Protocol summary

Summary
The aim of this study was to assess the effects of constraint-induced movement therapy (CIT) in comparison with traditional rehabilitation in chronic hemiplegic patients. Inclusion criteria was having at least 20 and 10 degree extension in affected wrist and fingers respectively, having sufficient balance in walking when the less affected arm was immobilized. Exclusion criteria were having serious cognitive problems (aphasia, attention deficits, visual neglect, serious uncontrolled medical problems, limited spasticity and pain, and having motor activity log (MAL) score more than 3) 12 patients (10 male ,2 female were assigned randomly to two groups. The first group received CIT (restraint of the less affected limb combined with intensive training of the affected limb for 2 hours daily, 5 days per week for 3 weeks and restraint of the less affected hand for 5 hours outside of the rehabilitation training). The second group received a traditional intervention without hand restraint for the same duration. Outcome measures were the MAL, Wolf Motor Function Test (WMFT). These tests were done one day before treatment, after 3 weeks in the end of treatment and three months later as follow-up.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138712111719N3
Registration date: 2009-09-19, 1388/06/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-09-19, 1388/06/28
Registrant information
Name
khadije Otadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 6134
Email address
k_otadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences (TUMS),IRAN
Expected recruitment start date
2005-10-30, 1384/08/08
Expected recruitment end date
2008-09-30, 1387/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of Constraint induced (CI)and traditional rehabilitation(TR) on motor activity log(MAL) and wolf motor function test(WMFT )in chronic hemiplegic patientpatient
Public title
The effect of Constraint induced movement and traditional rehabilitation on chronic hemiplegic patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of at least 20 and 10 degree extension in affected wrist and each finger respectively, sufficient balance to walk when the less affected arm is immobilized. Exclusion criteria: serious cognitive problems (aphasia, attention deficits, visual neglect, serious uncontrolled medical problems, limited spasticity and pain, and good MAL greater from 3 score
Age
From 30 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 12
Randomization (investigator's opinion)
Randomized
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
Research Center for Medical Ethics
Street address
No 21, 4th floor, Poorsina St
City
Tehran
Postal code
Approval date
2005-10-05, 1384/07/13
Ethics committee reference number
132/5744

Health conditions studied

1

Description of health condition studied
Other disorders of brain
ICD-10 code
G93.2
ICD-10 code description
Benign intracranial hypertension

Primary outcomes

1

Description
Functional movement
Timepoint
Before intervention, and after three weeks treatment
Method of measurement
wolf motor function test

2

Description
Daily function recovery
Timepoint
Before intervention, and after three weeks treatment
Method of measurement
motor activity log

Secondary outcomes

empty

Intervention groups

1

Description
Constraint induced movement therapy.This method involves motor restriction of the unaffected upper extremity by a resting hand splint and sling and training of the affected extremity,and the patients to repeatedly practice use of the paretic arm for many hours a day for a period of consecutive days.
Category
Rehabilitation

2

Description
Traditional hemiplegic rehabilitation
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Outpatient clinic of Rehabilitation Faculty
Full name of responsible person
Khadije Otadi
Street address
Pich e shemiran- Enghlab st.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences (Primary sponsor)
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Keshvarz.BLV,Kods street.central organization of TUMS
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences (Primary sponsor)
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
Faculty of Rehabilitation
Full name of responsible person
Khadije Otadi
Position
MS PT , Post Graduate Department, Instructor
Other areas of specialty/work
Street address
Pich e shemiran- Enghlab st.
City
Tehran
Postal code
1148965141
Phone
Fax
Email
k-otadi@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Rehabilitation
Full name of responsible person
Dr. Mohammad Reza Hadian and Khadije Otadi
Position
Ph.D. Professor, Faculty of Rehabilitation, Imam komeini Hospital-MS PT , Post Graduate Department,
Other areas of specialty/work
Street address
Pich e shemiran- Enghlab st.Tehran
City
Tehran
Postal code
1148965141
Phone
+98 21 7753 6134
Fax
Email
hadianrs@sina.tums.ac.ir ,- k_otadi @ razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Rehabilitation, TUMS
Full name of responsible person
Khadije Otadi
Position
Instructor ,Post Graduate Department
Other areas of specialty/work
Street address
Pich e shemiran- Enghlab st.
City
Tehran
Postal code
Phone
Fax
Email
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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