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Trial registered on ANZCTR


Registration number
ACTRN12625000062426
Ethics application status
Approved
Date submitted
27/01/2024
Date registered
21/01/2025
Date last updated
21/01/2025
Date data sharing statement initially provided
21/01/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of the interactive device Pablo System and art therapy on hand function and quality of life in patients with rheumatoid arthritis.
Scientific title
Assessment of the interactive device Pablo System and art therapy on hand function and quality of life in patients with rheumatoid arthritis.
Secondary ID [1] 311251 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 332603 0
Condition category
Condition code
Inflammatory and Immune System 329301 329301 0 0
Rheumatoid arthritis
Physical Medicine / Rehabilitation 329302 329302 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study participants with rheumatoid arthritis undergoing therapeutic intervention will be randomly divided into 2 groups. Participants in the first experimental group will receive therapeutic intervention using the interactive device Pablo System. In this group patients will train various hand function e.g. grip streingth or range of motion while playing computer games. They will control the games with motion sensors placed on the upper limb Duration of the one exercise will be 2 minutes and rest between exercises will be 2 minutes. Participants in the second experimental group will receive art therapy intervention. In this group patiens will train upper limb function with selected methods of art therapy such as plasticine, collage and coloring with paints. All participants will undergo assessments of hand function. This will include evaluating strength and range of motion in the upper limb using the Pablo System device, as well as assessing dexterity using the 25 Hole Peg Test, Box and Blocks Test, and Jebsen Taylor Hand Function Test. Additionally, an evaluation of daily activities will be conducted using the Canadian Occupational Performance Measure (COPM) questionnaire, and quality of life will be assessed using the SF-36v2 questionnaire. All measurements will be performed twice before and after the completion of therapy. Therapeutic interventions in the first and second groups will be administered individually three times a week for 45 minutes over a period of six weeks at the Academy of Physical Education in Krakow by an occupational therapist.
Intervention code [1] 327787 0
Rehabilitation
Intervention code [2] 327788 0
Treatment: Devices
Comparator / control treatment
In the control group, participants with rheumatoid arthritis will not undergo any therapeutic intervention. All participants in this group will undergo assessments of hand function. This will include evaluating strength and range of motion in the upper limb using the Pablo System device, as well as assessing dexterity using the 25 Hole Peg Test, Box and Blocks Test, and Jebsen Taylor Hand Function Test. Additionally, an evaluation of daily activities will be conducted using the Canadian Occupational Performance Measure (COPM) questionnaire, and quality of life will be assessed using the SF-36v2 questionnaire. All measurements for individuals in the control group will be performed twice at 6-week intervals. The assessments in the control group will be conducted individually at the Academy of Physical Education in Krakow by an occupational therapist.
Control group
Active

Outcomes
Primary outcome [1] 337120 0
grip strength
Timepoint [1] 337120 0
This measurement will be done twice, before and after 6-weeks in the all study groups.
Primary outcome [2] 337121 0
upper limb dexterity
Timepoint [2] 337121 0
These measurements will be done twice, before and after 6-weeks in the all study groups.
Secondary outcome [1] 436768 0
Performing daily activities
Timepoint [1] 436768 0
This measurement will be done twice, before and after 6-weeks in the all study groups.
Secondary outcome [2] 440578 0
Quality of Life
Timepoint [2] 440578 0
This measurement will be done twice, before and after 6-weeks in the all study groups.

Eligibility
Key inclusion criteria
Diagnosed with rheumatoid arthritis in remission,
Age in the range of 30-70 years,
Duration of the disease in the range of 5-10 years,
Informed consent to participate in the project.
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Upper limb injuries suffered up to one year before the start of the research project,
Other diseases apart from RA in the upper limbs (e.g. degenerative joint changes, carpal tunnel syndrome),
Participation in other forms of occupational therapy during participation in the research project.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2023
Date of last participant enrolment
Anticipated
27/01/2025
Actual
Date of last data collection
Anticipated
17/03/2025
Actual
Sample size
Target
50
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 26084 0
Poland
State/province [1] 26084 0
Cracow

Funding & Sponsors
Funding source category [1] 316814 0
Self funded/Unfunded
Name [1] 316814 0
Country [1] 316814 0
Primary sponsor type
Individual
Name
Marta Cichon-Krzysiek
Address
al. Jana Pawla II 78, Kraków
Country
Poland
Secondary sponsor category [1] 317793 0
None
Name [1] 317793 0
Address [1] 317793 0
Country [1] 317793 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314411 0
Bioethics Committee at the District Medical Chamber in Cracow
Ethics committee address [1] 314411 0
Ethics committee country [1] 314411 0
Poland
Date submitted for ethics approval [1] 314411 0
03/09/2021
Approval date [1] 314411 0
17/09/2021
Ethics approval number [1] 314411 0

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

Contacts
Principal investigator
Name 131482 0
Mrs Marta Cichon-Krzysiek
Address 131482 0
Academy of Physical Education in Cracow, al. Jana Pawla II 78, Cracow
Country 131482 0
Poland
Phone 131482 0
+48 667 986 784
Fax 131482 0
Email 131482 0
[email protected]
Contact person for public queries
Name 131483 0
Marta Cichon-Krzysiek
Address 131483 0
Academy of Physical Education in Cracow, al. Jana Pawla II 78, Cracow
Country 131483 0
Poland
Phone 131483 0
+48 667 986 784
Fax 131483 0
Email 131483 0
[email protected]
Contact person for scientific queries
Name 131484 0
Marta Cichon-Krzysiek
Address 131484 0
Academy of Physical Education in Cracow, al. Jana Pawla II 78, Cracow
Country 131484 0
Poland
Phone 131484 0
+48 667 986 784
Fax 131484 0
Email 131484 0
[email protected]

Data sharing statement
Will there be any conditions when requesting access to individual participant data?
No
-

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?

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.