UMIN-CTR Clinical Trial

Public title

Impact of Schroth Three-Dimensional versus Proprioceptive Neuromuscular Facilitation Techniques in Adolescent Idiopathic Scoliosis: A Rondomized Controlled Study

Acronym

Impact of Schroth Three-Dimensional versus Proprioceptive Neuromuscular Facilitation Techniques in Adolescent Idiopathic Scoliosis: A Rondomized Controlled Study

Scientific Title

Impact of Schroth Three-Dimensional versus Proprioceptive Neuromuscular Facilitation Techniques in Adolescent Idiopathic Scoliosis: A Rondomized Controlled Study

Scientific Title:Acronym

Impact of Schroth Three-Dimensional versus Proprioceptive Neuromuscular Facilitation Techniques in Adolescent Idiopathic Scoliosis: A Rondomized Controlled Study

Region

Asia(except Japan)

Condition

rehabilitation medicine

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the effectiveness of PNF on scoliosis angle, static plantar pressure distribution and functional capacity in AIS. Further aimed to compare the effectiveness of Schroth 3D technique to that of the PNF on scoliosis angle, static plantar pressure distribution and functional capacity.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Phase IV

Primary outcomes

Cobb angle
before and after six successive months of treatment.

Key secondary outcomes

angle trunk rotation
static plantar pressure distribution
functional capacity

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

The Schroth group underwent Schroth 3D technique. The patients received treatment for one hour/ three times per week for six successive months.

Interventions/Control_2

The PNF group received the PNF technique. The patients received treatment for one hour/ three times per week for six successive months. The program included 6 patterns and each pattern was trained for 10 min.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

14

years-old

<=

Age-upper limit

16

years-old

>=

Gender

Female

Key inclusion criteria

The angle of scoliosis was less than 25 degrees, a Risser sign of 2 or 4, and, not participated in other treatment.

Key exclusion criteria

previous spinal surgery, cardiac anomalies, obesity, asthma or other pulmonary disease, mental problems, neuromuscular or rheumatic diseases, kyphoscoliosis.

Target sample size

34

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

Al-Qassim University Saudi Arabia






department of physical therapy

Institute

Department

Personal name

Organization

non

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Faculty of Physical Therapy, Cairo University, Egypt

Address

El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, 11432, Egypt

Tel

+20 237617691

Email

dr.elsayedhassanpt@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

Outpatient Clinic of Al-Qassim University, Saudi Arabia.

Date of disclosure of the study information

2020

Year

11

Month

06

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/34982433/

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/34982433/

Number of participants that the trial has enrolled

34

Results

https://pubmed.ncbi.nlm.nih.gov/34982433/

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/34982433/

Participant flow

https://pubmed.ncbi.nlm.nih.gov/34982433/

Adverse events

https://pubmed.ncbi.nlm.nih.gov/34982433/

Outcome measures

https://pubmed.ncbi.nlm.nih.gov/34982433/

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2020

Year

05

Month

10

Day

Date of IRB

2020

Year

04

Month

03

Day

Anticipated trial start date

2020

Year

05

Month

10

Day

Last follow-up date

2020

Year

11

Month

06

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=R000048360