A study protocol for a randomized controlled trial evaluating vibration therapy as an intervention for postural training and fall prevention after distal radius fracture in elderly patients

Abstract

Background: Fractures of the distal radius are one of the most common osteoporotic fractures in elderly men and women. These fractures are a particular health concern amongst the elderly, who are at risk of fragility fractures, and are associated with long-term functional impairment, pain and a variety of complications. This is a sentinel event, as these fractures are associated with a two to four times increased risk of subsequent hip fractures in elderly patients. This is an important concept, as it is well established that these patients have an increased risk of falling. Fall prevention is therefore crucial to decrease further morbidity and mortality. The purpose of this study is to investigate the effect of low-magnitude high-frequency vibration (LMHFV) on postural stability and prevention of falls in elderly patients post distal radius fracture.Methods: This is a prospective single-blinded randomized controlled trial. Two hundred patients will be recruited consecutively with consent, and randomized to either LMHFV (n = 100) or a control group (n = 100). The primary outcome is postural stability measured by the static and dynamic ability of patients to maintain centre of balance on the Biodex Balance System SD. Secondary outcomes are the occurrence of fall(s), the health-related quality of life 36-item short form instrument, the Timed Up and Go test for basic mobility skills, compliance and adverse events. Outcome assessments for both groups will be performed at baseline (0 month) and at 6 weeks, 3 months and 6 months time points. Discussion: Previous studies have stressed the importance of reducing falls after distal radius fracture has occurred in elderly patients, and an effective intervention is crucial. Numerous studies have proven vibration therapy to be effective in improving balancing ability in normal patients; However, no previous study has applied the device for patients with fractures. Our study will attempt to translate LMHFV to patients with fractures to improve postural stability and prevent recurrent falls. Positive results would provide a large impact on the prevention of secondary fractures and save healthcare costs. Trial registration: ClinicalTrials.gov, NCT03380884. Registered on 21 December 2017.

Does Low-Magnitude High-Frequency Vibration (LMHFV) Worth for Clinical Trial on Dental Implant? A Systematic Review and Meta-Analysis on Animal Studies

“…At this stage, LMHFV clinical promotion is limited as follows: (Leung et al, 2014 ; Wong et al, 2020 ): (1) Lack of large-scale multi-center clinical RCTs; (2) Unknown exact instruction for jaw bone application; (3) Long treatment period; (4) High medical cost; (5) Lack of follow-up from professional guidance.…”

Vibration therapy as an intervention for enhancing trochanteric hip fracture healing in elderly patients: a randomized double-blinded, placebo-controlled clinical trial

“…Patients will be actively screened and recruited from the Department of Orthopaedics and Traumatology, Prince of Wales Hospital, Hospital Authority, Hong Kong, based on inclusion and exclusion criteria. According to our previously established protocol [ 22 ], a computer-generated set of random allocations are sealed in consecutively numbered opaque envelopes by an independent central technician. Once consent is obtained, the patient is randomized and assigned into either vibration or placebo group by opening the next sealed envelope by a specific staff member.…”

“…Patients will be randomly allocated to placebo or vibration group [ 22 ]. Vibration is treated with LMHFV (V-health Ltd, Hong Kong) at 35 Hz, 0.3 g ( g = gravitational acceleration) for 20 min/day, 5 times/week [ 17 ], while the placebo group will have sham treatment to stand on the LMHFV platform for 20 min/day, 5 times/week.…”

“…To assess balancing ability, the Biodex Balance System SD (Biodex Medical Systems Inc., Shirley, NY, USA) is used to measure the static and dynamic ability of patients to maintain center of balance. The score generated by the machine assesses the deviation from the center via an Overall Stability Index (OSI), Anterior/Posterior Stability Index (APSI), and Medial/Lateral Stability Index (MLSI), which have been shown to be reliable tools for objective assessment of postural stability in several studies in elderly patients [ 22 ].…”

“…The patient will stand from a chair, walk 3 m, and travel back and sit back on the chair. The time in seconds (s) is recorded [ 22 ].…”