Telerehabilitation on Hand-Affected Scleroderma
Telerehabilitation Approach on Individuals With Hand-Affected Scleroderma
1 other identifier
interventional
42
1 country
1
Brief Summary
Telerehabilitation Approach on Individuals with Hand-Affected Scleroderma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2020
CompletedFirst Posted
Study publicly available on registry
December 24, 2020
CompletedStudy Start
First participant enrolled
January 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedApril 10, 2023
April 1, 2023
8 months
December 19, 2020
April 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
change from baseline at 8 weeks
Secondary Outcomes (3)
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
Study Arms (3)
Telerehabilitation
EXPERIMENTALStretching 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
EXPERIMENTALStretching 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 INTERVENTIONThey will have no intervention for 8 weeks. After the period, they will do home exercises.
Interventions
Eligibility Criteria
You may qualify if:
- Having been diagnosed with scleroderma
- Stability of medical treatments
- To be able to adapt to the exercises
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tugba Civi Karaaslan
Istanbul, Buyukcekmece, Cerrahpasa Medical Faculty, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
TUGBA CIVI KARAASLAN
Istanbul University - Cerrahpasa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
December 19, 2020
First Posted
December 24, 2020
Study Start
January 6, 2021
Primary Completion
September 15, 2021
Study Completion
November 1, 2021
Last Updated
April 10, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share