NCT07339410

Brief Summary

Introduction: Hemarthrosis is the most common type of bleeding with 70-80% in patient with hemophilia (PwH) and the majority of hemarthrosis occurs in the knee and ankle joints. Recurrent hemarthrosis may cause pain, limited range of motion (ROM), atrophy, swelling, crepitus, and decreased proprioceptive sensation and ultimately causes hemophilic arthropathy. Preventing hemarthrosis and treating arthropathy symptoms in PwH may improve static and dynamic balance and walking capacity. The aim of this study was to investigate the effects of manual therapy and structured exercises on joint health, activity pain, walking capacity and static and dynamic balance. Method: Thirty-five AwH were randomly assigned to two groups using the computerised simple randomization method: the control group (CG) and the physiotherapy group (PG). The sample sizes for the CG and PG are 17 and 18, respectively. Hemophilia type and severity, treatment regime (prophylaxis or on-demand), age, height and weight were recorded. Joint health was assessed with Hemophilia Joint Health Score (HJHS) version 2.1 by a hemophilia specialist physiotherapist. Activity pain was assessed with Numeric Pain Scale (NPS). Walking capacity was evaluated 6 Minute Walking Test (6MWT). Postural balance (static and dynamic balance) were evaluated with the Pro-kin Technobody Posturographic Platform (Pro-kin 212, Technobody s.r.l, Dalmine, 21044 Bergamo, Italy). Static stability test was used for static balance assessment. Dynamic balance was evaluated with the Limits of Stability (LoS) test. The PG received 12 physiotherapy sessions twice a week for 6 weeks. The physiotherapy intervention consisted of manual therapy and a structured, progressive exercise program. The CG continued with their routine hemophilia care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

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

October 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

January 5, 2026

Last Update Submit

January 5, 2026

Conditions

Hemophilia

Keywords

Manual therapyExercisePostural balancewalkinghemophiliaarthropathy

Outcome Measures

Primary Outcomes (2)

  • Postural balance

    Static and dynamic postural balance were evaluated with the Pro-kin Technobody Posturographic Platform (Pro-kin 212, Technobody s.r.l, Dalmine, 21044 Bergamo, Italy).

    From enrollment to the end of treatment at 6 weeks

  • Walking capacity

    Walking capacity was evaluated with 6 Minute Walking Test.

    From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (2)

  • Activity pain

    From enrollment to the end of treatment at 6 weeks

  • Joint health

    From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Control Group

NO INTERVENTION

Physiotherapy Group

EXPERIMENTAL

Physiotherapy

Other: Physiotherapy

Interventions

PhysiotherapyOTHER

The physiotherapy intervention applied in this study included manual therapy and a structured and progressive exercise program.

Physiotherapy Group

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe or moderate hemophilia A or B
  • Aged 18-65
  • Having at least 3 points from at least one of the knee and ankle index joints in the Hemophilia Joint Health Score
  • Volunteering to attend physiotherapy sessions regularly

You may not qualify if:

  • Receiving physiotherapy or undergone surgery on lower extremity within the last 6 months
  • Having neurological or cognitive disease
  • Having visual and vestibular system pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl University

Van, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemophilia AMotor ActivityJoint Diseases

Interventions

Physical Therapy Modalities

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)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 14, 2026

Study Start

October 20, 2025

Primary Completion

December 20, 2025

Study Completion

January 5, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations

TU(1)