Comparative effects of modified otago exercise program(MOEP) and perturbation-based balance training(PBT)on reactive postural control and balance in patients with sub-acute stroke
To compare the effects of modified otago exercise program (MOEP) and perturbation based balance training (PBT) on reactive postural control and balance in patients with sub-acute stroke.
Design
Parallel group design of 64 patients and single blinded randomized control trial
Settings and conduct
Data will be collected from District Headquarter hospital ,Toba Tek Singh, Pakistan.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Sub-acute stroke patients.
Subjects should have stable condition after the stoke incidence.
Tolerance of balance and gait tasks without fatigue.
Both genders can participate in the study.
Age from 50 to 70years.
Exclusion Criteria:
Patients with any other neurological conditions
Patient with visual and vestibular impairment
Intervention groups
Modified otago exercise program: (MOEP)
it consists of 17 strength and balance exercises and a walking program, 15 minutes walking before and after strength and balance exercises.
Perturbation based balance training: (PBT) is a form of reactive balance training aimed at improving reactive balance control after unexpected external perturbations. Time for perturbation- based balance training will be 60 minutes.
Main outcome variables
Reactive postural control and balance are main outcomes variables.
Assessment of reactive postural control: Mini-bestest scale will be used. Each items is scored based on ordinal scale scoring from 0- 3 where 3 representing best performances and 0 representing worst performances.
Assessment of balance: Berg balance scale will be used. Scores range from 0 to 4, with 0 indicating inability and 4 representing independent completion. The total score, out of 56, categorizes balance as impaired (0-20), acceptable (21-40), or good (41-56).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240503061639N1
Registration date:2024-05-13, 1403/02/24
Registration timing:registered_while_recruiting
Last update:2024-05-13, 1403/02/24
Update count:0
Registration date
2024-05-13, 1403/02/24
Registrant information
Name
Rida Zahid
Name of organization / entity
Riphah international university Lahore
Country
Pakistan
Phone
+92 325 0405631
Email address
ridazahid173@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-08, 1403/02/19
Expected recruitment end date
2024-06-10, 1403/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of modified otago exercise program(MOEP) and perturbation-based balance training(PBT)on reactive postural control and balance in patients with sub-acute stroke
Public title
Comparative effects of modified otago exercise program(MOEP) and perturbation-based balance training (PBT)on reactive postural control and balance in patients with sub-acute stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sub-acute stroke patients
Survivors of ischemic stroke
Subjects should have stable condition after the stoke incidence
Tolerance of balance and gait tasks without fatigue
Both genders can participate in the study
Age from 50 to 70yearsPatient who can follow written, verbal directions and demonstration
Exclusion criteria:
Patients with any other neurological conditions (Brain Injury, Multiple Sclerosis, Parkinson’s disease and Vestibular Disorders).
Subjects with diagnosed peripheral neuropathy
Patient with visual and vestibular impairment
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through simple random sampling using lottery method. this will be cluster randomization because we had large sample size for two intervention groups with 32 patients in each group. In lottery method , we will assigned a number to patient as 1,23...…64, after which we select a random numbers for each interventions groups, so first 32 selected patients will receive modified otago exercise program and next 32 will receive perturbation based balance training.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are blind in my study, because they are divided into two intervention groups without knowing it.
Placebo
Not 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
Raza street 25, Bhabra' block M, Gulberg 3, Lahore, Pakistan
City
Lahore
Postal code
54660
Approval date
2024-04-29, 1403/02/10
Ethics committee reference number
REC/RCR&AHS/23/02106
Health conditions studied
1
Description of health condition studied
Sub-acute Stroke
ICD-10 code
Z82.3 G46.
ICD-10 code description
Family history of stroke, Cerebellar stroke syndrome , Brain stem stroke syndrome, Cerebrovascular disease, unspecified, Sequelae of cerebrovascular disease, Sequelae of stroke, not specified as haemorrhage or infarction,
Primary outcomes
1
Description
Reactive postural control
Timepoint
Before intervention, after 4 weeks of intervention program and 8 weeks after completion of intervention program
Method of measurement
Mini- bestest scale will be used for assessment of reactive postural control.
Secondary outcomes
1
Description
Balance
Timepoint
on start of treatment, after 4 weeks of treatment and 8 weeks after completion of intervention program
Method of measurement
Berg balance scale will be used for the assessment of balance
Intervention groups
1
Description
Intervention no 1 will be modified otago exercise program and routine physical therapy treatment. Participants will engage in 20 minute of routine physical therapy which includes range of motion and isometric exercises and 60 minutes of moderate-intensity otago exercises. The modified otago exercises consists of 17 strength(with 10 repetitions, with and without support) and balance exercises and a walking program, 15 minutes walking before and after strength and balance exercises. Balance exercises will be knee bends, backwards walking with or without assistive device, walking and turning around with or without assistive device, sideways walking with or without assistive device, tandem stance (heel toe stand) with or without assistive device , tandem walk (heel toe walk) with or without assistive device , one leg stand with or without assistive device , heel walking with or without assistive device , toe walk with or without assistive device , heel toe walking backwards with or without assistive device, sit to stand with or without assistive device , stair walking with or without assistive device. Intervention program will be continued for 8 weeks, and 3 times a week. Assistive devices will be used like canes etc.
Category
Rehabilitation
2
Description
Intervention group 2 will be Perturbation based balance training and routine physical therapy treatment. Participants will engage in 20 minute of routine physical therapy which includes range of motion and isometric exercises and 60 minutes of perturbation based balance training which includes double-leg foam balance activity, tilt board training and roller board and platform perturbations. Devices used are knee cushion, foam, tilt board and platform. Intervention program will be continued for 8 weeks, and 3 times a week. Assistive devices will be used like canes etc.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
District headquarter hospital
Full name of responsible person
Kashif bajwa
Street address
Rajana road, near Sabzi mandi Toba Tek Singh, Pakistan
City
Toba Tek Singh
Postal code
36050
Phone
+92 46 2200083
Email
Dhqtts@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah international university
Full name of responsible person
Sana riaz
Street address
Raza Street 25, Bhabra' Block M Gulberg III, Lahore
City
Lahore
Postal code
54660
Phone
+92 300 0720825
Email
Sana.rcrs@riphah.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rida zahid
Proportion provided by this source
100
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 Lahore
Full name of responsible person
Rida Zahid
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Street no 5 New Islam Pura ,Toba Tek Singh,Pakistan
City
Toba Tek Singh
Province
Punjab
Postal code
36050
Phone
+92 325 0405631
Fax
Email
ridazahid173@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah international university Lahore
Full name of responsible person
Rida Zahid
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Street no 5 New Islam Pura ,Toba Tek Singh,Pakistan
City
Toba Tek Singh
Province
Punjab
Postal code
36050
Phone
+92 325 0405631
Fax
Email
ridazahid173@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah international university Lahore
Full name of responsible person
Rida Zahid
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Street no 5 New Islam Pura ,Toba Tek Singh,Pakistan
City
Toba Tek Singh
Province
Punjab
Postal code
36050
Phone
+92 325 0405631
Fax
Email
ridazahid173@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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