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Completed

NCT Number: NCT04787861

Motorized Movement Therapy & Pulmonary Functions in Down Syndrome

To investigate the effects of the addition of motorized movement therapy versus conventional chest physiotherapy alone on pulmonary functions, exercise capacity, and endurance in children with Down Syndrome

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Key information

Conditions

Pulmonary Functions Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical Rehabilitation Hospital

Al Madīnah, Al Madinah Al Munawarah, Saudi Arabia

About this study

To investigate the effects of the addition of motorized movement therapy versus conventional chest physiotherapy alone on pulmonary functions, exercise capacity, and endurance in children with Down Syndrome (DS). Methods: This randomized controlled study included 40 children (24 boys & 16 girls) with DS. Their ages ranged from 9 to 13 years. The control group received conventional chest physical therapy program, three sessions per week for 12 weeks. The study group received an aerobic exercise regimen using a motorized movement therapy device 3 times /week in addition to the same traditional program used with the control group. Pulmonary function tests, and six-minutes walking test were measured at baseline, after 18 sessions and after 36 sessions of treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to walk independently
  • No involvement in any physical rehabilitation program or sports activity
  • Ability to understand and follow orders

Exclusion criteria

  • Children suffering from obesity
  • Severe visual and/or auditory impairment
  • Congenital heart disease
  • Children with musculoskeletal disorders

Treatment and study plan

motorized movement therapy

Other

The study group received an aerobic exercise regimen using a motorized movement therapy device 3 times /week in addition to the same traditional program used with the control group.

Primary outcomes

  1. Change from baseline in forced expiratory volume in 1st second (FEV1)

    Time frame: Baseline, week 6 and week 12

    FEV1 is the maximal volume of air that can be expired in 1st second of forced vital capacity maneuver using spirometry. We measured FEV1 at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).

  2. Change from baseline in forced vital capacity (FVC)

    Time frame: Baseline, week 6 and week 12

    Forced vital capacity (FVC) is the maximal volume of air that can be expired while patient performs forced expiration as fast and as deep as possible using spirometry.

    We measured FVC at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).

  3. Change from baseline in FEV1/FVC ratio

    Time frame: Baseline, week 6 and week 12

    FEV1/FVC is used to differentiate obstructive from restrictive patterns by spirometry. We measuredFEV1/ FVC at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).

  4. Change from baseline in peak expiratory flow rate (PEFR).

    Time frame: Baseline, week 6 and week 12

    Peak expiratory flow rate (PEFR).is the maximal flow rate achieved during FVC maneuver using spirometry.

    We measured PEFR at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).

  5. Change from baseline in maximum voluntary ventilation (MVV)

    Time frame: Baseline, week 6 and week 12

    maximum voluntary ventilation (MVV) is the maximal volume of air that can be moved by voluntary ventilation in 1 minute while the patient breathes deeply and rapidly for 12 to 15 seconds using spirometry.

    We measured MVV at baseline and at end of 18 sessions (week 6) and 36 sessions (week 12).

Secondary outcomes

  1. Six-minutes walking test

    Time frame: Week 1,6 and 12

    The distance covered during of 6 minutes

Sponsors and collaborators

Lead sponsor

Taibah University

Other

Registry information

Official study title

Improved Pulmonary Functions and Exercise Capacity in Children With Down Syndrome Following Motorized Movement Therapy: Comparison With Chest Physical Therapy

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 9, 2021
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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