NCT04966403

Brief Summary

To investigate the effect of a 3-month, trampoline-based stretch-shortening cycle (SSC) exercises on muscle strength and postural control in children with Down syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

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

December 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

July 14, 2021

Last Update Submit

September 8, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Grade of Muscle strength by hand-held dynamometer

    A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used

    at baseline

  • Grade of Muscle strength by hand-held dynamometer

    A calibrated hand-held dynamometer (Micro FET2, Hoggan Health Technologies Inc., UT, USA) was used

    after 12 weeks

Secondary Outcomes (2)

  • Postural control index by Balance Biodex System

    at baseline

  • Postural control index by Balance Biodex System

    after 12 weeks

Study Arms (2)

standard physical therapy

EXPERIMENTAL

Participants in the standard physical therapy received the standard physical therapy (sPT) program, which was conducted according to the needs of each participant and was generally concerned with building strength, enhancing developmental skills, boosting balance, coordination, and postural control, improving physical fitness, and minimizing the development of the compensatory movement patterns that children with DS are likely to develop.

Other: Standard physical therapy

trampoline-based stretch-shortening cycle exercises

EXPERIMENTAL

In addition to the sPT, the SSC group received 15-minute SSC exercise sessions, twice weekly, with a total of 24 sessions over 12 successive weeks.

Other: trampoline-based stretch-shortening cycle exercises

Interventions

building strength, enhancing developmental skills, boosting balance, coordination, and postural control

Also known as: physical fitness
standard physical therapy

muscle strength

Also known as: postural control
trampoline-based stretch-shortening cycle exercises

Eligibility Criteria

Age7 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age between 7 and 9 years.
  • able to follow one step motor commands.
  • independent ambulators.
  • not suffering from atlantoaxial joint instability as reported from their medical files.

You may not qualify if:

  • Children with un-corrected cardiac anomalies.
  • Children with un-corrected vision or hearing loss.
  • Children with un-corrected pulmonary disorders.
  • Children with un-corrected neurological signs as epilepsy.
  • Children who had a history of musculoskeletal surgery in the lower extremities through the past year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Khalid Hospital

Al Kharj, Riyadh Region, Saudi Arabia

Location

Related Publications (3)

  • 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
  • Aalizadeh B, Mohammadzadeh H, Khazani A, Dadras A. Effect of a Trampoline Exercise on the Anthropometric Measures and Motor Performance of Adolescent Students. Int J Prev Med. 2016 Jul 13;7:91. doi: 10.4103/2008-7802.186225. eCollection 2016.

  • Champagne D, Dugas C. Improving gross motor function and postural control with hippotherapy in children with Down syndrome: case reports. Physiother Theory Pract. 2010 Nov;26(8):564-71. doi: 10.3109/09593981003623659. Epub 2010 Jul 31.

MeSH Terms

Conditions

Down Syndrome

Interventions

Physical FitnessPostural Balance

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealthPopulation CharacteristicsProprioceptionVestibulocochlear Physiological PhenomenaPhysiological PhenomenaSensationNervous System Physiological Phenomena

Study Officials

  • Alshimaa Azab, PhD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor, College of Medical Rehabilitation, Qassim University, Saudi Arabia. Consultant Physical Therapist, El-Sahel Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Cairo, Egypt.

Study Record Dates

First Submitted

July 14, 2021

First Posted

July 19, 2021

Study Start

December 1, 2018

Primary Completion

August 20, 2019

Study Completion

June 5, 2020

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study is available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations