Effects of Core Muscles Strengthening Exercises With Routine Physical Therapy on Trunk Balance and Functional Mobility in Stroke Patients: A Randomized Controlled Trial
To compare the effects of core muscles strengthening exercises with routine physical therapy on trunk balance and functional mobility in stroke patients.
Design
Single blinded, Randomized controlled trial
Settings and conduct
Mubarak Medical Complex
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1) Patients who has the first on set of ischemic stroke.2)Age between 40-60 years. 3) Medically stable, understand and follow simple verbal instructions. 4) Both male and female with chronic stroke (6 months post stroke). 5) MMSE > 24
Exclusion Criteria:
1) Patients who could not communicate (severe aphasia). 2) Participants having neglect of paretic limb
3) Participants with severe spasticity (modified ash worth scale score >3). 4)Patient having visual and sensory deficit. 5)If patient had a neurological disease affecting balance other than stroke, such as cerebellar disease, Parkinson’s disease or vestibule disease.
Intervention groups
All the participant who came to physiotherapy department was considered and screened for chronic phase of stroke.74 patients were allotted in two groups i.e.; group A(RPT) and group B(RPT+ Core strengthening exercises) via lottery method, 37 in each group. Consider the inclusion and exclusion criteria before concerning them in study. Both groups will receive the routine physical therapy. Patient in A group will be treated by routine physical therapy and in B group with routine physical therapy plus core strengthening exercises. Dosage:- 30 minutes RPT in both groups and core strengthening exercises with 7-10 repetitions for 15-20 minutes with adequate rest interval in experimental group. Duration: - Four sessions/week (alternative days) and treatment last for 8 weeks.
Main outcome variables
1: Trunk Balance
2: Functional Mobility
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211116053070N1
Registration date:2021-12-20, 1400/09/29
Registration timing:registered_while_recruiting
Last update:2021-12-20, 1400/09/29
Update count:0
Registration date
2021-12-20, 1400/09/29
Registrant information
Name
Iqra Nadeem
Name of organization / entity
University of Sargodha
Country
Pakistan
Phone
+92 48 3219551
Email address
iqra.nadeem@uos.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-28, 1400/08/06
Expected recruitment end date
2022-04-28, 1401/02/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Core Muscles Strengthening Exercises With Routine Physical Therapy on Trunk Balance and Functional Mobility in Stroke Patients: A Randomized Controlled Trial
Public title
Effects of Core Muscles Strengthening Exercises With Routine Physical Therapy on Trunk Balance and Functional Mobility in Stroke Patients: A Randomized Controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who has the first on set of ischemic stroke
Age between 40-60 years.
Medically stable, understand and follow simple verbal instructions
Both male and female with chronic stroke (6 months post stroke).
MMSE > 24
Exclusion criteria:
Patients who could not communicate (severe aphasia).
Participants having neglect of paretic limb
Participants with severe spasticity (modified ash worth scale score >3)
Patient having visual and sensory deficit
If patient had a neurological disease affecting balance other than stroke, such as cerebellar disease, Parkinson’s disease or vestibular disease
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
A total no. of 74 participants suffering from stroke fulfilling the inclusion criteria will be recruited to volunteer in this randomized controlled study.Subjects will be randomized into two groups using lottery method.
Blinding (investigator's opinion)
Single blinded
Blinding description
it will be a single blinded study in which participant/ patients are kept blind for treatment techniques and patients are blind about which group they belong either intervention or control group.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Lahore
Street address
House no.85, Umer block Sargodha homes main Fsd road near 49 tail Sargodha
Intervention group: Routine physical therapy + core muscle strengthening exercises for 15-20 minutes (4 sessions per week) for 8 weeks
Category
Rehabilitation
2
Description
Control group: group A : Routine physical therapy for 30 minutes (4 sessions per week) for 8 weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mubarak medical complex, Sargodha
Full name of responsible person
Iqra Nadeem
Street address
House no. 85, Umer block Sargodha homes Sargodha
City
Sargodha
Postal code
40100
Phone
+92 48 9230783
Fax
Email
iqranadeem79@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore, Lahore
Full name of responsible person
Dr sara khawar Butt
Street address
Defense Road Campus University College of Medicine & Dentistry: 1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road, Lahore
City
Sargodha
Postal code
54792
Phone
+92 42 32300865
Email
sara.khawar@uipt.uol.edu.pk
Grant name
iqra nadeem
Grant code / Reference number
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
Mubarak medical complex, Sargodha
Full name of responsible person
Iqra Nadeem
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house no. 85, Umer block Sargodha homes main fsd road near 49 tail Sargodha
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 324 6461428
Email
iqra.nadeem@uos.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore, Lahore
Full name of responsible person
Dr. Sarah khawar Butt
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Physiotherapy
Street address
Defense Road Campus University College of Medicine & Dentistry: 1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road, Lahore
City
Lahore
Province
Punjab
Postal code
54792
Phone
+92 42 35963424
Email
sara.khawar@uipt.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore, Lahore
Full name of responsible person
Iqra Nadeem
Position
physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House # 85, umer block sargodha homes main Faisalabad 49 road tail sargodha
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 48 9230783
Email
iqra.nadeem@uos.edu.pk
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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
EFFECTS OF CORE MUSCLES STRENGTHENING EXERCISES WITH ROUTINE PHYSICAL THERAPY ON TRUNK BALANCE AND FUNCTIONAL MOBILITY IN STROKE PATIENTS: A RANDOMIZED CONTROLLED TRIAL
When the data will become available and for how long
Study is completed after 6 months and become available after its publication
To whom data/document is available
person in academic institute. Patient data will not be shown
Under which criteria data/document could be used
under the usage with terms in which journal is accessed /processed for publication it could be used in request
From where data/document is obtainable
+923246461428 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
can be on call or mail It will be only used in confidential way for improving research and benefit of humanity