NCT05271201

Brief Summary

The current study aimed to determine the appropriate exercise intensity for the rehabilitation of children with down syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

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

December 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

February 26, 2022

Last Update Submit

February 26, 2022

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (3)

  • knee extensor peak torque

    eccentric normalized peak torque of the knee extensors of the dominant limb.

    three months

  • ankle plantar fexors peak torque

    eccentric normalized peak torque of the ankle plantar flexors of the dominant limb.

    three months

  • functional mobility

    the assessment of the time up and go test

    three months

Study Arms (2)

mild intensity group

EXPERIMENTAL

Received mild intensity treadmill training according to Martti Karvonen's formula.

Other: treadmill exercise (mild)

moderate intensity group

EXPERIMENTAL

Received moderate intensity treadmill training according to Martti Karvonen's formula.

Other: treadmill exercise (moderate)

Interventions

treadmill exercise (mild)OTHER

mild intensity treadmill training.

mild intensity group
treadmill exercise (moderate)OTHER

moderate-intensity treadmill training

moderate intensity group

Eligibility Criteria

Age8 Years - 12 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • independent walking
  • Intelligence quotient range from 40 to 70
  • right dominant foot
  • body mass index from 50 to 75

You may not qualify if:

  • chronic diseases
  • congenital anomalies
  • involved in any competitive sport
  • previous injury to the lower limb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Applied Medical Sciemces

Ta'if, Mecca Region, 2425, Saudi Arabia

Location

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

  • Hatem H Allam, ass. prof.

    Taif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant prof.

Study Record Dates

First Submitted

February 26, 2022

First Posted

March 8, 2022

Study Start

December 10, 2019

Primary Completion

March 15, 2020

Study Completion

March 27, 2020

Last Updated

March 8, 2022

Record last verified: 2022-02

Locations

SA(1)