RheumatologyNCT05821335
Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis
A study testing Leap motion assisted rehabilitation and Traditional program in people with Rheumatology and Scleroderma, Systemic, run by Istanbul University.
Trial summary
Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Rheumatology, Scleroderma, Systemic, Video Games
- What is being tested?
- Leap motion assisted rehabilitation and Traditional program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2023to 30 May 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having the ability to adapt to exercises
- Not having any diagnosed cardiac or orthopedic disease that may prevent the application of assessment methods
Who cannot join
- Having a diagnosis of juvenile-onset SSc
- Having a history of neurological disease or trauma that will affect hand functions
- Receiving another treatment, such as intra-articular injection, surgery, that may affect hand rehabilitation in the last 6 months
- Having systemic involvement that may affect the treatment process or activities of daily living
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Development and Investigation of Effectiveness of Leap Motion Based Gamefication Exercises in Hand Rehabilitation of the Individuals With Systemic Sclerosis
Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis
Read the detailed description
The aim of this project is to develop Leap Motion Sensor-assisted rehabilitation games that can be easily applied in hand rehabilitation in individuals with SSc, motivating, directing to the right exercise, providing therapeutic evaluation and feedback during the game, and comparing the effectiveness of these rehabilitation games with traditional rehabilitation applications.
- Conditions
- Rheumatology, Scleroderma, Systemic, Video Games, Physiotherapy, Rehabilitation, Hand Rheumatism
- Being tested
- Leap motion assisted rehabilitation, Traditional program
- Keywords
- Scleroderma, Systemic, Hand therapy, Therapy, Computer-Assisted
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leap motion assisted rehabilitationOther
Hand Therapy via leap motion sensor
Traditional programOther
Hand Therapy by physiotherapist via traditional methods
| Study group | Role | What they receive |
|---|---|---|
| Leap motion assisted rehabilitation | Experimental | Individuals who will participate in the study will be treated 2 days a week for 5 weeks with Leap Motion sensor-supported games aimed at increasing patient-specific wrist flexion, wrist extension, ulnar and radial deviation of the wrist, flexion, extension and abduction of the fingers. Each training period will last 30 minutes. Receives: Other: Leap motion assisted rehabilitation |
| Traditional program | Experimental | They will be included in traditional rehabilitation training consisting of stretching exercises, strengthening exercises and functional exercises including activities of daily living for 2 days a week for 5 weeks. Receives: Other: Traditional program |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Hand Mobility in Scleroderma (mHAMIS)
Hand Mobility in Scleroderma is a hand function test developed for adults who have systemic sclerosis. HAMIS consists of 9 items designed to measure all movements assessed in an ordinary range of motion-measured hand test. Each item is graded on a 0-3 scale, where 0 corresponds to normal function and 3 denotes that the individual is unable to perform the item. Each hand is assessed separately. The total score of HAMIS for each hand is 370 Sandqvist and Eklund Vol. 13, No. 6, December 2000 27, which represents a high degree of dysfunction.
Measured: change from baseline at 5 weeks
Secondary outcomes (4)
Finger Joint Range of Motion
The patients will be asked to close their fingers tightly and the distance between the pulp of the 2nd, 3rd, 4th, and 5th finger - distal palmar line (PP-DPD) will be measured in cm with the help of a ruler. Dominant and nondominant hand total scores will be calculated by summing the values found for the fingers of each hand separately.
Measured: change from baseline at 5 weeks
Grip Strength
A hand dynamometer will be used. For measurements, patients will be asked to make a maximally voluntary grip while sitting, elbow flexed to 90 degrees, wrist in semi-pronation with thumb pointing up. Measurements on the sick and healthy hand will be made 3 times in a row, and the average values will be recorded in kilograms (kg). Finger grip will be evaluated with a pinchmeter in three different positions (lateral, palmar, fingertip).
Measured: change from baseline at 5 weeks
Skin Hardness
Skin hardness will be measured with a durometer. Although the durometer is a device designed to measure non-biomaterial surface hardness, it is used clinically to evaluate sclerosis. Measurements will be made on the dorsal surface of the third finger, midphalanx, dorsum of the hand, palmar and dorsal aspects of the forearm.
Measured: change from baseline at 5 weeks
Purdue Pegboard Test
Purdue Pegboard Test will be used to evaluate hand functions. This test is an objective and standardized test that is frequently used in practice to evaluate functional hand use. The test will be preferred because of its advantages in demonstrating the functional activities and ability of the hand and its ease of use. The patient will be asked to perform the test activities first with the dominant hand, then with the non-dominant hand in 30 seconds, and using both hands in 60 seconds. Scoring will be based on the number of successfully placed pins.
Measured: change from baseline at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start30 May 2023 (estimated)
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RheumatologyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Civi Karaaslan, Istanbul University - Cerrahpasa
- Investigators
- TUGBA CIVI KARAASLAN, PhD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821335
- Sponsor's protocol ID
- IstanbulC3
- Status last verified
- May 2023
- First submitted
- 7 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tarakci E, Arman N, Tarakci D, Kasapcopur O. Leap Motion Controller-based training for upper extremity rehabilitation in children and adolescents with physical disabilities: A randomized controlled trial. J Hand Ther. 2020 Apr-Jun;33(2):220-228.e1. doi: 10.1016/j.jht.2019.03.012. Epub 2019 Apr 19.
