Physiotherapy and Reaction Time in Hemophilia

March 29, 2024 updated by: Ayse Merve TAT, Yuzuncu Yıl University

The Effectiveness of Low Frequency Comprehensive Physiotherapy Combined With Home Exercise on Joint Health, Frequency of Hemartrosis, Dynamic Balance and Reaction Time in Hemophilic Arthropthy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Turkey
      • Van, Turkey, 65080
        • Van Yuzuncu Yıl University

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: -Clinical diagnosis of hemophilia

-Clinical diagnosis of hemophilic arthropathy in ankle and/or

Exclusion Criteria:

  • Clinical diagnosis of any neurological disease

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Home exercise
This group performed the same exercises given to comprehensive physiotherapy group at home 3 times a week for 6 weeks.
Other: Home exercise
Home exercise are done at home without the supervision of a specialist.
Experimental: Comprehensive physiotherapy
This 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 for 6 weeks.
Other: Home exercise
Home exercise are done at home without the supervision of a specialist.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reaction time
Time Frame: 6 week
Dynamic balance
6 week
Hemophilia Joint Health Score
Time Frame: 6 weeks
Joint health (Max values= 84, min values=0. As the value increases, joint health worsens.)
6 weeks

Collaborators and Investigators

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

Sponsor

Yuzuncu Yıl University

Investigators

  • Study Chair: Ayse Merve Tat, Asst. Prof., Van Yüzüncü Yıl University, Faculty of health science
  • Principal Investigator: Necati Muhammed Tat, Van Yüzüncü Yıl University, Faculty of health science
  • Principal Investigator: Serbay Şekeröz, Asst. Prof., Van Yüzüncü Yıl University, Faculty of health science
  • Principal Investigator: Meryem M Büke, Asst. Prof., Van Yüzüncü Yıl University, Faculty of health science
  • Study Chair: Kamuran M Karaman, Prof., Van Yüzüncü Yıl University, Faculty of Medicine

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 (Actual)

December 10, 2022

Primary Completion (Actual)

January 19, 2024

Study Completion (Actual)

January 19, 2024

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YuzuncuYıl2022/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study Protocol and Statistical Analysis Plan

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.

Clinical Trials on Hemophilia Arthropathy

Clinical Trials on Home exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe