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

NCT06077890 | Not Yet Recruiting

• 1 other identifier: 62/2023-1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Psoriatic; Arthritis, Rheumatoid; Deformity, Hand; Limitation, Mobility; Hand Arthritis; Hand Deformity

Keywords

Physical and Rehabilitation Medicine; Digital Technology; Occupational therapy; Hand; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of Participants with New Osteoarticular Deformities

  Average of 7 weeks

• Rate of Rescue Medications Usage

  Average of 7 weeks

• Number of Participants with Assistive Devices

  Average of 7 weeks

Other Outcomes (8)

• Numeric Pain Scale

  Average of 7 weeks

• Range of Motion

  Average of 7 weeks

• Muscular Strength

  Average of 7 weeks

Study Arms (2)

Digital Intervention Group

EXPERIMENTAL

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

Conventional Intervention Group

ACTIVE COMPARATOR

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

Interventions

Digital Rehabilitation OTHER

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.

Digital Intervention Group

Conventional Rehabilitation OTHER

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.

Conventional Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• " 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.

You may not qualify if:

• "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.

Sponsors & Collaborators

• Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.: lead

Study Sites (1)

Centro Hospitalar de Vila Nova de Gaia-Espinho, E.P.E.

Porto, Vila Nova De Gaia, 4434-502, Portugal

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Arthritis, Rheumatoid; Hand Deformities; Mobility Limitation

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eugénio M Gonçalves, MD

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

  PRINCIPAL INVESTIGATOR

• Ana M Campolargo, MD

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

  STUDY DIRECTOR

Central Study Contacts

Eugénio M Gonçalves, MD

CONTACT

+351914964951; eugenio.goncalves@chvng.min-saude.pt

Ana M Campolargo, MD

CONTACT

+351966961202; ana.campolargo@chvng.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2023
• First Posted: October 11, 2023
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)