Isokinetic Strength Training On Functional Performance

Study Identifier:
KFSIRB200-497
ClinicalTrials.gov Identifier:
NCT07035080
EudraCT Identifier:
N/A
Will Be Recruiting

Study Details

Medical Condition
  • Hemophilia
Study Drug
    Date
    Jun 2025 - Sep 2025
    Phase 1
    Phase 2
    Phase 3
    Phase 4
    N/A
    Patient Requirements
    Sex: Female & Male
    Age: 8 - 12 Years years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • 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.
    • They had no visual no hearing deficits B. Exclusion criteria
    • 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.

    Protocol Summary

    This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

    Trial Locations

    No locations found.