Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in Hand Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:

Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in Hand Arthritis: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06077890
• Other study ID #: 62/2023-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
• Contact: Eugénio M Gonçalves, MD
• Phone: +351914964951
• Email: eugenio.goncalves[@]chvng.min-saude.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Congenital Abnormalities
• Hand Arthritis
• Hand Deformities
• Limitation, Mobility
• Mobility Limitation

Intervention

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.
• 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.

Locations

Country	Name	City	State
Portugal	Centro Hospitalar de Vila Nova de Gaia-Espinho, E.P.E.	Porto	Vila Nova De Gaia

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Numeric Pain Scale	Score on the Numeric Pain Scale pre and post-intervention The Numeric Pain Scale is a unidimensional measurement instrument for pain intensity, frequently used in rheumatic diseases. The reliability of this scale is high (r = 0.96 to 0.95) with also high validity (r = 0.86 to 0.95). The minimal clinically significant difference is estimated at 1.1 points in patients with arthritis. (30, 31	Average of 7 weeks
Other	Range of Motion	Joint range of motion using a digit-o-meter pre and post-intervention	Average of 7 weeks
Other	Muscular Strength	Measurement of muscular strength using a pinch and palmar grip dynamometer pre and post-intervention.; Dynamometry for objective assessment of pinch and palmar grip strength will allow for the evaluation of muscle strength in the hand and fingers.; The minimal clinically important difference is estimated to be between 5 to 6 kgs.	Average of 7 weeks
Other	Moberg Pickup Test Score	Tool for objective assessment of manual dexterity and fine motor coordination pre and post-intervention.	Average of 7 weeks
Other	9-Hole Peg Test Score	Tool for objective assessment of manual dexterity and fine motor coordination pre and post-intervention.	Average of 7 weeks
Other	Kapandji score	Tool for objective assessment of manual dexterity and fine motor coordination pre and post-intervention.	Average of 7 weeks
Other	Disease Activity Index for Rheumatoid Arthritis Patients (DAS-28)	Score on Disease Activity Index pre and post-intervention for Rheumatoid Arthritis Patients.; The DAS-28, or Disease Activity Score in 28 joints, is a measure commonly used to assess disease activity in patients with rheumatoid arthritis. It evaluates the number of swollen and tender joints out of a total of 28, the patient's global assessment of their health, and an acute phase reactant (usually the erythrocyte sedimentation rate or C-reactive protein level). The DAS-28 provides a score that falls into one of the following categories to represent the patient's disease activity:Remission: DAS-28 < 2.6; Low disease activity: DAS-28 between 2.6 and 3.2; Moderate disease activity: DAS-28 between 3.2 and 5.1; High disease activity: DAS-28 > 5.1	Average of 7 weeks
Other	Disease Activity Index for Psoriatic Arthritis Patients (DAPSA)	Score on Disease Activity Index pre and post-intervention for Psoriatic Arthritis Patients.; DAPSA stands for Disease Activity index for PSoriatic Arthritis. It is a tool used to assess disease activity in patients with psoriatic arthritis. The score is calculated by summing the scores of the number of tender joints (68 joints are assessed), the number of swollen joints (66 joints are assessed), patient's assessment of pain, the patient's global disease activity and C-reactive protein (CRP) level (mg/dl). Low disease activity if DAPSA = 15, moderate disease activity if DAPSA > 15 and = 28 and, finally, high disease activity if DAPSA > 28.	Average of 7 weeks
Primary	Disabilities of the Arm, Shoulder and Hand (DASH) Score	Hand functionality in basic and instrumental daily life activities, occupational and artistic or sports activities, through the score in the Disabilities of the Arm, Shoulder and Hand (DASH) 30-item questionnaire, calculated before and after the intervention.; For each question, the patient rates on a 5-point Likert scale. The total score will range from 0 (no disability) to 100 (severe disability). It is a valid and reliable questionnaire (Pearson r > 0.70; ICC(2,1) = 0.96), with a minimal clinically important difference ranging between 10.83 and 15. (33, 37, 38).	Average of 7 weeks
Primary	QuickDASH Outcome Measure	Shortened version of the DASH questionnaire which includes 11 items for clinical and functional evaluation of the upper limb. The QuickDASH questionnaire assesses an individual's ability to complete daily life activities, the ability to bear load, as well as the intensity of symptoms. It is also a valid and reliable questionnaire (Pearson r > 0.70; ICC(2,1) = 0.90), with the minimal clinically important difference ranging between 15.91 and 20.	Average of 7 weeks
Secondary	Number of Participants with New Osteoarticular Deformities	Classification of osteoarticular deformities	Average of 7 weeks
Secondary	Rate of Rescue Medications Usage	Proportion of Pain-relief medications used	Average of 7 weeks
Secondary	Number of Participants with Assistive Devices	Determine the use of assistive devices and/or orthosis	Average of 7 weeks