Motorized Movement Therapy & Pulmonary Functions in Down Syndrome

Not Applicable

Completed

• Conditions: Pulmonary Functions; Down Syndrome
• Interventions: Other: motorized movement therapy

• Registration Number: NCT04787861
• Lead Sponsor: Taibah University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-12-17
• Primary Completion: 2020-03-07
• Study Completion: 2020-05-04
• Study First Submitted: 2021-02-12
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-04
• Last Update Submitted: 2021-03-04
• Study First Posted: 2021-03-09
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	motorized movement therapy	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.
Control group	motorized movement therapy	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in forced expiratory volume in 1st second (FEV1)	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).
Change from baseline in forced vital capacity (FVC)	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).
Change from baseline in peak expiratory flow rate (PEFR).	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).
Change from baseline in maximum voluntary ventilation (MVV)	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).
Change from baseline in FEV1/FVC ratio	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).

Secondary Outcome Measures

Name	Time	Method
Six-minutes walking test	Week 1,6 and 12	The distance covered during of 6 minutes

Trial Locations

Locations (1)

Medical Rehabilitation Hospital; 🇸🇦 Al Madīnah, Al Madinah Al Munawarah, Saudi Arabia