To compare the effectiveness of mirror therapy and motor relearning program in stroke.
This study will compare the effects of both techniques on the motor function after stroke. The document which states that mirror therapy has therapeutic effect is.
Jan, Shafqatullah, et al. "A randomized control trial comparing the effects of motor relearning program and mirror therapy for improving upper limb motor functions in stroke patients." JPMA 69.1242 (2019).
Design
Randomised control trial with blinded outcome assessment.Randomisation was computerised with concealed allocation sequence carried out at an external site.
Settings and conduct
The study will be conducted in the Sheikh Zayed Hospital and Al Noor Hospital of Rahim Yar Khan city.The outcome assessor will be blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria Age between 40 to 65 years, both ischemic and hemorrhagic stroke, both male and female will be included, Must have intact/unaffected extremity
Exclusion Criteria
Patients who are not medically stable, Patients who have dementia, Other musculoskeletal, vascular related conditions, impaired cognitive functions, Rare cardiac diseases, Progressive Neurological disorder, Orthopedic disorder involving any joint of limbs
Intervention groups
Group A.Motor relearning program(Experimental Group)
Group B.Mirror therapy(Control Group)
Main outcome variables
Motor function of upper and lower limb
(Fugl meyer assessment scale)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200316046791N1
Registration date:2020-04-01, 1399/01/13
Registration timing:prospective
Last update:2020-04-01, 1399/01/13
Update count:0
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Rabia Rauf
Name of organization / entity
Isra University
Country
Pakistan
Phone
+92 68 5886995
Email address
rabiarauf00@hotmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2641-04-20, 2020/01/31
Expected recruitment end date
2641-10-06, 2020/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Mirror Therapy and Motor Relearning program in improving the motor function of patients with stroke.
Public title
Comparison of Mirror Therapy and Motor Relearning program in stroke.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 to 65 years
Both ischemic and hemorrhagic stroke
Both male and female will be included
Must have intact/unaffected extremity
Exclusion criteria:
Patients who are not medically stable
Patients who have dementia
Other musculoskeletal, vascular related conditions, impaired cognitive functions.
Rare cardiac diseases
Progressive Neurological disorder
Orthopedic disorder involving any joint of limbs
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects fulfilling the inclusion criteria will be enrolled .For the purpose of randomisation first adequate generation of the allocation sequence and then Concealment of the allocation sequence will be done until assignment occurs.The allocation sequence will be concealed from the researcher enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes. Aluminum foil inside the envelope will be used to render the envelope impermeable to intense light. To prevent subversion of the allocation sequence, the name and date of birth of the participant will be written on the envelope and a video tape made of the sealed envelope with participant details visible. Carbon paper inside the envelope transferred the information onto the allocation card inside the envelope and a second researcher (outcome assessor) later view video tapes to ensure envelopes were still sealed when participants' names were written on them. Corresponding envelopes will be opened only after the enrolled participants completed all baseline assessments and it will be time to allocate the intervention."
Blinding (investigator's opinion)
Single blinded
Blinding description
It will be single blind and assessor will be blind .All assessments before and after the intervention will be performed by Independent assessor and only eligible subjects will be enrolled . Motor function,joint ROM,balance will be measured.Then subjects will be kept confidential and only it will be given after the assessor has completed an assessment at baseline , after 03 weeks and 06weeks
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Advance Studies and Research Committee(ASRC)
Street address
Farash town near sultana foundation lehtrar road islamabad
City
Islamabad
Postal code
45710
Approval date
2641-04-18, 2020/01/29
Ethics committee reference number
I/IUIC-IIRS/ASRC-055/2020
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
Motor function
Timepoint
on baseline ,then after 3 weeks and then after 6 weeks
Method of measurement
Motor Part of Fugl meyer assessment scale of Upper and Lower extremity
Secondary outcomes
empty
Intervention groups
1
Description
Treatment Group :Motor Relearning Program:5 sessions a week for 6 weeks.Duration of session will be 40 minutes.(In this intervention emphasis is placed on; utilizing theories of learning and knowledge of bio mechanics for analyzing movements and performance of task.It is based on the assumption that the impaired learning the same way as the unimpaired. Program is based on four factors 1.Elimination of unnecessary muscle activity 2.Feedback 3.Practice 4.Link between postural adjustment and movement,Improve sitting down and standing up,Balance standing: 5.Gait 6.Spasticity 7.Sensory problems)
Category
Rehabilitation
2
Description
Control Group:Mirror Therapy:5 sessions a week for 6 weeks.Duration of session will be 40 minutes.(For mirror therapy the size of mirror will be 35 x 25 inches.Basic motor exercises according to the available function of the patient.Functional tasks or exercises will be performed.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaikh Zayed Hospital Rahim Yar Khan
Full name of responsible person
Aqib Rao
Street address
Hospital road Rahim Yar Khan
City
Rahim Yar Khan
Postal code
64200
Phone
+92 68 5886995
Email
aqibrao80@yahoo.com
2
Recruitment center
Name of recruitment center
Al Noor Hospital.
Full name of responsible person
Rabia Rauf
Street address
Hospital road RYK.
City
Rahim yar Khan
Postal code
64200
Phone
+92 68 5886995
Email
rabiarauf007@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isra University
Full name of responsible person
Dr Sara Kafeel
Street address
Farash town phase 2 near sultana foundation,Park road
City
Islamabad
Postal code
45710
Phone
+92 51 8439905
Email
sarakafeel@hotmail.com
Grant name
Student
Grant code / Reference number
NA
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Academic support only
Proportion provided by this source
20
Public or private sector
Private
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
Royal College of physiotherapy
Full name of responsible person
Rabia Rauf
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Gulshan e usman rahim yar khan
City
Islamabad
Province
Punjab
Postal code
64200
Phone
092685886995
Email
rabiarauf007@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royal college of physiotherapy
Full name of responsible person
Rabia Rauf
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Gulshn e Usman Rahim yar khan
City
Rahim Yar Khan
Province
Punjab
Postal code
64200
Phone
092685886995
Email
rabiarauf007@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Royal college of physiotherapy
Full name of responsible person
Rabia Rauf
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Gulshan e Usman Rahim Yar Khan
City
Rahim Yar Khan
Province
Punjab
Postal code
64200
Phone
0923349907719
Email
Rabiarauf007@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Comparison of mirror therapy and motor relearning program in stroke.
When the data will become available and for how long
It will be available after study completion
To whom data/document is available
To researchers for study only.Patient data will not be shown .
Under which criteria data/document could be used
To researchers for study only.Patient data will not be shown .
From where data/document is obtainable
From the University office and Responsible supervisor and from journal we will process in future
What processes are involved for a request to access data/document
It will be only used in confidential way for improving research and benefit of humanity
Comments
It will be first study of such type in Pakistan involving the Upper and Lower limb for comparing the effects of mirror therapy and motor relearning program in stroke.