Effectiveness of routine physical therapy with and without equal weight bearing sit-to-stand exercise program on balance and functional independence in stroke patients
To determine the effectiveness of routine physical therapy with and without equal weight bearing exercise program on balance and functional outcome in stroke patients.
Design
randomized clinical trial, parallel groups, no blinding
Settings and conduct
The participants were allocated from Omer medical centre, Yaseen medical centre, UOL teaching hospital Lahore. The participant was asked to pick a sealed envelop and then according to the number in envelop the group was allocated. There was no blinding done.
Participants/Inclusion and exclusion criteria
Clinically diagnosed sub-acute stroke patients aged between 40-60 years by neurologist and able to understand command were included.
where as the patients with any Musculoskeletal Disorder, Disability or other comorbid disease, any Previous history of neurological disease, or enrolled in another experimental study were excluded.
Intervention groups
Control group: received the 3 sessions per week for 2 months of routine physical therapy treatment that includes electrical stimulation, Muscles Stretching, Strengthening and range of Motion Exercises for 45-60 minutes. In a session, electrical stimulation and Hot pack was given for 15 minutes. Static stretching of affected muscles was performed according to the participant requirement. The muscle strengthening included loading of affected leg with unaffected leg placed on a wooden block, stepping up exercise with the affected leg, stepping down with the affected leg, heels lift. Fifteen repetitions of each exercise was given with a resting period of 1minute between exercises.
Intervention group: received 3 sessions per week for 2 months of routine physical therapy with equal weight bearing sit-to-stand exercise for 45-60 minutes. In one session, routine physiotherapy was given with equal weight bearing sit-to-stand exercise (20 repetitions).
Main outcome variables
Balance,
Functional independence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200225046616N2
Registration date:2020-10-15, 1399/07/24
Registration timing:retrospective
Last update:2020-10-15, 1399/07/24
Update count:0
Registration date
2020-10-15, 1399/07/24
Registrant information
Name
Fariha Khalid
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 42 35220878
Email address
fariha.khalid@dhpt.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-01, 1398/08/10
Expected recruitment end date
2020-05-01, 1399/02/12
Actual recruitment start date
2019-11-23, 1398/09/02
Actual recruitment end date
2020-06-03, 1399/03/14
Trial completion date
2020-07-29, 1399/05/08
Scientific title
Effectiveness of routine physical therapy with and without equal weight bearing sit-to-stand exercise program on balance and functional independence in stroke patients
Public title
Equal weight bearing sit-to-stand exercise in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinically diagnosed stroke patients by neurologist
Sub-acute stage (between 2 weeks to 6 months after onset)
Both males and females aged 40-60 years
Both hemorrhagic or ischemic types
Able to understand command and have the capacity to provide informed consent
Exclusion criteria:
Musculoskeletal Disorder i.e. Substantial loss of joint range due to arthritis etc
Unstable Angina
Participation in other interventional or pharmacological studies which can affect the results of this study
Disability or other comorbid disease such as cancer or amputation that will limit or prevent assessment of the patients
Previous history of neurological disease other than stroke
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
28 participant were allocated in control or experimental group by simple randomization method at individual level. A random sequence for patients allocation was generated on computer using commentpicker.com. Each number was kept in a sealed envelope. For each patient a sealed envelope was opened and according to mentioned number, group was allocated. No allocation concealment was carried out.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
No
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic's committee of University of Lahore
Street address
1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road
City
Lahore
Postal code
54590
Approval date
2019-10-30, 1398/08/08
Ethics committee reference number
472
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
I63.50
ICD-10 code description
Cerebral infarction due to unspecified occlusion or stenosis of unspecified cerebral artery
Primary outcomes
1
Description
Balance
Timepoint
Before intervention, 4th week of intervention, 8th week of intervention
Method of measurement
Berg balance scale
2
Description
functional independence
Timepoint
Before intervention, 4th week of intervention, 8th week of intervention
Method of measurement
Functional independence measure scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: 3 sessions per week for 2 months of routine physical therapy treatment that includes electrical stimulation, Muscles Stretching, Strengthening and range of Motion Exercises for 45-60 minutes. In one session, electrical stimulation and Hot pack was given for 15 minutes. Static stretching of affected muscles was performed according to the participant requirement. The muscle strengthening exercises included loading of affected leg with unaffected leg placed on a wooden block, stepping up exercise with the affected leg (stepping up a wooden block with the affected leg), stepping down with the affected leg, heels lift. Fifteen repetitions of each exercise was given with a resting period of 1 minute between exercises.
Category
Rehabilitation
2
Description
Intervention group: 3 sessions per week for 2 months of routine physical therapy with equal weight bearing sit-to-stand exercise for 45-60 minutes. In one session, routine physiotherapy mentioned above was given with equal weight bearing Sit-to-stand exercise (20 rep). In Sit-to-stand exercise affected foot positioned alongside the unaffected foot rising with chair arm-rest assistance.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
UOL Teaching Hospital
Full name of responsible person
Dr Muhammad hussain Iqbal
Street address
1 - KM Defence Road, Lahore.
City
Lahore
Postal code
54590
Phone
+92 42 99200600
Email
hussainiqbal94@gmail.com
2
Recruitment center
Name of recruitment center
Omer medical centre
Full name of responsible person
Dr Fariha Khalid
Street address
JOHAR TOWN 42 A/III , College Road, near AL JANNAT MARRIAGE HALL, Lahore, Pakistan
City
Lahore
Postal code
54600
Phone
+92 42 35174737
Email
farihakhalid93@gmail.com
3
Recruitment center
Name of recruitment center
Yaseen Medical Centre
Full name of responsible person
Dr Fariha Khalid
Street address
246 Allama Iqbal road dharampura
City
Lahore
Postal code
39571
Phone
+92 42 35880878
Email
farihakhalid93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The university of Lahore
Full name of responsible person
Dr Ashfaq Ahmad
Street address
1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road, Lahore, Pakistan
City
Lahore
Postal code
54590
Phone
+92 42 99200600
Email
Farihakhalid93@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of Lahore
Proportion provided by this source
100
Public or private sector
Public
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
University of Lahore
Full name of responsible person
Dr Fariha khalid
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road, Lahore.
City
Lahore
Province
Punjab
Postal code
54590
Phone
+92 42 99200600
Email
farihakhalid93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Dr Fariha khalid
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
University of Lahore, Main Campus, Lahore
City
Lahore
Province
Punjab
Postal code
54590
Phone
+92 42 99200600
Email
farihakhalid93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Dr Fariha khalid
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
University of Lahore, Main Campus, Lahore
City
Lahore
Province
Punjab
Postal code
54590
Phone
+92 42 99200600
Email
farihakhalid93@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
Data will be available to other people after the completion of study and remained available till 3
months
To whom data/document is available
Data will be available to people working in academic institutions