SclerodermaNCT04684225
Telerehabilitation on Hand-Affected Scleroderma
A study testing Hand Therapy via Telerehabilitation and Hand Therapy via home-exercises in people with Scleroderma and Scleroderma, Systemic, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Telerehabilitation Approach on Individuals with Hand-Affected Scleroderma Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Scleroderma, Scleroderma, Systemic, Scleroderma Associated Digital Ulcer
- What is being tested?
- Hand Therapy via Telerehabilitation and Hand Therapy via home-exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2021to 1 Nov 2021
- 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 been diagnosed with scleroderma
- Stability of medical treatments
- To be able to adapt to the exercises
Who cannot join
- The patient has a history of neurological disease or trauma that may affect his symptoms
- Systemic involvement that affects the treatment process
- Being in the active phase of the disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tugba Civi Karaaslan
Istanbul, Buyukcekmece, Cerrahpasa Medical Faculty
About this study
Official title: Telerehabilitation Approach on Individuals With Hand-Affected Scleroderma
Telerehabilitation Approach on Individuals with Hand-Affected Scleroderma
Read the detailed description
The effects of exercises performed by telerehabilitation on individuals with hand-affected scleroderma on range of motion, grip strength, function, sensation, daily life activities and general health will be compared with the effects of home-exercises.
Firstly, the evaluation results will be published; and after all data are collected, the results will be published.
- Conditions
- Scleroderma, Scleroderma, Systemic, Scleroderma Associated Digital Ulcer, Hand Rheumatism, Physiotherapy, Rehabilitation
- Being tested
- Hand Therapy via Telerehabilitation, Hand Therapy via home-exercises
- Keywords
- Scleroderma, Systemic sclerosis, Telerehabilitation, Hand therapy
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Therapy via TelerehabilitationOther
Hand Therapy via Telerehabilitation
Hand Therapy via home-exercisesOther
Hand Therapy via home-exercises
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Stretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied to the patients via telerehabilitation for 3 sessions per week. Receives: Other: Hand Therapy via Telerehabilitation |
| Home-exercises | Experimental | Stretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied by their own at home for 3 sessions per week. Receives: Other: Hand Therapy via home-exercises |
| Control | No intervention | They will have no intervention for 8 weeks. After the period, they will do home exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Mobility in Scleroderma (HAMIS)
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 8 weeks
Secondary outcomes (3)
9-Hole Peg Test
It is used to evaluate patients' hand and finger skills. The pegboard is placed in the middle of the body. It is desirable that 9 wooden pins be placed randomly in the 9-hole wooden block as fast as possible, and then the pins are removed from the wooden block and placed in the storage compartment one by one. These times are measured and recorded with a stopwatch. A total of 20 seconds or more is considered a "loss of skill".
Measured: change from baseline at 8 weeks
Scleroderma Health Assessment Questionnaire (SHAQ)
The Scleroderma Health Assessment Questionnaire is a measurement tool for evaluating function in individuals with systemic scleroderma and has been used in a number of countries. SHAQ is made up of 20 items distributed among eight domains and has five additional domains that assess dysfunctions caused by the symptoms of systemic scleroderma. For this, five visual analogue scales (VASs) are used. The scores on these scales are converted to subscores ranging from 0 to 3 points. The overall score of the questionnaire is the sum of each of the five VAS subscores and the scores for the eight domains, divided by 13. Lower score indicates better health status.
Measured: change from baseline at 8 weeks
Semmes Weinstein Monofilaman Test
The severity of pain and paresthesia symptoms of the patients will be assessed using the 10 cm Visual Analogue Scale. Before the assessment, patients instruct that "0" for "no symptoms", "10" represents "the most severe pain that could be felt" and should mark the point that best describes the symptom. The patient's rest, activity and night pain in the last week will be questioned separately. To evaluate the paresthesia, the most severe paresthesia felt by the patient in the last 1 week will be questioned and it will be asked to mark the place that best expresses paresthesia on the scale. Marked points measure by a ruler and record in centimeters.
Measured: change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start6 Jan 2021
- Primary completion15 Sep 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies 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
- None (open label)
- Enrolment
- 42 participants (actual)
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, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684225
- Sponsor's protocol ID
- ISTANBULC2
- Status last verified
- Apr 2023
- First submitted
- 19 Dec 2020
- Last updated
- 10 Apr 2023
- 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 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation Approach on Individuals With Hand-Affected Scleroderma
- ClinicalTrials.gov ID
- NCT04684225
- Acronym / sponsor ID
- ISTANBULC2
- Conditions
- Scleroderma, Scleroderma, Systemic, Scleroderma Associated Digital Ulcer, Hand Rheumatism, Physiotherapy, Rehabilitation
- Keywords
- Scleroderma, Systemic sclerosis, Telerehabilitation, Hand therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 24 Dec 2020 (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.
Telerehabilitation Approach on Individuals with Hand-Affected Scleroderma
Detailed description
The effects of exercises performed by telerehabilitation on individuals with hand-affected scleroderma on range of motion, grip strength, function, sensation, daily life activities and general health will be compared with the effects of home-exercises.
Firstly, the evaluation results will be published; and after all data are collected, the results will be published.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: Hand Therapy via TelerehabilitationStretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied to the patients via telerehabilitation for 3 sessions per week. |
| Home-exercises | Experimental | Other: Hand Therapy via home-exercisesStretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied by their own at home for 3 sessions per week. |
| Control | No intervention | –They will have no intervention for 8 weeks. After the period, they will do home exercises. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Having been diagnosed with scleroderma
- Stability of medical treatments
- To be able to adapt to the exercises
Key exclusion criteria (3 listed)
- The patient has a history of neurological disease or trauma that may affect his symptoms
- Systemic involvement that affects the treatment process
- Being in the active phase of the disease
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 |
|---|---|---|
| Hand Therapy via TelerehabilitationHand Therapy via Telerehabilitation | Other | Telerehabilitation |
| Hand Therapy via home-exercisesHand Therapy via home-exercises | Other | Home-exercises |
Primary outcome
Hand Mobility in Scleroderma (HAMIS)
Time frame: change from baseline at 8 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.
3 secondary outcomes
9-Hole Peg Test
Time frame: change from baseline at 8 weeks
Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: change from baseline at 8 weeks
Semmes Weinstein Monofilaman Test
Time frame: change from baseline at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Scleroderma
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A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
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Cross-cultural Adaptation and Validation of the Localised Scleroderma Quality of Life Instrument (LoSQI) in Juvenile Localised Scleroderma (JLS)
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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 principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Therapy via Telerehabilitation and Hand Therapy via home-exercises in people with Scleroderma and Scleroderma, Systemic, run by Istanbul 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 3 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: finished, as of the sponsor's last update on 10 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Mobility in Scleroderma (HAMIS) (time frame: change from baseline at 8 weeks). 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 Apr 2023.