To find the effectiveness of facilitated electric stimulation of two alternating patterns
(abdominals cross hamstrings and lower back muscles cross quadriceps) on lower
extremity in stroke patients.
24 hemiplegic stroke patients 6 months post stroke aging between forty five to sixty
years old
Inclusion criteria
• All men and women
• Hemiplegic stroke patients
• Age between forty five to sixty years old
• Patient with static and dynamic sitting balance
• Patients with static standing balance
Exclusion criteria
• All patients had imaging tests to rule out their diagnosis for stroke during the
acute stage.
• People who frequently have strokes.
• Patients with peripheral or orthopedic neuropathy, substantial vision field
defects, or hemi neglect issues were not included.
• Poorly controlled epilepsy
• Pregnancy
• Heart pacemaker.
• Patients with malignant tumors
• Exposed metal
• Suspected, recognized, or uncontrolled cardiovascular conditions
• Neurological problems other than ischemic brain injury or hemorrhage that
can result in hemiplegic stroke.
Fracture
Intervention groups
Group A
Abdominals cross Hamstrings and additional exercises 3 days per week
with 30 minutes. Additional exercises will include lower limb joint mobilizations, stretching of lower extremity, and ROMS.
Group B
Lower back cross Quads and additional exercises 3 days per week with 30
minutes stimulation each session. Additional exercises will include ,lower limb joint mobilizations (including hips, knees, ankles and feet) stretching of lower extremity, and ROMS.
Main outcome variables
Pelvic tilt, Functional gait analysis, modified Ashworth scale, ranges of motion and cadence
General information
Reason for update
Acronym
Functional Gait Assessment (FGA) Modified Ashworth scale (MAS) Facilitated/functional electric stimulation (FES) Range of Motion (ROM) Anterior pelvic tilt (APT) Posterior pelvic tilt (PPT) Total pelvic tilt (TPT)
IRCT registration information
IRCT registration number:IRCT20230716058795N2
Registration date:2023-09-23, 1402/07/01
Registration timing:registered_while_recruiting
Last update:2023-09-23, 1402/07/01
Update count:0
Registration date
2023-09-23, 1402/07/01
Registrant information
Name
Moater Iftikhar
Name of organization / entity
The university of Faisalabad
Country
Pakistan
Phone
+92 301 6085203
Email address
moaterhassankazmi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-09, 1402/06/18
Expected recruitment end date
2023-11-09, 1402/08/18
Actual recruitment start date
2023-09-15, 1402/06/24
Actual recruitment end date
2023-11-15, 1402/08/24
Trial completion date
2023-11-30, 1402/09/09
Scientific title
COMPARING THE EFFECTIVENESS OF FACILITATED ELECTRIC STIMULATION OF TWO ALTERNATING PATTERNS ON LOWER EXTREMITY FUNCTION IN HEMIPLEGIC STROKE PATIENTS
Public title
Comparing the effectiveness of facilitated electric stimulation of two alternating patterns on lower extremity function in hemiplegic Stroke patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
• All men and women will be included in study.
• Hemiplegic stroke patients will be included in study
• Age between forty five to sixty years old will be included in study.
• Patient with static and dynamic sitting balance will be included.
• Patients with static standing balance will be included in this study.
Exclusion criteria:
All patients had imaging tests to rule out their diagnosis for stroke during the acute stage.• People who frequently have strokes.
Patients with peripheral or orthopedic neuropathy, substantial vision field defects, or hemi neglect issues were not included.
Hemiplegic stroke not due to a stroke but due to another neurological condition.• Poorly controlled epilepsy: When medicine is being used to treat epilepsy and there haven't been any seizures in a while
People who frequently have strokes
FES may be used.
Pregnancy: The effects of FES on the growing child during pregnancy are unknown.
Heart pacemakers: Any electrical activity could interfere with the electrical impulses that the pacemakers send out, rendering them inoperative.
Patients with malignant tumors should not be considered since the electrical stimulation's potential to increase local blood flow could promote the growth of the tumor.
Exposed metal: In patients with exposed orthopedic metalwork, electrical stimulation in the afflicted area should be avoided
Suspected, recognized, or uncontrolled cardiovascular conditions: The circulatory demand brought on by the FES-induced muscular contractions may necessitate taking extra precautions both before and during stimulation delivery.
