Hands on - a Hand Care Guide in Systemic Sclerosis
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|ClinicalTrials.gov Identifier: NCT02610842|
Recruitment Status : Unknown
Verified November 2015 by Eduardo de Paiva Magalhães, University of Campinas, Brazil.
Recruitment status was: Active, not recruiting
First Posted : November 20, 2015
Last Update Posted : December 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Scleroderma||Other: Handbook||Not Applicable|
Introduction: Hands are commonly affected in Systemic sclerosis (SS). Skin thickening, Raynaud phenomenon, digital ulcers and cutaneous calcinosis may result in pain, disability and claw deformity. Strategies to improve hand function are recommended since its diagnosis and throughout the treatment. Unfortunately hand care assistance is not often available. The objective of this study was to developed a brief guide about hand care and home-based exercises to be applied in our outpatient clinic.
Methods: A brief program , with instructions about the disease and home-based exercises will be applied in a group patients with Systemic Sclerosis (SS) during the period of 12 weeks. Hand function (Cochin Hand and Functional Scale), disability (HAQ-Scleroderma), quality of life (SF-36 hand pain (visual analogue scale), grip and pinch strength, hand mobility (delta finger) will be assessed in the first appointment and after twelve weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hands on - a Hand Care Guide in Systemic Sclerosis|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||December 2016|
Experimental: Handbook group
Patients will receive a home based program named "Hands on" - a hand care guide in Systemic Sclerosis" which includes a handbook with instructions about the disease and hand exercises. Patients will be asked to follow the program instructions and carry out the exercises daily during the following 12 weeks.
The handbook named "Hands on" - a hand care guide in Systemic Sclerosis" contains instructions about the Systemic Sclerosis and hand exercises.
- Cochin Hand Functional Scale [ Time Frame: 12 weeks ]
The purpose of this self-report scale is to measure functional ability in the hand.
The questions ask how much difficulty the person has performing 18 tasks without the help of any assistive device. Kitchen tasks include holding a bowl and a plate full of food, pouring liquid, cutting meat, and peeling fruit. The dressing items include buttoning and opening/closing a zipper. The hygiene items include squeezing a tube of toothpaste and holding a toothbrush. Office items include 2 writing tasks, while other items include turning a doorknob, cutting with scissors, and turning a key in a lock. Score range is from 0-90. A higher score indicates greater disability or more difficulty, whereas a lower score indicates less disability or difficulty.
- Visual analogue pain scale [ Time Frame: 12 weeks ]
- Delta finger-to-palm [ Time Frame: 12 weeks ]The standard finger-to-palm (FTP) measurement is obtained using a ruler to measure the distance (in centimetres)between the tip of the pulp on the 3rd finger and the distal palmar crease while the patient attempts to make a full fist (maximal finger flexion at all 3 finger joints: MCP, PIP, and DIP). The delta FTP is finger extension, the distance between the 3rd fingertip and the distal palmar crease while the patient attempts full finger extension, minus the FTP.
- The Short Form (36) Health Survey [ Time Frame: 12 weeks ]The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
- Scleroderma Health Assessment Questionnaire [ Time Frame: 12 weeks ]The HAQ DI is a self-reported questionnaire in 8 domains.The SHAQ consists of the HAQ (8 domains) and also includes the following scales: pain, patient global assessment, vascular, digital ulcers, lung involvement, and gastrointestinal involvement.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610842
|Clinical Hospital of University of Campinas|
|Campinas, São Paulo, Brazil, 13083-888|
|University of Campinas|
|Campinas, São Paulo, Brazil, 13603027|
|Study Director:||Bertolo B Manoel, MD,PhD||University of Campinas|