Rheumatic DiseasesNCT06385574
Technological Based Rehabilitation on Individuals With Rheumatic Disease
A study testing Virtual reality therapy in people with Rheumatic Diseases and Hand Rheumatism, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Affects such as pain, swelling, tenderness, deformities, limitations, strength and function losses, skill and coordination deficiencies in the hand joints, which are frequently seen in rheumatism patients with hand involvement, are included in body structure and function disorders within the framework of International… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Rheumatic Diseases, Hand Rheumatism, Virtual Reality Therapy
- What is being tested?
- Virtual reality therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 20 Jun 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having been diagnosed with a rheumatic disease that meets the latest criteria by a rheumatologist
- Involvement in hand joints (pain, swelling, tenderness)
- Being 18 years or older
- Being on stable drug treatment for the last 6 months
- Having sufficient cooperation to participate in the study
- Volunteering to participate in the study
Who cannot join
- Not volunteering to participate in the study
- Having difficulty in cooperating at work
- Having an additional orthopedic and/or neurological disease that will affect hand functions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sebahat Yaprak Cetin
Antalya, Konyaaltı, 07100
Sebahat Yaprak Cetin, PhD, fzt.ycetin@gmail.com
About this study
Official title: The Effects of Technological Based Rehabilitation on Individuals With Rheumatic Disease With Hand Involvement
Affects such as pain, swelling, tenderness, deformities, limitations, strength and function losses, skill and coordination deficiencies in the hand joints, which are frequently seen in rheumatism patients with hand involvement, are included in body structure and function disorders within the framework of International Classification of Function System. Leap Motion Controller is used in hand rehabilitation because it is small in size, low-cost, portable, non-contact, easy to use and provides visual and auditory feedback. The aim of our study is to examine the effect of technology-based rehabilitation on joint range of motion, grip strength, functionality and disease activity in adult individuals with rheumatic disease with hand involvement; and also to compare these effects with the effects of the hand rehabilitation program implemented under the guidance of a physiotherapist and the control group that continues its routine life.
Read the detailed description
In the study, 45 adult individuals diagnosed with rheumatic disease with hand involvement will be randomly divided into 3 groups. The first group will be given virtual reality exercises via Leap Motion Controller. Virtual reality exercises will be applied 30 minutes a day, 3 days a week for 8 weeks. To the second group, a conventional hand rehabilitation program will be applied under the supervision of a physiotherapist. The hand rehabilitation program will be applied 30 minutes a day, 3 days a week for 8 weeks. The third group will be the control group, which continues with its routine medications and is not included in any exercise program. After randomization, the individuals' joint range of motion, gross and fine grip strength, functionality, and disease activities will be evaluated. Evaluations will be made twice, at the beginning and at the end of the 8-week program. Disease Activity Score 28 (DAS 28), hand dynamometer, picnometer, Jebsen Hand Function Test, Nine Hole Peg Test, Duruoz Hand Index and Michigan Hand Outcome questionnairre will be used for evaluation.
- Conditions
- Rheumatic Diseases, Hand Rheumatism, Virtual Reality Therapy
- Being tested
- Virtual reality therapy
- Keywords
- rheumatic diseases, hand exercises, leap motion, functionality
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality therapyOther
Also called Hand exercises
Conventional hand therapy
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality therapy group | Experimental | Individuals in this group will be given hand exercises (wrist flexion, extension and deviations) for 45 minutes, 2 days a week for 8 weeks, using a leap motion control device and games selected in accordance with this device. Receives: Other: Virtual reality therapy |
| Conventional exercise group | Experimental | Hand exercises (wrist flexion, extension and deviations)) will be applied to individuals in this group under the supervision of a specialist physiotherapist for 45 minutes, 2 days a week for 8 weeks. Receives: Other: Virtual reality therapy |
| Control group | No intervention | This group is waiting list. After the study, patients will do hand exercises with the leap motion controller device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength measurement
Hand grip strength will be measured with a Jamar hydraulic hand dynamometer. Grip tests will be performed in the standard position recommended by the American Association of Hand Therapists. This is the standard position; The patient will be seated in a position that provides 90-20 degree flexion of the hip and knee, shoulder adduction, forearm neutral position, 90 degree flexion of the elbow, 0-30 degree extension of the wrist and 0-15 degree ulnar deviation. The measurement will be repeated three times. There will be a 15-second rest break at the end of each measurement. As a result, the average of three measurements will be recorded.
