ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

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]

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]

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]

All outcomes were measured at baseline then at 4 weeks and 12 weeks (at the completion of the intervention programme).

Secondary outcome [1]

Quality of life measured using the SF36 version 2 questionnaire

Timepoint [1]

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

Sex

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

1/03/2011

Actual

22/05/2012

Date of last participant enrolment

Anticipated

Actual

22/03/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

New Zealand College of Chiropractic and the Australian Spinal Research Foundation

Address [1]

6 Harrison Rd
Mount Wellington
Auckland
New Zealand

Country [1]

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]

University

Name [1]

University of Auckland

Address [1]

Private Bag 92019
Auckland 1142
New Zealand

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Y Regional Ethics Committee

Ethics committee address [1]

Ministry of Health
P.O. Box 1030
Hamilton 3204

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/01/2011

Approval date [1]

16/09/2011

Ethics approval number [1]

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

Dr Kelly Holt

Address

New Zealand College of Chiropractic
6 Harrison Road
Mount Wellington
Auckland 1060
New Zealand

Country

New Zealand

Phone

+6495266789

Fax

kelly.holt@nzchiro.co.nz

Contact person for public queries

Name

Kelly Holt

Address

New Zealand College of Chiropratic
6 Harrison Road
Mount Wellington
Auckland
New Zealand

Country

New Zealand

Phone

+64-9-526-6789

Fax

kelly.holt@nzchiro.co.nz

Contact person for scientific queries

Name

Kelly Holt

Address

New Zealand College of Chiropratic
6 Harrison Road
Mount Wellington
Auckland
New Zealand

Country

New Zealand

Phone

+64-9-526-6789

Fax

kelly.holt@nzchiro.co.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effectiveness of Chiropractic Care to Improve Sensorimotor Function Associated with Falls Risk in Older People: A Randomized Controlled Trial.	2016	https://dx.doi.org/10.1016/j.jmpt.2016.02.003

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically