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

NCT03380884 | Completed DMC

• 1 other identifier: 2017.447
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture; Fall Patients

Keywords

Distal Radius Fracture, Osteoporosis, Vibration Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Occurrence of fall for the patients in both groups

  0 days, 6 weeks, 3 months and 6 months. Change is being assessed

• Health-related quality of life

  0 days, 6 weeks, 3 months and 6 months. Change is being assessed

• Timed Up and Go (TUG) test

  0 days, 6 weeks, 3 months and 6 months. Change is being assessed

Study Arms (2)

Control

NO INTERVENTION

Control group will remain in their habitual life style and no vibration used

Vibration Group

EXPERIMENTAL

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)

Interventions

Low-magnitude high-frequency vibration (LMHFV) DEVICE

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.

Vibration Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) aged 60 or above
• \) fracture distal radius after 6 weeks to 3 months
• \) injury was due to unintentional fall.

You may not qualify if:

• \) medical condition causing balance disturbance
• \) participated in supervised regular exercise or physiotherapy for twice a week or more
• \) Activities of Daily Living (ADL) dependent
• \) malignancy
• \) medications or condition that affect metabolism of the musculoskeletal system e.g. bisphosphonates

Sponsors & Collaborators

• Prince of Wales Hospital, Shatin, Hong Kong: lead
• Chinese University of Hong Kong: collaborator

Study Sites (1)

Department of Orthopaedics and Traumatology, Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (20)

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  PMID: 17144789 BACKGROUND

• Karantana A, Downing ND, Forward DP, Hatton M, Taylor AM, Scammell BE, Moran CG, Davis TR. Surgical treatment of distal radial fractures with a volar locking plate versus conventional percutaneous methods: a randomized controlled trial. J Bone Joint Surg Am. 2013 Oct 2;95(19):1737-44. doi: 10.2106/JBJS.L.00232.

  PMID: 24088965 BACKGROUND

• Mellstrand-Navarro C, Pettersson HJ, Tornqvist H, Ponzer S. The operative treatment of fractures of the distal radius is increasing: results from a nationwide Swedish study. Bone Joint J. 2014 Jul;96-B(7):963-9. doi: 10.1302/0301-620X.96B7.33149.

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  PMID: 27440565 BACKGROUND

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• Crilly RG, Delaquerriere Richardson L, Roth JH, Vandervoort AA, Hayes KC, Mackenzie RA. Postural stability and Colles' fracture. Age Ageing. 1987 May;16(3):133-8. doi: 10.1093/ageing/16.3.133.

  PMID: 3604793 BACKGROUND

• Handoll HH, Elliott J. Rehabilitation for distal radial fractures in adults. Cochrane Database Syst Rev. 2015 Sep 25;2015(9):CD003324. doi: 10.1002/14651858.CD003324.pub3.

  PMID: 26403335 BACKGROUND

• Khazzani H, Allali F, Bennani L, Ichchou L, El Mansouri L, Abourazzak FE, Abouqal R, Hajjaj-Hassouni N. The relationship between physical performance measures, bone mineral density, falls, and the risk of peripheral fracture: a cross-sectional analysis. BMC Public Health. 2009 Aug 18;9:297. doi: 10.1186/1471-2458-9-297.

  PMID: 19689795 BACKGROUND

• Leung KS, Li CY, Tse YK, Choy TK, Leung PC, Hung VW, Chan SY, Leung AH, Cheung WH. Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial. Osteoporos Int. 2014 Jun;25(6):1785-95. doi: 10.1007/s00198-014-2693-6. Epub 2014 Mar 28.

  PMID: 24676848 BACKGROUND

• 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. J Musculoskelet Neuronal Interact. 2016 Mar;16(1):4-11.

  PMID: 26944817 BACKGROUND

• 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 Res. 2016 Aug;19(4):293-302. doi: 10.1089/rej.2015.1759. Epub 2016 Feb 19.

  PMID: 26608404 BACKGROUND

• 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. J Musculoskelet Neuronal Interact. 2015 Dec;15(4):316-24.

  PMID: 26636277 BACKGROUND

• Cheung WH, Mok HW, Qin L, Sze PC, Lee KM, Leung KS. High-frequency whole-body vibration improves balancing ability in elderly women. Arch Phys Med Rehabil. 2007 Jul;88(7):852-7. doi: 10.1016/j.apmr.2007.03.028.

  PMID: 17601464 BACKGROUND

• Roelants M, Verschueren SM, Delecluse C, Levin O, Stijnen V. Whole-body-vibration-induced increase in leg muscle activity during different squat exercises. J Strength Cond Res. 2006 Feb;20(1):124-9. doi: 10.1519/R-16674.1.

  PMID: 16503671 BACKGROUND

• de Groot MH, van der Jagt-Willems HC, van Campen JP, Lems WF, Lamoth CJ. Testing postural control among various osteoporotic patient groups: a literature review. Geriatr Gerontol Int. 2012 Oct;12(4):573-85. doi: 10.1111/j.1447-0594.2012.00856.x. Epub 2012 Jun 4.

  PMID: 22672622 BACKGROUND

• Broglio SP, Sosnoff JJ, Rosengren KS, McShane K. A comparison of balance performance: computerized dynamic posturography and a random motion platform. Arch Phys Med Rehabil. 2009 Jan;90(1):145-50. doi: 10.1016/j.apmr.2008.06.025.

  PMID: 19154841 BACKGROUND

• Arifin N, Abu Osman NA, Wan Abas WA. Intrarater test-retest reliability of static and dynamic stability indexes measurement using the Biodex Stability System during unilateral stance. J Appl Biomech. 2014 Apr;30(2):300-4. doi: 10.1123/jab.2013-0130. Epub 2013 Jul 20.

  PMID: 23878204 BACKGROUND

• Wong RMY, Ho WT, Tang N, Tso CY, Ng WKR, Chow SK, Cheung WH. A study protocol for a randomized controlled trial evaluating vibration therapy as an intervention for postural training and fall prevention after distal radius fracture in elderly patients. Trials. 2020 Jan 16;21(1):95. doi: 10.1186/s13063-019-4013-0.

  PMID: 31948477 DERIVED

MeSH Terms

Conditions

Wrist Fractures; Osteoporosis

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ronald Man Yeung Wong

  Prince of Wales Hospital, Sha Tin, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 21, 2017
• Study Start: December 1, 2017
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

HK (1)