CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 232 enrolled
Drug / intervention
Low-magnitude high-frequency vibration (LMHFV)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03380884
NCT03380884N/ACompleted

Vibration Therapy as a Rehabilitation Intervention for Postural Training and Fall Prevention After Distal Radius Fracture in Elderly Patients: A Randomized Controlled Trial

Prince of Wales Hospital, Shatin, Hong Kong·interventional·Posted Dec 21, 2017·Updated Apr 4, 2024

In Brief

A clinical study evaluating Low-magnitude high-frequency vibration (LMHFV) for Distal Radius Fracture and Fall Patients. Completed, enrolled 232 participants across 1 site.

Detailed Summary

The occurrence of distal radius fractures is well known to be a sentinel event as these fractures are associated with 2 to 4 times increased risk of subsequent hip fractures in elderly patients. Studies have shown a significantly increased degree of postural sway in these patients, which is strongly associated with recurrent falls. The latest Cochrane systematic review also shows a lack of evidence on the effectiveness of current rehabilitation interventions. Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and has been shown to improve muscle strength and balancing abilities in healthy, independent and active elderly women in our previous clinical study. Our animal studies have also shown LMHFV promoting myogenic proliferation and hypertrophy, muscle contractibility, and increased fast-fiber switching to muscle fiber type IIA.Previous rehabilitation studies have used clinical functional performance tests, which lack sensitivity and specificity in predicting impaired postural control. The Biodex Balance System SD consists of a dynamic balance platform interfaced with computer software, which offers objective and reliable tests for postural stability and fall risk. This study is a single-blinded, prospective randomized controlled trial to investigate the effect of 6 months of LMHFV after a distal radius fracture in elderly patients. Patients will be recruited and randomized to control or LMHFV group by envelope drawing of computer-generated random numbers. The intervention group will undergo LMHFV at 35Hz, 0.3g (peak to peak magnitude), displacement of \<0.1mm, 20 min/day, at least 3 days/week for 6 months in community centres. Control group will remain in their habitual life style and no vibration used. Outcome assessments will be performed at baseline 0 days, 6 weeks, 3 months and 6 months. Outcome assessor and statistician will be blinded to group allocation. The primary outcome is the effect of LMHFV on postural stability. The Biodex Balance System SD is used to measure the static and dynamic ability of the subjects to maintain the center of balance. Secondary outcomes are the occurrence of fall for the patients in both groups, the health-related quality of life (SF-36), and Timed Up and Go test for basic mobility skills.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHong Kong

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 21, 2017
Enrollment StartDec 1, 2017
Primary CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 8.5 years ago

Interventions

Low-magnitude high-frequency vibration (LMHFV)device

Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and has been reported to have no adverse effect.