An interventional study of Low-magnitude high-frequency vibration (LMHFV) in Distal Radius Fracture and Fall Patients, sponsored by Prince of Wales Hospital, Shatin, Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Prince of Wales Hospital, Shatin, Hong Kong · Not applicable, Interventional, and Treatment
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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.
Distal Radius Fractures and Medico-socioeconomic Impact
Fractures of the distal radius account for approximately 380,000 fractures in the United States each year and occur in 15% of women older than 50 years of age. 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. Over the past 10 years, there has been increased popularity of surgical interventions for the treatment of distal radius fractures, especially with the introduction of volar locking plates in 2000. Current medical costs for distal radius fractures are estimated to exceed USD 535 million each year and projected to rise as the incidence and use of internal fixation increases.
The Concept of Impaired Postural Stability and Prevention of Fall
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. 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. Studies have shown a significantly increased degree of postural sway in patients with distal radius fractures, in both anteroposterior and lateral directions, which is strongly characterized in older subjects for recurrent falls. A recent study has also revealed that older adults have significantly impaired postural stability by using objective measurements from computerized instruments. Despite on-going studies on distal radius fractures, the latest Cochrane systematic review shows a lack of evidence on the effectiveness of current rehabilitation interventions. The American Academy of Orthopaedic Surgeons (AAOS) position statement also recommends patients with fragility fractures to undergo evaluation of osteoporosis and treatment to prevent future fractures. Notably, there are no recommendations on the role of balance training or physical conditioning. Consequently, the evaluation and treatment of fall risks have been largely overlooked. Further research that target rehabilitation and treat postural instability after distal radius fracture to reduce fall rates are therefore warranted.
Low-magnitude High-Frequency Vibration as a Rehabilitation Intervention to Improve Postural Instability and Prevent Fall
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 institute's study. Furthermore, our animal studies have also shown the ability of LMHFV to promote myogenic proliferation and hypertrophy, muscle contractibility, and increase fast-fiber switching to muscle fiber type IIA compared with control. Numerous other studies have reported whole body vibration to have positive effects on blood circulation in lower extremities and enhanced muscle performance including muscle strength in the elderly.
Previous rehabilitation studies have mainly used clinical functional performance tests, which lack sensitivity and specificity in predicting impaired postural control in osteoporotic patients. Therefore, the use of more objective measures to assess instability and fall risk derived from computerized instruments have been recommended. The Biodex Balance System SD (Biodex Medical Systems Inc, Shirley, NY) consists of a dynamic balance platform interfaced with computer software that provides up to 20° tilt from horizontal in a 360° range of motion. The system offers objective and reliable tests for postural stability and fall risk, which have been shown in multiple studies and in elderly patients.
In order to provide effective rehabilitation regimens for our patients, the validation of our interventions using objective outcomes is essential. To our knowledge, this is the first study to use an objective device to assess and validate our rehabilitation tool to prevent falls in patients after a distal radius fracture.
330 studies on the registry are indexed under Wrist Fractures; 72 are open to participants now.
This study's enrollment of 232 is above the median of 63 across 265 interventional studies indexed under Wrist Fractures.
Browse Wrist Fractures studies →Prince of Wales Hospital, Shatin, Hong Kong is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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Control group will remain in their habitual life style and no vibration used
The intervention group will undergo Low-magnitude high-frequency vibration (LMHFV) at 35Hz, 0.3g (peak to peak magnitude), displacement of \<0.1mm, 20 min/day, at least 3 times per week, for 6 months in community centres
Device: Low-magnitude high-frequency vibration (LMHFV)
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.
Effect of LMHFV on postural stability
To assess the postural stability, the Biodex Balance System SD is used to measure the ability of the subjects to maintain the center of balance. The Biodex Balance System SD has been shown to be a reliable tool for objective assessment of postural stability in several studies for elderly patients.
Time frame: 0 days, 6 weeks, 3 months and 6 months. Change is being assessed
Occurrence of fall for the patients in both groups
To assess the occurrence of fall, subjects are required to self-report these events via a fall calendar, which has to be returned at every follow-up visit. Calendar reporting has been well proven to be reliable for fall studies
Time frame: 0 days, 6 weeks, 3 months and 6 months. Change is being assessed
Health-related quality of life
Health-related quality of life with a validated Chinese Version of the 36-Item Short-Form Health Survey (SF-36) will be used. All scores range from 0 to 100 with a higher score indicating better quality of life.
Time frame: 0 days, 6 weeks, 3 months and 6 months. Change is being assessed
Timed Up and Go (TUG) test
Timed Up and Go (TUG) test will be used to test the basic mobility skills.
Time frame: 0 days, 6 weeks, 3 months and 6 months. Change is being assessed
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Ran from Dec 2017 to primary completion in Mar 2023, 63 months.
Of 126 non-industry interventional studies with no phase under Wrist Fractures, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's 63 months is above that.
Counting every sponsor, half of 127 studies reached it within 25 months; a quarter within 16 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Prince of Wales Hospital, Shatin, Hong Kong