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

Primary Purpose

Arthritis, Psoriatic, Arthritis, Rheumatoid, Deformity, Hand

Status
Not yet recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Digital Rehabilitation
Conventional Rehabilitation
Sponsored by
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis, Psoriatic focused on measuring Physical and Rehabilitation Medicine, Digital Technology, Occupational therapy, Hand, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital Intervention Group

Conventional Intervention Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Number of Participants with New Osteoarticular Deformities
Classification of osteoarticular deformities
Rate of Rescue Medications Usage
Proportion of Pain-relief medications used
Number of Participants with Assistive Devices
Determine the use of assistive devices and/or orthosis

Full Information

First Posted
September 24, 2023
Last Updated
October 4, 2023
Sponsor
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
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1. Study Identification

Unique Protocol Identification Number
NCT06077890
Brief Title
Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in the Arthritis Hand
Official Title
Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in the Arthritis Hand: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Psoriatic, Arthritis, Rheumatoid, Deformity, Hand, Limitation, Mobility, Hand Arthritis, Hand Deformity
Keywords
Physical and Rehabilitation Medicine, Digital Technology, Occupational therapy, Hand, Rehabilitation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Intervention Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Digital Rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Description
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).
Time Frame
Average of 7 weeks
Title
QuickDASH Outcome Measure
Description
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.
Time Frame
Average of 7 weeks
Secondary Outcome Measure Information:
Title
Number of Participants with New Osteoarticular Deformities
Description
Classification of osteoarticular deformities
Time Frame
Average of 7 weeks
Title
Rate of Rescue Medications Usage
Description
Proportion of Pain-relief medications used
Time Frame
Average of 7 weeks
Title
Number of Participants with Assistive Devices
Description
Determine the use of assistive devices and/or orthosis
Time Frame
Average of 7 weeks
Other Pre-specified Outcome Measures:
Title
Numeric Pain Scale
Description
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
Time Frame
Average of 7 weeks
Title
Range of Motion
Description
Joint range of motion using a digit-o-meter pre and post-intervention
Time Frame
Average of 7 weeks
Title
Muscular Strength
Description
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.
Time Frame
Average of 7 weeks
Title
Moberg Pickup Test Score
Description
Tool for objective assessment of manual dexterity and fine motor coordination pre and post-intervention.
Time Frame
Average of 7 weeks
Title
9-Hole Peg Test Score
Description
Tool for objective assessment of manual dexterity and fine motor coordination pre and post-intervention.
Time Frame
Average of 7 weeks
Title
Kapandji score
Description
Tool for objective assessment of manual dexterity and fine motor coordination pre and post-intervention.
Time Frame
Average of 7 weeks
Title
Disease Activity Index for Rheumatoid Arthritis Patients (DAS-28)
Description
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
Time Frame
Average of 7 weeks
Title
Disease Activity Index for Psoriatic Arthritis Patients (DAPSA)
Description
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.
Time Frame
Average of 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eugénio M Gonçalves, MD
Phone
+351914964951
Email
eugenio.goncalves@chvng.min-saude.pt
First Name & Middle Initial & Last Name or Official Title & Degree
Ana M Campolargo, MD
Phone
+351966961202
Email
ana.campolargo@chvng.min-saude.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugénio M Gonçalves, MD
Organizational Affiliation
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana M Campolargo, MD
Organizational Affiliation
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Official's Role
Study Director
Facility Information:
Facility Name
Centro Hospitalar de Vila Nova de Gaia-Espinho, E.P.E.
City
Porto
State/Province
Vila Nova De Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugénio M Gonçalves
Phone
+351914964951
Email
eugenio.goncalves@chvng.min-saude.pt
First Name & Middle Initial & Last Name & Degree
Ana M Campolargo
Phone
+351966961202
Email
ana.campolargo@chvng.min-saude.pt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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