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Motorized Movement Therapy & Pulmonary Functions in Down Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04787861
Enrollment
40
Registered
2021-03-09
Start date
2018-12-17
Completion date
2020-05-04
Last updated
2021-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome, Pulmonary Functions

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.

Interventions

OTHERmotorized movement therapy

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.

Sponsors

Taibah University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in forced expiratory volume in 1st second (FEV1)Baseline, week 6 and week 12FEV1 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 12Forced 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 FEV1/FVC ratioBaseline, week 6 and week 12FEV1/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).
Change from baseline in peak expiratory flow rate (PEFR).Baseline, week 6 and week 12Peak 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 12maximum 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

MeasureTime frameDescription
Six-minutes walking testWeek 1,6 and 12The distance covered during of 6 minutes

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026