To compare the effects of calisthenic exercises and sensory-motor training on pain, range of
motion, balance and functional disability in patients with knee osteoarthritis.
Design
Randomized clinical trial, single blinded study, two parallel groups with 74 patients from Gosha e Shifa and Riaz Mansoor trust hospital.
Settings and conduct
Gosha-e-Shifa trust hospital and Riaz Mansoor trust hospital.
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA
Both male and female patients
Age 40 to 65 years
EXCLUSION CRITERIA
Patients with any systemic disease
Patients who had any neurologic deficit
Patients with any mental illness
Intervention groups
Group A: Calisthenic exercises will be given to group A.
Group B: Sensory-motor training will be given to group B.
Main outcome variables
Pain, range of motion, balance and functional disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044238N11
Registration date:2023-12-14, 1402/09/23
Registration timing:registered_while_recruiting
Last update:2023-12-14, 1402/09/23
Update count:2
Registration date
2023-12-14, 1402/09/23
Registrant information
Name
Fareeha Amjad
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 99200600
Email address
fari_fairy22@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-01, 1402/08/10
Expected recruitment end date
2024-02-28, 1402/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Effects of Calisthenic Exercises and Sensory-Motor Training in Patients with Knee Osteoarthritis Randomized trail
Public title
Comparative Effects of Calisthenic Exercises and Sensory-Motor Training in Patients with Knee Osteoarthritis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female patients
Age 40 to 65 years
Patients with clinical and radiographic findings of tibiofemoral osteoarthritis
Patients fulfilling Kellgren and Lawrence classification for knee OA
Patients with chronic OA symptom for more than 3 months
Patients with unilateral grade III OA
Exclusion criteria:
Patients with any systemic disease
Patients who had any neurologic deficit
Patients with any mental illness
Subjects with any history of lower limb fracture, knee joint, ligament or meniscal injury
Patients having metal implants in the lower limb
Any history of surgery related to lower extremity
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
fishbowl method method will be used for randomization process. each patient will be numbered using separate slips of paper and put into fishbowl and shuffled and each slip is randomly picked out.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each participant will be asked to choose between two pieces of paper, with group A and group B written on them. Participants will be allocated into treatment groups according to the piece of paper they choose. The patients will not know, in which group he/she is enrolled to avoid bias.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and ethics Commitee Riphah College of Rehabilitation and Allied Health Sciences
Street address
Riphah International University Gulberg campus lahore
City
Lahore
Postal code
54000
Approval date
2023-08-03, 1402/05/12
Ethics committee reference number
REC/RCR&AHS/23/0141
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M19.9
ICD-10 code description
Arthrosis, unspecified
Primary outcomes
1
Description
Pain
Timepoint
before intervention, 4 and 8 weeks
Method of measurement
Visual analogue scale(VAS)
2
Description
Range of motion
Timepoint
before intervention, 4 and 8 weeks
Method of measurement
Goniometer
3
Description
Balance
Timepoint
before intervention
Method of measurement
time up and go(TUG)
4
Description
Quality of life
Timepoint
before intervention
Method of measurement
Western Ontario and McMaster Universities(WOMAC)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group B: These patients will be treated with Sensory motor training. : Exercises will be performed following verbal commands from the therapist. Crossing steps while walking, crossing steps while walking backwards, implementing sudden changes of direction, walking on several types of surfaces (including mattresses) and maintaining posture during use of a balance board.
Category
Rehabilitation
2
Description
Intervention group A: This group will be treated with Calisthenic exercises. 10 repetitions of each exercise with no rest periods. Abductors leg raise , adductor leg raise, prone leg extension, knee bend, alternate toe touch, lunges, calf raises, leg kicks and jack twists.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Gosha-e-Shifa Trust Hospital Lahore
Full name of responsible person
Zainia Tariq
Street address
Gulshan-e-Ravi A block Lahore
City
Lahore
Postal code
54000
Phone
+92 340 4486197
Email
zainiatariq@gmail.com
2
Recruitment center
Name of recruitment center
Riaz Mansoor Trust Hospital Lahore
Full name of responsible person
Zainia Tariq
Street address
Gulsha-e-Ravi H block Lahore
City
Lahore
Postal code
54000
Phone
+92 340 4486197
Email
zainiatariq@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Zainia tariq
Street address
Riphah International University Gulberg Campus
City
Lahore
Postal code
54000
Phone
+92 340 4486197
Email
zainiatariq@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University Lahore
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
Riphah International University Lahore
Full name of responsible person
Zainia Tariq
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Lahore Gulberg campus
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 340 4486197
Email
zainiatariq@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University Lahore Gulberg campus
Full name of responsible person
Fareeha Amjad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Lahore Gulberg campus
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 334 3372779
Email
fari_fairy22@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University Lahore
Full name of responsible person
Zainia Tariq
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Riphah International University Lahore Gulberg campus
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 340 4486197
Email
zainiatariq@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
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Consent Form in its original format with no information about any participant study protocol- how the intervention was given to both groups
When the data will become available and for how long
Data would be available after the completion of the research.
To whom data/document is available
People working in an academic and clinical setting can have access to the above-mentioned information/documents
Under which criteria data/document could be used
Data can only be used for Research Purposes
From where data/document is obtainable
Data can be asked for at the following email address: zainiatariq@gmail.com
What processes are involved for a request to access data/document
One can ask for data at the given email address and it would be provided after knowing the general implications of sharing that particular data.