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

Primary Purpose

Distal Radius Fracture, Fall Patients

Status
Unknown status
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Low-magnitude high-frequency vibration (LMHFV)
Sponsored by
Prince of Wales Hospital, Shatin, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Distal Radius Fracture, Osteoporosis, Vibration Therapy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Orthopaedics and Traumatology, Prince of Wales HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Vibration Group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
Timed Up and Go (TUG) test
Timed Up and Go (TUG) test will be used to test the basic mobility skills.

Full Information

First Posted
November 30, 2017
Last Updated
April 4, 2018
Sponsor
Prince of Wales Hospital, Shatin, Hong Kong
Collaborators
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03380884
Brief Title
Vibration Therapy as a Rehabilitation Intervention for Postural Training and Fall Prevention
Official Title
Vibration Therapy as a Rehabilitation Intervention for Postural Training and Fall Prevention After Distal Radius Fracture in Elderly Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Anticipated)
Study Completion Date
May 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Wales Hospital, Shatin, Hong Kong
Collaborators
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Fall Patients
Keywords
Distal Radius Fracture, Osteoporosis, Vibration Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group will remain in their habitual life style and no vibration used
Arm Title
Vibration Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Low-magnitude high-frequency vibration (LMHFV)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of LMHFV on postural stability
Description
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
Secondary Outcome Measure Information:
Title
Occurrence of fall for the patients in both groups
Description
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
Title
Health-related quality of life
Description
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
Title
Timed Up and Go (TUG) test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald Man Yeung Wong
Phone
852 35051510
Email
ronaldwong@ort.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Wing-Hoi Cheung
Email
louis@ort.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Man Yeung Wong
Organizational Affiliation
Prince of Wales Hospital, Sha Tin, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics and Traumatology, Prince of Wales Hospital
City
Sha Tin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Man Yeung Wong
Phone
852 3505 2510
Email
ronaldwong@ort.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Ronald Man Yeung Wong, MRCS(Ed)
First Name & Middle Initial & Last Name & Degree
Wing-Hoi Cheung, PhD
First Name & Middle Initial & Last Name & Degree
Ning Tang, FRCS(Ed)
First Name & Middle Initial & Last Name & Degree
Chi Yin Tso, FRCS(Ed)
First Name & Middle Initial & Last Name & Degree
Kwok Sui Leung, FRCS(Ed)

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Vibration Therapy as a Rehabilitation Intervention for Postural Training and Fall Prevention

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