ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12616000825459

Ethics application status

Approved

Date submitted

15/04/2016

Date registered

23/06/2016

Date last updated

9/02/2021

Date data sharing statement initially provided

9/02/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

The effects of a chiropractic care in recent stroke patients - Study 2/2

Scientific title

The effects of a chiropractic care on functional outcomes, somatosensory processing and motor control in patients who have suffered from a recent stroke - Study 2/2

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1181-9486

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention is a single session of chiropractic care for the intervention group. The session will take approximately ten minutes. The entire spine and both sacroiliac joints will be assessed for vertebral subluxation, and adjusted where deemed necessary, by a registered chiropractor. The clinical indicators that will be used to assess the function of the spine prior to and after each chiropractic adjustment session include assessing for tenderness to palpation of the relevant joints, manually palpating for restricted intersegmental range of motion, assessing for palpable asymmetric intervertebral muscle tension, and any abnormal or blocked joint play and end-feel of the joints. All of these biomechanical characteristics are used by the chiropractors as clinical indicators of vertebral subluxations. All of the spinal adjustments carried out in this study will be high-velocity, low-amplitude thrusts to the spine or pelvic joints. These are standard adjustment techniques used by chiropractors. The mechanical properties of this intervention has been investigated; and although the actual force applied to the subject's spine depends on the chiropractor, the patient, and the spinal location of the adjustment, the general shape of the force-time history of spinal adjustments is very consistent and the duration of the thrust is always less than 200 milliseconds. The high velocity type of adjustments chosen specifically because previous research has shown that reflex electromyographic activation observed after adjustments only occurred after high velocity, low amplitude adjustments (as compared with lower velocity mobilizations). This adjustment technique has also been previously used in studies that have investigated the neurophysiological effects of chiropractic care. Within 30 minutes of receiving the intervention, the participant will be reassessed using the same outcome measurement procedures. The participants will then be reassessed within a 7 day period with the alternate intervention applied between pre/post-assessments.

Intervention code [1]

Rehabilitation

Comparator / control treatment

The control is a single session. The subject’s head and/or spine will be moved in ways that include passive and active movements, similar to what is done by the chiropractor that provide actual chiropractic care during the experimental intervention. Thus this control intervention involves the subject being moved into the adjustment setup positions similar to how the chiropractor would normally setup a subject prior to applying the thrust to the spine to achieve the adjustment. No spinal adjustments will be performed during any control intervention. This control intervention is intended to act as a sham treatment session as well as to act as a physiological control for possible changes occurring due to the cutaneous, muscular or vestibular input that would occur with the type of passive and active movements involved in preparing a subject/patient for an adjustment.

Control group

Active

Outcomes

Primary outcome [1]

In this second study the primary objectives is to use somatosensory evoked potentials (SEP) to:
Investigate which brain areas are involved in processing somatosensory information in a stroke population.

Timepoint [1]

Immediately pre and post spinal manipulation session and immediately pre and post control intervention.

Primary outcome [2]

Spatio-spectral power in the resting-state EEG. For this classical frequency band (delta (1-4 Hz), theta (4.1-8 Hz), alpha (8.1-12 Hz), beta (12.1-32 Hz), and gamma (32.1-80 Hz)) will be used.

Timepoint [2]

Immediately pre and post spinal manipulation session and immediately pre and post control intervention.

Secondary outcome [1]

The secondary outcome is to use somatosensory evoked potentials to study what changes occur with in the brain structures,calculated using source localization methods of the SEPs and resting EEG .

Timepoint [1]

Immediately pre and post spinal manipulation session and immediately pre and post control intervention.

Secondary outcome [2]

A further outcome is Brain Source Identification (EEG):
Brain sources of SEPs recorded n the scalp reflective upstream activation of brain activity in different centres. Brain sources are identified by inverse modelling of the evoked brain activity.

