Arthritis, PsoriaticNCT06077890
Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in Hand Arthritis
A study testing Digital Rehabilitation and Conventional Rehabilitation in people with Arthritis, Psoriatic and Arthritis, Rheumatoid, run by Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic, Arthritis, Rheumatoid, Deformity, Hand
- What is being tested?
- Digital Rehabilitation and Conventional Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePortugal
- Study dates
- Jul 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- " 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.
Who cannot join
- "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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Centro Hospitalar de Vila Nova de Gaia-Espinho, E.P.E.
Porto, Vila Nova De Gaia, 4434-502
Eugénio M Gonçalves, +351914964951, eugenio.goncalves@chvng.min-saude.pt
Ana M Campolargo, +351966961202, ana.campolargo@chvng.min-saude.pt
About this study
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.
Read the 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.
- Conditions
- Arthritis, Psoriatic, Arthritis, Rheumatoid, Deformity, Hand, Limitation, Mobility, Hand Arthritis, Hand Deformity
- Being tested
- Digital Rehabilitation, Conventional Rehabilitation
- Keywords
- Physical and Rehabilitation Medicine, Digital Technology, Occupational therapy, Hand, Rehabilitation
- Medical subject headings
- Arthritis, Psoriatic, Arthritis, Rheumatoid, Hand Deformities, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital RehabilitationOther
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 RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Average of 7 weeks
Secondary outcomes (3)
Number of Participants with New Osteoarticular Deformities
Classification of osteoarticular deformities
Measured: Average of 7 weeks
Rate of Rescue Medications Usage
Proportion of Pain-relief medications used
Measured: Average of 7 weeks
Number of Participants with Assistive Devices
Determine the use of assistive devices and/or orthosis
Measured: Average of 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study startJul 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, PsoriaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eugénio Moita Gonçalves, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
- Investigators
- Eugénio M Gonçalves, MD, Principal investigator, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.Ana M Campolargo, MD, Study director, Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077890
- Sponsor's protocol ID
- 62/2023-1
- Status last verified
- Apr 2024
- First submitted
- 24 Sep 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Digital Rehabilitation (SIMPLI.REHAB) in Hand Arthritis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06077890
- Acronym / sponsor ID
- 62/2023-1
- Conditions
- Arthritis, Psoriatic, Arthritis, Rheumatoid, Deformity, Hand, Limitation, Mobility, Hand Arthritis, Hand Deformity
- Keywords
- Physical and Rehabilitation Medicine, Digital Technology, Occupational therapy, Hand, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.Other government
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Intervention Group | Experimental | Other: Digital RehabilitationThis 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. |
| Conventional Intervention Group | Active comparator | Other: Conventional RehabilitationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- " 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.
Key exclusion criteria (5 listed)
- "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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital RehabilitationParticipants 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. | Other | Digital Intervention Group |
| Conventional RehabilitationParticipants 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. | Other | Conventional Intervention Group |
Primary outcome
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time frame: Average of 7 weeks
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
Time frame: Average of 7 weeks
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.
3 secondary outcomes
Number of Participants with New Osteoarticular Deformities
Time frame: Average of 7 weeks
Rate of Rescue Medications Usage
Time frame: Average of 7 weeks
Number of Participants with Assistive Devices
Time frame: Average of 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugénio M Gonçalves, MD principal investigator
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Ana M Campolargo, MD study director
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Rehabilitation and Conventional Rehabilitation in people with Arthritis, Psoriatic and Arthritis, Rheumatoid, run by Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eugénio M Gonçalves, MD (+351914964951, eugenio.goncalves@chvng.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of the Arm, Shoulder and Hand (DASH) Score (time frame: Average of 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.