ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625000968471

Ethics application status

Approved

Date submitted

30/06/2025

Date registered

3/09/2025

Date last updated

3/09/2025

Date data sharing statement initially provided

3/09/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

Comparison of the impact of two occupational therapy programs on selected indicators in women with rheumatoid arthritis

Scientific title

Comparison of the impact of two occupational therapy programs on selected indicators in women with rheumatoid arthritis

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

rheumatoid arthritis

Condition category

Condition code

Physical Medicine / Rehabilitation

Occupational therapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Rheumatoid arthritis (RA) is one of the most common autoimmune diseases in the world, and the occurrence of symptoms characteristic for this condition reduces hand function.

It is planned to examine a group of 80 women between 50 and 70 years of age diagnosed with rheumatoid arthritis in remission.

All women participating in the project will be randomly assigned to one of 3 groups:
• Group P (study) – people from this group will undergo a 6-week therapy program using the Pablo® System computer device
• Group A (study) – people from this group will undergo a 6-week therapy program using art therapy techniques
• Group C (control) – people from this group will not participate in any form of therapy

Therapeutic programs
1. The original therapeutic program in the study group P and in the study group A will be carried out individually with each patient 3 times a week for 6 weeks.
2. In both groups (P and A) attendance at each session will be mandatory. Even a single absence will exclude you from participating in the research program.
3. In both groups (P and A) all exercises throughout the session will be performed in the presence and under the supervision of a therapist who will observe how the patient performs individual tasks.
4. In group P (Pablo system) patient will perform main part exercises sitting in front of monitor and wearing special sensors attached to their hands using Velcro.
5. Assessment of level of intensity:
a. For group P - All exercises will be carried out in 2-minute series, and each of them will start with a measurement of the maximum strength or range of motion, which will allow for the appropriate adjustment of the level of difficulty of the game directly to the capabilities of a given patient and their possible therapeutic progress. This means that although each patient will be carrying out the same programs, the strength or range of motion necessary to perform a specific task for each person will be a different, individually selected value.
b. For group A - The techniques will be selected so that the tasks require work with both hands, in order to maintain similar intensity in both the dominant and non-dominant limbs. The tasks in this group will be designed so that they are carried out in the most adequate way possible to the tasks carried out in group P.
6. Each therapeutic unit in both programs will last approximately 60 minutes and will consist of the following parts:
a) Warm-up part (5 min.) – preparing the upper limbs for exercise and preventing possible overloads and injuries. Examples of exercises include: arm circles, flexion and extension movements in individual joints of the upper limbs, rotational movements of the forearms or abduction and adduction of the fingers. The exercises in this part of the program will be the same for groups P and A;
b) Main part (50 min.) – improving the functionality of the patients' upper limbs. The exercises in this part of the program will be different for groups P and A, but the researchers will try to ensure that the movements of the upper limbs performed during the therapy are as similar as possible.
• The tasks in the main part carried out in the P study group will be carried out using the therapeutic function of the interactive Pablo® System device, which operates on the basis of feedback. All exercises will be selected in such a way that the performed movements are aimed at strengthening grip strength, improving the range of motion of the hands and wrists and improving the performance of the selected activity. The order and selection of exercises for all participants in this group will be carried out according to the same scheme. Depending on the selected exercise, it will be performed separately with one hand, then the other, or with both hands simultaneously. Level of intensity: Examples of exercises:
o "Highway" – the patient's task will be to steer a car, avoiding other vehicles. The car steers to the right or left in response to wrist flexion or extension.
o "Apple Picking" – the patient's task will be to collect as many falling apples as possible into a basket. The basket is controlled using appropriately adjusted gripping force. The greater the force, the basket moves further to the left. Reducing the force causes the basket to move to the right.
o "Shooting at a Target" – the patient's task will be to shoot at moving targets with a crossbow. The shot will be generated by squeezing the sensor at the right moment and with the appropriate, pre-determined force.
o "Waste Sorting" – the patient's task will be to sort waste by throwing it into the appropriate container. Opening the sliding gripper over the appropriate container will be generated by the rotational movement of the forearm.
• The main tasks carried out in the study group A will be carried out using appropriately selected art therapy techniques and, similarly to the study group A, their aim will be to improve grip strength, improve the range of motion of the hands and wrists and to improve the performance of activities related to the selected activity. Within the individual therapeutic units, tasks will be carried out using selected techniques that require work with both hands. Examples of exercises:
o "Painting with Plasticine" – the patient will decorate a picture with plasticine. Individual steps of this technique, such as preparing and grinding the clay, will be accomplished by applying appropriate strength in the upper limbs and performing appropriate movements in the wrist and hand joints.
o "Origami Flowers" – the patient will create flowers using the origami technique. Individual steps of this technique, such as folding and pressing the paper, as well as arranging it into appropriate forms, will be accomplished by using appropriate strength in the upper limbs and performing appropriate movements in the wrist and hand joints.
o "Collage" – the patient will create any composition from pieces of paper (newspaper, leaflets, etc.). The patient will tear off the selected elements for the composition rather than cut them out, thus requiring the use of appropriate strength in the upper limbs and appropriate movements in the hand joints.
o "Sensory Plays" – the patient will prepare sensory play materials. Individual stages of this technique, such as mixing or kneading the mass, will be carried out by using appropriate force in the upper limbs as well as making appropriate movements in the joints of the wrists and hands.
• Relaxation part (5 min.) - relaxing the muscles in the upper limbs activated during the exercises in the main part, ensuring their proper regeneration, and calming down the entire body. The exercises in this part of the program will be the same for groups P and A.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Devices

Comparator / control treatment

Group C (control) – people from this group will not participate in any form of therapy

Control group

Active

Outcomes

Primary outcome [1]

Evaluation of movement biomechanics - assessed as a composite outcome

Timepoint [1]