To compare the combined effects of Retro walking exercises and Clamshell exercises on pain, strength and balance among Osteoarthritic patients.
Design
Single blinded, Parallel, Randomized clinical trial
Settings and conduct
This study will be conducted at Arif Memorial Teaching Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients who will above 40 years old and diagnosed with osteoarthritis or have previous knee pain will be included in this study.
Exclusion criteria:
Patients diagnosed with rheumatoid arthritis, having history of ankle or knee surgery or intra-articular injection in knee joint in past 1 year or having dizziness or balance problems and pregnant women will excluded from this study
Intervention groups
There will be two intervention groups. Group A will be treated with clamshell exercise and group B will be treated with retro walking exercises and clamshell exercises
Main outcome variables
1. Numeric Pain Rating Scale will be used for knee pain intensity 2. Berg Balance Scale will be used to check balance while 3. Sit To Stand Test will be used to measure glutei strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221205056713N3
Registration date:2024-07-26, 1403/05/05
Registration timing:registered_while_recruiting
Last update:2024-07-26, 1403/05/05
Update count:0
Registration date
2024-07-26, 1403/05/05
Registrant information
Name
hafiza Nida Rasheed
Name of organization / entity
Rashid Latif Medical college, Lahore
Country
Pakistan
Phone
+92 336 4535979
Email address
naddia.rasheed20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-25, 1403/05/04
Expected recruitment end date
2024-12-27, 1403/10/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Combined Effects of Retro Walking Exercises and Clamshell Exercises on Pain, Strength and Balance among Osteoarthritis Patients
Public title
Effects of retro walking exercises and clamshell exercises in osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both genders male and female age above 40 years .
Patients diagnosed with OA and confirmed by radiographic imaging
History of knee pain in past 30 days
Exclusion criteria:
Patients diagnosed with rheumatoid arthritis
Having history of ankle or knee surgery
History of intra-articular injection in knee joint in past 1 year
Patients having dizziness or balance problems
Pregnant females
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will randomly divided in two groups (group A group B) by using lottery method. Both groups will be given conventional physical therapy treatment. Group A patients will be treated with the retro walking exercises and Group B patients will be treated with retro walking and clamshell exercises.
Blinding (investigator's opinion)
Single blinded
Blinding description
Subjects in two groups will blinded from other treatment options. However they will be instructed to report any adverse effects during trial. Data will assessed by a third person which will not known about the study so trial will be single blinded study. (as outcome assessor will be blinded)
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The institutional board of Rashid Latif Medical College, Lahore
Street address
35KM Ferozepur Road, Lahore.
City
Lahore
Postal code
54900
Approval date
2023-10-10, 1402/07/18
Ethics committee reference number
IRB/2023/137
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain
Timepoint
Before treatment and 4 weeks after treatment
Method of measurement
By using Numeric pain rating scale
2
Description
Balance
Timepoint
Before treatment and 4 weeks after treatment
Method of measurement
By using Balance berg scale
3
Description
Muscle strength
Timepoint
Before treatment and 4 weeks after treatment
Method of measurement
Sit to stand test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group will be treated with Clamshell exercise. we will take diagnosed patients of Osteoarthritis and perform clamshell walking exercises. Firstly patient is positioned in supine lying regular period of 6 days in a week for application of hot pack over knee for 10 min and start Clamshell walking in treadmill which includes clamshell walking two session per day (10 min per session) for 3 weeks on a treadmill at their maximum pace. The treatment duration will be 45 min in each session for a regular period of 6 days in a week. Both groups will receive hot pack for 10 min prior to exercise in order to warm up the muscle. Pre-test values will be taken on the first day and the post-test values will be taken after the total study duration of 3 week
Category
Treatment - Other
2
Description
Intervention group: Group B will be treated with , we take diagnosed patients of osteoarthritis and performed clamshell exercises along with retro walking exercises. Firstly, apply hot pack for 10 minutes in order to warm up and for improvement of circulation in muscles. Then we will strengthen the gluteus-medius to-tensor-fasciae latae by performing the clamshell and abduction exercises. unilateral wall-squat showed a significantly greater Gluteus med/TFL activation, side-lying hip abduction with anterior log-rolling position showed significantly greater Gluteus med activation, side-lying hip abduction exercise, side bridge exercise with knee flexion strengthen the Gluteus med/TFL muscle activation ratio than side bridge exercise or side bridge exercise with knee flexion and hip abduction
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arif memorial teaching hospital, Lahore
Full name of responsible person
Sidra Ishaq
Street address
35-KM, Ferozepur Road. Lahore.
City
Lahore
Postal code
54900
Phone
+92 311 6580724
Email
ishaqsidra8@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rashid Latif Medical college
Full name of responsible person
Hafiza Nida Rasheed
Street address
35-KM, Ferozepur Road. Lahore.
City
Lahore
Postal code
54900
Phone
+92 336 4535979
Email
naddia.rasheed20@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rashid Latif Medical college
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Sidra Ishaq
Position
Physical Therapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-KM, Ferozepur Road. Lahore.
City
Lahore
Province
Punjab
Postal code
54900
Phone
+92 321 1185253
Email
ishaqsidra8@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Hafiza Nida Rasheed
Position
Physical Therapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-KM, Ferozepur Road. Lahore
City
Lahore
Province
Punjab
Postal code
54900
Phone
+92 336 4535979
Email
naddia.rasheed20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Hafiza Nida Rasheed
Position
Physical Therapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
35-KM, Ferozepur Road. Lahore
City
Lahore
Province
Punjab
Postal code
54900
Phone
+92 336 4535979
Email
naddia.rasheed20@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