The aim of the study is to compare the effects of Motor Relearning program and Action Observation therapy on balance and gait in chronic stroke patients.
Design
study design is Randomized control trial
Settings and conduct
DHQ hospital sahiwal
Participants/Inclusion and exclusion criteria
• Those who were diagnosed with cerebral hemorrhage and cerebral infarction based on computed tomography or magnetic resonance imaging.
• Both male and female
• Patients age 50-70 years
• Chronic stroke patients (after 6 months of first stroke)
• Medically stable patients having a single stroke
• No visual field defects
• No abnormality in the vestibular organs
• A score greater than 24-30 in mini-mental test
• Patients that will be able to fulfill and comprehend the command.
• 2–4 muscle power in the affected side (Medical Research Council-MRC Muscle scale 2–4)
exclusion criteria:
• Patients with orthopedic diseases (such as contracture) in the trunk and both lower extremity.
• History of fall in last 6 months
• A history of other neurological diseases or disorders (Multiple Sclerosis, Parkinson’s)
• Manual muscle testing below grade II
• Those who are receiving other related therapy through the study, which may affect the efficacy of this study;
• Those with any contraindications to start rehabilitation (i.e. severe uncontrolled hypertension, uncontrolled diabetes or unstable angina)
Intervention groups
Group A will receive intervention Motor Relearning Program with conventional treatment and Group B will receive Action Observation Therapy with conventional treatment. All participants will receive interventions for 35-40 minutes per session, three times a week, for eight weeks.
Main outcome variables
Balance and Gait
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231015059732N1
Registration date:2023-10-28, 1402/08/06
Registration timing:registered_while_recruiting
Last update:2023-10-28, 1402/08/06
Update count:0
Registration date
2023-10-28, 1402/08/06
Registrant information
Name
Ayesha Nazir
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 46 95995061
Email address
ayeshanazir670@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-01, 1402/05/10
Expected recruitment end date
2023-12-01, 1402/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
COMPARATIVE EFFECTS OF MOTOR RELEARNING PROGRAM AND ACTION OBSERVATION THERAPY ON BALANCE AND GAIT IN CHRONIC STROKE PATIENTS.
Public title
MOTOR RELEARNING PROGRAM AND ACTION OBSERVATION THERAPY FOR STROKE PATIENTS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Those who were diagnosed with cerebral hemorrhage and cerebral infarction based on computed tomography or magnetic resonance imaging.
Both male and female
Patients age 50-70 years
Chronic stroke patients (after 6 months of first stroke)
Medically stable patients having a single stroke
No visual field defects
No abnormality in the vestibular organs
A score greater than 24-30 in mini-mental test
Patients that will be able to fulfill and comprehend the command.
2–4 muscle power in the affected side (Medical Research Council-MRC Muscle scale 2–4
Exclusion criteria:
Patients with orthopedic diseases (such as contracture) in the trunk and both lower extremity
History of fall in last 6 months
A history of other neurological diseases or disorders (Multiple Sclerosis, Parkinson’s)•
Manual muscle testing below grade II
Those who are receiving other related therapy through the study, which may affect the efficacy of this study
Those with any contraindications to start rehabilitation (i.e. severe uncontrolled hypertension, uncontrolled diabetes or unstable angina)
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method by using a table of random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
participants and data analyzer will be blind in this study
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Riphah International University
Street address
Riphah international university Gulberg 3 campus Lahore
City
Lahore
Postal code
54660
Approval date
2023-08-03, 1402/05/12
Ethics committee reference number
REC/RCR & AHS/23/0249
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Balance & Gait
Timepoint
pre intervention and post intervention
Method of measurement
by using Berg balance scale, 10-m walk test and timed up and go test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A
Category
Treatment - Other
2
Description
Intervention group: Group B
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
District head quarter hospital Sahiwal
Full name of responsible person
DR sherazi
Street address
DHQ hospital Road sahiwal
City
sahiwal
Postal code
57000
Phone
+92 57 95995061
Email
ayeshanazir670@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah international university
Full name of responsible person
Ethics committee of Riphah International University
Street address
Riphah international university Gulberg 3 campus Lahore
City
Lahore
Postal code
54660
Phone
+92 57 67881831
Email
ayeshanazir670@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
research fund
Proportion provided by this source
2
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
Riphah International university
Full name of responsible person
Ayesha Nazir
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Riphah international university Gulberg 3 campus Lahore
City
Lahore
Province
PUNJAB
Postal code
54660
Phone
+92 57 95995061
Email
ayeshanazir670@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
RIPHAH INTERNATIONAL UNIVERESITY
Full name of responsible person
AYESHA NAZIR
Position
STUDENT
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Riphah international university Gulberg 3 campus Lahore
City
Lahore
Province
PUNJAB
Postal code
54660
Phone
+92 57 95995061
Email
ayeshanazir670@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
RIPHAH INTERNATIONAL UNIVERSITY
Full name of responsible person
AYESHA NAZIR
Position
STUDENT
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Riphah international university Gulberg 3 campus Lahore
City
Lahore
Province
PUNJAB
Postal code
54660
Phone
+92 57 95995061
Email
ayeshanazir670@gmail.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
COMPARATIVE EFFECTS OF MOTOR RELEARNING PROGRAM AND ACTION OBSERVATION THERAPY ON BALANCE AND GAIT IN CHRONIC STROKE PATIENTS.
When the data will become available and for how long
starting 6 months after pubication
To whom data/document is available
dr sana riaz
Under which criteria data/document could be used
dr sana riaz
From where data/document is obtainable
Dr SANA RIAZ
What processes are involved for a request to access data/document