NCT04590456

Brief Summary

To assess the effect of pulsed electero- magnetic field on swelling, range of motion and muscle strength of hemarthrotic knee joints of haemophilic subjects.

Trial Health

43
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 Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

September 22, 2020

Last Update Submit

December 19, 2020

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (1)

  • swelling

    The swelling degree was detected by tape

    basline and after 3 months of intervention.

Secondary Outcomes (2)

  • range of motion

    basline and after 3 months of intervention.

  • muscle strength

    basline and after 3 months of intervention.

Study Arms (2)

Placebo group

EXPERIMENTAL
Other: PEMF

PEMF group

EXPERIMENTAL
Other: PEMF

Interventions

PEMFOTHER

group A received 60 minutes of traditional program physical therapy which consisted of passive range of motion, stretching,proprioception, isotonic and isometric and 20 minutes of placebo treatment using PEMF, while group B received the same traditional physical therapy program given to the control group in addition of 20 minutes of PEMF therapy

PEMF groupPlacebo group

Eligibility Criteria

Age13 Years - 16 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • type A hemophilia (moderate)
  • free from any musculoskeletal deformities.

You may not qualify if:

  • patients who performed surgical procedures 6 weeks before conducting the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delta University for Science and Technology

Gamasa, Dakahelia, 4030, Egypt

Location

Related Publications (1)

  • Gringeri A, Ewenstein B, Reininger A. The burden of bleeding in haemophilia: is one bleed too many? Haemophilia. 2014 Jul;20(4):459-63. doi: 10.1111/hae.12375. Epub 2014 Jan 29.

    PMID: 24472015BACKGROUND

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hala I. Kassem, Professor

    Professor of physical therapy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy

Study Record Dates

First Submitted

September 22, 2020

First Posted

October 19, 2020

Study Start

September 1, 2020

Primary Completion

December 19, 2020

Study Completion

December 19, 2020

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)