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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06331091
Other study ID # YuzuncuYil2022/2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 10, 2022
Est. completion date January 19, 2024

Study information

Verified date March 2024
Source Yuzuncu Yil University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomised controlled study was conducted to investigate the comprehensive physiotherapy combined with home exercises on individuals with hemophilic arthropathy in the lower extremity. There are two groups in the study: home exercises and comprehensive physiotherapy combined with home exercises. Is physiotherapy combined with home exercises superior to home exercises on joint health, bleeding frequency, reaction time, dynamic balance, muscle strength? The aim of this study is to increase the compliance of hemophilic individuals to physiotherapy and adapt home exercises to their lives with weekly sessions.


Description:

Introduction: The positive effects of physiotherapy and exercise on joint health, frequency of hemartrosis (FoH) in patient with hemophilic arhropathy (PwHA) are well explained in the literature. However, adaptation problems to physiotherapy sessions (usually 3 times a week) may cause PwHA to ignore the need for therapy. It may be more beneficial for PwHA to adapt physiotherapy and exercise into daily live. Aim: To investigate the effect of a once-a-week physiotherapy combined with home exercises on joint health, FoH, muscle strength, pain, reaction time and dynamic balance. Methods: 20 patients have hemophilic arthropathy in knee and/or ankle were randomly divided into 2 groups, named home exercise (HE) and comprehensive physiotherapy combined with home exercise (CPcwHE). In the clinical assessment, HJHS, manuel muscle tester, Fitlight® system for reaction time, functional reach test for dynamic balance were used and questioned the number of bleedings in the last 6 weeks for FoH. The CP group received comprehensive physiotherapy (manual therapy, neuromuscular electrical stimulation and exercises) 1 day a week, and did the exercises at home the other 2 days a week. The HE group performed the exercises given to CP at home 3 times a week. Evaluations were repeated at the end of 6 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date January 19, 2024
Est. primary completion date January 19, 2024
Accepts healthy volunteers No
Gender Male
Age group 10 Years to 32 Years
Eligibility Inclusion Criteria: -Clinical diagnosis of hemophilia -Clinical diagnosis of hemophilic arthropathy in ankle and/or Exclusion Criteria: - Clinical diagnosis of any neurological disease

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Home exercise
Home exercise are done at home without the supervision of a specialist.
Manual therapy
Manual therapy is special techniques for soft tissues and joints applied by a physiotherapist.
Device:
Neuromuscular electrical stimulation
Home exercise are done at home without the supervision of a specialist. Manual therapy is special techniques for soft tissues and joints applied by a physiotherapist. Neuromuscular electrical stimulation is the application of electrical current to the muscle through special electrodes in order to increase muscle strength. Supervised exercise is done under the supervision of a physiotherapist.
Other:
Supervised exercise
Supervised exercise is done under the supervision of a physiotherapist.

Locations

Country Name City State
Turkey Van Yüzüncü Yil University Van

Sponsors (1)

Lead Sponsor Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemophilia Joint Health Score Joint health (Max values= 84, min values=0. As the value increases, joint health worsens.) 6 weeks
Primary Reaction time Dynamic balance 6 week
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