Measured: 8 weeks
Jebsen Hand Function Test (JHFT)
This test consists of tasks involving grasping types commonly used in daily living activities and evaluates people's speed in these tasks. Each stage of the Jebsen Taylor Hand Function Test, which consists of seven sub-steps, will be explained to the individuals in detail before the task and the individuals will be asked to try the task. Estimated time to complete 7 subtasks is 20 minutes. Individuals will complete tasks with both their dominant and non-dominant hands. The task will start with the practitioner's "start" command, and when the task is completed, the test performance will be recorded separately for the tested hand as the time to complete the task. Below is the tasks.
Task 1: Stack 4 checkers, Task 2: Card flipping, Task 3: Collecting objects, Task 4: Writing,Task 5: Eating, Task 6: Moving Light Objects, Task 7: Moving Heavy Objects
Measured: 8 weeks
Nine Hole Peg Test (NHPT)
This device is a device consisting of a square platform and a storage box. There are 9 holes in the square-shaped area (12.7x2cm) and 9 cylinders suitable for these holes. The diameter of the holes is 0.71 cm, the diameter of the cylinders is 0.64 cm, the length is 3.2 cm, the distance between the holes is 3.2 cm, the hole depth is 1.3 cm and the size of the storage box is 13x13 cm. During the test, the patient sits at the table with the 9-hole board, and the patient is asked to quickly take the 9 cylinders from the storage box, place them in the holes in random order, and quickly remove them from the holes without taking a break and place them in the storage box. Meanwhile, time is measured in seconds with a stopwatch. The test is performed 2 times consecutively for both hands and the average of the result is taken. The total test score is calculated by taking the average of the scores for both hands.
Measured: 8 weeks
Duruoz Hand Index (DHI)
The test consists of 18 questions. It is a simple, useful and reliable test that is presented by separating daily life functions (kitchen, clothing, cleaning, workplace and other daily life activities), does not require additional training and equipment for the test, and takes approximately 2-3 minutes to apply. It is a simple and understandable test in which questions are answered according to a Likert scale, with a minimum score of 0 and a maximum of 90 points. A lower score indicates a better functional state.
Measured: 8 weeks
Michigan Hand Outcome questionnaire (MHQ)
This questionnaire is a scale consisting of six sections and 57 different items. It helps us question how well patients perform tasks they frequently perform. The patient answers the questions according to the Likert measurement method, which gives values from one to five. Each of the 6 different categories in the scale is scored uniquely. High scores indicate good functionality.
Measured: 8 weeks
Secondary outcomes (2)
Disease Activity Score 28 (DAS 28)
It includes swelling and tenderness in 28 joints including the proximal interphalangeal joint, metacarpophalangeal joint, wrist, elbow, shoulder and knee joints, erythrocyte sedimentation rate (ESR) value, and global evaluation of the patient (VAS 0-100 mm). The DAS 28 value is calculated using a special formula:
DAS28 = (0.56 x √ Number of Tender Joints) + (0.28 x √ Number of Swollen Joints) + (0.70 x Ln (ESR value)) + (0.014 x Patient global assessment) High score; indicates high disease activity. Values higher than 5.1 indicate high disease activity, values between 3.2<DAS28≤5.1 indicate medium disease activity, values of 2.6<DAS28≤3.2 indicate low disease activity, and values less than or equal to 2.6 indicate that the patient is in remission.
