Trial Review

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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] 304166 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 321857 0
Condition category
Condition code
Neurological 319583 319583 0 0
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] 320494 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327441 0
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] 327441 0
Throughout the study, to be assessed at all sessions for the 6 week intervention period.
Primary outcome [2] 327442 0
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] 327442 0
Post-intervention

After the completion of the final session at week 6.
Secondary outcome [1] 395139 0
Barthel Index - measuring performance in activities of daily living
Timepoint [1] 395139 0
at baseline and 6-weeks post commencement of the intervention
Secondary outcome [2] 395140 0
Lawton Instrumental Activities of Daily Living Scale - measuring performance in instrumental activities of daily living
Timepoint [2] 395140 0
at baseline and 6-weeks post commencement of the intervention
Secondary outcome [3] 395141 0
Canadian Occupational Performance Measure - measuring self-perception of occupational performance
Timepoint [3] 395141 0
at baseline and 6-weeks post commencement of the intervention
Secondary outcome [4] 395142 0
Timed Up and Go Test - measuring physical function
Timepoint [4] 395142 0
at baseline and 6-weeks post commencement of the intervention
Secondary outcome [5] 395143 0
Trail Making Test - measuring attention
Timepoint [5] 395143 0
at baseline and 6-weeks post commencement of the intervention

Eligibility
Key inclusion criteria
• Aged 18 or above
• Diagnosed with Parkinson's disease
• Of mild to moderate severity with scores of 2, 2.5 and 3 on the Hoehn and Yahr scale
• Have been screened for intact attention and short-term memory functions using the ‘memory’ question and the ‘read list of digits’ in the ‘attention’ question of the Montreal Cognitive Assessment (MoCA)
• Able to communicate in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The attendance of the participants will be reported to show the program feasibility. The results of the acceptability survey on each attribute (perceived effectiveness, relevancy, convenience and clarity) and each feature (face-to-face sessions, self-administered home sessions, accompanying resources and overall program) will be reported.
Any changes in the results of the assessments before and after the program will also be reported by Wilcoxon signed-rank test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
15/07/2021
Actual
Date of last data collection
Anticipated
30/09/2021
Actual
Sample size
Target
12
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19346 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 33929 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 308546 0
University
Name [1] 308546 0
Western Sydney University
Country [1] 308546 0
Australia
Funding source category [2] 308776 0
Hospital
Name [2] 308776 0
Concord Repatriation General Hospital
Country [2] 308776 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797, Penrith NSW 2751, Australia
Country
Australia
Secondary sponsor category [1] 309396 0
Hospital
Name [1] 309396 0
Concord Hospital
Address [1] 309396 0
Hospital Rd, Concord NSW 2139, Australia
Country [1] 309396 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308492 0
Sydney Local Health District (SLHD) Research Office - - Concord Repatriation General Hospital
Ethics committee address [1] 308492 0
Concord Repatriation General Hospital (CRGH)
Ground Floor Building 20, Hospital Road
Concord NSW 2139
Ethics committee country [1] 308492 0
Australia
Date submitted for ethics approval [1] 308492 0
02/11/2020
Approval date [1] 308492 0
13/01/2021
Ethics approval number [1] 308492 0
2020/ETH02885

Summary
Brief summary
Self-regulation, a type of self-management, takes an active learning approach to rehabilitation by enhancing the person’s self-awareness and encourages self-reflection to overcome problems. Mental imagery is when a person imagines every detail of the actions required to perform a task without actually physically moving to do the task.

We postulate that self-regulation and mental imagery may enhance the self-awareness and attention developed and can enhance the everyday task performance, such as dressing and cooking for people with Parkinson's disease.

Objectives of the study:
1. To pilot-test the self-regulation and mental imagery program to enhance performance of everyday activities, motor function, and cognitive function for people with Parkinson’s disease.
2. To evaluate the feasibility and acceptability of the SRII program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110890 0
Prof Karen Liu
Address 110890 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 110890 0
Australia
Phone 110890 0
+61 0246203432
Fax 110890 0
Email 110890 0
[email protected]
Contact person for public queries
Name 110891 0
Prof Karen Liu
Address 110891 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 110891 0
Australia
Phone 110891 0
+61 0246203432
Fax 110891 0
Email 110891 0
[email protected]
Contact person for scientific queries
Name 110892 0
Prof Karen Liu
Address 110892 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 110892 0
Australia
Phone 110892 0
+61 0246203432
Fax 110892 0
Email 110892 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11608Ethical approval  [email protected] 381958-(Uploaded-07-05-2021-10-32-49)-Study-related document.pdf



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.