Timepoint [2]

Post recording

Eligibility

Key inclusion criteria

20-25 participants will be recruited to participate in each of these studies. Participants will be inpatients or outpatients at Shifa International Hospital, in Islamabad or Railway Hospital, Rawalpindi, Pakistan. To be eligible to participate volunteers must have suffered from a stroke at least 12 weeks prior to their involvement in the trial and have some ongoing neurological deficit. For the study they must have some ongoing neurological deficit but this deficit may not be in the lower limb.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Volunteers will be ineligible to participate if they exhibit no evidence of spinal dysfunction, have absolute contraindications to spinal manipulation, have experienced previous significant adverse reactions to chiropractic care, or if they are deemed unsuitable to receive chiropractic care by their treating physicians.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

8/04/2016

Date of last participant enrolment

Anticipated

Actual

6/02/2019

Date of last data collection

Anticipated

Actual

28/02/2019

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

Islamabad

Funding & Sponsors

Funding source category [1]

Other

Name [1]

New Zealand College of Chiropractic

Address [1]

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

Country [1]

New Zealand

Primary sponsor type

Other

Name

New Zealand College of Chiropractic

Address

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

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Riphah International University in Islamabad

Ethics committee address [1]

7th Ave
Islamabad - Pakistan

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

28/03/2016

Approval date [1]

05/04/2016

Ethics approval number [1]

Summary

Brief summary

Stroke is one of the leading causes of death and disability in the world.  It is estimated that worldwide 17 million people per year suffer from a significant stroke with 5 million of those people experiencing long term physical disability following the stroke. The long term impaired nervous system function that accompanies many strokes means millions of stroke survivors around the world are reliant on care-givers to assist them with rudimentary activities of daily living such as bathing, dressing, and toileting. The burden of care is immense and has a significant impact on modern society.
Numerous rehabilitative approaches have been shown to promote motor recovery after a stroke, but advanced strategies are constantly being developed and tested in an attempt to improve long term outcomes for stroke survivors. One possible intervention that may improve post-stroke motor recovery, but has to date not been adequately tested, is chiropractic care. 

Over the past two decades numerous research studies have shown that chiropractic care can significantly influence central neural function. Studies have shown changes in somatosensory processing, sensorimotor integration and motor control following as little as a single session of chiropractic adjustments. Sensorimotor integration is the ability of the central nervous system (CNS) to integrate sensory information from different body parts and formulate appropriate motor outputs to muscles. Effective sensorimotor integration is essential when learning new motor skills, or recovering from an injury. Another essential component for accurately movement, learning new motor skills, and/or recovering from an injury is the accuracy of internal representation of our body map, or body schema. It is essential for your brain to be accurately aware of the location of our limbs and core body in 3D space. The spine is linked biomechanically and neurologically to the limbs and yet, we know very little about how altered sensory feedback from the spine affects limb sensorimotor integration and motor performance. However, there is emerging evidence that altered spinal sensory input can alter central neural processing, possibly by impacting the brains inner body schema. There is also emerging evidence that improving spinal function with chiropractic care can rapidly alter central neural function in a variety of ways, and that these changes outlast the altered changes of input, i.e. that they are neural plastic changes. Neural plasticity is the name given by neuroscientists to any lasting change in structure or function within the CNS due to alterations in sensory input, basically the brain’s ability to learn and adapt to an ever-changing environment. The addition of chiropractic care to the treatment program for a variety of central nervous system disorders, such as stroke victims, may have a profound impact on these peoples’ ability to heal and recover central neural function.

Trial website

Trial related presentations / publications

Public notes

Data collection happened in two separate visits to Pakistan first in 2016 and second in 2019.

Contacts

Principal investigator

Name

Dr Imran Niazi

Address

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

Country

New Zealand

Phone

+6495266789

Fax

imran.niazi@nzchiro.co.nz

Contact person for public queries

Name

Kelly Holt

Address

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

Country

New Zealand

Phone

+6495266789

Fax

kelly.holt@nzchiro.co.nz

Contact person for scientific queries

Name

Kelly Holt

Address

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

Country

New Zealand

Phone

+6495266789

Fax

kelly.holt@nzchiro.co.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

because the ethics approval did not include permission to share data

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

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically