training will be performed on a commercial vibrating platform (Healthmate HM01-08VF Gym Fitness Equipment Step Vibration Machine, China), which produces vertical sinusoidal vibrations. Participants in the dynamic WBV group will be provided with dynamic exercises along with WBV training. The vibration speed level will be progressed from level 5 to level 10 during the course of the treatment sessions
Core Stability TrainingProcedure or surgery
Core stability exercises will include pelvic bridge, straight leg bridge, modified kneeling with elbow support and leg lifts and squats, with 60 seconds rest interval between each activity. All these core exercises will be performed on a stable surface and will be progressed in difficulty by increasing the no. of repetitions and no. of sets on a weekly basis. Every session will be preceded by 5 minutes of warm-up and end with 5 minutes of cool-down exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Core Stability Training Group) | Active comparator | Participants in the control group/ core stability training group will be instructed to perform core stability exercises which will include pelvic bridge, straight leg bridge, modified kneeling with elbow support, and leg lifts and squats, with 60 seconds rest intervals between each activity. All these core exercises will be performed on a stable surface and will be progressed in difficulty by increasing the no. of repetitions and no. of sets weekly. Every session will be preceded by 5 minutes of warm-up and end with 5 minutes of cool-down exercises. A total of 12 sessions will be conducted over a period of 04 weeks. Receives: Procedure: Core Stability Training |
| Group B (Whole body Vibration Training Group) | Experimental | Participants in the dynamic WBV group will be provided with dynamic exercises along with WBV training at 50 Hz frequency.
Participants will be instructed to perform 1-3 sets of 5-12 repetitions each of pelvic bridge, straight leg bridge, modified kneeling with elbow support, and leg lifts and squats on the WBV equipment, with a 60-second rest interval between each activity. The vibration speed and no. of sets and repetitions will be increased progressively. A total of 12 sessions will be conducted over a period of 04 weeks. Receives: Other: Whole Body Vibration Training; Procedure: Core Stability Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Proprioception/ Lumbar Joint Position Sense Test
Lumbar Proprioception/ Lumbar Joint Position Sense Test will be measured using inclinometer having excellent validity and reliability. Two inclinometers will be used simultaneously for measuring the flexion and extension ROM. Repositioning accuracy will be assessed with participants trying to reproduce the target position. Active repositioning error i.e. the difference between a target position and the reached position of the patient will be measured. A higher repositioning error indicates poor joint position sense or proprioception.
Measured: 04 Weeks
Secondary outcomes (1)
Postural Stability
Postural stability of participants will be assessed using Biodex balance system SD. Scores for overall stability, anteroposterior and mediolateral stability will be noted for each participant. A higher score indicates poor postural stability.
Measured: 04 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Aug 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proprioception, Postural BalanceStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- Model description
- Single Blinded Parallel Randomised controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644847
- Sponsor's protocol ID
- FUI/CTR/2022/17
- Status last verified
- Nov 2022
- First submitted
- 30 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole Body Vibration Training on Lumbar Proprioception and Postural Stability in Healthy Adults
- ClinicalTrials.gov ID
- NCT05644847
- Acronym / sponsor ID
- FUI/CTR/2022/17
- Conditions
- Proprioception, Postural Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 9 Dec 2022 (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.
Spinal proprioception is integral for maintaining trunk stability during the performance of both static and dynamic tasks. Proprioceptive feedback contributes towards joint position sense and postural stability. Several treatment approaches are available for improving proprioception, one such modality is whole body vibration. The evidence supporting the effectiveness of WBV in improving postural stability is scarce. Moreover, the population of interest for this study is healthy adults because this age group is often neglected in the research related to balance and postural stability however incidence of falls in this age group is high as per latest evidence. The aim of this study is to compare the effect of whole-body vibration along with core stability training versus core stability training alone on lumbar proprioception and postural stability in healthy adults.
Detailed description
Stability of the lumbar spine is required for static and dynamic functioning in daily life activities. Spinal proprioception is one of the major feedback mechanisms which contribute to spine positioning and trunk stability. Sense of proprioception is processed by the central nervous system based on the afferent information received by mechanoreceptors located in muscle spindles, Golgi tendon organs, and joint capsules. Proprioceptive feedback contributes toward joint position sense which is integral for trunk control, postural stability, and balance. Defective proprioceptive feedback can impair normal coordinated trunk motion which, in turn, can lead to decreased stability and a higher risk of musculoskeletal injury.
