Distal Radius Fracture Clinical Trial
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
Verified date | April 2024 |
Source | Prince of Wales Hospital, Shatin, Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 232 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Orthopaedics and Traumatology, Prince of Wales Hospital | Sha Tin |
Lead Sponsor | Collaborator |
---|---|
Prince of Wales Hospital, Shatin, Hong Kong | Chinese University of Hong Kong |
Hong Kong,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 0 days, 6 weeks, 3 months and 6 months. Change is being assessed | |
Secondary | 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 | 0 days, 6 weeks, 3 months and 6 months. Change is being assessed | |
Secondary | 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. | 0 days, 6 weeks, 3 months and 6 months. Change is being assessed | |
Secondary | Timed Up and Go (TUG) test | 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 |
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