Knee Ligament InjuryNCT05856071
TEL and Clam Shell Exercises Affect After ACL
A study testing goniometer, clamshells exercises and traditional physical therapy in people with Knee Ligament Injury, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of this study to determine the effects of the addition of isolated hip strengthening exercises to traditional rehabilitation after Anterior cruciate ligament reconstruction (ACLR). Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Ligament Injury
- What is being tested?
- goniometer, clamshells exercises and traditional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2023to 1 Jul 2023
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-40
- Both Genders (male \& female)
- History of Anterior Cruciate Ligament Reconstruction (ACLR) between 1-3 years
Who cannot join
- Any other previously serious knee pain and/or surgery.
- Limiting of knee range of motion.
- Any traumatic conditions around the knee, or any infectious or tumors conditions
- Pregnancy, any recently underwent abdominal and back surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Clamshell Exercises in Terminal Extension Lag After Anterior Cruciate Ligament
The purpose of this study to determine the effects of the addition of isolated hip strengthening exercises to traditional rehabilitation after Anterior cruciate ligament reconstruction (ACLR). Clamshells exercises unique in scene because it mainly focuses on the muscle surrounding the hip whereas the traditional exercises mostly paid attention on quads and hams exercise
Read the detailed description
In 2020, researcher conducted a randomized controlled clinical trial to determine "Does six-weeks of Hip-focused exercises has the effects on Time to Stabilization after Anterior Cruciate Ligament Reconstruction". The purpose of these study to determine the relationship between muscle strength and time taking to increase the performance of knee. The main findings suggesting that rehabilitation program targets on strengthen the hip muscles in comparison with traditional exercises of knee demonstrate an improvement of knee functions in individual with Anterior cruciate ligament reconstruction (ACLR).
In previous studies there is very less literature regarding determining effects of the clamshells exercises on extension lag after anterior cruciate ligament reconstruction. Therefore there is a dire need to explore the effect of the clamshells exercises on post anterior cruciate ligament reconstruction extension lag. This study aims in the management of pain disability and functional impairment in persons with extension lag with clamshells exercises after ACL reconstruction.
- Conditions
- Knee Ligament Injury
- Being tested
- goniometer, clamshells exercises, traditional physical therapy
- Keywords
- anterior cruciate ligament reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
goniometerDevice
to measure the range of motion
clamshells exercisesOther
clamshells exercises
traditional physical therapyOther
traditional physical therapy
| Study group | Role | What they receive |
|---|---|---|
| clamshells exercises | Experimental | Not described Receives: Device: goniometer; Other: clamshells exercises |
| traditional physical therapy | Active comparator | Not described Receives: Device: goniometer; Other: traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
extension knee range of motion
Change from the baseline ROM of knee extension was taken with the help of goniomter
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Ligament InjuryStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856071
- Sponsor's protocol ID
- REC/RCR /23/0119 sohaib Kaleem
- Status last verified
- Dec 2023
- First submitted
- 4 May 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Clamshell Exercises in Terminal Extension Lag After Anterior Cruciate Ligament
- ClinicalTrials.gov ID
- NCT05856071
- Acronym / sponsor ID
- REC/RCR /23/0119 sohaib Kaleem
- Conditions
- Knee Ligament Injury
- Keywords
- anterior cruciate ligament reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 12 May 2023 (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.
The purpose of this study to determine the effects of the addition of isolated hip strengthening exercises to traditional rehabilitation after Anterior cruciate ligament reconstruction (ACLR). Clamshells exercises unique in scene because it mainly focuses on the muscle surrounding the hip whereas the traditional exercises mostly paid attention on quads and hams exercise
Detailed description
In 2020, researcher conducted a randomized controlled clinical trial to determine "Does six-weeks of Hip-focused exercises has the effects on Time to Stabilization after Anterior Cruciate Ligament Reconstruction". The purpose of these study to determine the relationship between muscle strength and time taking to increase the performance of knee. The main findings suggesting that rehabilitation program targets on strengthen the hip muscles in comparison with traditional exercises of knee demonstrate an improvement of knee functions in individual with Anterior cruciate ligament reconstruction (ACLR).
In previous studies there is very less literature regarding determining effects of the clamshells exercises on extension lag after anterior cruciate ligament reconstruction. Therefore there is a dire need to explore the effect of the clamshells exercises on post anterior cruciate ligament reconstruction extension lag. This study aims in the management of pain disability and functional impairment in persons with extension lag with clamshells exercises after ACL reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clamshells exercises | Experimental | Device: goniometer, Other: clamshells exercises |
| traditional physical therapy | Active comparator | Device: goniometer, Other: traditional physical therapy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 20-40
- Both Genders (male \& female)
- History of Anterior Cruciate Ligament Reconstruction (ACLR) between 1-3 years
Key exclusion criteria (4 listed)
- Any other previously serious knee pain and/or surgery.
- Limiting of knee range of motion.
- Any traumatic conditions around the knee, or any infectious or tumors conditions
- Pregnancy, any recently underwent abdominal and back surgery.
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 |
|---|---|---|
| goniometerto measure the range of motion | Device | clamshells exercises, traditional physical therapy |
| clamshells exercisesclamshells exercises | Other | clamshells exercises |
| traditional physical therapytraditional physical therapy | Other | traditional physical therapy |
Primary outcome
extension knee range of motion
Time frame: 4th week
Change from the baseline ROM of knee extension was taken with the help of goniomter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Knee Ligament Injury
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Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
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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.
Rabiya Noor, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing goniometer, clamshells exercises and traditional physical therapy in people with Knee Ligament Injury, run by Riphah International University 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 27 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
extension knee range of motion (time frame: 4th week). 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 27 Dec 2023.