NCT03983746

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

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

January 2, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

2 months

First QC Date

June 10, 2019

Last Update Submit

June 11, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    30 minutes

  • 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

    30 minutes

Study Arms (1)

traditional physical therapy program (control group)

EXPERIMENTAL

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

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
traditional physical therapy program (control group)

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Cairo Governorate, 12111, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Faculty of Physical Therapy

Study Record Dates

First Submitted

June 10, 2019

First Posted

June 12, 2019

Study Start

January 2, 2019

Primary Completion

March 12, 2019

Study Completion

April 15, 2019

Last Updated

June 12, 2019

Record last verified: 2019-06

Locations