Trial Review

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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] 289011 0
None
Universal Trial Number (UTN)
U1111-1181-9486
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 298420 0
Condition category
Condition code
Stroke 298516 298516 0 0
Ischaemic
Stroke 318521 318521 0 0
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] 294494 0
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] 298012 0
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] 298012 0
Immediately pre and post spinal manipulation session and immediately pre and post control intervention.
Primary outcome [2] 326478 0
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] 326478 0
Immediately pre and post spinal manipulation session and immediately pre and post control intervention.
Secondary outcome [1] 322891 0
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] 322891 0
Immediately pre and post spinal manipulation session and immediately pre and post control intervention.
Secondary outcome [2] 324872 0
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] 324872 0
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?
No
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
27
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 7820 0
Pakistan
State/province [1] 7820 0
Islamabad

Funding & Sponsors
Funding source category [1] 293380 0
Other
Name [1] 293380 0
New Zealand College of Chiropractic
Country [1] 293380 0
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] 292199 0
None
Name [1] 292199 0
Address [1] 292199 0
Country [1] 292199 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294837 0
Riphah International University in Islamabad
Ethics committee address [1] 294837 0
Ethics committee country [1] 294837 0
Pakistan
Date submitted for ethics approval [1] 294837 0
28/03/2016
Approval date [1] 294837 0
05/04/2016
Ethics approval number [1] 294837 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65190 0
Dr Imran Niazi
Address 65190 0
New Zealand College of Chiropractic
6 Harrison Road Mount Wellington Auckland 1060
Country 65190 0
New Zealand
Phone 65190 0
+6495266789
Fax 65190 0
Email 65190 0
[email protected]
Contact person for public queries
Name 65191 0
Kelly Holt
Address 65191 0
New Zealand College of Chiropractic
6 Harrison Road Mount Wellington Auckland 1060
Country 65191 0
New Zealand
Phone 65191 0
+6495266789
Fax 65191 0
Email 65191 0
[email protected]
Contact person for scientific queries
Name 65192 0
Kelly Holt
Address 65192 0
New Zealand College of Chiropractic
6 Harrison Road Mount Wellington Auckland 1060
Country 65192 0
New Zealand
Phone 65192 0
+6495266789
Fax 65192 0
Email 65192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.