NCT04308876

Brief Summary

Manual treatment involves techniques based on the principles of moving the joint faces and separating the joint gap, and soft tissues mobilization techniques. The use of manual therapy in hemophilia is gradually increasing although it previously described as a contraindication. The utility and use of strengthening exercises in hemophilia has been going on for a long time. In this study, the effect of manual therapy and strengthening exercises joint was investigated in hemophilic arthropathy of the elbow.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

March 12, 2020

Last Update Submit

March 12, 2020

Conditions

HemophiliaArthritis

Keywords

HemophiliaArthropathyElbow jointManual therapyExercise

Outcome Measures

Primary Outcomes (3)

  • Hemophilia Joint Health Score

    We used the elbow point of Joint Health Status. Elbow Point is scored 0-20. A high score indicates that arthropathy findings worsen

    5 week

  • Frequency of bleeding

    It was evaluated wit bleeding number in elbow joint over last 5 week

    5 week

  • Numerical Pain Scale

    It was used for evaluation of activity and resting pain.

    5 week

Secondary Outcomes (5)

  • Range of motion

    5 week

  • Muscle strength

    5 week

  • Functionality of the upper extremity

    5 week

  • Oxford Elbow Score

    5 week

  • Physical status of the elbow

    5 week

Study Arms (2)

Manual therapy and strengthening exercises

EXPERIMENTAL

Manual therapy and strengthening exercises were applied totally 15 sessions for 5 weeks 3 times a week in hospital by physiotherapist.

Other: Manual therapyOther: Strengthening exercises

Strengthening exercises

ACTIVE COMPARATOR

Patients in this group performed the strengthening exercises given to the experimental group on their own at home with experimental group at the same time, frequency and dose.

Other: Strengthening exercises

Interventions

Manual therapyOTHER

Manual therapy includes techniques applied to elbow joints and surrounding tissues

Manual therapy and strengthening exercises
Strengthening exercisesOTHER

Strengthening exercises used in this study includes resistant exercises to increase muscle strength of upper extremity

Manual therapy and strengthening exercisesStrengthening exercises

Eligibility Criteria

Age12 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Having signs of hemophilic arthropathy in one or both elbow joints, Being between the ages of 12-30 (Adolescent and young adult), Receiving prophylactic factor replacement therapy.

You may not qualify if:

  • Having undergone any surgical procedure for elbow arthropathy, Having an orthopedic problem, such as a fracture, ligament or tendon injury, related to the upper limb in the past year, Receiving physiotherapy and rehabilitation for the elbow joint in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Sarıcam, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemophilia AArthritisJoint DiseasesMotor Activity

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 AbnormalitiesMusculoskeletal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Filiz Can, Professor

    Hacettepe University, Faculty of Physical Therapy

    STUDY CHAIR

  • Ilgen Sasmaz

    Cukurova University, Faculty of Medicine, Department of Pediatric Hematology

    STUDY DIRECTOR

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
Lecturer

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 16, 2020

Study Start

April 9, 2018

Primary Completion

March 10, 2019

Study Completion

February 6, 2020

Last Updated

March 16, 2020

Record last verified: 2020-03

Locations

TU(1)