The effect of neuromuscular training of gastrocnemius and Gluteus maximus compared to quadriceps muscles by biofeedback method on pain, function and changes in electromyography findings in subjects with knee osteoarthritis, during gait: A randomized single blind clinical trial intervention
Comparing the increase in activity in the stance phase of walking in the direction of biomechanics and pattern changes (gluteus maximus and gastrocnemius) in comparison with the increase in activities against the changed pattern (quadriceps) and bringing people with KOA closer to healthy people on the symptoms and Electromyography findings of subjects with moderate KOA before, after the first session, after the end of the session and three months later
Design
Both groups: ten sessions of routine rehabilitation
One group received neuromuscular training of the gastrocnemius and gluteus maximus by biofeedback method during walking at desired speed and the second group received neuromuscular training of the quadriceps by biofeedback method during walking at desired speed in addition to routine treatment for ten sessions.
Settings and conduct
All pre- and post-assessment stages, including EMG tests, pain and function tests, will be performed in the biomechanics laboratory and treatment sessions will be performed in the physiotherapy clinic of the rehabilitation faculty of Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
unilateral and moderate osteoarthritis of the knee (40 to 75 years) with VAS >3 in the last month and the ability to walk for 15 to 30 minutes
without a history of previous knee and hip surgery; hip and ankle arthrosis; Arthritis of the joints and a history of joint injection; steroid use and physiotherapy in the last six months; and BMI > 35 Kg/m2
Intervention groups
-Routine treatment: including TENS, Pulsed US, stretching exercises and joint and soft tissue mobilization
-Neuromuscular training of gastrocnemius and gluteus maximus / & Quadriceps neuromuscular training by biofeedback method during walking task at desired speed
Main outcome variables
Pain; Function; EMG findings
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231024059846N1
Registration date:2023-11-30, 1402/09/09
Registration timing:prospective
Last update:2023-11-30, 1402/09/09
Update count:0
Registration date
2023-11-30, 1402/09/09
Registrant information
Name
Soheila Ganjeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 093 0449
Email address
s.ganjeh100@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-21, 1402/09/30
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neuromuscular training of gastrocnemius and Gluteus maximus compared to quadriceps muscles by biofeedback method on pain, function and changes in electromyography findings in subjects with knee osteoarthritis, during gait: A randomized single blind clinical trial intervention
Public title
Physiotherapy and exercise therapy by biofeedback method in people with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with moderate knee osteoarthritis in the age range of 40 to 75 years
With pain number more than 3 on the VAS scale
have unilateral KOA (in bilateral cases, the side where the pain and symptoms predominate is considered the studied side
The subjects have experienced pain in most of the days of the last month
Have the ability to walk normally for 15 to 30 minutes.
Exclusion criteria:
Have a previous history of hip or knee joint replacement.
have hip or ankle osteoarthritis at the same time.
have rheumatoid arthritis of the joints at the same time.
Have a BMI > 35 Kg/m2
In the past six months, she/he has received treatments such as oral or injectable corticosteroids, any knee surgery such as osteotomy, conservative treatments such as physical therapy, manual therapy, acupuncture, and exercise therapy.
Any neuromuscular-skeletal disease that made walking "difficult" for the patient
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
A simple non-random sampling method is available and the sample allocation in the groups will be random
The grouping is also done by a random method of sequential type and one by one in chronological order of the referring people
(Patients from among the people referred to the orthopedic clinic of Akhtar Hospital (non-randomized) who have grade 3 knee arthritis and then are randomly assigned to treatment group 1 or 2 (randomization)
Blinding (investigator's opinion)
Single blinded
Blinding description
The therapist and the data evaluator are two different people and the evaluator has no information about the group therapy of the patients
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
ندارد
Approval date
2023-10-22, 1402/07/30
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.375
Health conditions studied
1
Description of health condition studied
moderate knee osteoarthritis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
VAS: Before and after the first session, after the tenth session, after three months/ KOOS: Before first session, after the tenth session, after three months
Method of measurement
visual analog scale- KOOS
2
Description
Function
Timepoint
KOOS: Before the first session, after the tenth session, after three months/ 10 M Fast walking: Before and after the first session, after the tenth session, after three months
Method of measurement
KOOS, 10 M Fast walking
3
Description
Amplitude of muscle action
Timepoint
Before and after the first session, after the tenth session, after three months
Method of measurement
Surface electromyography and force plate
4
Description
Muscle contraction duration
Timepoint
Before and after the first session, after the tenth session, after three months
Method of measurement
Surface electromyography and force plate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Neuromuscular training by biofeedback method for the quadriceps muscle during walking In addition to routine physiotherapy treatment
Category
Rehabilitation
2
Description
Intervention group: Neuromuscular training by biofeedback method for gastrocnemius and gluteus maximus muscles during walking In addition to routine physiotherapy treatment
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Akhtar Orthopedic Specialist Hospital
Full name of responsible person
Dr Hamidreza Aslani
Street address
Elahieh
City
Tehran
Province
Tehran
Postal code
ندارد
Phone
+98 21 2260 8246
Email
hraslani@yahoo.com
Web page address
https://amc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Research Organization of Shahid Beheshti University of Medical Sciences
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
ندارد
Phone
+98 21 2243 9788
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soheila Ganjeh
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Tajrish
City
Tehran
Province
Tehran
Postal code
ندارد
Phone
+98 913 093 0449
Email
s.ganjeh100@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soheila Ganjeh
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Tajrish
City
Tehran
Province
Tehran
Postal code
ندارد
Phone
+98 913 093 0449
Email
s.ganjeh100@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
soheila Ganjeh
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Tajrish
City
Tehran
Province
Tehran
Postal code
ندارد
Phone
+98 913 093 0449
Email
s.ganjeh100@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available