Neurological problems other than ischemic brain injury or hemorrhage that can result in hemiplegic stroke.
If the muscles around a fracture that hasn't healed up contract, the fracture may get displaced.
People who have cerebellar, brain stem, or bilateral hemisphere lesions.
Age
From 45 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
24
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized through sealed envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and data analyzer
Placebo
Not used
Assignment
Parallel
Other design features
purposive sampling tecjnique
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The University of Faisalabad
Street address
University of Faisalabad, canal road campus, Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2023-02-03, 1401/11/14
Ethics committee reference number
TUF/Addl Reg/SB/387
Health conditions studied
1
Description of health condition studied
HEMIPLEGIC STROKE
ICD-10 code
I69.359
ICD-10 code description
Hemiplegia and hemiparesis following cerebral infarction affecting unspecified side
Primary outcomes
1
Description
Pelvic tilt
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Inclinometer
Secondary outcomes
1
Description
Cadence
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Carbon Foot Prints
2
Description
Range of motion of lower extremity
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Universal Goniometer
3
Description
Spasticity
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Modified Ashworth Scale
4
Description
Gait analysis
Timepoint
Before intervention and 8 weeks after intervention
Method of measurement
Functional Gait Analysis
Intervention groups
1
Description
Intervention group: Abdominals cross Hamstrings and additional conventional exercises 3 days per week with 30 minutes. Additional conventional exercises will include lower limb joint mobilizations(including hips, knees, ankles and feet), stretching of lower extremity, and ROMS. .
Category
Rehabilitation
2
Description
Intervention group: : Lower back cross Quads and additional conventional exercises 3 days per week with 30 minutes stimulation each session. Additional conventional exercises will include lower limb joint mobilizations (including hips, knees, ankles and feet), stretching of lower extremity, and ROMs
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied hospital Faisalabad
Full name of responsible person
Maria Hussain
Street address
Dr. Tusi Rd, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 9210082
Email
mariahussain@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Sahil hospital Faisalabad
Full name of responsible person
Moater Iftikhar
Street address
house # 43, university villas, Ismail road, faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 2409608
Email
moaterhassankazmi@gmail.com
Web page address
3
Recruitment center
Name of recruitment center
Aziz Fatima hospital Faisalabad
Full name of responsible person
Moater Iftikhar
Street address
house # 43, university villas, Ismail road, faisalabad
City
FAISALABAD
Postal code
38000
Phone
+92 41 2409608
Email
moaterhassankazmi@gmail.com
Web page address
4
Recruitment center
Name of recruitment center
Maqsooda Zia hospital Faisalabad
Full name of responsible person
Moater Iftikhar
Street address
house # 43, university villas, Ismail road, faisalabad
City
FAISALABAD
Postal code
38000
Phone
+92 41 2409608
Email
moaterhassankazmi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University Of Faisalabad | TUF University
Full name of responsible person
Moater Iftikhar
Street address
house # 43, university villas, Ismail road, faisalabad
City
FAISALABAD
Postal code
38000
Phone
+92 301 6085203
Email
moaterhassankazmi@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 Faisalabad | TUF University
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
The University Of Faisalabad | TUF University
Full name of responsible person
Marium Zafar
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
TUF University canal campus,Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2409608
Email
marium.zafar@tuf.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University Of Faisalabad | TUF University
Full name of responsible person
Marium Zafar
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
The University Of Faisalabad | TUF University canal campus Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 2409608
Email
marium.zafar@tuf.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University Of Faisalabad | TUF University
Full name of responsible person
Moater Iftikhar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
house # 43, university villas, Ismail road, faisalabad
City
FAISALABAD
Province
Punjab
Postal code
38000
Phone
+92 301 6085203
Email
moaterhassankazmi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
patient confidentiality
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
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
COMPARING THE EFFECTIVENESS OF FACILITATED ELECTRIC
STIMULATION OF TWO ALTERNATING PATTERNS ON LOWER
EXTREMITY FUNCTION IN HEMIPLEGIC STROKE PATIENTS
When the data will become available and for how long
starting from September 2023
To whom data/document is available
People working in Academics
Under which criteria data/document could be used
To the researchers with valid affiliation to any institute
From where data/document is obtainable
moaterhassankazmi@gmail.com
What processes are involved for a request to access data/document