Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001360505
Ethics application status
Approved
Date submitted
18/10/2024
Date registered
13/11/2024
Date last updated
13/11/2024
Date data sharing statement initially provided
13/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can Self-Applied Local Vibration Help Older Adults Improve Their Balance?
Scientific title
Does Self-Applied Local Vibration Improve Dynamic Balance in Older Adults?
Secondary ID [1] 312555 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance 334452 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331072 331072 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name
Self-Applied Local Vibration Therapy

Description of Intervention(s) / Exposure

Intervention Arm: Self-Applied Local Vibration Therapy

Physical or Informational Materials:
- Vibration Device: the ‘General Purpose Massager', manufactured by Dr Graeme Massagers (Bairnsdale, Australia). This handheld device has a single flat applicator head and has vibration "speeds" ranging from 38 to 64 Hz. During the trial the "slow speed" setting of 38 Hz will be used.
- Instruction Sheet: Detailing the protocol for safely and correctly applying the vibration therapy to the lower limbs.
- Instructional video: Demonstrating the protocol for safely and correctly applying the vibration therapy to the lower limbs.
- Diary: For participants to log their application of the therapy and any significant health information.
- Participant Information Sheet and Consent Form: Provided during recruitment and initial screening.

Procedures, Activities, and Processes:
- Training Session: Participants will receive an initial training session on how to use the vibration device safely and effectively.
- Application Protocol: Participants will apply the vibration therapy to their lower limbs for approximately 2 minutes each day for 6 weeks.
- Health and Lifestyle Data Collection: Participants will provide baseline and follow-up health and lifestyle data at specified intervals during the study (at the start of the study, at the six week point and then again at 12 weeks).
- ABC Scale: Participants will complete the Activities-specific Balance Confidence Scale, a short 15-item questionnaire, which asks people to rate what they feel their 'balance confidence' would be when performing various activities.
- Four-Square Step Test: Participants will perform this test, which involves stepping in a clockwise and anticlockwise direction through four squares, with the overall movement timed by an assessor. This test will serve as the primary outcome measure for assessing improvements in dynamic balance.
- Vibration Sensation Testing: Participants will undergo vibration sensation testing using a 128Hz tuning fork applied to successive bony points on the legs, starting from the toes and moving upwards. The point at which the participant first perceives the vibration will be recorded.

Delivery:
- Who Will Deliver the Intervention: The initial training will be provided by a trained investigator, who has over 15 years of experience in assessing and treating balance disorders.
- Mode of Delivery: The training will be conducted face-to-face during the initial visit to the study centre. Subsequent application of the intervention will be self-administered by participants at home.
- Frequency and Duration: A group of participants will apply the vibration therapy daily for 6 weeks while a second group does not. After the initial 6-week period, there will be a re-assessment and crossover, and the second group will start their 6-week application period while the first group stops. A final reassessment will occur at 12 weeks. Total duration for each participant's involvement in the study will be 12 weeks.
- When in the vibration application stage, the participant will apply the vibration to four points on the thigh, two on the lower leg and one on the sole of the foot of each leg. Vibration will be applied at each point for approximately 10 seconds. This will be done once a day at a time chosen by the participant.

Location:
- Initial Training and Assessments: Conducted at the RMIT University Bundoora campus.
- Daily Intervention: Conducted at the participants' homes.

Personalisation:
- Adaptation: The intervention is standardised and not personalised, as the application protocol is the same for all participants.

Adherence and Fidelity:
- Assessment of Adherence: Participants will maintain a diary to log the daily application of the vibration therapy, noting the time of application and any significant health changes or events.
- Strategies to Maintain Fidelity: Follow-ups and reminders will be provided to ensure participants adhere to the intervention protocol at the six-week and twelve-week points. Participants will receive additional instructions and support from an investigator if they report any difficulties or concerns. This additional support may be delivered by email, phone or if necessary, in person. A final check-in session will be conducted at the study centre to reinforce the protocol and address any issues.
Intervention code [1] 329069 0
Treatment: Devices
Comparator / control treatment
This crossover design means that each participant will experience both the intervention (vibration therapy) and the control (no therapy) phases, allowing them to serve as their own control. This helps to minimise the variability in the results and provides a clearer comparison of the effects of the vibration therapy on balance. Once each group has completed the initial 6-week phase, they will be immediately be re-assessed, and commence the Crossover Phase (the Second 6 Weeks). There is no 'wash out' period between the two phases of the study.

Initial Phase (First 6 Weeks):
Group 1: No vibration therapy.
Group 2: Daily self-applied local vibration therapy.

Crossover Phase (Second 6 Weeks):
Group 1: Begins daily self-applied local vibration therapy.
Group 2: Stops vibration therapy and receives no further therapy.

