NCT05928949

Brief Summary

Down syndrome is one of the genetic disorders that affect postural control and balance in children. Balance involves controlling the position of the body in space to achieve stability and orientation. pilates exercises are one of several techniques that are used to improve balance and postural control in adults and children. the purpose of the study is To investigate the effect of Pilates exercises on balance and gross motor co-ordination in children with Down syndrome

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 25, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

June 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2023

Completed
Last Updated

July 3, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

June 25, 2023

Last Update Submit

June 25, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • balance

    Balance assessment will be performed in both groups before and after the intervention to find any significant difference, by using the Biodex Balance System to evaluate all measurable variables of stability indices (anteroposterior stability index and mediolateral stability index).

    3 months

  • Bruininks-oseretsky test of motor proficiency-second version (BOT-2)

    BOT-2 measures gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation. The test is tailored to school-aged children, who have varying motor control abilities ranging from normal to mild or moderate. In this study, it will be used to measure gross motor co-ordination.

    3 months

Study Arms (2)

conventional physical therapy

ACTIVE COMPARATOR

Group A performed flexibility, strength, and endurance exercises that focused on the lower extremity and trunk muscles, exercise for postural stability in various positions and surfaces, including flexibility exercises for the hip, knee and calf muscle. Strengthening exercises included the core muscles, hip abductors, hip extensors hamstrings and quadriceps knee extension in high sitting. Postural control involved walking in all directions, exceeding the limits of stability in various positions such as kneeling, half kneeling, standing on rough and soft surfaces, Each session started with a warming up and cooling down of 5 minutes for each period and each session lasted for 45 minutes.

Other: pilates exercises

pilates exercises

EXPERIMENTAL

group B received the same program of exercises given to group A in addition to 45 minutes of Pilates exercises to improve balance and gross motor coordination. Exercises were performed on a mat, a medical ball, and from a standing position, focusing on maintaining core contraction, spinal and pelvic alignment, and respiration rhythm. Ten repetitions of Pilates exercises will be performed with a 2-minute rest period between repetitions. Both groups will attend the intervention program three times/week for 3 months

Other: pilates exercises

Interventions

Pilates is a system of repetitive exercises performed on a yoga mat or other equipment to promote strength, stability, and flexibility. Pilates exercises develop the body through muscular effort that stems from the core.

conventional physical therapypilates exercises

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • (1) diagnosed with Trisomy 21 through genetic testing, (2) aged 6 to 11 years and (3) able to follow a minimum of two-step instructions. The minimum motor ability of participants with DS was independent locomotion.

You may not qualify if:

  • (1) medical condition that is contraindicated to moderate to vigorous physical activity such as cardiovascular problems, (2) orthopaedic instability, including those associated with DS (e.g. atlanto-axial instability) and (3) behavioural issues that hindered instruction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Of Physical Therapy

Cairo, Giza Governorate, Egypt

RECRUITING

Related Publications (1)

  • Al-Nemr A, Reffat S. Effect of Pilates exercises on balance and gross motor coordination in children with Down syndrome. Acta Neurol Belg. 2024 Oct;124(5):1499-1505. doi: 10.1007/s13760-024-02517-w. Epub 2024 Apr 1.

MeSH Terms

Conditions

Down Syndrome

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Central Study Contacts

Alaa F AL-Nemr, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD

Study Record Dates

First Submitted

June 25, 2023

First Posted

July 3, 2023

Study Start

June 26, 2023

Primary Completion

August 1, 2023

Study Completion

September 11, 2023

Last Updated

July 3, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations