NCT07035080

Brief Summary

Hemophilia is a congenital , recessive clotting disease featured by cerebra ( The most dangerous ) and musculoskeletal (the most common and disabling) hemorrhages . It is a gender -specific coagulopathy resulting from a factor VIII (F VIII) deficiency in hemophilia A and factor IX (F IX) deficiency in hemophilia B( Felip et al., 2011) Loss of muscle mass is typical of hemophilia arthropathy, There are two basic reasons that account for such muscle loss. The first reason is due to inactive joints as the result of long -term immobilization that hemophilic patients are obliged to do because of continuous lesions in muscles and joints, and the second reason is a decrease in physical exercise by hemophilic patients because of the risk of lesions that they face (Toca-Herrera et al., 2008). Interferential therapy is a type of transcutaneous electrical nerve stimulation (TENS). Two slightly different, medium frequency- alternating currents are simultaneously applied to the affected area through electrodes. Superpisition or interference between the currents causes the combined electrical current to rise and fall (Burch et al, 2008). Low amplitude modulated frequencies elicit a "beating" or "tapping" sensation and muscle twitch response, while higher amplitude modulated frequencies elicit "buzzing" or "tingling sensation" and titanic muscle contraction ( Defrin et al., 2007). Several methods are available for testing muscle strength. These include manual muscle testing and dynamometry includes the use of handheld dynamometers, handgrip dynamometers, and isokinetic dynamometers (Sisto and Dyson-hudson, 2007). Isokinetic dynamometers measure torque produced at the anatomic joint throughout the available range of motion (ROM). Isokinetic dynamometers. Such as the kinCom (Chatanooga Corp, Chatanooga, Tennessee). Biodex (Biodex Medical systems. Inc) and Lido Active isokinetic System (Loredan, Inc, Davis , California ) measure torque by controlling the velocity of the movement and measuring the force applied via a force transducer (Sisto and Dyson-hunson, 2007). Isokinetic test record the torque produced throughout the entire ROM and allow for the identification of regions of strength or weakness within the range ( Remauld et al., 2005). Isokinetic assessment has primarily been recommended for strength testing as maximal force is applied during all phase of the movement at a constant velocity . The isokinetic mode is also safe to use with children because there is minimal risk of the muscle and joint injuries that can results from efforts to control the load if using free weights in one repetition -maximum testing (Mark et al., 2003).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

June 9, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

June 20, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 9, 2025

Last Update Submit

June 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • changes in muscle strength

    after 3 months

Secondary Outcomes (2)

  • change in level of pain

    after 3 months

  • change in function ability

    after 3 months

Study Arms (2)

group 1

EXPERIMENTAL

the control group will receive traditional treatment program for one hour per session including (ultrasound stretching and strengthening exercise )

Other: tradional physical therapy

group 2

EXPERIMENTAL

the study group will receive interferential therapy in addition to the same treatment program given to the control groups.

Other: interferential therapy

Interventions

Thirty hemophilic males (type A and B) children with unilateral hemarthrosis, age ranged from 8 to 12 years participated in this study. They were selected from the outpatient clinic. Faculty of physical therapy, kafrelsheik university. The patients were divided randomly into two groups of equal number , control and study groups, 15 patients each . the control group (7 left and 8 right hemarthrosis) received traditional treatment program for one hour per session includeing (ultrasound stretching and strengthening exercise ) , while the study group (6 left and 9 right hemarthrosis) received interferential therapy in addition to the same treatment program given to the control groups.

group 2

Thirty hemophilic males (type A and B) children with unilateral hemarthrosis, age ranged from 8 to 12 years participated in this study. They were selected from the outpatient clinic. Faculty of physical therapy, kafrelsheik university. The patients were divided randomly into two groups of equal number , control and study groups, 15 patients each . the control group (7 left and 8 right hemarthrosis) received traditional treatment program for one hour per session includeing (ultrasound stretching and strengthening exercise ) , while the study group (6 left and 9 right hemarthrosis) received interferential therapy in addition to the same treatment program given to the control groups.

group 1

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients of both groups (study and control groups ) were selected according to the following criteria:
  • Each group contained 15 male children. They were suffering from unilateral knee heamarthrothesis .
  • The joint problems (pain and bleeding ) ranges from mild to moderate according to the classification of hemophilia recommended by the Orthopedic advisory committee of the World Federation of hemophilia (appendix 1) (Holder and Cotta, 1989).
  • Patients were able to stand and walk independently.
  • They had no neurological or psychological problems.
  • All patients were clinically and medically stable.
  • They were able to understand the requirements of the study.
  • They were suffering from moderate hemophilia.
  • They were not suffering from acute joint and muscle bleeds during treatment time.
  • None of the children suffered from fixed deformities of the affected lower limb.
  • All the children received the same medical treatment to control bleeding.

You may not qualify if:

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  • Patients with advanced radiographic changes including:
  • Bone destruction.
  • Bony ankylosis .
  • Knee joint subluxation.
  • Epiphyseal fracture.
  • Patients who had congenital or acquired skeletal deformities in both lower limbs.
  • Patients who had any neurological deficits such as convulsions involuntary movements or those receiving muscle relaxants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemophilia A

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

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
lecture of pediatric physical therapy

Study Record Dates

First Submitted

June 9, 2025

First Posted

June 24, 2025

Study Start

June 20, 2025

Primary Completion

September 20, 2025

Study Completion

September 30, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06