Effect of Core Stability Exercises and Treadmill Training on Balance in Children With Down Syndrome
Randomized Controlled Trial
1 other identifier
interventional
45
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2019
CompletedFirst Submitted
Initial submission to the registry
June 10, 2019
CompletedFirst Posted
Study publicly available on registry
June 12, 2019
CompletedJune 12, 2019
June 1, 2019
2 months
June 10, 2019
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)
EXPERIMENTALfifteen children with DS received a traditional exercises program with instructions to the children for 60 minutes aiming to improve posture control and balance
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.
Eligibility Criteria
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
- Cairo Universitylead
Study Sites (1)
Faculty of Physical Therapy, Cairo University
Giza, Cairo Governorate, 12111, Egypt
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