(1) Objectives:
Aim of the present study is to determine effects of mirror therapy on upper limb function in patients with impaired active range of motion in hand.
(2) Design:
Prospective Randomized Controlled Trial
(3) Setting and conduct:
A convenient sample of patients with flexor lag (age range between 18-65) after signing the consent form, are randomized to 2 groups (mirror therapy (n=11) and control (n=11)). All patients were uninformed about which part of their treatment was aim of this study and also, there is not any relation between two groups.In the present study, all patients are treated by an intensive rehabilitation program (tendon gliding exercises, place and holding exercises, dynamic splinting, activities of daily living) for 30-minute a day, 5 days a week for 3-week. Patients in the mirror group receive 30 minutes of mirror therapy in a quiet environment before initiation of the rehabilitation program.
During mirror therapy, healthy hand is placed in front of the mirror and affected hand behind the mirror, and as a result patients through looking into the mirror perceived two healthy hand. An occupational therapist is responsible for implementing all of the treatment protocol.
(4) Participants:
Inclusion Criteria: Patients with flexor lag following different orthopedic conditions; Age between 18 and 65 years.
Exclusion Criteria: Patients with crush injuries; Patients with hand deformities; Patients with not treated fractures and tendon ruptures; Patients with complex regional pain syndrome; Patients with psychiatric problems; Patients with neurologic disorders; Patients with impaired motor function because of a nerve lesion; Patients with pain score more than one in visual analog scale
(5) Intervention:
Mirror Therapy Group: Mirror Therapy with rehabilitation techniques; Control Group: just rehabilitation techniques
(6) main outcome measures:
A person blinded to the group assignment performed measurement tests including Total Active Motion and Disabilities of the Arm, Shoulder and Hand are evaluated before and after the treatment period and 3-week after the final treatment session.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108074945N3
Registration date:2012-01-28, 1390/11/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-28, 1390/11/08
Registrant information
Name
Hamid Reza Rostami
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3101
Email address
rostamihr@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2011-11-22, 1390/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Mirror therapy effects on the hand function in patients with orthopedic injuries
Public title
Mirror therapy effects on the hand function in patients with orthopedic injuries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Patients with flexor lag following different orthopedic conditions; Age between 18 and 65 years.
Exclusion Criteria:
Patients with crush injuries; Patients with hand deformities; Patients with not treated fractures and tendon ruptures; Patients with complex regional pain syndrome; Patients with psychiatric problems; Patients with neurologic disorders; Patients with impaired motor function because of a nerve lesion; Patients with pain score more than one in visual analog scale
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
22
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
1
Registry name
ClinicalTrials.gov Registration
Secondary trial Id
NCT01503762
Registration date
2012-01-03, 1390/10/13
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Research Deputy of Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Approval date
2011-12-03, 1390/09/12
Ethics committee reference number
ETH-300
Health conditions studied
1
Description of health condition studied
Upper Limb Orthopedic Injury
ICD-10 code
M60, M62,
ICD-10 code description
Disorders of muscles, Disorders of synovium and tendon, Other soft tissue disorders; Osteopathies and chondropathies, Disorders of bone density and structure, Other osteopathies, Chondropathies
Primary outcomes
1
Description
Total Active Motion
Timepoint
Session 1: Before the study, Session 2: 3-Week after the initiation of study, Session 3: 3-week after the study
Method of measurement
Goniometery
Secondary outcomes
1
Description
Upper Limb Performance
Timepoint
Session1: Before the study, Session 2: 3-week after initiation of study, Session3: 3-week after the study
Method of measurement
Disability of the Arm, Shoulder, and Hand Questionnaire (DASH)
Intervention groups
1
Description
Intervention Group: Mirror therapy + Rehabilitation program
Mirror Therapy:During mirror therapy, healthy hand is placed in front of the mirror and affected hand behind the mirror, and as a result patients through looking into the mirror perceived two healthy hand.
Rehabilitation Program: tendon gliding exercises, place and holding exercises, dynamic splinting, activities of daily living, active and passive and resistive exercises.
In the present study, all patients are treated by an intensive rehabilitation program (tendon gliding exercises, place and holding exercises, dynamic splinting, activities of daily living) for 30-minute a day, 5 days a week for 3-week. Patients in the mirror group receive 30 minutes of mirror therapy in a quiet environment before initiation of the rehabilitation program.
Category
Rehabilitation
2
Description
Control Group: Rehabilitation program
Rehabilitation Program: tendon gliding exercises, place and holding exercises, dynamic splinting, activities of daily living, active and passive and resistive exercises.
Ppatients in the control group are treated by an intensive rehabilitation program for 30-minute a day, 5 days a week for 3-week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Mohammad Reza Ehsanpour
Street address
First Square of Kianpars, Razi Hospital
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. M.R. Abbaspoor
Street address
Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Ahvaz Jundishapur 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
Occupational Therapy Department, School of Rehabilitation Sciences, Ahvaz Jundishapur University of
Full name of responsible person
Hamid Reza Rostami
Position
M.Sc. Lecturer
Other areas of specialty/work
Street address
Occupational Therapy Department,School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1374 3101
Fax
Email
rostamihr@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Occupational Therapy Department,School of Rehabilitation Sciences, Ahvaz Jundishapur University of
Full name of responsible person
Hamid Reza Rostami
Position
Lecturer
Other areas of specialty/work
Street address
Occupational Therapy Department,School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1374 3101
Fax
Email
rostamihr@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Occupational Therapy Department,School of Rehabilitation Sciences, Ahvaz Jundishapur University of
Full name of responsible person
Hamid Reza Rostami
Position
MsC Lecturer
Other areas of specialty/work
Street address
Occupational Therapy Department,School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Postal code
Phone
+98 61 1374 3101
Fax
Email
rostamihr@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)