Vibration Therapy as a Rehabilitation Intervention for Postural Training and Fall Prevention After Distal Radius Fracture in Elderly Patients: A Randomized Controlled Trial
Phase: NA
Conditions: Distal Radius Fracture, Fall Patients
Sponsor: Prince of Wales Hospital, Shatin, Hong Kong

 
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Vibration Therapy as a Rehabilitation Intervention for 
Postural Training and Fall Prevention after Distal Radius 
Fracture in Elderly Patients: A Randomized Controlled Trial 
Principal Investigator: WONG, Ronald Man Yeung 
Date: 13/12/17 
 
 
 
 
 
 
 
 
 
 
 
 
 
Research Protocol (version 1.0) 
 

 
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Project Title: Vibration Therapy as a Rehabilitation Intervention for Postural Training 
and Fall Prevention after Distal Radius Fracture in Elderly Patients: A Randomized 
Controlled Trial 
 
Executive 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 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. 100 
patients will be recruited and randomized to control or LMHFV group (n=50 per 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 

 
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basic mobility skills. 
 
Background 
 
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 (1). 
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 (2, 3). 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 (1, 4).  
 
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 (5, 6). This is an important concept as it is well established that these 
patients have an increased risk of falling (7). 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 (8). A recent study has also revealed that older adults have significantly impaired 
postural stability by using objective measurements from computerized instruments (5). 
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 (9). 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 (5). 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 
(10). 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 

 
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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 (11, 12).  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 (13, 14). 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 (15, 16).  
Previous rehabilitation studies have mainly used clinical functional performance tests, 
which lack sensitivity and specificity in predicting impaired postural control in 
osteoporotic patients (17). Therefore, the use of more objective measures to assess 
instability and fall risk derived from computerized instruments have been 
recommended (17, 18). 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 (19, 20).  
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. 
 
Specific Aims and Hypotheses 
 
Aims:  
1. Investigate the effect of LMHFV on postural stability in elderly patients post distal 
radius fracture treatment  
2. To investigate the effect of LMHFV on recurrent falls in elderly patients post distal 
radius fracture treatment 
 
Hypotheses:  
1. LMHFV enhances postural stability in elderly patients post distal radius fracture 
treatment  
2. LMHFV decreases recurrent falls in elderly patients post distal radius fracture 
treatment 

 
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Pilot and/or previous data 
Our previous randomized controlled trial with 710 healthy, active and independent 
postmenopausal women over 60 years old has shown LMHFV, as an intervention for 
18 months, to have significant improvements in reaction time, movement velocity, 
and maximum excursion of balancing ability assessment and also quadriceps muscle 
strength (p<0.001). In addition to these findings, the LMHFV intervention group had 
significantly lower fall or fracture incidences with 18.6% of 334 vibration group 
subjects compared with 28.7% of 327 control group subjects (adjusted HR=0.56, 
p=0.001). The conclusion is that LMHFV was effective in fall prevention with 
improved muscle strength and balancing ability in the elderly (11).  Our recent 
case-control study showed that at 1 year post-intervention of LMHFV for the subjects, 
the muscle strength, balancing ability and quality of life relative to 18 months did not 
show significant differences. Therefore, the benefits of LMHFV were retained 1 year 
after cessation of LMHFV. Our animal studies have also supported the data with 
significant improvement in the LMHFV group to promote myogenic proliferation and 
hypertrophy, muscle contractibility, and fast-fiber switching to fiber type IIA 
compared with the control group (13, 14). 
 
Research design: patients, materials and methods 
This study will be a single-blinded, prospective randomized controlled trial to 
investigate the effect of 6 months of LMHFV on postural stability and fall rates after a 
distal radius fracture. 100 patients will be recruited consecutively for the study with 
consent.  
 
Inclusion criteria: 1) aged 60 or above 2) fracture distal radius after 6 weeks to 3 
months 3) injury was due to unintentional fall. Exclusion criteria: 1) medical 
condition causing balance disturbance 2) participated in supervised regular exercise or 
physiotherapy for twice a week or more 3) Activities of Daily Living (ADL) 
dependent 4) malignancy 5) medications or condition that affect metabolism of the 
musculoskeletal system e.g. bisphosphonates  
 
Randomization: Randomization to either control or LMHFV group (n=50 per group) 
will be performed by envelope drawing of computer-generated random numbers. 
 
LMHFV: Each patient in the intervention group will undergo vibration in community 
centers. The patient will stand upright without knee bending on a specially designed 
vibration platform that provides vertical synchronous vibration at 35Hz, 0.3g (peak to 

 
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peak magnitude), displacement of <0.1mm, 20 min/day, at least 3 days/week for 6 
months. The research staff will instruct the safety issues and operative procedures.  
 
