NCT05026294

Brief Summary

Obesity is one of the main factors that contribute to an acquired flat foot deformity which in turn impairs the balance strategies. The purpose of the current study was to compare the effect of plyometric exercises with flatfoot corrective exercise on balance, foot posture, and functional mobility in obese children with flexible flatfoot.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

August 16, 2021

Last Update Submit

August 23, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • Foot posture

    condition of the medial longitudinal arch of the foot

    10 weeks

  • Balance (measure 1)

    Perimeter area (mm).

    10 weeks

  • Balance (measure 2)

    Ellipse area (mm2).

    10 weeks

  • Balance (measure 3)

    Standard backward-forward deviation.

    10 weeks

  • Balance (measure 4)

    Standard medial-lateral deviation.

    10 weeks

  • Functional mobility

    Timed up and go test

    10 weeks

Study Arms (3)

Experimental group I

EXPERIMENTAL

The experimental group received plyometric training

Other: plyometric exercises

Experimental group II

EXPERIMENTAL

The experimental group received flat feet rehabilitation training

Other: Exercises for flat feet rehabilitation

Control group

NO INTERVENTION

The Control group didn't receive intervention

Interventions

Exercises for strength and flexibility

Experimental group I

Exercises for intrinsic muscles strength

Experimental group II

Eligibility Criteria

Age7 Years - 11 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsA sample of 47 male children participated in the current study without having female participants because of the cultural perspective.
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Body mass index percentile equal to or greater than the 95th percentile
  • All had no previous history of strength or balance training or involvement in competitive sports emphasizing muscular strength or balance.
  • All participants had balance deficiency and mobile flat foot.

You may not qualify if:

  • Previous injury to the lower limb required medical care.
  • Confounding conditions, such as a deformity of or surgery in the lower limb.
  • visual impairment, or neuromuscular disorders.
  • engagement in obesity treatment programs, three months prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Applied Medical Sciences

Ta'if, Mecca Region, 62552, Saudi Arabia

Location

MeSH Terms

Conditions

Flatfoot

Interventions

Plyometric ExerciseExercise

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hatem Allam, A.professor

    Taif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Pretest-posttest control group design was used. A sample of 47 male children participated in the current study. After gathering the baseline measurements, the participants were randomly assigned into three groups: experimental group I, (EGI) contained 16 participants, experimental group II (EGII) contained 16 participants, and control group, (CG) contained 15. The stratification was done using sealed envelopes. The children were not aware of their group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 30, 2021

Study Start

December 1, 2020

Primary Completion

April 1, 2021

Study Completion

May 13, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations