Protocol summary

Study aim
The comparative effects of progressive resistance exercise and task-specific training in Ischemic stroke patients.
Design
Randomized control trial with participants divided into two group progressive resistance exercises and task specific training with 52 sample size.
Settings and conduct
Trial is conducted in the University of Lahore Teaching Hospital with assesser is blinded and physiotherapist is not blinded
Participants/Inclusion and exclusion criteria
Inclusion Criteria: • Both male and female • Age between 40 and 70 years • First event of ischemic stroke • A Mini- Mental Status Examination score more than and equal to 24 • No facial palsy and receptive aphasia • No prior thoracic or abdominal surgery • Subjects able to sit for 30 secs without using upper extremities for support • Stable patients Exclusion Criteria: • Other disorders such as blindness, deafness, amputation of lower or upper limb, cerebellar stroke • Impaired cognition or other severe medical condition • Patients with abdominal aortic aneurysms; unstable chronic disease; life-incapacitating cardiac disease, severe balance impairment; psychiatric illness. • Musculoskeletal problems in the pelvis or spine • Sensory involvement
Intervention groups
Both groups will receive interventions for 12 weeks, 2 times/week with routine physical therapy for 20 mins before every session. The first intervention group received Progressive Resistance Training for 12 weeks with increased repetitions after every two weeks. The second intervention group received Task Specific Training for 12 weeks with different task after every two weeks
Main outcome variables
Reflex activity, Volitional Movement Within Synergies, Volitional Movement Mixing Synergies, Volitional Movement With little or no Synergies, Normal Reflex Activity, Coordination/speed, Sensation, Passive joint motion, Joint Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240609062063N1
Registration date: 2024-10-29, 1403/08/08
Registration timing: retrospective

Last update: 2024-10-29, 1403/08/08
Update count: 0
Registration date
2024-10-29, 1403/08/08
Registrant information
Name
Wajheeha Khan
Name of organization / entity
The University Of Lahore
Country
Pakistan
Phone
+92 335 6166147
Email address
wajheehakhan23@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-12, 1402/09/21
Expected recruitment end date
2024-07-10, 1403/04/20
Actual recruitment start date
2024-01-10, 1402/10/20
Actual recruitment end date
2024-09-16, 1403/06/26
Trial completion date
empty
Scientific title
Effects of Progressive Resistance Training versus Task-specific Training for lower extremity function for Ischemic stroke patients
Public title
Effects of Progressive Resistance Training versus Task-specific Training for lower extremity function for Ischemic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female Age between 40 and 70 years First event of ischemic stroke A Mini- Mental Status Examination score more than and equal to 24 No facial palsy and receptive aphasia No prior thoracic or abdominal surgery Subjects able to sit for 30 secs without using upper extremities for support Stable patients
Exclusion criteria:
Other disorders such as blindness, deafness, amputation of lower or upper limb, cerebellar stroke Not able to cooperate in FMA testing due to impaired cognition or other severe medical condition Patients with abdominal aortic aneurysms; unstable chronic disease; life-incapacitating cardiac disease, severe balance impairment; psychiatric illness. Musculoskeletal problems in the pelvis or spine Sensory involvement
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 62
Actual sample size reached: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Coin Toss method
Blinding (investigator's opinion)
Single blinded
Blinding description
All the participants will be blinded to reduce biases in the study. Because of the nature of the intervention, there will be no blinding of the physical therapist following randomization
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee Faculty of Allied Health Sciences The university of Lahore
Street address
Multan Cantt
City
Multan
Postal code
60000
Approval date
2023-12-12, 1402/09/21
Ethics committee reference number
REC-UOL-650-01-2024

Health conditions studied

1

Description of health condition studied
Ischemic Stroke
ICD-10 code
G81.0
ICD-10 code description
Flaccid hemiplegia

Primary outcomes

1

Description
Lower Extremity Function, coordination, sensations, joint pain, passive joint motion
Timepoint
Before Intervention, 6th week after intervention, 12th week after intervention
Method of measurement
Fugel Myer Assessment Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Progressive Resistance Training for 12 weeks with increased repetitions after every two weeks
Category
Rehabilitation

2

Description
Intervention group: Task Specific Training for 12 weeks with different task after every two weeks
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
The University of Lahore Teaching Hospital
Full name of responsible person
Dr Wardah
Street address
Multan Cantt
City
Multan
Postal code
60000
Phone
+92 313 6166047
Email
wajheehakhan23@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr Samia
Street address
Multan Cantt
City
Multan
Postal code
60000
Phone
+92 313 6166047
Email
wajheehakhan23@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
40
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
The University of Lahore
Full name of responsible person
Dr Asim Arif
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Multan Cantt
City
Multan
Province
Punjab
Postal code
60000
Phone
+92 333 6124371
Email
wajheehakhan23@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr Asim Arif
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Multan Cantt
City
Multan
Province
punjab
Postal code
60000
Phone
+92 333 6124371
Email
wajheehakhan23@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Dr Warda
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Neurology
Street address
Multan Cantt
City
Multan
Province
Punjab
Postal code
60000
Phone
+92 313 6166047
Email
wajheehakhan23@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
Undecided - It is not yet known if there will be 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 Progressive Resistance Training versus Task-specific Training for lower extremity function for Ischemic stroke patients
When the data will become available and for how long
starting in January 2024
To whom data/document is available
This only available for people working in academic institutions or people working in businesses can also apply to receive it.
Under which criteria data/document could be used
For information purposes
From where data/document is obtainable
Wajheehakhan23@gmail.com
What processes are involved for a request to access data/document
Request for access to data and also mention the purpose for which the data is required by the applicant.
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