UMIN-CTR Clinical Trial

Public title

efficacy of different approaches on quality of upper extremity function, Dexterity and grip strength in hemiplegic children

Acronym

efficacy of different approaches on quality of upper extremity function, Dexterity and grip strength in hemiplegic children

Scientific Title

efficacy of different approaches on quality of upper extremity function, Dexterity and grip strength in hemiplegic children

Scientific Title:Acronym

efficacy of different approaches on quality of upper extremity function, Dexterity and grip strength in hemiplegic children

Region

Asia(except Japan)

Condition

hemiplegic cerebral palsy

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare between the effects of modified constraint induced movement therapy and mirror therapy on upper limb motor functions and hand grip strength in children with hemiplegic cerebral palsy

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

quality of upper extremity function
Dexterity

Key secondary outcomes

grip strength

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

the same suggested upper limb exercises program with mirror therapy and elastic tapping for 1h/ 5 days/ week for 3 successive months.

Interventions/Control_2

performed this program with modified constraint movement therapy for 1h/ 5 days/ week for 3 successive months.

Interventions/Control_3

the same program with the mirror therapy of the affected side

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

6

years-old

<=

Age-upper limit

8

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. They had sufficient cognition
2. were able to understand commands given to them.
3. They had level II on Gross Motor Function Classification Scale (GMFCS).
4. The degree of spasticity was grade 1+ and 2 according to Modified Ashowrth Scale. They had level II on the Manual Ability Classification System (MACS).
5. They had sufficient trunk control to be able to sit unsupervised in a normal chair during the treatment.

Key exclusion criteria

Patients who had one or more of the following criteria were excluded from this study: genetic or metabolic problems, blood diseases, congenital heart disease, previous surgery of the UL, Botox injection of the UL within the preceding 6 months, contractures of the UL, vision problems, and epilepsy.

Target sample size

45

Name of lead principal investigator

1st name	Rasha
Middle name	abdelmoneim
Last name	Mohamed

Organization

faculty of physcial therapy, cairo university

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

College of Applied Medical Sciences, Prince Sattam Bin Abdul-Aziz University

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

College of Applied Medical Sciences, Prince Sattam Bin Abdul-Aziz University

Address

ollege of Applied Medical Sciences, Prince Sattam Bin Abdul-Aziz University

Tel

0096656194858

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

Date of disclosure of the study information

2020

Year

11

Month

07

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/34533816/

Publication of results

Unpublished

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/34533816/

Number of participants that the trial has enrolled

45

Results

https://pubmed.ncbi.nlm.nih.gov/34533816/

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/34533816/

Participant flow

https://pubmed.ncbi.nlm.nih.gov/34533816/

Adverse events

https://pubmed.ncbi.nlm.nih.gov/34533816/

Outcome measures

https://pubmed.ncbi.nlm.nih.gov/34533816/

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2020

Year

02

Month

09

Day

Date of IRB

2020

Year

12

Month

10

Day

Anticipated trial start date

2020

Year

12

Month

15

Day

Last follow-up date

2021

Year

03

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

11

Month

07

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=R000048370