Motorized Movement Therapy & Pulmonary Functions in Down Syndrome

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Pulmonary Functions, Down Syndrome

Intervention / Treatment
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* Other: motorized movement therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Control group treatment is identical to treatment of the study group but without a motorized movement device.Childen in this group received chest physical therapy program including positioning, breathing exercises, and postural drainage in addition to incentive spirometer training for 20 minutes, 3 times/week for 12 weeks. | Other: motorized movement therapy<br>* 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.<br>|
| Experimental: study group<br>This group received the same program given to the control group in addition to an aerobic training regimen for 25 minutes 3 times/week for 12 weeks using a motorized movement device. | Other: motorized movement therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in forced expiratory volume in 1st second (FEV1) | 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). | Baseline, week 6 and week 12 | 
| Change from baseline in forced vital capacity (FVC) | 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). | Baseline, week 6 and week 12 | 
| Change from baseline in FEV1/FVC ratio | 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). | Baseline, week 6 and week 12 | 
| Change from baseline in peak expiratory flow rate (PEFR). | 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). | Baseline, week 6 and week 12 | 
| Change from baseline in maximum voluntary ventilation (MVV) | 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). | Baseline, week 6 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minutes walking test | The distance covered during of 6 minutes | Week 1,6 and 12 |