Arthritis, Rheumatoid Clinical Trial
Official title:
Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in Hand Arthritis: A Randomized Clinical Trial
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.
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. |
Country | Name | City | State |
---|---|---|---|
Portugal | Centro Hospitalar de Vila Nova de Gaia-Espinho, E.P.E. | Porto | Vila Nova De Gaia |
Lead Sponsor | Collaborator |
---|---|
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. |
Portugal,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01682512 -
Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT00539760 -
A Phase I Rheumatoid Arthritis Study in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT03312465 -
Anatomical Shoulder Domelock System Study
|
||
Completed |
NCT01208181 -
A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)
|
Phase 3 | |
Completed |
NCT03254810 -
Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects
|
Phase 1 | |
Completed |
NCT01711814 -
A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
|
Phase 2 | |
Completed |
NCT03315494 -
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers
|
Phase 1 | |
Withdrawn |
NCT03241446 -
Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA)
|
Phase 1 | |
Completed |
NCT02553018 -
Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe
|
Phase 3 | |
Completed |
NCT02748785 -
MTX Discontinuation and Vaccine Response
|
Phase 4 | |
Active, not recruiting |
NCT02260778 -
Treat-to-target in RA: Collaboration To Improve adOption and adhereNce
|
N/A | |
Completed |
NCT02569736 -
Characterization of the Effect of Tocilizumab in Vivo and in Vitro on T Follicular Helper Cells in Rheumatoid Arthritis Patients and Consequence on B Cells Maturation
|
||
Completed |
NCT01750931 -
This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets.
|
Phase 2 | |
Withdrawn |
NCT01204138 -
Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA
|
Phase 2 | |
Not yet recruiting |
NCT01154647 -
Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes
|
N/A | |
Completed |
NCT00913458 -
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
|
Phase 4 | |
Completed |
NCT00973479 -
An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy
|
Phase 3 | |
Completed |
NCT00975130 -
Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)
|
Phase 3 | |
Completed |
NCT00550446 -
A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis
|
Phase 2 | |
Completed |
NCT00660647 -
Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA)
|
Phase 3 |