Comparison of the effect of action observation therapy and mirror therapy on upper extremity functions in patients with stroke
Design
Randomized clinical trial with control group, single blind, in each group n=11
Settings and conduct
This study will be performed in occupational therapy clinic of SBMU School of Rehabilitation Sciences.
Subjects will be selected from stroke patients and randomly allocated in 3 groups.
They do not inform from each other intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: A diagnosis of hemiplegia due to stroke; 6 months to 5 years of stroke; Stage 3, 4, 5 and 6 Brunnstrom in proximal and distal of upper extremity; Obtaining at least 18 score from the Mini-Mental Status Examination; Voluntary consent to participate in the study; Age range 30-70 years
Exclusion criteria: Visual or perceptual impairments such as hemineglect; Presence any neurological and orthopedic disease in upper extremity; Receiving simultaneously another services
Intervention groups
Intervention group -Mirror therapy: performs 30 minutes per day, 3 days per week, for a total of 4 weeks. Patient will perform the functional tasks with nonparetic upper extremity in front of mirror.
Intervention group -action observation therapy: performs 30 minutes per day, 3 days per week, for a total of 4 weeks. Patients perform motor tasks after viewing them in the video.
Control group: Conventional intervention includes upper extremity range of motion exercises, Bobath and PNF Techniques and strength training will perform for 45 minutes per day, 3 days per week, for a total of 4 weeks.
Main outcome variables
Upper extremity function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180815040804N1
Registration date:2018-10-26, 1397/08/04
Registration timing:registered_while_recruiting
Last update:2018-10-26, 1397/08/04
Update count:0
Registration date
2018-10-26, 1397/08/04
Registrant information
Name
Elnaz Fadaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1721
Email address
fadaei_elnaz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"Comparison of the effect of action observation therapy and mirror therapy on upper extremity functions in patients with stroke"
Public title
"The action observation therapy and mirror therapy on treatment of upper limb stroke patients"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A diagnosis of hemiplegia due to stroke
6 months to 5 years of stroke
Stage3, 4, 5 and 6 Brunnstrom in proximal and distal of upper extremities
Obtaining at least 18 score from the Mini-Mental Status Examination
Voluntary consent to participate in the study
Age range 30-70 years
Exclusion criteria:
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants do not inform about interventions present to each other.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
"Upper extremity function based on Box and Block Test and Fugl-Meyer Assessment"
Timepoint
"Measurement by Box and Block Test: Before intervention and end of sessions 3, 6, 9 and 12. Measurement by Fugl-Meyer Assessment: Before and after intervention"
Method of measurement
"Box and Block Test, Fugl-Meyer Assessment"
Secondary outcomes
1
Description
"functional independence score"
Timepoint
"Before the intervention, after the intervention"
Method of measurement
"Functional Independence Measure"
Intervention groups
1
Description
Intervention group 1: Patients in the mirror group will receive mirror therapy for 30 minutes per session, 3 sessions per week, for 4 weeks in addition to the intervention of the control group. In this intervention, the patient sit on a chair in front of a table and a mirror dimensions 50*62 cm will be placed on the desk, parallel with the midline of the body and between the paretic and nonparetic upper extremity. Patients will be asked to gaze at the nonparetic upper extremity reflected in the mirror. The activities of the mirror therapy group includes: Range of motion exercises such as elbow flexion.extension, forearm supination.pronation , wrist and fingers flexion.extension, fisting and releasing, reaching and upper extremity functional tasks. The exercises will be presented proportionally to each person's ability of the upper extremity. The patients will be asked to repeat each movement 30 times per set for three sets, with 1-minute break between sets. During intervention participants will be encouraged to actively move their hands and simultaneously move their nonparetic side reflected in the mirror. If patients unable to move their paretic upper extremity the therapist will help them.
Category
Rehabilitation
2
Description
Intervention group 2: Patients in the action observation therapy group will receive action observation therapy for 30 minutes per session, 3 sessions per week, for 4 weeks in addition to the intervention of the control group. In this intervention, the patient sit on a chair in front of the laptop. In the action observation group, patients will see the activities through the video and then perform the observed movements with both upper extremities simultaneously. Each functional task is divided into three motor actions. After observing a motor action for 2 minutes, patients will be asked to perform the observed motor action for 3 minutes. This step will be repeated three times, with 1-minute break between times. Then the patients will observe the functional task as a whole motor action for 2 minutes and then perform whole task for 3 minutes. This step will also be repeated three times. The activities of the action observation therapy group will include the range of motion exercises such as elbow flexion.extension, forearm supination.pronation, wrist and fingers flexion.extension, fisting and releasing, reaching and upper extremity functional tasks. The exercises will be presented proportionally to each person's ability of the upper extremity. If patients unable to move their paretic upper extremity the therapist will help them.
Category
Rehabilitation
3
Description
Control group: Conventional intervention includes upper extremity range of motion exercises, Bobath and PNF Techniques and strength training. Conventional intervention will apply for 45 minutes per session, 3 sessions per week, for 4 weeks. The control group will receive upper extremity exercises for 45 minutes without watching video or performing activities in front of the mirror.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Occupational therapy clinic of SBMU School of Rehabilitation Sciences
Full name of responsible person
Minoo Kalantari
Street address
SBMU School of Rehabilitation Sciences, Damavand St, Across from Bu Ali Hospital, Tehran, Iran
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elnaz Fadaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
SBMU School of Rehabilitation Sciences, Damavand St, Across from Bu Ali Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
fadaei_elnaz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo Kalantari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
SBMU School of Rehabilitation Sciences, Damavand St, Across from Bu Ali Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
mn_kalantari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elnaz Fadaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
SBMU School of Rehabilitation Sciences, Damavand St, Across from Bu Ali Hospital
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Fax
+98 21 7759 1807
Email
Fadaei_Elnaz@yahoo.Com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Statistical outcomes include MD, SD
When the data will become available and for how long
"From article acceptation"
To whom data/document is available
"Practitioners and students"
Under which criteria data/document could be used
"Use of data with permission"
From where data/document is obtainable
Dr Mino Kalantari, Assistant professor of SBMU School of Rehabilitation Sciences
Address: SBMU School of Rehabilitation Sciences, Damavand St, Across from Bu Ali Hospital, Tehran, Iran
Email: mn_kalantari@yahoo.com
Zip Code: 1616913111
Tel: 00982177548496
What processes are involved for a request to access data/document