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

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: Not yet recruiting
• Conditions: Muscle Strength; Quality of Life (QOL); Joint Position Sense; Hemophilia a
• Intervention / Treatment: Other: Exercise; Other: 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: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YASMEIN EL-TANANY, M.Sc. in Physical Therapy; Phone Number: 00201065080993; Email: 10722018587060@pg.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 4260044
    • Out Patient clinic of Atfal Misr hospital
    • Contact: NAGLAA SHAHEN; Phone Number: PRO.DR 00201005183031; Email: m.refat2006@yahoo.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 : 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.; 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 : 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.; 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

Outcome Measure	Measure Description	Time Frame
a) Assessment of muscle strength:	The isometric muscle strength of bilateral knee extensors muscles will be measured with a handheld dynamometer.	baseline only

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
b) Assessment of knee joint position sense.	Knee joint position sense will be measures with a Saunders digital inclinometer.	baseline only

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
c) Assessment of Quality of life.	The Haemo-QoL questionnaire is a quality of life assessment instrument for children with haemophilia.	baseline only

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A
• Other Study ID 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