Trials / Not Yet Recruiting
Not Yet RecruitingNCT06077890
Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in Hand Arthritis
Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in Hand Arthritis: A Randomized Clinical Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- Sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study investigates the effectiveness of SIMPLI.REHAB, a digital tool employed as an interface for administering occupational rehabilitation programs to patients diagnosed with Rheumatoid and Psoriatic Arthritis. Both of these conditions are inflammatory joint disorders capable of causing significant morphofunctional alterations in the hands, especially in their advanced stages. The introduction of digital technology emerges as a complementary tool when implementing rehabilitation programs. Utilizing a prospective, longitudinal, single-blinded experimental study, 35 patients will be allocated into two groups: one receiving a complementary digital intervention through SIMPLI.REHAB and the other through a conventional rehabilitation program. Each group consists of six patients and the program spans seven weeks, focusing on therapeutic exercises, training in manual dexterity, and motor coordination, among other interventions, led by a Physiatrist. The study intends to measure outcomes based on functionality scores, pain, disease activity, joint range, grip, pinch strength, and manual dexterity, both before and after each intervention, in order to ascertain the efficacy of integrating dynamic content through the digital tool SIMPLI.REHAB, as a supplementary resource in occupational rehabilitation programs. The potential limitations of the study include potential losses of follow-up and difficulties in assessing adherence to the digital tool precisely. Nonetheless, the digital tool aims to augment functional gains in rehabilitation programs by providing patients with accessible dynamic content of home-based strategies.
Detailed description
Rheumatoid arthritis and psoriatic arthritis are inflammatory joint conditions that often affect the distal extremity of the upper limb responsible for manual functionality. If these conditions progress, they can lead to significant morphofunctional alterations. Occupational rehabilitation programs are essential for controlling and improving functional limitations. With the advent of the COVID-19 pandemic, various technologies have emerged that allow the implementation of rehabilitation programs in distinct manners. This study aims to assess the effectiveness of an occupational rehabilitation program using the digital tool SIMPLI.REHAB as an interface for administering home-based strategies to patients diagnosed with rheumatoid and psoriatic arthritis compared to a conventional rehabilitation program. Using a prospective, longitudinal, single-blinded experimental study of superiority and randomized block design, 35 patients will be allocated to two intervention groups. An experimental intervention group will integrate an occupational rehabilitation program using the digital tool SIMPLI.REHAB for smartphones, compared to a group for a conventional rehabilitation program using a leaflet. Each group will consist of 6 patients and the program duration will be 7 weeks. This rehabilitation program, coordinated by a Physiatrist, includes classes for therapeutic exercises for flexibility and muscle strengthening, training in manual dexterity and motor coordination, thermotherapy, and patient education on joint protection principles conducted by the Occupational Therapy Team. The primary outcome to be assessed will be the functionality score with the Disabilities of the Arm, Shoulder, and Hand questionnaire. The surrogate endpoints will be pain (numerical pain scale), disease activity (DAS-28/DAPSA), joint range (digit-o-meter), grip and pinch strength (dynamometer), and assessment of manual dexterity (Moberg Pickup Test; 9-Hole Peg Test, and Kapandji's Pinches). The measurement of outcomes will be done before and after each intervention. This study aims to assess the effectiveness of integrating a digital tool that provides dynamic content as a supplement to an occupational rehabilitation program, compared to the strategy traditionally used in patients with rheumatoid or psoriatic arthritis with morphofunctional alterations in the hand. Certain study limitations may relate to losses of follow-up during the rehabilitation program period and difficulty in precisely assessing adherence to the digital tool. However, this tool will allow patients to access dynamic content of home-based strategies that will enhance the functional gains obtained in a rehabilitation program.
Conditions
- Arthritis, Psoriatic
- Arthritis, Rheumatoid
- Deformity, Hand
- Limitation, Mobility
- Hand Arthritis
- Hand Deformity
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Digital Rehabilitation | Participants in this arm will undergo an in-person rehabilitation program coordinated by a Physiatrist and will be able to access home-based rehabilitation strategies through dynamic content provided by SIMPLI.REHAB digital tool. |
| OTHER | Conventional Rehabilitation | Participants in this arm will undergo an in-person rehabilitation program coordinated by a Physiatrist and will be given home-based strategies in a printed paper brochure. |
Timeline
- Start date
- 2024-07-01
- Primary completion
- 2024-12-01
- Completion
- 2024-12-01
- First posted
- 2023-10-11
- Last updated
- 2024-04-30
Locations
1 site across 1 country: Portugal
Source: ClinicalTrials.gov record NCT06077890. Inclusion in this directory is not an endorsement.