ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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

ACTRN12621001178831

Ethics application status

Approved

Date submitted

27/07/2021

Date registered

2/09/2021

Date last updated

16/08/2022

Date data sharing statement initially provided

2/09/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Telerehab activity intervention for people with Guillain Barre Syndrome

Scientific title

Impact of a telerehabilitation physical activity intervention on fatigue levels for people with Guillain Barre Syndrome

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Guillain Barre Syndrome

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

We have developed a limited contact telerehabilitation intervention based on behavioural change principles. A physiotherapist will customise the intervention for each participant with consultation and based on the goal elicited and the participant’s contextual factors. The intervention comprises the coaching style used by the physiotherapist, supplemented with use of a wrist worn activity tracker by each participant. These two components of the intervention encompass a number of known behaviour change techniques from a well-established taxonomy. All contact will be made by phone and/or videoconferencing and limited to a maximum of six hours in total over a 12-week period.
The physiotherapist will follow a similar intervention outline for each participant with the ability to tailor the content of the session to each participant’s goals, concerns, problems and ability by selecting from a menu of options based on the behavioural change taxonomy. It is anticipated that the behavioural change techniques used for each participant will encompass goal setting, provision of feedback, problem solving, action planning and instruction but that the specific techniques selected will differ because they will be customised for each participant. The physiotherapist will meet remotely with each participant on a weekly basis via teleconferencing or phone, as best suits the participant. It is anticipated that the first session will take 30-60 minutes and the aim of the first session will be for the physiotherapist and participant to identify an activity the participant is most likely to engage in (acceptable, pleasant and practical), negotiate and agree a weekly goal and action plan and for the physiotherapist to provide support and encouragement. The physiotherapist will also specifically provide information and instruction on the promotion of activity based on current guidelines (1) relative to each participant’s current level of activity whilst also accounting for their level of fatigue, which is of particular concern for individuals with persistent fatigue. At the first session, the physiotherapist will review the main behaviour change features (goal setting, self monitoring, provision of feedback, prompting through environmental cues) of the activity tracker (sent to each participant prior to their first session). The physiotherapist and participant will collaboratively decide how best to integrate the use of the activity tracker into the participant’s action plan.
The duration of subsequent sessions will be 15-30 minutes each. In these weekly sessions, the physiotherapist and participant will review the week’s progress, identify barriers that the participant has encountered and discuss possible solutions, resulting in an agreed goal and action plan for the subsequent week. The physiotherapist will supplement the weekly sessions with one text message (or email) per week to encourage progress towards the agreed goal.
Monitoring fidelity /'adherence' - Outcomes assessment includes collection of steps and sedentary time from fitbits, and activity engagement will be captured as part of the intervention itself.

1 US Department of Health and Human Services. Physical Activity Guidelines for Americans [Internet]. 2nd ed. Washington, DC, 2018; and Walk. Run. Dance. Play. What’s your move? - Move Your Way | health.gov [Internet]. [cited 2021 Jul 6].

Intervention code [1]

Rehabilitation

Comparator / control treatment

Participants in this study act as their own controls, baseline being establised in the initial phase of the Single System Design by collecting all outcome questionnaire based measures and fitbit data at week 0,2 and 4.

Control group

Active

Outcomes

Primary outcome [1]

Fatigue severity - assessed by Fatigue Severity Scale

Timepoint [1]