The purpose of this study is find the comparison of effects of ankle position on isometric quadriceps strengthening in osteoarthritis of knee joint
Design
Randomized control trial
Settings and conduct
Shaikh Zayed Hospital lahore
Participants/Inclusion and exclusion criteria
Inclusion Criteria
o X-ray findings of primary osteoarthritis patients with grade ≥ 2 according to Kellgren Lawrence scale
o Male and female both were included
o Age from 40-60 years old patients were included
o Unilateral and bilateral involvement, in case of bilateral involvement more symptomatic knee was included; pain in and around the knee
Exclusion Criteria
Participants were excluded if they exhibited.
o less ankle ROM
o History with any injury either soft tissue or bony
o Pain radiating into leg in patients with lowback pain
o Any neurological signs
o History with NSAID past three months
o Any inflammatory disease such as Gout
o History with RA, ankylosing spondylitis,
o History with metal implants, noncooperative patient, patient with mental disorders,
o Patients with BMI ≥40 kg/m2 (morbid obesity)
Intervention groups
Group 1 will perform quadriceps exercise with ankle in planterflexion position + shortwave diathermy , Group 2 will perform quadriceps exercise with ankle in dorsiflexion position + shortwave diathermy and Group 3 will perform quadriceps exercise with ankle in neutral position + shortwave diathermy.
Main outcome variables
pain , strength and functional activity
General information
Reason for update
Acronym
COEOAPOIQSIOOKJ
IRCT registration information
IRCT registration number:IRCT20190715044216N5
Registration date:2022-01-09, 1400/10/19
Registration timing:registered_while_recruiting
Last update:2022-01-09, 1400/10/19
Update count:0
Registration date
2022-01-09, 1400/10/19
Registrant information
Name
Naveed Anwar
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
naveedanwar982@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-01, 1400/10/11
Expected recruitment end date
2022-06-30, 1401/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of ankle position on isometric quadriceps strengthening in osteoarthritis of knee joint
Public title
Comparison of effects of ankle position on isometric quadriceps strengthening in osteoarthritis of knee joint
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
X-ray findings of primary osteoarthritis patients with grade ≥ 2 according to Kellgren Lawrence scale
Male and female both were included
Age from 40-60 years old patients were included
Unilateral and bilateral involvement, in case of bilateral involvement more symptomatic knee was included; pain in and around the knee
Exclusion criteria:
less ankle ROM
History with any injury either soft tissue or bony
Pain radiating into leg in patients with low back pain
Any neurological signs
History with NSAID past three months
Any inflammatory disease such as Gout
History with RA, ankylosing spondylitis
History with metal implants, noncooperative patient, patient with mental disorders
Patients with BMI ≥40 kg/m2 (morbid obesity)
Age
From 40 years old to 60 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
36
More than 1 sample in each individual
Number of samples in each individual:
12
group 1=planterflex position, group 2=dorsiflex position, group=3 neutral position
Randomization (investigator's opinion)
Randomized
Randomization description
Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited in the study through convenient sampling technique and then will be randomly assigned to each group according to consort guideline 2010. Written informed consent will be taken. After enrollment into study, patient will be allocated either to Group 1 , Group 2 and Group 3 by lottery method. No. of Chits will be equal to total sample size. Each patients will be requested to draw a chit from the box and after that patient will be recruited into either Group 1 or Group 2 and 3
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah international research and ethics committe
Street address
28M Quid e azam industrial estate kot lakhpat lahore
City
Lahore
Postal code
57400
Approval date
2021-06-07, 1400/03/17
Ethics committee reference number
REC/REC&AHS/21/0107
Health conditions studied
1
Description of health condition studied
knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
pain, strength
Timepoint
4 weeks after intervention
Method of measurement
NPRS scale,MMT and WOMAC scale
Secondary outcomes
1
Description
pain, strength and functional activity level will be measure in planterflexion group
Timepoint
Pre-readings than post-readings after 4 weeks . 4 treatment sessions in a week will be given to the subjects
Method of measurement
WOMAC scale, NPRS, MMT
2
Description
pain, strength and functional activity level will be measure in Dorsiflexion group
Timepoint
Pre-readings than post-readings after 4 weeks . 4 treatment sessions in a week will be given to the subjects
Method of measurement
WOMAC, NPRS, MMT
3
Description
pain, strength and functional activity level will be measure in neutral ankle position group
Timepoint
Pre-readings than post-readings after 4 weeks . 4 treatment sessions in a week will be given to the subjects
Method of measurement
WOMAC, NPRS , MMT
Intervention groups
1
Description
Intervention group 1:will perform quadriceps exercise with ankle in planter flexion position in supine lying + shortwave diathermy for 20 minutes and A foam roller will be place under the knee and advice the patient to extend their knee by pushing the back of knee into plinth without using hip extension while keep your ankle in planter flexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of quadriceps exercise perform once at the hospital and once at home for the 4 days/4-week time for testing.
Category
Rehabilitation
2
Description
Intervention group 2: will perform quadriceps exercise with ankle in dorsiflexion position in supine lying + shortwave diathermy for 20 minutes and A foam roller will be place under the knee and advice the patient to extend their knee by pushing the back of knee into plinth without using hip extension while keep your ankle in planter flexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of quadriceps exercise perform once at the hospital and once at home for the 4 days/4-week time for testing.
Category
Rehabilitation
3
Description
Intervention group 3: will perform quadriceps exercise with ankle in neutral ankle position in supine lying + shortwave diathermy for 20 minutes and A foam roller will be place under the knee and advice the patient to extend their knee by pushing the back of knee into plinth without using hip extension while keep your ankle in planter flexion during exercise.The hold time for isometric contraction will be 10 sec follow by a rest period of 5 sec in between the contractions. Each patient will be complete 2 sessions in a day , in each session consist of 1 set of 10 repetitions of quadriceps exercise perform once at the hospital and once at home for the 4 days/4-week time for testing
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaikh Zayed Hospital Lahore
Full name of responsible person
Dr. Syed Wasif Ali Shah
Street address
university avenue ,block d ,muslim town lahore
City
Lahore
Postal code
40050
Phone
+92 307 8325405
Email
amnabashir41@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Amna bashir
Street address
House#924 street# 12 Umar Farooq Block Mohalla Islam Colony Pakpattan
City
pakpattan
Postal code
57400
Phone
+92 307 8325405
Email
amnabashir41@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
student
Proportion provided by this source
10
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
Riphah international university
Full name of responsible person
Amna Bashir
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House#924 street# 12 Umar Farooq Block Mohalla Islam Colony Pakpattan
City
Lahore
Province
punjab
Postal code
57400
Phone
+92 305 9710474
Email
amnabashir41@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Amna Bashir
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House#924 street# 12 Umar Farooq Block Mohalla Islam Colony Pakpattan
City
lahore
Province
punjab
Postal code
57400
Phone
+92 307 8325405
Email
amnabahir41@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Amna Bashir
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House#924 street# 12 Umar Farooq Block Mohalla Islam Colony Pakpattan
City
lahore
Province
punjab
Postal code
57400
Phone
+92 307 8325405
Email
amnabashir41@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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
comparison of effects of ankle position on isometric quadriceps strengthening in osteoarthritis of knee joint
When the data will become available and for how long
30-6-2022
To whom data/document is available
people working in academic situation
Under which criteria data/document could be used
Author will review the request
From where data/document is obtainable
amnabashir41@gmail.com
What processes are involved for a request to access data/document
request will be entertained through email after which people working in academic institutions will be granted request