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Trial registered on ANZCTR


Registration number
ACTRN12608000333314
Ethics application status
Approved
Date submitted
27/06/2008
Date registered
15/07/2008
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Chiropractic Care to Improve Risk of Falls and Sensorimotor Function in Older People
Scientific title
Randomised Controlled Trial of Chiropractic Care to Improve Risk of Falls and Sensorimotor Function in Older People
Secondary ID [1] 253215 0
Chiropractic and Sensorimotor Introduction
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postural stability, sensorimotor function 3321 0
Condition category
Condition code
Musculoskeletal 3480 3480 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was twelve weeks of chiropractic care. Chiropractic care involved the ongoing provision of care, whether a subjective complaint was present or not, with the intention of correcting spinal dysfunction, which is termed vertebral subluxation by chiropractors. Chiropractic care was provided at no charge by licensed chiropractors who have volunteered to assist with this study and who have at least five years clinical experience and practice in Auckland, New Zealand. On average each chiropractic visit will take approximately 20 minutes. The frequency of care was left up to the discretion of the chiropractor providing care.

Intervention code [1] 3059 0
Prevention
Comparator / control treatment
Participants in the control group will receive usual care as well as a pamphlet that is produced by the New Zealand Accident Compensation Corporation about prevention of falls in older adults. Usual care will include any health care options that the participants wish to engage in during the course of the study including allopathic or other complimentary care. Usual care will continue throughout the nine and a half months that participants are involved in the trial.
Control group
Active

Outcomes
Primary outcome [1] 4386 0
The primary objective of this study will be to assess the effect of chiropractic care on objective markers of sensorimotor function. The objective measures of sensorimotor function that were included in this study were choice stepping reaction time, postural stability, joint positions sense of the ankle, and the sound-induced flash illusion. All assessments were conducted at the New Zealand College of Chiropractic in Auckland, New Zealand.
Timepoint [1] 4386 0
All outcomes were measured at baseline then at 4 weeks and 12 weeks (at the completion of the intervention programme).
Secondary outcome [1] 7401 0
Quality of life measured using the SF36 version 2 questionnaire
Timepoint [1] 7401 0
4 weeks and 12 weeks

Eligibility
Key inclusion criteria
Community dwelling adults aged 65 years or older who permanently reside in or near the Ellerslie / Mount Wellington region of Auckland, New Zealand will be eligible to participate in this trial.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Volunteers will be ineligible if they are wheel-chair bound, or unable to remain standing unassisted for a minimum of one minute, as they will be unable to complete the required balance testing. Other exclusion criteria include presence of absolute contraindications to chiropractic care, being unable to comprehend the study information or consent processes, the known presence of severe cognitive, somatic or psychiatric impairment or disease, presence of a terminal illness and being unavailable to participate for one week or more during the study period due to planned travel arrangements or other commitments. A risk assessment for vertebrobasilar insufficiency / vertebral artery dissection (VBI / VAD) will also be conducted and at risk volunteers will be ineligible for inclusion until specialist referral confirms no VBI/VAD exists. Volunteers will also be ineligible if they have received chiropractic care within the previous six months or if they have received spinal manipulation during the previous six months from another healthcare provider.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by using an off-site schedule at a central adminsitration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be used
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Assessors will be blinded but subjects will be aware of which group they're assigned to.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1008 0
New Zealand
State/province [1] 1008 0
Auckland

Funding & Sponsors
Funding source category [1] 3526 0
Charities/Societies/Foundations
Name [1] 3526 0
New Zealand College of Chiropractic and the Australian Spinal Research Foundation
Address [1] 3526 0
6 Harrison Rd
Mount Wellington
Auckland
New Zealand
Country [1] 3526 0
New Zealand
Primary sponsor type
Other
Name
New Zealand College of Chiropractic
Address
6 Harrison Rd
Mount Wellington
Auckland
New Zealand
Country
New Zealand
Secondary sponsor category [1] 3166 0
University
Name [1] 3166 0
University of Auckland
Address [1] 3166 0
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 3166 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5565 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 5565 0
Ministry of Health
P.O. Box 1030
Hamilton 3204
Ethics committee country [1] 5565 0
New Zealand
Date submitted for ethics approval [1] 5565 0
01/01/2011
Approval date [1] 5565 0
16/09/2011
Ethics approval number [1] 5565 0
NTY 11/06/63

Summary
Brief summary
Falls are a major health concern for older adults. They are a significant cause of death, injury and loss of quality of life. In people over the age of 65, falls account for over 80% of injury related hospital admissions and they are the leading cause of unintentional injury related death in older adults.

Falls often occur due to a decline in nervous system function with advancing age. This can lead to a loss of balance, or poor control of the limbs which dramatically increases the risk of falling. In the past ten years researchers have demonstrated that chiropractic adjustments can improve aspects of nervous system function including muscle reflexes, reaction time and the speed at which the brain processes information. This study will investigate the relationship between chiropractic care and components of the nervous system important for maintaining balance and preventing falls in older adults. To study this relationship the researchers will follow and assess two groups of older participants at regular intervals over a 16 week period. One group will be under regular chiropractic care for sixteen weeks and the other group will receive no chiropractic care during the study but will be offered the programme at the completion of the study.
Trial website
Trial related presentations / publications
Holt K, Haavik H, Murphy B, Chi Lun Lee A, Elley CR. Effectiveness of Chiropractic Care to Improve Sensorimotor Function Associated with Falls Risk in Older People: A Randomized Controlled Trial. J Manip Phys Ther. Approved for publication.

Holt K, Haavik H, Lee ACL, Murphy B & Raina Elley R. (2014) Effectiveness of Chiropractic Care to Improve Sensorimotor Function Associated with Falls Risk in Older People: A Randomized Controlled Trial. Association of Chiropractic Colleges Research Agenda Conference, Meeting in Orlando, Florida, USA, March.
Public notes

Contacts
Principal investigator
Name 28706 0
Dr Kelly Holt
Address 28706 0
New Zealand College of Chiropractic
6 Harrison Road
Mount Wellington
Auckland 1060
New Zealand
Country 28706 0
New Zealand
Phone 28706 0
+6495266789
Fax 28706 0
Email 28706 0
kelly.holt@nzchiro.co.nz
Contact person for public queries
Name 11863 0
Dr Kelly Holt
Address 11863 0
New Zealand College of Chiropratic
6 Harrison Road
Mount Wellington
Auckland
New Zealand
Country 11863 0
New Zealand
Phone 11863 0
+64-9-526-6789
Fax 11863 0
Email 11863 0
kelly.holt@nzchiro.co.nz
Contact person for scientific queries
Name 2791 0
Dr Kelly Holt
Address 2791 0
New Zealand College of Chiropratic
6 Harrison Road
Mount Wellington
Auckland
New Zealand
Country 2791 0
New Zealand
Phone 2791 0
+64-9-526-6789
Fax 2791 0
Email 2791 0
kelly.holt@nzchiro.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary