Vibration Therapy as a Rehabilitation Intervention for Postural Training and Fall Prevention

April 2, 2024 updated by: Ronald Man Yeung WONG, Prince of Wales Hospital, Shatin, Hong Kong

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Sha Tin, Hong Kong
        • Department of Orthopaedics and Traumatology, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control group will remain in their habitual life style and no vibration used
Experimental: Vibration Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of LMHFV on postural stability
Time Frame: 0 days, 6 weeks, 3 months and 6 months. Change is being assessed
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.
0 days, 6 weeks, 3 months and 6 months. Change is being assessed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of fall for the patients in both groups
Time Frame: 0 days, 6 weeks, 3 months and 6 months. Change is being assessed
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
0 days, 6 weeks, 3 months and 6 months. Change is being assessed
Health-related quality of life
Time Frame: 0 days, 6 weeks, 3 months and 6 months. Change is being assessed
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.
0 days, 6 weeks, 3 months and 6 months. Change is being assessed
Timed Up and Go (TUG) test
Time Frame: 0 days, 6 weeks, 3 months and 6 months. Change is being assessed
Timed Up and Go (TUG) test will be used to test the basic mobility skills.
0 days, 6 weeks, 3 months and 6 months. Change is being assessed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Collaborators

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Ronald Man Yeung Wong, Prince of Wales Hospital, Sha Tin, Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

March 31, 2023

Study Registration Dates

First Submitted

November 30, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017.447

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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