Effect of Kinetic Chain Exercises on Muscle Strength, Joint Position Sense and Quality of Life in Children with Haemophilia.

October 17, 2024 updated by: Yasmein Nabil Mohamed El Tanany, Cairo University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  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.

Exclusive criteria:

The children will be excluded if they have one of the following:

  1. Visual or auditory problem.
  2. Radiographic changes as bone erosions, destruction, or joint subluxation, or congenital or acquired skeletal deformities in both lower limbs.
  3. Surgical procedures performed six weeks prior to or during study.
  4. Bleeding in joint 2 week prior to assessment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt, 4260044
        • Out Patient clinic of Atfal Misr hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The children will be excluded if they have one of the following:

    1. Visual or auditory problem.
    2. Radiographic changes as bone erosions, destruction, or joint subluxation, or congenital or acquired skeletal deformities in both lower limbs.
    3. Surgical procedures performed six weeks prior to or during study.
    4. Bleeding in joint 2 week prior to assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: group(A):exercise group.

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.
Other: Exercise

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 Names:
  • Close Kinetic Chain Exercise (CKC)
Other: Exercise

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).
Other Names:
  • Traditional physical therapy program
Active Comparator: Group(B): modified exercise group.
Group (B): will receive a program of close kinetic chain exercises for 30 min.
Other: Exercise

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 Names:
  • Close Kinetic Chain Exercise (CKC)
Other: Exercise

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).
Other Names:
  • Traditional physical therapy program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline only

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
b) Assessment of knee joint position sense.
Time Frame: baseline only
Knee joint position sense will be measures with a Saunders digital inclinometer.
baseline only

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
c) Assessment of Quality of life.
Time Frame: baseline only
The Haemo-QoL questionnaire is a quality of life assessment instrument for children with haemophilia.
baseline only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/005128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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