- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06211387
ADDITIVE BENEFITS of KALTENBORN SUSTAINED STRETCH JOINT MOBILIZATION with RESISTANCE EXERCISE TRAINING in KNEE OSTEOARTHRITIS
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Federal
-
Islamabad, Federal, Pakistan, 66000
- Foundation University Islamabad
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Grade I-III knee OA Both male and female nee osteoarthritis for at least 3 months knee pain no more than 8/10
Exclusion Criteria:
Malignancy Any additional Inflammatory disorders Infection Knee trauma lower limb fracture Lumbar radiculopathy or myelopathy knee surgery Intra-articular steroid therapy in the last 2 months Total knee replacement (TKR). Total hip replacement (THR). Any neurological disorder Any cardio-pulmonary complications Rheumatoid arthritis Septic arthritis Recent history of trauma Osteoporosis or osteomyelitis Grade IV osteoarthritis
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Resistance Exercise
|
Resistance Exercise Training for knee
|
|
Experimental: Resistance exercise + joint mobilization
|
Resistance Exercise Training for knee
Tibiofemoral and Patellofemoral Joint Mobilization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee Pain
Time Frame: 4 weeks
|
Knee Pain will be quantified using Numeric Pain Rating Scale (NPRS).
NPRS is a 11 point scale form 0-10. Lower Score on NPRS signifies less pain, whereas higher score on NPRS signifies more pain.
|
4 weeks
|
|
Physical Function
Time Frame: 4 weeks
|
To determine the physical function related to knee osteoarthritis Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be used with a total of 24 items and a higher score on WOMAC signifies poor outcome.
|
4 weeks
|
|
Isometric Muscle Strength
Time Frame: 4 weeks
|
Modified Sphygmomanometer will be used to measure isometric muscle strength of the muscles of the knee joint.
A higher score signifies greater strength.
|
4 weeks
|
|
Functional Mobility strength
Time Frame: 4 weeks
|
5 repetition sit to stand test will be used to determine functional mobility strength.
Less time to complete the task signifies better outcome.
|
4 weeks
|
|
Cadence
Time Frame: 4 weeks
|
Observational gait analysis will be used to determine cadence.
A higher score signifies better outcome.
|
4 weeks
|
|
Gait velocity
Time Frame: 4 weeks
|
Observational gait analysis will be used to determine cadence.
A higher score signifies better outcome.
|
4 weeks
|
|
Stride length
Time Frame: 4 weeks
|
Observational gait analysis will be used to determine cadence.
A higher score signifies better outcome.
|
4 weeks
|
|
Knee range of motion (ROM)
Time Frame: 4 weeks
|
Gonimeter will be used to measure knee range of motion..
A higher score signifies better outcome.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anas Hameed, Foundation University Islamabad
- Study Chair: Muhammad Osama, Foundation University Islamabad
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2023/22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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