Comparing the effectiveness of facilitated electric stimulation on two alternating patterns on lower extremity pelvic tilts in hemiplegic stroke patients
To find the effectiveness of facilitated electric stimulation of two alternating patterns
(abdominals cross hamstrings and lower back muscles cross quadriceps) on lower
extremity pelvic tilts in stroke patients.
Design
community based, parallel group, double blind, randomized controlled trial
Inclusion criteria
• All men and women will be included in study.
• Hemiplegic stroke patients will be included in study.
32
• 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.
• People who have cerebellar, brain stem, or bilateral hemisphere lesions.
• People who suffer from severe spasticity or cognitive impairment.
• Patients with peripheral or orthopaedic neuropathy, substantial vision field
defects, or hemi neglect issues were not included.
Intervention groups
both groups are interventional. Group A
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.
Group B
Lower back cross Quads and additional conventional exercises 3 days per week with 30
minutes stimulation each session.
Main outcome variables
Functional gait analysis
Modified Ashworth scale
Ranges of motion
Pelvic tilts
Carbon foot prints to measure cadence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230716058795N1
Registration date:2023-09-17, 1402/06/26
Registration timing:retrospective
Last update:2023-09-17, 1402/06/26
Update count:0
Registration date
2023-09-17, 1402/06/26
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
2023-04-01, 1402/01/12
Expected recruitment end date
2023-06-30, 1402/04/09
Actual recruitment start date
2023-04-01, 1402/01/12
Actual recruitment end date
2023-06-30, 1402/04/09
Trial completion date
2023-07-06, 1402/04/15
Scientific title
Comparing the effectiveness of facilitated electric stimulation on two alternating patterns on lower extremity pelvic tilts in hemiplegic stroke patients
Public title
Comparing the effectiveness of facilitated electric stimulation on two alternating patterns on lower extremity pelvic tilts 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 45 to60 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.
Patients with peripheral or orthopaedic neuropathy, substantial vision field defects, or hemi neglect issues were not included.
Exclusion criteria:
All patients had imaging tests, such as brain computed tomography (CT) or magnetic resonance imaging (MRI), to determine their diagnosis for stroke during the acute stage.
People who frequently have strokes.
People who have cerebellar, brain stem, or bilateral hemisphere lesions.
People who suffer from severe spasticity or cognitive impairment.
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
Tools used in randomization is sealed envelops. Group A and Group B allocation is done by picking the sealed envelope by the patients randomly. Each envelope contained either group A designation or group B designation. So the patients were allocated accordingly in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
participant and data analyzer
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The University of Faisalabad
Street address
house # 43, university villas, Ismail road, 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
I69.959
ICD-10 code description
Hemiplegia and hemiparesis, unspecified cerebrovascular disease affecting unspecified side
Primary outcomes
1
Description
Pelvic tilt
Timepoint
before intervention and eight weeks after intervention
Method of measurement
inclinometer
Secondary outcomes
empty
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
Dr. Maria
Street address
Allied hospital, Jail road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9210082
Email
mariahussain@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Maqsooda zia hospital, Faisalabad
Full name of responsible person
Kinza Idrees
Street address
Main Sargodha Rd, near Allied hospital, opposite Crescent Textile Mills،, Afshan Colony, Faisalabad, Punjab