NCT06649175

Brief 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 position sense and Quality of life in children with haemophilia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

October 21, 2024

Status Verified

March 1, 2024

Enrollment Period

29 days

First QC Date

October 17, 2024

Last Update Submit

October 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • a) Assessment of muscle strength:

    The isometric muscle strength of bilateral knee extensors muscles will be measured with a handheld dynamometer.

    baseline only

Secondary Outcomes (1)

  • b) Assessment of knee joint position sense.

    baseline only

Other Outcomes (1)

  • c) Assessment of Quality of life.

    baseline only

Study Arms (2)

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.

Other: Exercise

Group(B): modified exercise group.

ACTIVE COMPARATOR

Group (B): will receive a program of close kinetic chain exercises for 30 min.

Other: Exercise

Interventions

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.

Also known as: Close Kinetic Chain Exercise (CKC)
Group(B): modified exercise group.

Eligibility Criteria

Age5 Years - 7 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Out Patient clinic of Atfal Misr hospital

Cairo, 4260044, Egypt

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Exercise

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

YASMEIN EL-TANANY, M.Sc. in Physical Therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

October 17, 2024

First Posted

October 18, 2024

Study Start

November 1, 2024

Primary Completion

November 30, 2024

Study Completion

March 1, 2025

Last Updated

October 21, 2024

Record last verified: 2024-03

Locations