Protocol summary
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Study aim
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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.
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Design
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Randomized clinical trial, single blinded study, two parallel groups with 108 patients from Gosha e Shifa and Riaz Mansoor trust hospital.
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Settings and conduct
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Gosha-e-Shifa trust hospital and Riaz Mansoor trust hospital.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Group A: Calisthenic exercises will be given to group A.
Group B: Sensory-motor training will be given to group B.
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Main outcome variables
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Pain, range of motion, balance and functional disability
General information
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Reason for update
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To update the blinding description
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190717044238N11
Registration date:
2023-12-14, 1402/09/23
Registration timing:
registered_while_recruiting
Last update:
2024-12-24, 1403/10/04
Update count:
2
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Registration date
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2023-12-14, 1402/09/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-08-01, 1402/05/10
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Expected recruitment end date
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2024-12-30, 1403/10/10
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Actual recruitment start date
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2023-08-07, 1402/05/16
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Actual recruitment end date
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2024-01-15, 1402/10/25
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Trial completion date
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2024-03-18, 1402/12/28
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Scientific title
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Comparative Effects of Calisthenic Exercises and Sensory-Motor Training in Patients with Knee Osteoarthritis Randomized trail
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Public title
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Comparative Effects of Calisthenic Exercises and Sensory-Motor Training in Patients with Knee Osteoarthritis
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 40 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
108
Actual sample size reached:
108
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In the trial the participant is blinded by not knowing or being unaware which intervention they are receiving , but the researcher know. This trial will be single blinded.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-08-03, 1402/05/12
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Ethics committee reference number
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REC/RCR&AHS/23/0141
Health conditions studied
1
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Description of health condition studied
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Knee Osteoarthritis
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Pain
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Timepoint
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Before intervention, 4 and 8 weeks
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Method of measurement
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Visual analogue scale(VAS)
2
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Description
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Range of motion
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Timepoint
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Before intervention, 4 and 8 weeks
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Method of measurement
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Goniometer
3
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Description
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Balance
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Timepoint
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Before intervention
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Method of measurement
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Time up and go(TUG)
4
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Description
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Quality of life
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Timepoint
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Before intervention
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Method of measurement
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Western Ontario and McMaster Universities(WOMAC)
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Riphah International University Lahore
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Consent Form in its original format with no information about any participant study protocol- how the intervention was given to both groups
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When the data will become available and for how long
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Data would be available after the completion of the research.
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To whom data/document is available
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People working in an academic and clinical setting can have access to the above-mentioned information/documents
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Under which criteria data/document could be used
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Data can only be used for Research Purposes
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From where data/document is obtainable
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Data can be asked for at the following email address: zainiatariq@gmail.com
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What processes are involved for a request to access data/document
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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.
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Comments
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