This approach allows for a direct comparison within the same individual between the period of receiving the intervention and the period of not receiving the intervention, thus enhancing the reliability of the results..
Control group
Active

Outcomes
Primary outcome [1] 338834 0
Time taken to complete the Four-Square Step Test (FSST), which is a test of dynamic balance.
Timepoint [1] 338834 0
Assessments will be conducted at three key timepoints during the study to evaluate the effects of the intervention on participants' balance and confidence. These timepoints are: 1) the initial Baseline assessment (the Primary timepoint), 2) 6 weeks after the Baseline assessment, and 3) 12 weeks after the Baseline assessment.

The first assessment will occur at baseline, prior to the commencement of any intervention. Both groups will undergo initial measurements of their balance and confidence levels before starting the study. This provides a starting point to compare future changes.

The second assessment will take place six weeks after the study commencement, marking the end of the first phase. At this timepoint, Group 1, which has not yet received the vibration therapy, and Group 2, which has been using the vibration therapy, will both undergo assessments. This allows for a comparison of balance and confidence between the two groups after one has received the intervention and the other has not.

The final assessment will occur twelve weeks after the study commencement, at the end of the second phase. By this point, Group 1 will have completed six weeks of vibration therapy, and Group 2 will have completed their six weeks without therapy. Assessments at this timepoint will enable the comparison of changes within each group before and after their respective intervention periods.
Secondary outcome [1] 437654 0
Percentage score on the Activities-specific Balance Confidence (ABC) Scale
Timepoint [1] 437654 0
Baseline, 6 weeks after study commencement, and 12 weeks after study commencement as described in detail above.
Secondary outcome [2] 437655 0
Vibration Sensation Threshold
Timepoint [2] 437655 0
Baseline, 6 weeks after study commencement, and 12 weeks after study commencement as described in detail above.

Eligibility
Key inclusion criteria
Aged of 65 years and over,
Conversant in English,
Able to stand upright without losing balance for one minute without the aid of a physical device (for example a walker or a stick),
In the opinion of the researchers has the cognitive capacity to a) understand the requirements of the study and give consent, and b) be able to safely undertake the activities required in the study,
Both people who have suffered two or more falls in the past 12 months (fallers) and non-fallers will be included, and
Willing and able to attend the RMIT Bundoora West campus for the required assessments.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently receiving care/treatment for balance and/or falls or falling from a healthcare professional,
Undertaking an exercise programme for the improvement of balance or reducing the risk of falling,
Receiving vibration therapy for any condition,
Recent injury or conditions such as ulcers or Clinical impact, Etiology, Anatomy and Pathophysiology (CEAP) Grade 2 (1) or greater varicose veins on the lower limbs,
Currently taking anticoagulant (blood thinning) medication or suffering from a medically diagnosed blood clotting disorder, Medically diagnosed Parkinson’s disease or other neurological conditions,
Participant identified medically diagnosed moderate or severe osteoporosis
Chronic pain (> 3months) in the lower extremities that interferes with standing and walking,
Residing in an aged care facility or hospital,
Use of a walking assistance devices such as a frame or cane (ongoing regular use or occasional use within the last month) Use of an orthotic device on the lower limbs (except simple arch supports), or
Participation in a clinical trial in the last 30 days.

1. Wright N, Fitridge R. Varicose veins: Natural history, assessment and management. Australian Family Physician. Accessed May 31, 2024. https://www.racgp.org.au/afp/2013/june/varicose-veins

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation with stratification using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/11/2024
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316981 0
University
Name [1] 316981 0
RMIT University
Country [1] 316981 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Country
Australia
Secondary sponsor category [1] 319228 0
None
Name [1] 319228 0
Address [1] 319228 0
Country [1] 319228 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315735 0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Ethics committee address [1] 315735 0
Ethics committee country [1] 315735 0
Australia
Date submitted for ethics approval [1] 315735 0
04/07/2024
Approval date [1] 315735 0
08/10/2024
Ethics approval number [1] 315735 0
2024-27725-25798

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135646 0
Dr Dein Vindigni
Address 135646 0
RMIT University, 225-245 Plenty Rd, Bundoora VIC 3083
Country 135646 0
Australia
Phone 135646 0
+61 399257311
Fax 135646 0
Email 135646 0
dein.vindigni@rmit.edu.au
Contact person for public queries
Name 135647 0
Matthew Holmes
Address 135647 0
RMIT University, 225-245 Plenty Rd, Bundoora VIC 3083
Country 135647 0
Australia
Phone 135647 0
+61 399257311
Fax 135647 0
Email 135647 0
S9110994@student.rmit.edu.au
Contact person for scientific queries
Name 135648 0
Dein Vindigni
Address 135648 0
RMIT University, 225-245 Plenty Rd, Bundoora VIC 3083
Country 135648 0
Australia
Phone 135648 0
+61 399257311
Fax 135648 0
Email 135648 0
dein.vindigni@rmit.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.