NCT05951543

Brief Summary

Down syndrome is a condition in which a person has an extra chromosome. Typically, a baby is born with 46 chromosomes. Down syndrome is a genetic condition that causes mild to serious physical and developmental problems. Symptoms associated with the syndrome include mental retardation, distinctive facial characteristics, and increased risk for heart defects and digestive problems, which can range from mild to severe.. Early treatment programs can help improve skills. They may include speech, physical, occupational, and/or educational therapy. The aim of the the current study is to determine the effects of plyometric exercise on static and dynamic balance in children with Down syndrome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

June 6, 2023

Last Update Submit

November 9, 2023

Conditions

Keywords

Balance, Dynamic, Down syndrome, Plyometric, Static.

Outcome Measures

Primary Outcomes (1)

  • Balance and standing

    Paediatric berg balance scale

    8 weeks

Study Arms (2)

plyometric group

EXPERIMENTAL

Experimental group will be given baseline exercises along with plyometric exercises such as Vertical jump, run and jump, drop jump (jump height between 40 and 50 cm) drop jump and horizontal jump with same height from 3rd week.particepents perform exercises carrying medicine balls. Participants will place their hands on the wall and performed foot stretches with the feet apart, 30 to 50 cm from the wall. Side row, biceps stretch and frontal row. Throwing and receiving, with a distance between 3 to 4 m.

Other: plyometric exercises

dynamic balance group control group

OTHER

Control group will be given with the standard physical therapy intervention that includes progressive resistance training that will be performed using weights, two sets of 10 repetitions will be given for each muscle group, resistance will be increased by ½ Kg as children are able to complete without undue stresses); balance exercises (stand on a balance board, one-leg stance, heal-to-toes stance, walking on balance board, walking on a balance beam, walking on a line, and walking on the inclined surface); flexibility exercises

Other: dynamic balance group control group

Interventions

Experimental group will be given baseline exercises along with plyometric exercises such as Vertical jump, run and jump, drop jump (jump height between 40 and 50 cm) drop jump and horizontal jump with same height from 3rd week.particepents perform exercises carrying medicine balls. Participants will place their hands on the wall and performed foot stretches with the feet apart, 30 to 50 cm from the wall. Side row, biceps stretch and frontal row. Throwing and receiving, with a distance between 3 to 4 m.

Also known as: Balance
plyometric group

Control group will be given with the standard physical therapy intervention that includes progressive resistance training that will be performed using weights, two sets of 10 repetitions will be given for each muscle group, resistance will be increased by ½ Kg as children are able to complete without undue stresses); balance exercises (stand on a balance board, one-leg stance, heal-to-toes stance, walking on balance board, walking on a balance beam, walking on a line, and walking on the inclined surface); flexibility exercises

dynamic balance group control group

Eligibility Criteria

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

You may qualify if:

  • to 12 years of age both genders will be included.
  • Children with medical diagnosis of DS.
  • Able to follow the command

You may not qualify if:

  • Recent injury to lower extremities.
  • Children with cerebral palsy and other neuromuscular disease will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, Pakistan

Location

Related Publications (1)

  • Elnaggar RK. Effects of plyometric exercises on muscle-activation strategies and response-capacity to balance threats in children with hemiplegic cerebral palsy. Physiother Theory Pract. 2022 Sep;38(9):1165-1173. doi: 10.1080/09593985.2020.1833389. Epub 2020 Oct 12.

    PMID: 33044886BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ayesha Khalid, 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 efferts will be put to mask the both groups about their treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It is a randomize control trail ,used to evaluate the effects of plyometric exercises on static and dynamic balance of children with down syndrome.subjects with down syndrome meeting the predetermine inclusion and exclusion criteria will be devided into two groups using simple random sampling technique.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

July 19, 2023

Study Start

May 23, 2023

Primary Completion

August 31, 2023

Study Completion

September 15, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations