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Clinical Trials/NCT04563481
NCT04563481
Unknown
Not Applicable

Investigation of the Effectiveness of Telerehabilitation on Individuals With Hand-Affected Scleroderma

Istanbul University1 site in 1 country32 target enrollmentStarted: May 1, 2022Last updated:

Overview

Phase
Not Applicable
Enrollment
32
Locations
1
Primary Endpoint
Hand Mobility in Scleroderma (HAMIS)

Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Having been diagnosed with scleroderma
  • Stability of medical treatments
  • To be able to adapt to the exercises

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 9-Hole Peg Test(change from baseline at 8 weeks)
  • Scleroderma Health Assessment Questionnaire (SHAQ)(change from baseline at 8 weeks)
  • Semmes Weinstein Monofilaman Test(change from baseline at 8 weeks)
  • Pittsburgh Sleep Quality Index (PSQI)(change from baseline at 8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tugba Civi Karaaslan

Research Assistant

Istanbul University - Cerrahpasa (IUC)

Study Sites (1)

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