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CompletedNCT03983746Updated Jun 12, 2019

Effect of Core Stability Exercises and Treadmill Training on Balance in Children With Down Syndrome

An interventional study of core stability exercises and treadmill training exercises in Physical Therapy, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2019-06-12.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2019, registered Jun 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
4 Years to 6 Years
Sex
All
01

Study summary

Introduction: Core stability exercises and treadmill training play a crucial role in physical therapy interventions and have an effect on balance in children with Down syndromes (DS), whether core stability exercises or treadmill training has more effect on improve balance has not been investigated yet. The aim of the study was to investigate the effect of core stability training versus treadmill exercises on balance in children with Down syndrome. Methods: Forty-five children with Down syndrome included in the study. The children aged 4-6 years, and they were equally divided randomly into three groups (A), (B) and (C). Group A received traditional physical therapy intervention strategies to facilitate the balance of participated children. Group (B) received same as the group (A), with additional core stability exercises training. Group (C) received same intervention strategies as group (A) in conjunction with a treadmill exercise program. The children's balance was evaluated using the Berg Balance Scale and the Biodex Balance System. Treatment sessions were for 60 min, thrice a week, for eight consecutive weeks.

02

Conditions studied

  • Physical Therapy
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Able to recognize commands given to them,
  • Able to understand our verbal command and encouragement, and
  • Able to stand and walk independently without repeated falling

Exclusion criteria

Exclusion Criteria:

  • Any neurological or musculoskeletal disorders (signs of epilepsy and instability of atlantoaxial joint),
  • Any mobility disorders
  • Any cardiac anomalies
  • Any vision or hearing loss
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    traditional physical therapy program (control group)

    fifteen children with DS received a traditional exercises program with instructions to the children for 60 minutes aiming to improve posture control and balance

    Device: core stability exercises and treadmill training exercises

Interventions

  • Devicecore stability exercises and treadmill training exercises

    Forty-five children with Down syndrome included in the study. The children aged 4-6 years, and they were equally divided randomly into three groups (A), (B) and (C). Group A received traditional physical therapy intervention strategies to facilitate the balance of participated children. Group (B) received same as the group (A), with additional core stability exercises training. Group (C) received same intervention strategies as group (A) in conjunction with a treadmill exercise program. The children's balance was evaluated using the Berg Balance Scale and the Biodex Balance System. Treatment sessions were for 60 min, thrice a week, for eight consecutive weeks.

    Also known as: traditional physical therapy program

06

What researchers measure

Primary outcomes

  1. Functional Balance

    The Biodex Balance System (BBS) is used to adjust the stability of a suspended circular force plate. The force platform has a maximum of twenty degrees tilt in any direction when completely un-stabilized and determines the stability of participant based on the variance of the platform from the center. The Berg Balance Scale is a clinical assessment of functional balance. It consists of fourteen functional tasks of increasing difficulty, and each scored on a scale ranging from 0 to 4 (task is performed independently=4; unable to complete the task=0). The maximum possible score is fifty-six which indicating no identifiable balance difficulties.

    Time frame: 30 minutes

  2. Overall Stability Index

    The Biodex Balance System (BBS) is used to adjust the stability of a suspended circular force plate. The force platform has a maximum of twenty degrees tilt in any direction when completely un-stabilized and determines the stability of participant based on the variance of the platform from the center . The Berg Balance Scale is a clinical assessment of functional balance. It consists of fourteen functional tasks of increasing difficulty, and each scored on a scale ranging from 0 to 4 (task is performed independently=4; unable to complete the task=0). The maximum possible score is fifty-six which indicating no identifiable balance difficulties

    Time frame: 30 minutes

07

Study locations

1 site
  • Faculty of Physical Therapy, Cairo University
    Giza, Cairo 12111, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03983746
Lead sponsor
Cairo University
Responsible party
Reham Saeed Alsakhawi (Lecturer, Faculty of Physical Therapy, Cairo University) — Principal investigator
First posted
Jun 12, 2019
Start date
Jan 2, 2019
Primary completion
Mar 12, 2019
Completion
Apr 15, 2019
Last update
Jun 12, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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