Protocol summary

Study aim
To compare the effects of modified Otago exercises and Vestibular rehabilitation therapy on balance, postural stability, and risk of fall in sub-acute stroke.
Design
Randomized Clinical Trial, a single blinded study, sample size 42, computer generated randomization
Settings and conduct
Data is being collected from General Hospital, Lahore.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosed cases of ischemic stroke. Age between 40-70 years Both males and females. Stroke with unilateral hemiplegia in less than 6 months. Participants are able to walk 10 meters with or without assistive device. Participants should be able to understand and follow simple verbal instructions, Mini-Mental Status Examination (MMSE ≥24). Exclusion criteria: Participants with spasticity (modified Ashworth scale grade ≥3) or flaccidity in lower limbs and upper limbs. Individuals suffering from unstable angina, symptomatic heart failure or uncontrolled hypertension. Balance or gait impairments prior to the stroke. Visual field defects Severe unilateral spatial neglect. Neurological and orthopedic comorbidities like significant osteoarthritis, particularly in the lower limbs.
Intervention groups
Group A will be treated by Vestibular Rehabilitation Therapy (25 minutes) and Conventional physical therapy (30 minutes). Group B will be treated by Modified Otago Exercises (25 minutes) and Conventional physical therapy (30 minutes).
Main outcome variables
Balance, postural stability and risk of fall.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240503061638N1
Registration date: 2024-05-09, 1403/02/20
Registration timing: registered_while_recruiting

Last update: 2024-05-09, 1403/02/20
Update count: 0
Registration date
2024-05-09, 1403/02/20
Registrant information
Name
Aaminah Nawaz
Name of organization / entity
Riphah International University Lahore
Country
Pakistan
Phone
+92 332 4080727
Email address
aaminahnawaz7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-08-15, 1403/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effectiveness of modified otago exercises and vestibular rehabilitation therapy on balance, postural stability, and risk of fall in sub-acute stroke.
Public title
Comparative effects of modified otago exercises and vestibular rehabilitation therapy on balance, postural stability, and risk of fall in sub-acute stroke.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed cases of ischemic stroke. Age between 40-70 years Both males and females. Stroke with unilateral hemiplegia in less than 6 months. Participants are able to walk 10m with or without assistive device. Participants should be able to understand and follow simple verbal instructions, Mini-Mental Status Examination (MMSE ≥24).
Exclusion criteria:
Participants with spasticity (modified Ashworth scale grade ≥3) or flaccidity in lower limbs and upper limbs. Individuals suffering from unstable angina, symptomatic heart failure or uncontrolled hypertension. Balance or gait impairments prior to the stroke. Visual field defects Severe unilateral spatial neglect. Neurological and orthopedic comorbidities like significant osteoarthritis, particularly in the lower limbs.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
After baseline assessment, eligible subjects will be randomly allocated into two groups, Group A and Group B through computerized table generator method of randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessors involved in outcome assessment will be blinded to the treatment, ensuring an unbiased evaluation of the measured outcomes.
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
25 Raza Saeed Rd, Bhabra Block M gulberg 3, Lahore, Pakistan
City
Lahore
Postal code
54660
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
F22C14G37037

Health conditions studied

1

Description of health condition studied
Sub-acute Stroke
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
First outcome variable is balance.
Timepoint
Variable will be assessed after 6 weeks of time, including 5 sessions per week.
Method of measurement
Balance will be assessed by using the Berg Balance Scale (BBS).

2

Description
The second outcome variable is postural stability.
Timepoint
Variable will be assessed after 6 weeks of time, including 5 sessions per week.
Method of measurement
Postural stability will be assessed using the Functional Reach Test.

3

Description
Third outcome variable is risk of fall.
Timepoint
Variable will be assessed after 6 weeks of time, including 5 sessions per week.
Method of measurement
The risk of fall will be assessed using the Falls Efficacy Scale-International (FES-I).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group 1: This group will receive a modified otago exercise intervention along with conventional physical therapy.
Category
Rehabilitation

2

Description
Intervention group 2: This group will receive a vestibular rehabilitation therapy intervention along with conventional physical therapy.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
General Hospital, Lahore
Full name of responsible person
Dr Umul Baneen
Street address
Street no 3 house no 9 Jahangir tomb, Shahdara, Lahore, Pakistan
City
Lahore
Postal code
54940
Phone
+92 332 4080727
Email
aaminahnawaz7@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Dr Sana Riaz
Street address
Shalimar Lahore
City
Lahore
Postal code
32579
Phone
+92 347 4716107
Email
sana.rcrs@riphah.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University Lahore
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
Dr Sana Riaz
Position
Assosiate professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Shalimar Lahore
City
Lahore
Province
Punjab
Postal code
32579
Phone
+92 347 4716107
Email
sana.rcrs@riphah.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Dr Sana Riaz
Position
Assosiate professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Shalimar Lahore
City
Lahore
Province
Punjab
Postal code
32579
Phone
+92 347 4716107
Email
sana.rcrs@riphah.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Dr Sana Riaz
Position
Assosiate professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Shalimar Lahore
City
Lahore
Province
Punjab
Postal code
32579
Phone
+92 347 4716107
Email
sana.rcrs@riphah.edu.pk

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
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