UMIN-CTR Clinical Trial

Public title

Impact of two different pulmonary rehabilitations methods in Children with Down syndrome

Acronym

Impact of two different pulmonary rehabilitations methods in Children with Down syndrome

Scientific Title

Impact of two different pulmonary rehabilitations methods in Children with Down syndrome

Scientific Title:Acronym

Impact of two different pulmonary rehabilitations methods in Children with Down syndrome

Region

Africa

Condition

down syndrome

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate and compare the effect of proprioceptive neuromuscular facilitation of respiratory muscles with that of inspiratory muscle training as a preventive measure on respiratory muscle strength, chest expansion, pulmonary functions and functional capacity in children with Down syndrome.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1.Respiratory muscle strength
2. ratio of the upper to lower chest wall

Key secondary outcomes

1. pulmonary functions
2. functional capacity.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

The study group received proprioceptve neuromuscular facilitation of respiratory muscles. The treatment program was conducted for 20-30 minutes (min), five times /week for 12 successive weeks.

Interventions/Control_2

the study group B underwent inspiratory muscle training. The treatment program was conducted for 20-30 minutes (min), five times /week for 12 successive weeks.

Interventions/Control_3

Third group consisted of healthy children without down syndrome who were selected according to the same inclusion criteria applied to the study groups. They were not subjected to any exercise program but they were included in this study solely as a control group.

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

10

years-old

<=

Age-upper limit

13

years-old

>=

Gender

Male and Female

Key inclusion criteria

abled to walk independently, not participating in any organized physical activity programs during the study, ligamentous laxity was 6 according to Beighton score. The IQs level were more than 70 indicating that they could understand and follow instructions.

Key exclusion criteria

associated cardiopulmonary diseases or surgeries, obesity, serious visual and/or auditory problems, musculoskeletal problems, orthopedic surgeries or inability to cope with the protocol for intervention and tests after the familiarity sessions.

Target sample size

30

Name of lead principal investigator

1st name	Rasha
Middle name	abdelmoneim
Last name	Mohamed

Organization

Faculty of Physical Therapy, Cairo University, Egypt

Division name

Department of Physical Therapy for Growth and Developmental Disorders in Children and its Surgery

Zip code

0000

Address

Burrydah, al qassim

TEL

00966508771352

Email

dr.rashapt@gmail.com

Name of contact person

1st name	Rasha
Middle name	abdelmoneim
Last name	Mohamed

Organization

Faculty of Physical Therapy, Cairo University, Egypt

Division name

Department of Physical Therapy for Growth and Developmental Disorders in Children and its Surgery

Zip code

0000

Address

Burrydah, al qassim

TEL

00966508771352

Homepage URL

Email

dr.rashapt@gmail.com

Institute

Faculty of Physical Therapy, Cairo University, Egypt

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Abu-Reesh Mounira Hospitals

Address

mouneera, cairo, Egypt

Tel

00201284680606

Email

maya.sameh.menese@gmail.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

11

Month

06

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/34391280/

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/34391280/

Number of participants that the trial has enrolled

30

Results

https://pubmed.ncbi.nlm.nih.gov/34391280/

Results date posted

2023

Year

11

Month

24

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

https://pubmed.ncbi.nlm.nih.gov/34391280/

Participant flow

https://pubmed.ncbi.nlm.nih.gov/34391280/

Adverse events

https://pubmed.ncbi.nlm.nih.gov/34391280/

Outcome measures

https://pubmed.ncbi.nlm.nih.gov/34391280/

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

08

Month

07

Day

Date of IRB

2020

Year

09

Month

10

Day

Anticipated trial start date

2020

Year

08

Month

07

Day

Last follow-up date

2020

Year

11

Month

07

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

11

Month

06

Day

Last modified on

2023

Year

11

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048367