NCT06331091

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 10, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

March 19, 2024

Last Update Submit

March 29, 2024

Conditions

Keywords

hemophiliaphysiotherapyexercisereaction timejoint healtharthropathy

Outcome Measures

Primary Outcomes (2)

  • Hemophilia Joint Health Score

    Joint health (Max values= 84, min values=0. As the value increases, joint health worsens.)

    6 weeks

  • Reaction time

    Dynamic balance

    6 week

Study Arms (2)

Home exercise

ACTIVE COMPARATOR

This group performed the same exercises given to comprehensive physiotherapy group at home 3 times a week for 6 weeks.

Other: Home exercise

Comprehensive physiotherapy

EXPERIMENTAL

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 exerciseOther: Manual therapyDevice: Neuromuscular electrical stimulationOther: Supervised exercise

Interventions

Home exercise are done at home without the supervision of a specialist.

Comprehensive physiotherapyHome exercise

Manual therapy is special techniques for soft tissues and joints applied by a physiotherapist.

Comprehensive physiotherapy

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.

Comprehensive physiotherapy

Supervised exercise is done under the supervision of a physiotherapist.

Comprehensive physiotherapy

Eligibility Criteria

Age10 Years - 32 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical diagnosis of hemophilic arthropathy in ankle and/or

You may not qualify if:

  • Clinical diagnosis of any neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl University

Van, 65080, Turkey (Türkiye)

Location

Related Publications (1)

  • Tat AM, Tat NM, Sekeroz S, Buke M, Karaman K. Low frequency physiotherapy on joint health, hemarthrosis, walking, balance and reaction time in hemophilic arthropathy: a controlled trial. BMC Musculoskelet Disord. 2025 Apr 4;26(1):332. doi: 10.1186/s12891-025-08549-4.

MeSH Terms

Conditions

Hemophilia AMotor ActivityJoint Diseases

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehaviorMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Ayse Merve Tat, Asst. Prof.

    Van Yüzüncü Yıl University, Faculty of Health Science

    STUDY CHAIR
  • 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

    PRINCIPAL INVESTIGATOR
  • Kamuran M Karaman, Prof.

    Van Yüzüncü Yıl University, Faculty of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 26, 2024

Study Start

December 10, 2022

Primary Completion

January 19, 2024

Study Completion

January 19, 2024

Last Updated

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Study Protocol and Statistical Analysis Plan

Locations