ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000903886

Ethics application status

Approved

Date submitted

7/05/2021

Date registered

12/07/2021

Date last updated

12/07/2021

Date data sharing statement initially provided

12/07/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

The feasibility of a self-regulation and mental imagery program to enhance everyday functioning in people with Parkinson’s Disease

Scientific title

The feasibility of a self-regulation and mental imagery program to enhance everyday functioning in people with Parkinson’s Disease

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Parkinson's disease

Condition category

Condition code

Neurological

Parkinson's disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Self-regulation and mental imagery for Parkinson's disease (SReMi-PD) program
The SReMI-PD program is developed based on a review of theory and scientific evidence on people with stroke as well as two consumer co-design workshops. The strategies are proposed to assist people with Parkinson's disease in focusing attention on task requirements. Previous studies reviewed the benefits of using self-regulation and mental imagery in promoting relearning and generalisation of skills learnt for people with stroke.
The SReMI-PD program is run once a week for six weeks with a home program and a phone call by the facilitators to supplement for a second weekly session. The facilitators include an occupational therapist and an occupational therapy honours student. The weekly 45-minute sessions are run face-to-face with between 2-4 members per group. The program is modified for each group’s specific needs by focusing on the activities of daily living with which the specific group may be having difficulty.
The program begins with two weeks of learning and applying self-regulation through a step-based problem-solving process designed by the researchers. This includes choosing a task, breaking it down into steps, identifying steps that are problematic or difficult, identifying what the specific problems they are experiencing and brainstorming solutions. Throughout the program, appropriate rehabilitation strategies are suggested and used as solutions to build the participants' knowledge of possible solutions. They include modifying the ‘Task’ and ‘Environment’ and getting ‘Assistance’ (‘TEA’). The acronym ‘TEA’ for ‘Task, Environment, Assistance’ is taught to assist participants with coming up with solutions. External cueing is introduced to the participants as a potential solution. Participants are given the opportunity to try them during the session and then encouraged to implement the solutions at home. The third and fourth sessions introduce mental imagery into the self-regulation process as a method of practicing the task as well as assisting participants to plan their movements. The final two sessions consolidate the use of self-regulation and mental imagery with various everyday tasks while considering current difficulties and potential future difficulties.
The home program includes the activities practiced during the face-to-face session that week. It aims at encouraging participants to implement the strategies and solutions at home. To monitor the adherence to the home program, a telephone phone call will be given to the participants to check on any issues or extra support required.

Intervention code [1]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Attendance

Participant’s attendance in each face-to-face group session, a record of their participation in the home program and the follow-up phone call will be collected to determine the feasibility of the program.

Timepoint [1]

Throughout the study, to be assessed at all sessions for the 6 week intervention period.

Primary outcome [2]

Acceptability

At the end of the six-week program, participants will be asked to partake in a structured interview where questions from a developed form will be asked around the acceptability of the intervention program. The questions will reflect themes of program acceptability. They include four attributes (perceived effectiveness, relevancy, convenience, and clarity) and four features (face-to-face sessions, self-administered home sessions, accompanying resources and overall program). These questions will be examined through a 4-point Likert scale where ‘4’ represents ‘completely agree’, and ‘1’ represents ‘completely disagree’.

Timepoint [2]

Post-intervention

After the completion of the final session at week 6.

Secondary outcome [1]

Barthel Index - measuring performance in activities of daily living

Timepoint [1]