Control group: Each patient in the control group will remain in their habitual life style 
and no vibration machine is used.  
 
Outcome assessments for both groups will be performed at baseline 0 months, 6 
weeks, 3 months and 6 months time-points. The change will be assessed. Outcome 
assessors and the statistician will be blinded to group allocation.  
 
Blinding: Group allocation of the patients will be performed by an independent 
research staff by envelope drawing of computer-generated random numbers. The 
outcome assessor and statistician will be blinded to the group allocation. A central 
technical staff in our Orthopaedics and Traumatology Department will perform all 
measurements. The participants will be reminded not to tell the assessor of their 
allocation. Blinding the subjects is not feasible because the vibration signal from the 
platform is easily felt and placebo is rare in vibration clinical trials (11).  
 
The primary outcomes are the effect of LMHFV on postural stability. To assess the 
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. 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), measuring in degrees, the tilt about each axis. The Limits of Stability (LOS) 
will be assessed, which measures the Directional Control in % and Test Duration in 
seconds, this test is a good indicator of dynamic control. 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 (20).  
 
Secondary outcome is the 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 (11). Additionally, the health-related 
quality of life with a validated Chinese Version of the 36-Item Short-Form Health 
Survey (SF-36) will be assessed. The physical component, mental component and 
total score will be analysed. All scores range from 0 to 100 with a higher score 
indicating better quality of life. In addition the Timed Up and Go (TUG) test will be 
used to test the basic mobility skills. 

 
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Sample size calculation 
Postural stability is used as the primary outcome in this study. As this is the first 
clinical study to evaluate the effects of LMHFV on postural control of distal radius 
fracture patients, we can only use our institute's previous clinical data of LMHFV on 
balancing ability in elderly (11) for reference. In our study, we detected 7.89 mean 
difference in endpoint excursion (key parameter of balancing ability) between two 
groups after treatment. A sample size of 43 in each group will have 80% power to 
detect a significant difference using two-sided independent t-test with a 0.05 
significance level (PASS 11.0, NCSS, LLC, Utah, USA). Our previous clinical trial 
also showed a satisfactory compliance rate of LMHFV (averaged 66%) with a ~15% 
dropout (11). Taking account of the dropout, we further increase the sample size to 
n=50 for each arm (total n=100). 
 
Data Analysis/Statistical analysis 
Data in this study will be analysed according to the intention-to-treat principle. All 
results will be expressed in mean±SD (parametric data). Normality test will be 
performed to determine the normal distribution of data. Independent t-test and 
equivalent non-parametric tests (for non-parametric data) will be performed to 
compare the above parameters between groups. The statistical analysis will be 
performed using SPSS 20.0 (IBM, NY, USA). Significant level is set at p≤0.05 
(2-tailed). 
 
Clinical relevance for Orthopaedic Trauma Patients 
With our aging population and increase in fragility fractures, this study will have a 
large impact for distal radius fractures in the elderly by providing an effective 
rehabilitation intervention to improve postural stability and prevent future falls. 
 
Relevant publications of members of project group 
11. Leung KS, Li CY, Tse YK, Choy TK, Leung PC, Hung VW, et al. Effects of 
18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 
710 community elderly--a cluster-randomized controlled trial. Osteoporosis 
international : a journal established as result of cooperation between the European 
Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA. 
2014;25(6):178-95. 
12. Cheung WH, Li CY, Zhu TY, Leung KS. Improvement in muscle performance 
after one-year cessation of low-magnitude high-frequency vibration in community 
elderly. Journal of musculoskeletal & neuronal interactions. 2016;16(1):4-11. 

 
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13. Guo AY, Leung KS, Qin JH, Chow SK, Cheung WH. Effect of Low-Magnitude, 
High-Frequency Vibration Treatment on Retardation of Sarcopenia: 
Senescence-Accelerated Mouse-P8 Model. Rejuvenation research. 
2016;19(4):293-302. 
14. Sun KT, Leung KS, Siu PM, Qin L, Cheung WH. Differential effects of 
low-magnitude high-frequency vibration on reloading hind-limb soleus and 
gastrocnemius medialis muscles in 28-day tail-suspended rats. Journal of 
musculoskeletal & neuronal interactions. 2015;15(4):316-24. 
15. Cheung WH, Mok HW, Qin L, Sze PC, Lee KM, Leung KS. High-frequency 
whole-body vibration improves balancing ability in elderly women. Archives of 
physical medicine and rehabilitation. 2007;88(7):852-7. 
 
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Karantana A, Downing ND, Forward DP, Hatton M, Taylor AM, Scammell BE, 
et al. Surgical treatment of distal radial fractures with a volar locking plate versus 
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bone and joint surgery American volume. 2013;95(19):1737-44. 
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