Knee OsteoarthritisNCT06211387
ADDITIVE BENEFITS of KALTENBORN SUSTAINED STRETCH JOINT MOBILIZATION with RESISTANCE EXERCISE TRAINING in KNEE OSTEOARTHRITIS
A study testing Resistance Exercise Training and Joint Mobilization in people with Knee Osteoarthritis, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
to determine the supplementary effects of Kaltenborn sustained stretch mobilization when combined with resistance training in the management of knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Resistance Exercise Training and Joint Mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2024to 2 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Grade I-III knee OA Both male and female nee osteoarthritis for at least 3 months knee pain no more than 8/10
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
to determine the supplementary effects of Kaltenborn sustained stretch mobilization when combined with resistance training in the management of knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Resistance Exercise Training, Joint Mobilization
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise TrainingProcedure or surgery
Resistance Exercise Training for knee
Joint MobilizationProcedure or surgery
Tibiofemoral and Patellofemoral Joint Mobilization
| Study group | Role | What they receive |
|---|---|---|
| Resistance exercise + joint mobilization | Experimental | Not described Receives: Procedure: Resistance Exercise Training; Procedure: Joint Mobilization |
| Resistance Exercise | Active comparator | Not described Receives: Procedure: Resistance Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Pain
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.
Measured: 4 weeks
Physical Function
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.
Measured: 4 weeks
Isometric Muscle Strength
Modified Sphygmomanometer will be used to measure isometric muscle strength of the muscles of the knee joint. A higher score signifies greater strength.
Measured: 4 weeks
Functional Mobility strength
5 repetition sit to stand test will be used to determine functional mobility strength. Less time to complete the task signifies better outcome.
Measured: 4 weeks
Cadence
Observational gait analysis will be used to determine cadence. A higher score signifies better outcome.
Measured: 4 weeks
Gait velocity
Observational gait analysis will be used to determine cadence. A higher score signifies better outcome.
Measured: 4 weeks
Stride length
Observational gait analysis will be used to determine cadence. A higher score signifies better outcome.
Measured: 4 weeks
Knee range of motion (ROM)
Gonimeter will be used to measure knee range of motion.. A higher score signifies better outcome.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Oct 2024
- Primary completion2 Apr 2025 (estimated)
- Study completion2 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anas Hameed, Principal investigator, Foundation University IslamabadMuhammad Osama, Study chair, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211387
- Sponsor's protocol ID
- FUI/CTR/2023/22
- Status last verified
- Oct 2024
- First submitted
- 8 Jan 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADDITIVE BENEFITS of KALTENBORN SUSTAINED STRETCH JOINT MOBILIZATION with RESISTANCE EXERCISE TRAINING in KNEE OSTEOARTHRITIS
- ClinicalTrials.gov ID
- NCT06211387
- Acronym / sponsor ID
- FUI/CTR/2023/22
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 2 Apr 2025 (estimated)
- Study completion
- 2 Apr 2025 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to determine the supplementary effects of Kaltenborn sustained stretch mobilization when combined with resistance training in the management of knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance exercise + joint mobilization | Experimental | Procedure: Resistance Exercise Training, Procedure: Joint Mobilization |
| Resistance Exercise | Active comparator | Procedure: Resistance Exercise Training |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Grade I-III knee OA Both male and female nee osteoarthritis for at least 3 months knee pain no more than 8/10
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Exercise TrainingResistance Exercise Training for knee | Procedure or surgery | Resistance Exercise, Resistance exercise + joint mobilization |
| Joint MobilizationTibiofemoral and Patellofemoral Joint Mobilization | Procedure or surgery | Resistance exercise + joint mobilization |
Primary outcome
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.
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.
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.
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.
Cadence
Time frame: 4 weeks
Observational gait analysis will be used to determine cadence. A higher score signifies better outcome.
Gait velocity
Time frame: 4 weeks
Observational gait analysis will be used to determine cadence. A higher score signifies better outcome.
Stride length
Time frame: 4 weeks
Observational gait analysis will be used to determine cadence. A higher score signifies better outcome.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anas Hameed principal investigator
Foundation University Islamabad
Muhammad Osama study chair
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise Training and Joint Mobilization in people with Knee Osteoarthritis, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain (time frame: 4 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.