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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Arthritis, Rheumatoid; Arthritis, Psoriatic; Limitation, Mobility; Hand Deformity; Hand Arthritis; Deformity, Hand
• Intervention / Treatment: Other: Digital Rehabilitation; Other: Conventional Rehabilitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eugénio M Gonçalves, MD; Phone Number: +351914964951; Email: eugenio.goncalves@chvng.min-saude.pt
• Study Contact Backup: Name: Ana M Campolargo, MD; Phone Number: +351966961202; Email: ana.campolargo@chvng.min-saude.pt

Study Locations

• Portugal
  • Vila Nova De Gaia
    • Porto, Vila Nova De Gaia, Portugal, 4434-502
      • Centro Hospitalar de Vila Nova de Gaia-Espinho, E.P.E.
      • Contact: Eugénio M Gonçalves; Phone Number: +351914964951; Email: eugenio.goncalves@chvng.min-saude.pt
      • Contact: Ana M Campolargo; Phone Number: +351966961202; Email: ana.campolargo@chvng.min-saude.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Intervention Group; This group incorporates the SIMPLI.REHAB digital tool as a complementary strategy for a rehabilitation program, including flexibility exercises and muscle strengthening, manual dexterity and motor coordination training, thermotherapy, and education on joint protection principles.	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.
Active Comparator: Conventional Intervention Group; This group follows a conventional rehabilitation program delivered in a more traditional, non-digital manner to serve as a comparison to assess the superiority of the experimental intervention using 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with New Osteoarticular Deformities	Classification of osteoarticular deformities	Average of 7 weeks
Rate of Rescue Medications Usage	Proportion of Pain-relief medications used	Average of 7 weeks
Number of Participants with Assistive Devices	Determine the use of assistive devices and/or orthosis	Average of 7 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Range of Motion	Joint range of motion using a digit-o-meter pre and post-intervention	Average of 7 weeks
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
Moberg Pickup Test Score	Tool for objective assessment of manual dexterity and fine motor coordination pre and post-intervention.	Average of 7 weeks
9-Hole Peg Test Score	Tool for objective assessment of manual dexterity and fine motor coordination pre and post-intervention.	Average of 7 weeks
Kapandji score	Tool for objective assessment of manual dexterity and fine motor coordination pre and post-intervention.	Average of 7 weeks
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
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

Collaborators and Investigators

• Sponsor: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
• Investigators: Principal Investigator: Eugénio M Gonçalves, MD, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.; Study Director: Ana M Campolargo, MD, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 24, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 28, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Hand; Occupational therapy; Physical and Rehabilitation Medicine; Digital Technology
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Psoriasis; Arthritis; Arthritis, Rheumatoid; Congenital Abnormalities; Arthritis, Psoriatic; Mobility Limitation; Hand Deformities
• Other Study ID Numbers: 62/2023-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No