Protocol summary

Summary
34 hemiplegic patients were randomly assigned in Constraint – Induced Therapy and Progressive Resistive Exercise groups. Both groups were assessed before and after the intervention. Pinch and grip strengths, abductor and extensor muscle isometric strengths were measured by dynamometer. In addition, dexterity was evaluated by Minnesota manual dexterity test. Patients were under treatment for 6 weeks. The unaffected upper limb was restrained in CIT group, for five days a week (5 hours a day). In PRE group, progressive loads were applied along with improvement of strengths in patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138811101722N2
Registration date: 2013-08-18, 1392/05/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-18, 1392/05/27
Registrant information
Name
Samira Karimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
hadianrs@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
This study, sponsored by a grant from the postgraduate Studied and Research Program, Tehran University of Medical Sciences
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2009-11-22, 1388/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Constraint – Induced Therapy and Progressive Resistive Exercise on strength and dexterity of upper extremity in hemiplegic adults
Public title
Comparison of Constraint – Induced Therapy and Progressive Resistive Exercise
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with hemiplegia; Time to lesion at least six months; Age between 70 to 50 years; patients understand simple instructions and have body image; Lack of frozen shoulder joint; Ability to sit independently on the edge of bed for at least 10 minutes; At least 20 degrees in the wrist and 10 degrees Ext MP; according to modified ashworth scale, 1, +1 and 2; Minnesota Manual Dexterity Test minimum score for entrance to study not less than 6. exclusion criteria: non_cooperation during the intervention; Orthopedic diseases and stroke occurrence this.
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Deputy of research, tehran university of medical scinces
Street address
keshavarz Blvd,qods street
City
Tehran
Postal code
14167
Approval date
1388-06-06, 769/01/-651
Ethics committee reference number
1388/06/06

Health conditions studied

1

Description of health condition studied
Spastic hemiplegic cerebral palsy
ICD-10 code
G80.2
ICD-10 code description
hereditary spastic paraplegia

Primary outcomes

1

Description
upper limb strength
Timepoint
6 weeks after intervention
Method of measurement
Kg and number, JAMA Dinamometer, Nikolas Isometric evaluation device

Secondary outcomes

empty

Intervention groups

1

Description
CIT group
Category
Rehabilitation

2

Description
PRE group
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation centers of rehabilitation Faculty
Full name of responsible person
Somaye Abbasi
Street address
Rehabilitation Faculty,Pich e shemiran, Enghlab street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputty of education , Tehran Univercity of Medical Scinces
Full name of responsible person
Dr Hosein Keshavarz
Street address
Qods street, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputty of education , Tehran Univercity of Medical Scinces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Rehabilitation Faculty
Full name of responsible person
Somaye Abbasi
Position
M.Sc student
Other areas of specialty/work
Street address
Rehabilitation Faculty, Pich e shemiran, Enghlab street
City
Tehran
Postal code
1148965141
Phone
+98 217756134
Fax
Email
somaye.abbasi@ymail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences,TUMS
Full name of responsible person
Dr. Mohammad Reza Hadian
Position
Professor, Faculty of Rehabilitation, TUMS
Other areas of specialty/work
Street address
Rehabilitation faculty, pich e shemiran, enghlab street
City
Tehran
Postal code
1148965141
Phone
+98 21 7753 6134
Fax
+98 21 7753 4133
Email
hadianrs@sina.tums.ac.ir; hadian_ras@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rehabilitation faculty
Full name of responsible person
Somaye Abbasi
Position
M.Sc student
Other areas of specialty/work
Street address
Rehabilitation faculty, Pich e shemiran, Enghlab street
City
Tehran
Postal code
1148965141
Phone
+98 21 7753 6134
Fax
Email
hadianrs@sina.tums.ac.ir; somaye.abbasi@ymail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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