Measured: 8 weeks
Hand fine grip strength measurement
Fine grip strength measurements will be made with finger dynamometry. Grip tests will be performed in the standard position recommended by the American Association of Hand Therapists. This is the standard position; The patient will be seated in a position that provides 90 degrees of hip and knee flexion, shoulder adduction, forearm neutral position, 90 degree flexion of the elbow, 0-30 degree extension of the wrist and 0-15 degree ulnar deviation. Three different finger grips will be evaluated. These:
1- Fingertip grip strength, 2- Lateral grip strength, 3- Three point grip strength.
Measurements will be repeated three times. There will be a 15-second rest break at the end of each measurement. As a result, the average of three measurements will be recorded.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start15 Mar 2024
- Primary completion15 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are three groups in the study. First group is leap motion interventional group, second group is hand exercises group and the third group is waiting list.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebahat Yaprak Cetin, PT, Akdeniz University
- Investigators
- Sebahat Yaprak Cetin, PhD, Principal investigator, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385574
- Sponsor's protocol ID
- 2023-088
- Status last verified
- Jun 2024
- First submitted
- 22 Apr 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will share data to the other individuals with some analyses program.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Technological Based Rehabilitation on Individuals With Rheumatic Disease With Hand Involvement
- ClinicalTrials.gov ID
- NCT06385574
- Acronym / sponsor ID
- 2023-088
- Conditions
- Rheumatic Diseases, Hand Rheumatism, Virtual Reality Therapy
- Keywords
- rheumatic diseases, hand exercises, leap motion, functionality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 26 Apr 2024 (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.
Affects such as pain, swelling, tenderness, deformities, limitations, strength and function losses, skill and coordination deficiencies in the hand joints, which are frequently seen in rheumatism patients with hand involvement, are included in body structure and function disorders within the framework of International Classification of Function System. Leap Motion Controller is used in hand rehabilitation because it is small in size, low-cost, portable, non-contact, easy to use and provides visual and auditory feedback. The aim of our study is to examine the effect of technology-based rehabilitation on joint range of motion, grip strength, functionality and disease activity in adult individuals with rheumatic disease with hand involvement; and also to compare these effects with the effects of the hand rehabilitation program implemented under the guidance of a physiotherapist and the control group that continues its routine life.
Detailed description
In the study, 45 adult individuals diagnosed with rheumatic disease with hand involvement will be randomly divided into 3 groups. The first group will be given virtual reality exercises via Leap Motion Controller. Virtual reality exercises will be applied 30 minutes a day, 3 days a week for 8 weeks. To the second group, a conventional hand rehabilitation program will be applied under the supervision of a physiotherapist. The hand rehabilitation program will be applied 30 minutes a day, 3 days a week for 8 weeks. The third group will be the control group, which continues with its routine medications and is not included in any exercise program. After randomization, the individuals' joint range of motion, gross and fine grip strength, functionality, and disease activities will be evaluated. Evaluations will be made twice, at the beginning and at the end of the 8-week program. Disease Activity Score 28 (DAS 28), hand dynamometer, picnometer, Jebsen Hand Function Test, Nine Hole Peg Test, Duruoz Hand Index and Michigan Hand Outcome questionnairre will be used for evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- There are three groups in the study. First group is leap motion interventional group, second group is hand exercises group and the third group is waiting list.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality therapy group | Experimental | Other: Virtual reality therapyIndividuals in this group will be given hand exercises (wrist flexion, extension and deviations) for 45 minutes, 2 days a week for 8 weeks, using a leap motion control device and games selected in accordance with this device. |
| Conventional exercise group | Experimental | Other: Virtual reality therapyHand exercises (wrist flexion, extension and deviations)) will be applied to individuals in this group under the supervision of a specialist physiotherapist for 45 minutes, 2 days a week for 8 weeks. |
| Control group | No intervention | –This group is waiting list. After the study, patients will do hand exercises with the leap motion controller device. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Having been diagnosed with a rheumatic disease that meets the latest criteria by a rheumatologist
- Involvement in hand joints (pain, swelling, tenderness)
- Being 18 years or older
- Being on stable drug treatment for the last 6 months
- Having sufficient cooperation to participate in the study
Key exclusion criteria (3 listed)
- Not volunteering to participate in the study
- Having difficulty in cooperating at work
- Having an additional orthopedic and/or neurological disease that will affect hand functions
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 |
|---|---|---|
| Virtual reality therapyAlso: Hand exercisesConventional hand therapy | Other | Conventional exercise group, Virtual reality therapy group |
Primary outcome
Hand grip strength measurement
Time frame: 8 weeks
Hand grip strength will be measured with a Jamar hydraulic hand dynamometer. Grip tests will be performed in the standard position recommended by the American Association of Hand Therapists. This is the standard position; The patient will be seated in a position that provides 90-20 degree flexion of the hip and knee, shoulder adduction, forearm neutral position, 90 degree flexion of the elbow, 0-30 degree extension of the wrist and 0-15 degree ulnar deviation. The measurement will be repeated three times. There will be a 15-second rest break at the end of each measurement. As a result, the average of three measurements will be recorded.
