HemophiliaIsokineticNCT07035080
Isokinetic Strength Training On Functional Performance
A study testing interferential therapy and tradional physical therapy in people with Hemophilia, run by Kafrelsheikh University.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Hemophilia
- What is being tested?
- interferential therapy and tradional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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
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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.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy Of Isokinetic Strength Training On Functional Performance In Children With Hemophilia
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).
Read more
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).
Read the detailed description
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).
With time , hemophilic arthropahy results in weak and unstable joints. The patient is also very vulnerable to stressful locomotors stimulation, which, in turn, causes greater instability and risk of lesions. This cicious circle of pain immobility , atrophy , joint instability , and new hemorrhagic episodes may eventually lead to total invalidity ( Gomis et al., 2009).
- Conditions
- Hemophilia
- Being tested
- interferential therapy, tradional physical therapy
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferential therapyOther
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.
tradional physical therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | the control group will receive traditional treatment program for one hour per session including (ultrasound stretching and strengthening exercise ) Receives: 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. Receives: Other: interferential therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in muscle strength
Measured: after 3 months
Secondary outcomes (2)
change in level of pain
Measured: after 3 months
change in function ability
Measured: after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start20 Jun 2025 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Yousef Abdel Elglil Yousef Elsebahy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035080
- Sponsor's protocol ID
- KFSIRB200-497
- Acronym
- Isokinetic
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Isokinetic Strength Training On Functional Performance In Children With Hemophilia
- ClinicalTrials.gov ID
- NCT07035080
- Acronym / sponsor ID
- Isokinetic / KFSIRB200-497
- Conditions
- Hemophilia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
With time , hemophilic arthropahy results in weak and unstable joints. The patient is also very vulnerable to stressful locomotors stimulation, which, in turn, causes greater instability and risk of lesions. This cicious circle of pain immobility , atrophy , joint instability , and new hemorrhagic episodes may eventually lead to total invalidity ( Gomis et al., 2009).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Other: tradional physical therapythe control group will receive traditional treatment program for one hour per session including (ultrasound stretching and strengthening exercise ) |
| group 2 | Experimental | Other: interferential therapythe study group will receive interferential therapy in addition to the same treatment program given to the control groups. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (20 listed)
- Patients of both groups (study and control groups ) were selected according to the following criteria:
- <!-- -->
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interferential therapyThirty 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. | Other | group 2 |
| tradional physical therapyThirty 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. | Other | group 1 |
Primary outcome
changes in muscle strength
Time frame: after 3 months
2 secondary outcomes
change in level of pain
Time frame: after 3 months
change in function ability
Time frame: after 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing interferential therapy and tradional physical therapy in people with Hemophilia, run by Kafrelsheikh University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Elsebahy, phd (+201094998882, sarah_elsehy2014@pt.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in muscle strength (time frame: after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.