Clinical trial effectiveness of Mirror Visual feedback on sensory relearning outcomes in patients following Median/Ulnar nerve repair in the upper limbs.
The present randomized clinical trial conducted to determine the effect of Mirror Visual Feedback (MVF) on sensory relearning outcomes in patients with median/ulnar nerve repairs
Design
In this clinical trial, 20 eligible patients referring to Hazrate Fatemeh Hospital and Sina Hospital were chosen purposefully. Then, patients were randomly divided into two control and intervention groups.
Settings and conduct
In Hazrate Fatemeh Hospital and Sina Hospital, traditional rehabilitation program conducted by a therapist for both intervention and control groups for eight weeks.
The intervention group also received MVF sessions.
Participants/Inclusion and exclusion criteria
The study inclusion criteria consisted of having undergone median or ulnar nerve surgery or both, age 18 to 60 years, four to six weeks interval after surgery and the Non-compliance criteria include diabetes or other peripheral neuropathy
and other orthopedic or neurological injuries other than tendon and arterial injury.
Intervention groups
Traditional rehabilitation program conducted by a therapist for both intervention and control groups including sessions about 40 minutes, three days per week, for eight weeks.
The intervention group also received MVF about15 minutes per day, five days per week, for eight weeks.
Main outcome variables
The state of superficial sensation and sensory function.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023277N5
Registration date:2018-02-25, 1396/12/06
Registration timing:retrospective
Last update:2018-02-25, 1396/12/06
Update count:0
Registration date
2018-02-25, 1396/12/06
Registrant information
Name
Laleh Lajevardi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
lajevardi.l@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial effectiveness of Mirror Visual feedback on sensory relearning outcomes in patients following Median/Ulnar nerve repair in the upper limbs.
Public title
effectiveness of Mirror Visual Feedback on sensory relearning outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having median or ulnar nerve surgery or both
age 18 to 60 years
a minimum score of 21 in the Mini-Mental State Examination
Four to six weeks interval after surgery (i.e. epineural repair)
Exclusion criteria:
Diabetes or other peripheral neuropathy
The presence of other orthopedic or neurological damage other than tendon and arterial injury
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed Envelope
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
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Between the intersection of Sheikh Fazlollah Noori and Shahid Chamran, Shahid Hemmat Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2015-02-14, 1393/11/25
Ethics committee reference number
93/D/105/5530
Health conditions studied
1
Description of health condition studied
Injury of median nerve at wrist of upper extrimity
ICD-10 code
G56.1
ICD-10 code description
other lesions of median nerve
2
Description of health condition studied
Injury of ulnar nerve at wrist of upper extrimity
ICD-10 code
G56.2
ICD-10 code description
lesions of ulnar nerve
Primary outcomes
1
Description
The threshold of cutaneous touch/pressure
Timepoint
before the intervention and After the end of the intervention ( two months)
Method of measurement
pocket version of Semmes Weinstein Monofilaments (SWMs)
2
Description
two points discrimination
Timepoint
before the intervention and After the end of the intervention ( two months)
Method of measurement
( two points discrimination with using a caliper
3
Description
Tactile gnosis
Timepoint
before the intervention and After the end of the intervention ( two months)
Method of measurement
Stereognosis
Secondary outcomes
empty
Intervention groups
1
Description
Treatment group: A therapist will be performed a traditional rehabilitation program of 40 minutes, three days per week, for eight weeks. In addition to the traditional rehabilitation program, the treatment group also will receive mirror therapy sessions 15 minutes per day, five days per week, for eight weeks; three of the mirror therapy sessions are done in a clinic under the supervision by a therapist every week, and the other two sessions will perform by the patients themselves at home using a mirror therapy box with the help of a booklet with instructions. The mirror box contain a 35×45cm mirror set at an 80-degree angle that will construct by the researchers and will distribute among the patients. During their mirror therapy sessions, the patients sit in front of a table that had a mirror box placed at its center and hold their intact hand in front and their injured hand at the back of the mirror with an equal distance from the mirror. The mirror therapy sessions consist of three stages. Stage one involves performing of movements such as pronation, supination, opposition, etc. for five minutes. Stage two include the patient touching objects with various degrees of coarseness in front of the mirror for five minutes. Stage three involve the performance of activities with the intact hand in front of the mirror; in this stage, the patient will be asked to perform actions such as wiping the table with a cloth, grabbing a book, plate, cell phone, pen, spoon, glass and coin or keys with the intact hand and focus on the image of the intact hand in the mirror throughout the entire activity
Category
Rehabilitation
2
Description
control group: traditional rehabilitation program of 40 minutes, three days per week, for eight weeks, which included rehabilitation techniques such as proprioceptive neuromuscular facilitation, individual blocking exercise, gliding exercise, sensory precaution training, the use of different splints, functional activities and daily life activities
Sina Hospital, not reaching Hassan Abad Square, Imam Khomeini Avenue (RA), Tehran.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
hosp_sina@sina.tus.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Mrs. Hossein Mardi
Street address
Iran University of Medical Sciences, Between the intersection of Sheikh Fazlollah Noori and Shahid Chamran, Shahid Hemmat Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
14961535
Phone
+98 21 86701
Email
fnm@iums.ac.ir
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, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Full name of responsible person
Dr Laleh Lajevardi
Position
PhD of Occupational Therapy, Assistant Professor, Department of Occupational Therapy
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Nezam Street, Shahid Shah Nazari Street, Mother Square, Mirdamad Boulevard, Tehran.
City
Tehran
Province
Tehran
Postal code
rehab@iums.ac.ir
Phone
+98 212222205
Fax
Email
www.laleh23275@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Dr laleh Lajevardi
Position
Ph.D. Occupational Therapy
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Faculty of Rehabilitation Sciences, Nezam Street, Shahid Shah Nazari Street, Mother Square, Mirdamad Boulevard, Tehran.
City
Tehran
Province
Tehran
Postal code
154591348
Phone
+98 21 2222 7124
Fax
Email
rehab@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Rehabilitation, Isfahan University of Medical Sciences
Full name of responsible person
Farzane Saberi
Position
Master of Occupational Therapy, Associate Professor, Department of Occupational Therapy, Isfahan Reh
Latest degree
Master
Other areas of specialty/work
Street address
Faculty of Rehabilitation, Isfahan University of Medical Sciences, University Boulevard, Isfahan.
City
esfahan
Province
Isfehan
Postal code
8518945571
Phone
+98 31 4244 3389
Fax
Email
tavanbakhshi@rehab.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD