Hemophilia aNCT06649175
Effect of Kinetic Chain Exercises on Muscle Strength, Joint Position Sense and Quality of Life in Children with Haemophilia.
A study testing Exercise in people with Hemophilia a and Muscle Strength, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if there are effect of close kinetic chain exercises on muscle strength, joint position sense and Quality of life in children with haemophilia? Null hypothesis It will be hypothesized that: There is no effect of close kinetic chain exercises on muscle strength, joint… Read more about this study
- Who is it for?
- Ages 5 to 7 years, men only
- Conditions the study is for
- Hemophilia a, Muscle Strength, Joint Position Sense
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 7 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 1. Their chronological age will be 5-7yeasr. 2. All children will receive prophylaxis therapy. 3. They will able to stand and walk independently. 4. They will be able to follow instructions during evaluation and treatment.
Who cannot join
- The children will be excluded if they have one of the following:
- Visual or auditory problem.
- Radiographic changes as bone erosions, destruction, or joint subluxation, or congenital or acquired skeletal deformities in both lower limbs.
- Surgical procedures performed six weeks prior to or during study.
- Bleeding in joint 2 week prior to assessment.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Out Patient clinic of Atfal Misr hospital
Cairo, 4260044
NAGLAA SHAHEN, 00201005183031 ext. PRO.DR, m.refat2006@yahoo.com
About this study
The goal of this clinical trial is to learn if there are effect of close kinetic chain exercises on muscle strength, joint position sense and Quality of life in children with haemophilia? Null hypothesis
It will be hypothesized that:
There is no effect of close kinetic chain exercises on muscle strength, joint position sense and Quality of life in children with haemophilia.
Read the detailed description
Sample size estimation will be carried out to determine the recruited number of children selected randomly from Out Patient clinic of Atfal Misr hospital, Cairo governorate to participate in this study. The study targets male children with hemophilia A.
They will be selected based on the following:
Inclusion criteria:
- Their chronological age will be 5-7yeasr.
- All children will receive prophylaxis therapy.
- They will able to stand and walk independently.
- They will be able to follow instructions during evaluation and treatment.
Exclusive criteria:
The children will be excluded if they have one of the following:
- Visual or auditory problem.
- Radiographic changes as bone erosions, destruction, or joint subluxation, or congenital or acquired skeletal deformities in both lower limbs.
- Surgical procedures performed six weeks prior to or during study.
- Bleeding in joint 2 week prior to assessment.
- Being tested
- Exercise
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Close Kinetic Chain Exercise (CKC)
Close kinetic chain (CKC) exercises :
- Supine wall push exercise: Start position: supine with the both leg against wall, other limb straight. Exercise action: push against wall for thirty seconds.
- Wall push against Swiss ball exercise: Start position: Supine with a Swiss ball between patient's legs and the wall. Exercise action: push against the wall for thirty seconds.
- Supine half bridging exercise: Start position: Lying on back, knees bent Exercise action: keeping spine neutral and hinging up from the hips, move into a bridge.
ExerciseOther
Also called Traditional physical therapy program
Control Group (A): will receive the traditional physical therapy (PT) , the traditional physical therapy program will include the following:
- Stretching exercise for shortening muscle of lower limbs (LL) mainly (hip flexors, adductors, knee flexors and ankle planter flexors).
- Balance training from standing while giving perturbations.
- Balance board training.
- Step ups: repeated stepping anteriorly and laterally onto a step with both legs alternatively, progressing to higher step and decreasing upper extremity support.
- Forward and backward walking (with or without handheld mobility devices).
- Side walking (with or without handheld mobility devices).
- Walking in astride line (with or without handheld mobility devices).
| Study group | Role | What they receive |
|---|---|---|
| group(A):exercise group. | Active comparator | Control Group (A): will receive the traditional physical therapy (PT) program for one hour two times weekly for six successive weeks.
Intervention: traditional physical therapy program. Receives: Other: Exercise |
| Group(B): modified exercise group. | Active comparator | Group (B): will receive a program of close kinetic chain exercises for 30 min. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
a) Assessment of muscle strength:
The isometric muscle strength of bilateral knee extensors muscles will be measured with a handheld dynamometer.
