NCT05460910

Brief Summary

To find the effects of core stability exercises with and without treadmill training on balance 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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

July 15, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

July 14, 2022

Last Update Submit

July 14, 2022

Conditions

Keywords

core stability exercisesbalancetreadmill

Outcome Measures

Primary Outcomes (1)

  • Berg balance scale

    berg balance scale was used to measure the functional balance in children.

    8th week

Secondary Outcomes (1)

  • Reach test

    8week

Study Arms (2)

core stability exercise, treadmill

EXPERIMENTAL

core stability exercises and treadmill training

Other: core stability exercises with treadmill

core stability exercises

EXPERIMENTAL

core stability exercises without treadmill training

Other: core stability exercise without treadmill

Interventions

swiss ball use patient is lying in supine position with 15 repitations and 3 sets.

core stability exercise, treadmill

technique used to improve stability

core stability exercises

Eligibility Criteria

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

You may qualify if:

  • able to stand and walk independently
  • able to understand and follow a verbal command
  • cutoff score less than 6 or 7 in functional balance in indicated

You may not qualify if:

  • patients have any neurological issue,
  • Instability of atlantoaxial joint
  • Vision and hearing loss
  • History of fall

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Therapy Services Center

Lahore, Punjab Province, 40050, Pakistan

RECRUITING

Related Publications (3)

  • Szafraniec R, Baranska J, Kuczynski M. Acute effects of core stability exercises on balance control. Acta Bioeng Biomech. 2018;20(4):145-151.

    PMID: 30520448BACKGROUND
  • Alsakhawi RS, Elshafey MA. Effect of Core Stability Exercises and Treadmill Training on Balance in Children with Down Syndrome: Randomized Controlled Trial. Adv Ther. 2019 Sep;36(9):2364-2373. doi: 10.1007/s12325-019-01024-2. Epub 2019 Jul 12.

    PMID: 31301057BACKGROUND
  • Amini HA, Fazel Kalkhoran J, Salehi M, Jazini F. Effect of backward walking training on improves postural stability in children with down syndrome. International Journal of Pediatrics. 2016;4(7):2171-81.

    BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Wajiha Shahid, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2022

First Posted

July 15, 2022

Study Start

May 18, 2022

Primary Completion

October 1, 2022

Study Completion

November 15, 2022

Last Updated

July 15, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations