ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000791437

Ethics application status

Approved

Date submitted

11/04/2016

Date registered

17/06/2016

Date last updated

23/08/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

The effects of a chiropractic care in recent stroke patients - Study 1/2

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 1/2

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1181-7292

Trial acronym

Linked study record

Health condition

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

Stroke

Condition category

Condition code

Stroke

Ischaemic

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 after a 7 day washout 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]

The primary outcome measure will be changes in absolute maximum force of contraction (strength). Muscle force will be measured using an isometric strain gauge (Model MLP100 transducer Techniques Tennecula California USA) mounted on a custom-built platform. This device will be used to record maximum isometric plantarflexion force. The subjects will perform three progressive maximum voluntary contractions (MVCs) of the ankle plantar flexors of 5 s duration each, separated by a minimum of 2-min rest. Subjects will be verbally encouraged to produce maximal force. The highest plantar flexor EMG activity during MVC and absolute force measured in each experimental or control session will be used for analysis and to compute the submaximal target contraction levels for H and M-recruitment curve recordings.

Timepoint [1]