Measured: baseline only
Secondary outcomes (1)
b) Assessment of knee joint position sense.
Knee joint position sense will be measures with a Saunders digital inclinometer.
Measured: baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia aStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmein Nabil Mohamed El Tanany, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649175
- Sponsor's protocol ID
- P.T.REC/012/005128
- Status last verified
- Mar 2024
- First submitted
- 17 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kinetic Chain Exercises on Muscle Strength, Joint Position Sense and Quality of Life in Children with Haemophilia.
- ClinicalTrials.gov ID
- NCT06649175
- Acronym / sponsor ID
- P.T.REC/012/005128
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 18 Oct 2024 (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.
The goal of this clinical trial is to learn if there are effect of close kinetic chain exercises on muscle strength, joint position sense and Quality of life in children with haemophilia? Null hypothesis
It will be hypothesized that:
There is no effect of close kinetic chain exercises on muscle strength, joint position sense and Quality of life in children with haemophilia.
Detailed description
Sample size estimation will be carried out to determine the recruited number of children selected randomly from Out Patient clinic of Atfal Misr hospital, Cairo governorate to participate in this study. The study targets male children with hemophilia A.
They will be selected based on the following:
Inclusion criteria:
- Their chronological age will be 5-7yeasr.
- All children will receive prophylaxis therapy.
- They will able to stand and walk independently.
- They will be able to follow instructions during evaluation and treatment.
Exclusive criteria:
The children will be excluded if they have one of the following:
- Visual or auditory problem.
- Radiographic changes as bone erosions, destruction, or joint subluxation, or congenital or acquired skeletal deformities in both lower limbs.
- Surgical procedures performed six weeks prior to or during study.
- Bleeding in joint 2 week prior to assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group(A):exercise group. | Active comparator | Other: ExerciseControl Group (A): will receive the traditional physical therapy (PT) program for one hour two times weekly for six successive weeks. Intervention: traditional physical therapy program. |
| Group(B): modified exercise group. | Active comparator | Other: ExerciseGroup (B): will receive a program of close kinetic chain exercises for 30 min. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Their chronological age will be 5-7yeasr. 2. All children will receive prophylaxis therapy. 3. They will able to stand and walk independently. 4. They will be able to follow instructions during evaluation and treatment.
Key exclusion criteria (5 listed)
- The children will be excluded if they have one of the following:
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 |
|---|---|---|
| ExerciseAlso: Close Kinetic Chain Exercise (CKC)Close kinetic chain (CKC) exercises : 1. Supine wall push exercise: Start position: supine with the both leg against wall, other limb straight. Exercise action: push against wall for thirty seconds. 2. Wall push against Swiss ball exercise: Start position: Supine with a Swiss ball between patient's legs and the wall. Exercise action: push against the wall for thirty seconds. 3. Supine half bridging exercise: Start position: Lying on back, knees bent Exercise action: keeping spine neutral and hinging up from the hips, move into a bridge. | Other | Group(B): modified exercise group. |
| ExerciseAlso: Traditional physical therapy programControl Group (A): will receive the traditional physical therapy (PT) , the traditional physical therapy program will include the following: * Stretching exercise for shortening muscle of lower limbs (LL) mainly (hip flexors, adductors, knee flexors and ankle planter flexors). * Balance training from standing while giving perturbations. * Balance board training. * Step ups: repeated stepping anteriorly and laterally onto a step with both legs alternatively, progressing to higher step and decreasing upper extremity support. * Forward and backward walking (with or without handheld mobility devices). * Side walking (with or without handheld mobility devices). * Walking in astride line (with or without handheld mobility devices). | Other | group(A):exercise group. |
Primary outcome
a) Assessment of muscle strength:
Time frame: baseline only
The isometric muscle strength of bilateral knee extensors muscles will be measured with a handheld dynamometer.
1 secondary outcome
b) Assessment of knee joint position sense.
Time frame: baseline only
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Hemophilia a and Muscle Strength, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YASMEIN EL-TANANY, M.Sc. in Physical Therapy (00201065080993, 10722018587060@pg.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a) Assessment of muscle strength: (time frame: baseline only). 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 21 Oct 2024.