PubMed 31010703Murphy SL, Poole JL, Chen YT, Lescoat A, Khanna D. Rehabilitation Interventions in Systemic Sclerosis: A Systematic Review and Future Directions. Arthritis Care Res (Hoboken). 2022 Jan;74(1):59-69. doi: 10.1002/acr.24737. Epub 2021 Dec 22.
PubMed 34165263
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Investigation of Effectiveness of Leap Motion Based Gamefication Exercises in Hand Rehabilitation of the Individuals With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05821335
- Acronym / sponsor ID
- IstanbulC3
- Conditions
- Rheumatology, Scleroderma, Systemic, Video Games, Physiotherapy, Rehabilitation, Hand Rheumatism
- Keywords
- Scleroderma, Systemic, Hand therapy, Therapy, Computer-Assisted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (estimated)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 20 Apr 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.
Leap Motion Based Gamefication Exercises in the Individuals With Systemic Sclerosis
Detailed description
The aim of this project is to develop Leap Motion Sensor-assisted rehabilitation games that can be easily applied in hand rehabilitation in individuals with SSc, motivating, directing to the right exercise, providing therapeutic evaluation and feedback during the game, and comparing the effectiveness of these rehabilitation games with traditional rehabilitation applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leap motion assisted rehabilitation | Experimental | Other: Leap motion assisted rehabilitationIndividuals who will participate in the study will be treated 2 days a week for 5 weeks with Leap Motion sensor-supported games aimed at increasing patient-specific wrist flexion, wrist extension, ulnar and radial deviation of the wrist, flexion, extension and abduction of the fingers. Each training period will last 30 minutes. |
| Traditional program | Experimental | Other: Traditional programThey will be included in traditional rehabilitation training consisting of stretching exercises, strengthening exercises and functional exercises including activities of daily living for 2 days a week for 5 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Having the ability to adapt to exercises
- Not having any diagnosed cardiac or orthopedic disease that may prevent the application of assessment methods
Key exclusion criteria (4 listed)
- Having a diagnosis of juvenile-onset SSc
- Having a history of neurological disease or trauma that will affect hand functions
- Receiving another treatment, such as intra-articular injection, surgery, that may affect hand rehabilitation in the last 6 months
- Having systemic involvement that may affect the treatment process or activities of daily living
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 |
|---|---|---|
| Leap motion assisted rehabilitationHand Therapy via leap motion sensor | Other | Leap motion assisted rehabilitation |
| Traditional programHand Therapy by physiotherapist via traditional methods | Other | Traditional program |
Primary outcome
modified Hand Mobility in Scleroderma (mHAMIS)
Time frame: change from baseline at 5 weeks
Hand Mobility in Scleroderma is a hand function test developed for adults who have systemic sclerosis. HAMIS consists of 9 items designed to measure all movements assessed in an ordinary range of motion-measured hand test. Each item is graded on a 0-3 scale, where 0 corresponds to normal function and 3 denotes that the individual is unable to perform the item. Each hand is assessed separately. The total score of HAMIS for each hand is 370 Sandqvist and Eklund Vol. 13, No. 6, December 2000 27, which represents a high degree of dysfunction.
4 secondary outcomes
Finger Joint Range of Motion
Time frame: change from baseline at 5 weeks
Grip Strength
Time frame: change from baseline at 5 weeks
Skin Hardness
Time frame: change from baseline at 5 weeks
Purdue Pegboard Test
Time frame: change from baseline at 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 31010703Tarakci E, Arman N, Tarakci D, Kasapcopur O. Leap Motion Controller-based training for upper extremity rehabilitation in children and adolescents with physical disabilities: A randomized controlled trial. J Hand Ther. 2020 Apr-Jun;33(2):220-228.e1. doi: 10.1016/j.jht.2019.03.012. Epub 2019 Apr 19.
- Background: PubMed 34165263Murphy SL, Poole JL, Chen YT, Lescoat A, Khanna D. Rehabilitation Interventions in Systemic Sclerosis: A Systematic Review and Future Directions. Arthritis Care Res (Hoboken). 2022 Jan;74(1):59-69. doi: 10.1002/acr.24737. Epub 2021 Dec 22.
- Individual participant dataSharing planned: Undecided
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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.
TUGBA CIVI KARAASLAN, PhD principal investigator
Istanbul University - Cerrahpasa
Questions about this trial
What is this clinical trial studying?
A study testing Leap motion assisted rehabilitation and Traditional program in people with Rheumatology and Scleroderma, Systemic, run by Istanbul University.
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 2 inclusion and 4 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 TUGBA CIVI KARAASLAN, PhD (+905343855606, tugba.civi@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Hand Mobility in Scleroderma (mHAMIS) (time frame: change from baseline at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05821335, which also lists 2 linked publications.
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 6 May 2023.