Clinical trial NCT06077890: Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in Hand Arthritis
Official title: Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in Hand Arthritis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthritis, Psoriatic
Arthritis, Rheumatoid
Deformity, Hand
Limitation, Mobility
Hand Arthritis
Hand Deformity
Keywords: Physical and Rehabilitation Medicine
Digital Technology
Occupational therapy
Hand
Rehabilitation
Lead sponsor: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Sponsor class: OTHER_GOV
First posted: 2023-10-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

" Must be referred patients from the Rheumatology Service of CHVNG/E. " Age 18 or older. " Must have a clinical diagnosis of either rheumatoid arthritis or psoriatic arthritis by a Rheumatology specialist, as per the diagnostic criteria of the American College of Rheumatology.

" Must present pain, joint stiffness, joint instability, or osteoarticular deformities in the joints of the wrist, hand, and fingers.

" Must have a functional impact with a QuickDASH score \> 31.5. " Must be capable of using the SIMPLI.REHAB app on a smartphone with internet connectivity.

" Must possess digital literacy allowing the use of the app. " Must have the ability to understand and provide informed consent.

Exclusion Criteria:

"Presence of other medical conditions that might interfere with participation or interpretation of results, such as: neoplasms, other systemic autoimmune diseases, diabetic polyneuropathy and/or uncontrolled diabetes " Having had local surgery on the joint of the wrist, hand, and fingers or a history of fracture in the last 6 months.

" History of intra-articular or intramuscular corticoanesthetic infiltration in the previous 4 weeks.

" Inability to perform hand exercises due to significant understanding, cognitive, or physical limitation.

" Participation in an occupational rehabilitation program during the study period or in the last 6 months.

" Severe hearing loss or visual impairment. " Undergoing other types of therapies or localized interventions in the hand and fingers during the study period.

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: Average of 7 weeks
measure: QuickDASH Outcome Measure
timeFrame: Average of 7 weeks
Secondary outcomes:
measure: Number of Participants with New Osteoarticular Deformities
timeFrame: Average of 7 weeks
measure: Rate of Rescue Medications Usage
timeFrame: Average of 7 weeks
measure: Number of Participants with Assistive Devices
timeFrame: Average of 7 weeks
Other outcomes:
measure: Numeric Pain Scale
timeFrame: Average of 7 weeks
measure: Range of Motion
timeFrame: Average of 7 weeks
measure: Muscular Strength
timeFrame: Average of 7 weeks
measure: Moberg Pickup Test Score
timeFrame: Average of 7 weeks
measure: 9-Hole Peg Test Score
timeFrame: Average of 7 weeks
measure: Kapandji score
timeFrame: Average of 7 weeks
measure: Disease Activity Index for Rheumatoid Arthritis Patients (DAS-28)
timeFrame: Average of 7 weeks
measure: Disease Activity Index for Psoriatic Arthritis Patients (DAPSA)
timeFrame: Average of 7 weeks
Locations:
city: Porto
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia-Espinho, E.P.E.
state: Vila Nova De Gaia
Study officials:
affiliation: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
name: Eugénio M Gonçalves, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
name: Ana M Campolargo, MD
role: STUDY_DIRECTOR
References: