NCT05969873

Brief Summary

Down's syndrome (DS) is a genetic condition characterized by the presence of an extra chromosome 21, leading to various clinical symptoms. Individuals with DS often experience challenges in balance, posture, and motor skills, which can impact their daily activities. Pilates activities focus on the concept of control of muscles. Pilates increases trunk flexibility, abdominal and core strength and endurance, and deep core muscle activation hence improving balance and posture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

July 23, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

BalanceContrologyDown syndromePilatesPediatric Balance Scale

Outcome Measures

Primary Outcomes (1)

  • Pediatric Balance Scale

    This tool is used for assessing change from baseline. The PBBS is easy to administer, does not require specialized equipment, and can be completed in \<20 minutes. A 0 to 4 grading scale provides a quantitative and qualitative measure of performance. It involves 14 mobility tasks, with the tasks varying in degrees of difficulty. The tasks are divided into 3 domains: sitting balance, standing balance, and dynamic balance. PBS has high validity and reliability of 0.98. 41-56= low fall risk, 21-40= medium fall risk, 0-20=high risk

    12 weeks

Secondary Outcomes (1)

  • Timed up and go test

    12 weeks

Study Arms (2)

Pilates Group

EXPERIMENTAL

In this group patients will be treated with physical therapy treatment pilates exercise. Group A underwent 45 minutes of Pilates exercises in addition to the identical exercise programme as group A to improve the strength, coordination and flexibility of the lower limbs. Pilates movements were carried out ten times, with a two-minute break in between each repetition. For six weeks, both groups participated in the intervention programme three times per week. Starting the programme off with supine exercises of segmental motions that include using the trunk muscles to maintain a neutral posture is normal. To enhance shoulder girdle control, supine arm workouts were gradually added. The spine's ability to flex and extend was steadily increased.

Other: Pilates exercise

Balance training group

ACTIVE COMPARATOR

In this group patients will be treated with PT treatment with balance training. Exercises for stability of posture on numerous surfaces and positions were performed by Group B, including exercises for the flexors and adductors of hip, flexors and extensors of knee, and calf muscle (15-second hold and five repetitions) for improving their flexibility. The lower extremity and trunk muscles were the focus of Group B. The postural control exercise included walking in every direction, moving past the point of stability in various postures like half-kneeling, standing on hard and soft surfaces, stepping down and up, walking and standing at the same time, and one leg standing with eyes open and closed. Each session started with a 5-minute warm-up and ended with a 5-minute cool-down in between each phase.

Other: Balance training

Interventions

Patients in this group will be treated with pilates exercise and conventional physical therapy as baseline treatment.

Also known as: Experimental group
Pilates Group

Patients in this group will be treated with balance training and conventional physical therapy as baseline treatment.

Also known as: Control group
Balance training group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Down's syndrome children with age between 6 and 12 years.
  • The ability to execute required motor skill proficiency and executive function tests.
  • The capacity to walk and stand by oneself

You may not qualify if:

  • Children who are not able to comprehend commands.
  • Associated cardiovascular and orthopedic condition.
  • Loss of functional hearing and vision or a related respiratory disease.
  • History of traumatic injury
  • History of previous surgery
  • Inability of parents to understand the procedure and their unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Abd-Elfattah HM, Galal DOSM, Aly MIE, Aly SM, Elnegamy TE. Effect of Pilates Exercises on Standing, Walking, and Balance in Children With Diplegic Cerebral Palsy. Ann Rehabil Med. 2022 Feb;46(1):45-52. doi: 10.5535/arm.21148. Epub 2022 Feb 28.

    PMID: 35272439BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Interventions

Exercise Movement TechniquesControl Groups

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 ModalitiesTherapeuticsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Rida Khawar Dar, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will be randomized controlled trial used to evaluate the effectiveness of pilates on posture and balance in children with down's syndrome. Subjects with down's syndrome meeting the pre-detremined inclusion and exclusion criteria will be divided into two groups using non-probability sampling technique.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2023

First Posted

August 1, 2023

Study Start

July 16, 2023

Primary Completion

November 1, 2023

Study Completion

November 15, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations