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Efficacy of occupation-based interventions versus exercise therapy in constraint-induced movement therapy on upper limb function after median and ulnar nerve repair

Protocol summary

Summary
The aim of the present study is to investigate effects of occupation-based interventions (purposeful and meaningful occupations in real context) compared to exercise therapy on results of CIMT. This study as a prospective, assessor-blind, randomized clinical trial would be performed on 30 patients with median and ulnar nerve injury in 3 groups (CIMT based on occupation-based intervention, CIMT based on exercise therapy, control). In CIMT group based on occupation-based intervention, sensory-motor reeducation is fully based on occupational preferences of own patients (preferred occupations and activities with real stuff and tools provided by patients inside their houses). In CIMT group based on exercise therapy, sensory-motor reeducation is based on present abilities and disabilities according to the usual rehabilitation programs such as repetitive and intensive movement of joints. Outcome measures includes total active motion, box & block test, disabilities of the arm, shoulder, hand questionnaire, self assessment manikin scale, and canadian occupational performance measure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016011710806N4
Registration date: 2016-04-22, 1395/02/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-04-22, 1395/02/03
Registrant information
Name
Malahat Akbarfahimi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
akbarfahimi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Reserrch Deputy of Iran University of Medical Sciences, Thesis of PhD
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of occupation-based interventions versus exercise therapy in constraint-induced movement therapy on upper limb function after median and ulnar nerve repair
Public title
Effect of constraint-induced movement therapy on hand function of patients with median and ulnar nerve injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: chronic condition (at least 6 months after nerve repair); Non-use learning in injured limb (score less than 2.5 in Motor Activity Log); lack of any non-healed fractures or tendon ruptures; score less than 10 in Beck depression questionnaire; Lack of neurologic disorders related to the central nervous system; Age between 18-55 years Exclusion criteria: any surgery during the study period; complex regional pain syndrome; No participation in more than 2 intervention sessions
Age
From 18 years old to 55 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Hemmat highway, next to the milad hospital
City
Tehran
Postal code
Approval date
2016-02-16, 1394/11/27
Ethics committee reference number
IR.IUMS.REC.13949211525212

Health conditions studied

1

Description of health condition studied
Median and Ulnar Nerve Injury
ICD-10 code
G56.1 , G5
ICD-10 code description
Other lesions of median nerve, Lesion of ulnar nerve

Primary outcomes

1

Description
Sensation of fingers
Timepoint
before, after, and 1 month afterthe intervention ending
Method of measurement
touch perception at volar side of the pulp of index finger (median nerve) and littile finger (ulnar nerve) by semmes-weinstein monofilaments

2

Description
Occupational performance
Timepoint
before, after, and 1 month afterthe intervention ending
Method of measurement
patients own score to the performance and satisfaction of performance in preferred occupations in a 0-10 scale in COPM Questionnaire

3

Description
Disability rate of upper limb
Timepoint
before, after, and 1 month afterthe intervention ending
Method of measurement
patients own score to 30 questions of DASH questionnaire in a 1-5 likert scale

4

Description
hand dexterity
Timepoint
before, after, and 1 month afterthe intervention ending
Method of measurement
number of transfered cubes in one minutes in Box and Block test

Secondary outcomes

1

Description
Motivation
Timepoint
before, after, and 1 month afterthe intervention ending
Method of measurement
This scale is a visual scale. patient chooses one of the pictures that is according to his/her view about Dominancy, Valence, and arousal

Intervention groups

1

Description
Occupation-based constraint-induced movement therapy group: immobilization of healthy hand for 6 hours each day 4 weeks. occupation-based interventions for 3 hours a day, 3 days a week, during 4 weeks.
Category
Rehabilitation

2

Description
Exercise therapy based constraint-induced movement therapy group: immobilization of healthy hand for 6 hours each day 4 weeks. Exercise-based interventions for 3 hours a day, 3 days a week, during 4 weeks.
Category
Rehabilitation

3

Description
control group: 1.5 hours of practice each day by own patient alone in his/her home without therapist for 4 weeks
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemeh Hospital
Full name of responsible person
Hamid Reza Rostami
Street address
Faculty of Rehabilitation Sciences, Nezam Aly, Shah Nazari Street,Madar Square, Mirdamad blv.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Iran University of Medical Sciences
Full name of responsible person
seyed Ali Javad Mousavi
Street address
Hemat Express Way -near milad hospital-Iran University of Medical University-centeral block
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Iran 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
Iran Univertsity of Medical Sciences
Full name of responsible person
Malahat Akbarfahimi
Position
Assisstant Professor, Occupational Therapy Department
Other areas of specialty/work
Street address
Faculty of rehabilitation sciences, Nezam Aly, Shah nazari street, Madar square, Miirdamad blv.
City
Tehran
Postal code
Phone
+98 21 2222 8052
Fax
Email
akbarfahimi.m@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Malahat Akbarfahimi
Position
Assisstant Professor, Occupational Therapy Department
Other areas of specialty/work
Street address
Faculty of rehabilitation sciences, Nezam Aly, Shah nazari street, Madar square, Miirdamad blv.
City
Tehran
Postal code
Phone
+98 21228052
Fax
Email
akbarfahimi.m@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hamid Reza Rostami
Position
PhD student of Occupational therapy
Other areas of specialty/work
Street address
Faculty of Rehabilitation Sciences, Nezam Aly, Shah Nazari Street,Madar Square, Mirdamad blv.
City
Tehran
Postal code
Phone
+98 21 2222 8052
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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