Several treatment approaches are available that aim to improve proprioception such as balance board, taping, bracing, manual therapy techniques, etc. However, with recent technological advancements, newer treatment modalities have been introduced that aim to improve joint position sense. One such modality is whole body vibration where the individual is exposed to mechanical vibrations through a device or a vibrating platform. It requires the individual to perform exercises on a platform vibrating between 1-50 Hz. The effects of WBV are currently being studied in the field of rehabilitation. Past research has established the neurophysiological basis of whole-body vibration on proprioception. Studies have demonstrated that training via WBV causes a continuous proprioceptive stimulation which enhances neuromuscular receptivity of the muscle spindle and helps improve muscle function. Existing literature has established the effectiveness of WBV to improve muscle strength, endurance, and power, moreover, it is also suitable for individuals who cannot perform strenuous exercise. However, there is conflicting evidence on the role of WBV on postural stability, and needs further exploration. Core strengthening is already a part of treatment regimens focused on improving trunk stability, and is backed by a vast literature. The current study is focused on comparing the effects of WBV along with core strengthening protocol verse core stability training alone in adults. If WBV is found effective, it can help in providing training protocols using WBV for improving muscle activation among untrained and enhancing performance among trained sports personnel. The main objective of this study is to compare the effect of whole-body vibration along with core stability training versus core stability training alone on lumbar joint position sense error and postural stability in healthy adults. For the purpose of this study, 42 participants meeting the inclusion criteria will be recruited. After baseline assessment participants will be randomly allocated to two groups i.e. Whole-Body Vibration along with core training and core stability training alone. Participants will receive 12 treatment sessions over the course of four weeks after which post treatment assessment of outcome measures will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single Blinded Parallel Randomised controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Group A (Core Stability Training Group) | Active comparator | Procedure: Core Stability TrainingParticipants in the control group/ core stability training group will be instructed to perform core stability exercises which will include pelvic bridge, straight leg bridge, modified kneeling with elbow support, and leg lifts and squats, with 60 seconds rest intervals between each activity. All these core exercises will be performed on a stable surface and will be progressed in difficulty by increasing the no. of repetitions and no. of sets weekly. Every session will be preceded by 5 minutes of warm-up and end with 5 minutes of cool-down exercises. A total of 12 sessions will be conducted over a period of 04 weeks. |
| Group B (Whole body Vibration Training Group) | Experimental | Other: Whole Body Vibration Training, Procedure: Core Stability TrainingParticipants in the dynamic WBV group will be provided with dynamic exercises along with WBV training at 50 Hz frequency. Participants will be instructed to perform 1-3 sets of 5-12 repetitions each of pelvic bridge, straight leg bridge, modified kneeling with elbow support, and leg lifts and squats on the WBV equipment, with a 60-second rest interval between each activity. The vibration speed and no. of sets and repetitions will be increased progressively. A total of 12 sessions will be conducted over a period of 04 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy young adults aged 18-25 years
- Both males and females willing to participate in the study
- No participation in a regular exercise or physical activity program
- Subjects with fall risk score (FRS) > 1.5 on Biodex balance system
Key exclusion criteria (3 listed)
- Individuals suffering from any acute or chronic co-morbidities of musculoskeletal, neurologic, cardiovascular or systemic origin
- Subjects with history of low back pain or any vestibular disorders, inner ear infections, or hearing loss, which could affect balance and proprioception
- Pregnant females
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 TrainingWBV training will be performed on a commercial vibrating platform (Healthmate HM01-08VF Gym Fitness Equipment Step Vibration Machine, China), which produces vertical sinusoidal vibrations. Participants in the dynamic WBV group will be provided with dynamic exercises along with WBV training. The vibration speed level will be progressed from level 5 to level 10 during the course of the treatment sessions | Other | Group B (Whole body Vibration Training Group) |
| Core Stability TrainingCore stability exercises will include pelvic bridge, straight leg bridge, modified kneeling with elbow support and leg lifts and squats, with 60 seconds rest interval between each activity. All these core exercises will be performed on a stable surface and will be progressed in difficulty by increasing the no. of repetitions and no. of sets on a weekly basis. Every session will be preceded by 5 minutes of warm-up and end with 5 minutes of cool-down exercises. | Procedure or surgery | Group A (Core Stability Training Group), Group B (Whole body Vibration Training Group) |
Primary outcome
Lumbar Proprioception/ Lumbar Joint Position Sense Test
Time frame: 04 Weeks
Lumbar Proprioception/ Lumbar Joint Position Sense Test will be measured using inclinometer having excellent validity and reliability. Two inclinometers will be used simultaneously for measuring the flexion and extension ROM. Repositioning accuracy will be assessed with participants trying to reproduce the target position. Active repositioning error i.e. the difference between a target position and the reached position of the patient will be measured. A higher repositioning error indicates poor joint position sense or proprioception.
1 secondary outcome
Postural Stability
Time frame: 04 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
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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.
1 site 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 Training and Core Stability Training in people with Proprioception, Postural Balance, run by Foundation University Islamabad 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 4 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: status not confirmed, as of the sponsor's last update on 9 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Ali Tareen, MS* (+923455162228, alikhantareen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar Proprioception/ Lumbar Joint Position Sense Test (time frame: 04 Weeks). 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 9 Dec 2022.