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Can Self-Applied Local Vibration Help Older Adults Improve Their Balance?

Does Self-Applied Local Vibration Improve Dynamic Balance in Older Adults?

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001360505
Enrollment
30
Registered
2024-11-13
Start date
2024-11-20
Completion date
2025-02-28
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to evaluate whether local vibration therapy self-applied to the lower limbs can improve balance in older adults. Participants will use a handheld vibration device on their lower limbs daily for six weeks. Their balance will be measured using the Four-Square Step Test and what they feel their 'balance confidence' in would be when performing various activities will be measured with the Activities-specific Balance Confidence Scale. We hypothesise that this therapy will improve balance and increase confidence. The results could provide a simple, cost-effective method to help older adults improve their balance.

Interventions

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: Detailin

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.

Sponsors

RMIT University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
Yes

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026