Physiotherapy to Improve Balance and Walking Capacity in... | NCT07339410

Studies
Physiotherapy to Improve Balance and Walking Capacity in Hemophilia

NCT07339410

Sponsor

Yuzuncu Yil University

Status

Completed

Last Update Posted

Jan 14, 2026Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Hemophilia

Interventions

Physiotherapy

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2025Actual

Primary Completion Date

Dec 20, 2025Actual

Completion Date

Jan 5, 2026Actual

First Submitted Date

Jan 5, 2026

First Submission Date that Met QC Criteria

Jan 5, 2026

First Posted Date

Jan 14, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2026

Last Update Posted Date

Jan 14, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ayse Merve TAT, Assistant Professor, Yuzuncu Yil UniversityPrincipal Investigator

Lead Sponsor

Yuzuncu Yil UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	No Intervention
Physiotherapy Group	Experimental	Physiotherapy	Other: Physiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physiotherapy	Other	The physiotherapy intervention applied in this study included manual therapy and a structured and progressive exercise program.	Physiotherapy Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Activity pain	Activity pain was evaluated with Numeric Pain Scale	From enrollment to the end of treatment at 6 weeks
Joint health	Joint health was evaluated with Hemophilia Joint Health Score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Van Yüzüncü Yıl University		Van		65080	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006467	Hemophilia A
D009043	Motor Activity
D007592	Joint Diseases

Ancestor Terms

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided