Quality of Life in Hemophilia by Clinical Scoring System (FISH)Score

January 27, 2020 updated by: Shymaa Saber, Assiut University

Assesment of Quality of Life by Functional Independance Score in Hemophilia Patients

To asses quality of life in patients with hemophilia clinically.-

-To avoid or minimize structural damage to goints and muscles by making patients aware of importance of rehabilitation

Study Overview

Status

Unknown

Conditions

Detailed Description

Hemophilia is a blood-clotting disorder caused by a deficiency in factor VIII (FVIII) or factor IX (FIX), which manifests itself through bleeding in the muscles and joints [1].

There are three categories, depending on the percentage of the blood-clotting factor: severe hemophilia (<1% FVIII/IX), characterised by spontaneous bleeding; moderate hemophilia (1-5% FVIII/FIX), with bleeding from slight injuries; and mild hemophilia (>5-40% FVIII/FIX) with bleeding during surgical procedures or from severe injuries(2).(3) Hemophilia C (a deficiency of Factor XI) is encountered, but its effect on clotting is far less pronounced than A or B Hemophilic arthropathy of the ankle causes pain and deterioration in gait, causing disability. Although some physiotherapy modalities are effective in the management of acute bleeding, the results are unknown in chronic arthropathy Due to the progression of hemophilic arthropathy and the resulting deterioration of the joint, deformities such as the estriction of motion (4). Physiotherapy through the RICE method (Rest, Ice, Compression, and Elevation) has been described for the improvement of acute joint injuries (5)as well as in the management of hemarthrosis in patients with hemophilia (6) Treatment of the ankle with physical therapy is complicated because it involves a small joint surface that bears significant ranges of body weight and the joint limitation alters biomechanical movement during walking(7) Prevention of musculoskeletal morbidity is an important objective in the treatment of hemophilia. Efficacy of such therapy has classically been measured by quantifying the extent of arthropathy using a joint scoring (8)(9)

Design of the Functional Independence Score in Hemophilia

Patients with hemophilia and their therapists were asked to list activities that could be affected by hemophilia. These were categorized according to the International Classification of Functioning, Disability and Health (ICF) (10)Activities that were considered unsafe to perform were excluded from the assessment. Other activities such as the use of transport, education and employment - that could not be assessed objectively in the clinic were also excluded. We finally included seven activities under three categories - self-care, transfers and locomotion (Table 1). Each activity was graded from 1 to 4 according to the amount of assistance required to perform the activity. Each activity and level of independence was clearly defined to reduce interobserver variation.core from 1 to 4 in each area:

  1. = the subject is unable to perform the activity, or needs complete assistance to perform the activity;
  2. = the subject needs partial assistance/aids/modified (9) (10) instruments/modified environment to perform the activity;
  3. = the subject is able to perform the activity without aids or assistance, but with slight discomfort. He is unable to perform the activity like his healthy peers 11 4= the subject is able to perform the activity without any difficulty like other healthy pears

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hemophilia A and B with goint affection

Description

Inclusion Criteria:

  • congenital Hemophilia A and B patients more than 18 years old

Exclusion Criteria:

  • All hemophilia patient less than 18 years old
  • Patients with other bleeding disorders
  • Patients with other comorbidities that can affect joint function as collagen disease
  • Patients on steroids or non-steroidal analgesics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life in hemophilia
Time Frame: One year
Assesment of quality of life by functional independance score in hemophilia
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Osama A Ibrahim, professor, Unafifiliated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 28, 2020

Primary Completion (Anticipated)

September 22, 2020

Study Completion (Anticipated)

October 10, 2020

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FISH score in hemophilia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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