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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042377
Receipt No. R000048370
Scientific Title efficacy of different approaches on quality of upper extremity function, Dexterity and grip strength in hemiplegic children
Date of disclosure of the study information 2020/11/07
Last modified on 2021/05/18

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Basic information
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
Condition hemiplegic cerebral palsy
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes quality of upper extremity function
Dexterity
Key secondary outcomes grip strength

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

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

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 45
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
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
Other related information

Management information
Registered date
2020 Year 11 Month 07 Day
Last modified on
2021 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048370

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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