Jebsen Hand Function Test (JHFT)
Time frame: 8 weeks
This test consists of tasks involving grasping types commonly used in daily living activities and evaluates people's speed in these tasks. Each stage of the Jebsen Taylor Hand Function Test, which consists of seven sub-steps, will be explained to the individuals in detail before the task and the individuals will be asked to try the task. Estimated time to complete 7 subtasks is 20 minutes. Individuals will complete tasks with both their dominant and non-dominant hands. The task will start with the practitioner's "start" command, and when the task is completed, the test performance will be recorded separately for the tested hand as the time to complete the task. Below is the tasks. Task 1: Stack 4 checkers, Task 2: Card flipping, Task 3: Collecting objects, Task 4: Writing,Task 5: Eating, Task 6: Moving Light Objects, Task 7: Moving Heavy Objects
Nine Hole Peg Test (NHPT)
Time frame: 8 weeks
This device is a device consisting of a square platform and a storage box. There are 9 holes in the square-shaped area (12.7x2cm) and 9 cylinders suitable for these holes. The diameter of the holes is 0.71 cm, the diameter of the cylinders is 0.64 cm, the length is 3.2 cm, the distance between the holes is 3.2 cm, the hole depth is 1.3 cm and the size of the storage box is 13x13 cm. During the test, the patient sits at the table with the 9-hole board, and the patient is asked to quickly take the 9 cylinders from the storage box, place them in the holes in random order, and quickly remove them from the holes without taking a break and place them in the storage box. Meanwhile, time is measured in seconds with a stopwatch. The test is performed 2 times consecutively for both hands and the average of the result is taken. The total test score is calculated by taking the average of the scores for both hands.
Duruoz Hand Index (DHI)
Time frame: 8 weeks
The test consists of 18 questions. It is a simple, useful and reliable test that is presented by separating daily life functions (kitchen, clothing, cleaning, workplace and other daily life activities), does not require additional training and equipment for the test, and takes approximately 2-3 minutes to apply. It is a simple and understandable test in which questions are answered according to a Likert scale, with a minimum score of 0 and a maximum of 90 points. A lower score indicates a better functional state.
Michigan Hand Outcome questionnaire (MHQ)
Time frame: 8 weeks
This questionnaire is a scale consisting of six sections and 57 different items. It helps us question how well patients perform tasks they frequently perform. The patient answers the questions according to the Likert measurement method, which gives values from one to five. Each of the 6 different categories in the scale is scored uniquely. High scores indicate good functionality.
2 secondary outcomes
Disease Activity Score 28 (DAS 28)
Time frame: 8 weeks
Hand fine grip strength measurement
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No. We will share data to the other individuals with some analyses program.
Related trials for Rheumatic Diseases
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
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.
Sebahat Yaprak Cetin, PhD principal investigator
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality therapy in people with Rheumatic Diseases and Hand Rheumatism, run by Akdeniz University at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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 10 Jun 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 Turkey (Türkiye). 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 İshak Isik, MD (+90 242 249 00 00 ext. 4217, etik.kurul.07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand grip strength measurement (time frame: 8 weeks). The study lists 5 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 10 Jun 2024.