SclerodermaNCT04563481
Effectiveness of Telerehabilitation on Scleroderma
A study testing Hand Therapy via Telerehabilitation and Hand Therapy by Physiotherapist in people with Scleroderma and Scleroderma, Systemic, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
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 traditional physiotherapy practices. 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 by Physiotherapist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 30 Dec 2023
- 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
TUGBA CIVI KARAASLAN, PhD (c), +905343855606, tugba.civi@istanbul.edu.tr
ELA TARAKCI, Prof.
About this study
Official title: Investigation of the Effectiveness of Telerehabilitation on Individuals With Hand-Affected Scleroderma
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 traditional physiotherapy practices.
- Conditions
- Scleroderma, Scleroderma, Systemic, Scleroderma Associated Digital Ulcer, Hand Rheumatism, Physiotherapy, Rehabilitation
- Being tested
- Hand Therapy via Telerehabilitation, Hand Therapy by Physiotherapist
- 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
stretching exercises; all finger joints, wrist and supination-pronation direction strengthening exercises; finger and wrist functional exercises retrograde massage; starting from the distal phalanx to the elbow sensory education; desentilation training (cotton…) breathing exercises 5 days / week, 8 weeks in total
- 3 days / week with physiotherapist
- 2 days / week as home program 30 minutes / day 12 repetitions
Hand Therapy by PhysiotherapistOther
stretching exercises; all finger joints, wrist and supination-pronation direction strengthening exercises; finger and wrist functional exercises retrograde massage; starting from the distal phalanx to the elbow sensory education; desentilation training (cotton…) breathing exercises 5 days / week, 8 weeks in total
- 3 days / week with physiotherapist
- 2 days / week as home program 30 minutes / day 12 repetitions
| 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 |
| Rehabilitation by Physiotherapist in the Clinic | Experimental | Stretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied to the patients by physiotherapist in the clinic for 3 sessions per week. Receives: Other: Hand Therapy by Physiotherapist |
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 (4)
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
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
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 Sep 2020
- Study start1 May 2022 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
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.
- More trials run by Istanbul 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
- Randomized Clinical Study
- Masking
- None (open label)
- 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 (c), Principal investigator, Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563481
- Sponsor's protocol ID
- ISTANBULC
- Status last verified
- Apr 2022
- First submitted
- 23 Sep 2020
- Last updated
- 13 Apr 2022
- Results posted
- 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 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Telerehabilitation on Individuals With Hand-Affected Scleroderma
- ClinicalTrials.gov ID
- NCT04563481
- Acronym / sponsor ID
- ISTANBULC
- Conditions
- Scleroderma, Scleroderma, Systemic, Scleroderma Associated Digital Ulcer, Hand Rheumatism, Physiotherapy, Rehabilitation
- Keywords
- Scleroderma, Systemic sclerosis, Telerehabilitation, Hand therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 24 Sep 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.
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 traditional physiotherapy practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Clinical Study
| 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. |
| Rehabilitation by Physiotherapist in the Clinic | Experimental | Other: Hand Therapy by PhysiotherapistStretching and strengthening exercises, functional exercises, massage techniques, sensory training and breathing exercises will be applied to the patients by physiotherapist in the clinic for 3 sessions per week. |
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 Telerehabilitationstretching exercises; all finger joints, wrist and supination-pronation direction strengthening exercises; finger and wrist functional exercises retrograde massage; starting from the distal phalanx to the elbow sensory education; desentilation training (cotton…) breathing exercises 5 days / week, 8 weeks in total * 3 days / week with physiotherapist * 2 days / week as home program 30 minutes / day 12 repetitions | Other | Telerehabilitation |
| Hand Therapy by Physiotherapiststretching exercises; all finger joints, wrist and supination-pronation direction strengthening exercises; finger and wrist functional exercises retrograde massage; starting from the distal phalanx to the elbow sensory education; desentilation training (cotton…) breathing exercises 5 days / week, 8 weeks in total * 3 days / week with physiotherapist * 2 days / week as home program 30 minutes / day 12 repetitions | Other | Rehabilitation by Physiotherapist in the Clinic |
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.
4 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
Pittsburgh Sleep Quality Index (PSQI)
Time frame: change from baseline at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- 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.
TUGBA CIVI KARAASLAN, PhD (c) principal investigator
Research Assistant
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 by Physiotherapist 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: status not confirmed, as of the sponsor's last update on 13 Apr 2022. 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 TUGBA CIVI KARAASLAN, PhD (c) (+905343855606, tugbacivi@hotmail.com), or a site near the patient. 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 13 Apr 2022.