Motorized Movement Therapy & Pulmonary Functions in Down Syndrome

NCT ID: NCT04787861

Last Updated: 2021-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-17

Study Completion Date

2020-05-04

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.

Conditions

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Pulmonary Functions Down Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control group

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.

Group Type ACTIVE_COMPARATOR

motorized movement therapy

Intervention Type 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.

study group

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.

Group Type EXPERIMENTAL

motorized movement therapy

Intervention Type 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.

Interventions

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motorized 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.

Intervention Type OTHER

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
Minimum Eligible Age

9 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taibah University

OTHER

Sponsor Role lead

Responsible Party

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Hatem Abd Elmohsen Abdel Hamid Emara

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hatem A Emara, A.Prof

Role: PRINCIPAL_INVESTIGATOR

Taibah University

Locations

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Medical Rehabilitation Hospital

Al Madīnah, Al Madinah Al Munawarah, Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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Yoshimi K, Ueki J, Seyama K, Takizawa M, Yamaguchi S, Kitahara E, Fukazawa S, Takahama Y, Ichikawa M, Takahashi K, Fukuchi Y. Pulmonary rehabilitation program including respiratory conditioning for chronic obstructive pulmonary disease (COPD): Improved hyperinflation and expiratory flow during tidal breathing. J Thorac Dis. 2012 Jun 1;4(3):259-64. doi: 10.3978/j.issn.2072-1439.2012.03.17.

Reference Type BACKGROUND
PMID: 22754664 (View on PubMed)

Pehlivan E, Niksarlioglu EY, Balci A, Kilic L. The Effect of Pulmonary Rehabilitation on the Physical Activity Level and General Clinical Status of Patients with Bronchiectasis. Turk Thorac J. 2019 Jan 1;20(1):30-35. doi: 10.5152/TurkThoracJ.2018.18093.

Reference Type BACKGROUND
PMID: 30664424 (View on PubMed)

Other Identifiers

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Down Syndrome

Identifier Type: -

Identifier Source: org_study_id

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