Protocol summary

Summary
Rehabilitation of the affected paretic arm after stroke is one of the main concerns of occupational therapists, especially in the chronic phase. the aims of this study is to investigate the effect of MIRROR THERAPY on hand function in adults with hemiparesis.In this randomized double blinded study a total of 30 chronic stroke patients (mean time post .onset, 6 mounts) will be assigned to the mirror group (n = 15) or the control group (n = 15). Inclusion criteria is spend at least 6 months after stroke and the Ability to understand therapeutic instructions and exclusion criteria includes s any structural problems that hinder the implementation of treatment program and cognitive , perceptual or visual deficits that interfere with treatment program.Treatment program will consist of 15 sessions which every session for the mirror group includes bi-manual training with mirror and conventional therapies, and for the control group includes bi-manual training without mirror and conventional therapies. hand function will be assessed before and after treatments through FMA,Box&Block test and Jamar dynamometer.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201128713N1
Registration date: 2012-01-25, 1390/11/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-01-25, 1390/11/05
Registrant information
Name
Hossein Alibakhshi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
alibakhshi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Neuromuscular Research Center, Semnan University of medical sciences
Expected recruitment start date
2012-01-21, 1390/11/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The investigation of Mirror Therapy on hand function in adults with hemiparesis in Semnan
Public title
Effect of Mirror therapy in the treatment of adult patients with hemiplegia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Spend at least 6 months after stroke, the Ability to understand therapeutic instructions exclusion criteria: any structural problems that hinder the implementation of treatment program, cognitive or perceptual deficits that interfere with treatment program , visual dificulties
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan University of medical sciences
Street address
Semnan- Semnan University of medical sciences
City
Semnan
Postal code
Approval date
2012-01-10, 1390/10/20
Ethics committee reference number
90/134961

Health conditions studied

1

Description of health condition studied
stroke
ICD-10 code
I67.9
ICD-10 code description
Cerebrovascular disease, unspecified

Primary outcomes

1

Description
dexterity
Timepoint
before/after treatment
Method of measurement
Box & Block Test

2

Description
hand function
Timepoint
befor / after treatment
Method of measurement
Fugl Meyer Assessment r

3

Description
strengthening grip
Timepoint
before/after treatment
Method of measurement
Jammar Dynamometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: mirror therapy + conventional occupational therapy
Category
Rehabilitation

2

Description
Control : bimanual training + conventional occupational therapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuro-muscular Research Center
Full name of responsible person
Street address
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
research and technology deputy of Semnan university of medical sciences
Full name of responsible person
Dr. Raheb Ghorbani
Street address
Semnan university of medical sciences
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research and technology deputy of Semnan university of medical sciences
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
Semnan University of medical sciences
Full name of responsible person
Hossein Alibakhshi
Position
Msc. Occupational therapy/ lecturer
Other areas of specialty/work
Street address
Neuromuscular research center- Ghods blvd.
City
Semnan
Postal code
Phone
+98 23 1332 8502
Fax
Email
alibakhshi@sem-ums.ac.irhalibakhshi.m@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of medical sciences
Full name of responsible person
Hossein Alibakhshi
Position
Msc. Occupational therapy
Other areas of specialty/work
Street address
Neuromuscular research center-Ghods blvd.
City
Semnan
Postal code
Phone
+98 23 1332 8502
Fax
Email
alibakhshi@sem-ums.ac.ir halibakhshi.m@gmail . com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of medical sciences
Full name of responsible person
Hossein Alibakhshi
Position
Msc. Occupational therapy
Other areas of specialty/work
Street address
Neuromuscular research center- Ghods blvd.
City
Semnan
Postal code
Phone
+98 23 1332 8502
Fax
Email
alibakhshi@sem-ums.ac.irhalibakhshi.m@gmail.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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