Post Operative Anterior Cruciate Ligament RehabilitationNCT06750198
Effects of Hip Focused Exercises in Patients With Post Operative Anterior Cruciate Ligament Rehabilitation
A study testing Hip focused and Standard rehabilitation in people with Post Operative Anterior Cruciate Ligament Rehabilitation, run by Riphah International University at 1 site in Pakistan.
Trial summary
A Randomized Controlled Trial will be conducted at Mahaban Medical and Research Hospital through consecutive sampling technique on 66 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Anterior Cruciate Ligament Rehabilitation
- What is being tested?
- Hip focused and Standard rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2024to 20 Nov 2024
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both males and females of age group between 18 and 45 years
- Patients with ACL reconstruction in early rehabilitation phase.
- Physically or recreationally active a minimum of three times per week.(26)
- 1-5 day post operatively(26)
- Physically healthy and without patients with other medical history or joint deformities
- Patients without severe meniscus or cartilage damage (27)
- Complaints of pain (NPRS 3-7) and swelling in the operated knee
Who cannot join
- Patients with multiple ligament injuries in the knee joint
- Patients with knee osteoarthritis
- Patients with joint infection (27)
- An associated chondral defect requiring surgical intervention
- A meniscus tear requiring a repair.
- Patients with incomplete follow-up (28)
Show all 10Show fewer
- Presence of unstable medical conditions preventing the patient from participating in the rehabilitation program.
- History of ipsi-lateral hip replacement
- Ipsi-lateral hip osteoarthritis or lateral hip pain
- Neurological or any other conditions affecting strength or function of lower limbs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hip Focused Exercises on Pain, Range of Motion, Functional Disability, Muscle Strength and Endurance in Patients With Post Operative Anterior Cruciate Ligament Rehabilitation
A Randomized Controlled Trial will be conducted at Mahaban Medical and Research Hospital through consecutive sampling technique on 66 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with hip focused exercises and standard rehabilitation protocol while Group B will be treated with traditional exercises at the frequency of 2 sets with 10 repetitions and thrice a week. Outcome measures will be conducted through pain, range of motion, functional disability, muscle strength and endurance after 12 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non- parametric test will be used within a group or between two groups.
Read the detailed description
Anterior cruciate ligament plays an important role in knee stability and is prone to contact and and non-contact injuries. ACL reconstruction followed by proper rehabilitation is the most successful procedure to restore knee stability and ROM. Keeping in mind the lower limb kinematics and biomechanics the aim of this study will be to see the effects of hip focused exercises on pain, range of motion, functional disability, muscle strength and endurance in patients with post-operative ACL rehabilitation. A Randomized Controlled Trial will be conducted at Mahaban Medical and Research Hospital through consecutive sampling technique on 66 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with hip focused exercises and standard rehabilitation protocol while Group B will be treated with traditional exercises at the frequency of 2 sets with 10 repetitions and thrice a week. Outcome measures will be conducted through pain, range of motion, functional disability, muscle strength and endurance after 12 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non- parametric test will be used within a group or between two groups.
- Being tested
- Hip focused, Standard rehabilitation
- Keywords
- Anterior cruciate ligament Rehabilitation, Hip focused Exercises, pain, Range of Motion
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip focusedOther
Group A will be treated with hip focused exercises and standard rehabilitation protocol.
Hip focused exercises will be comprised of following exercises in phase 1 will be Side lying hip abduction, Hip abduction in standing, Hip extension from prone, Single leg bridge, Side lying clam with resistance while exercises in phase 2 will be same with more repetitions in addition to Side lunges, Forward lunges
Standard rehabilitationOther
Group B will be only be treated with standard rehabilitation protocol. When participant reach full ROM of knee, perform four sets of 20 repetitions of straight leg raising with full extension, and maintain one minute single leg balance on a solid surface with the affected side, subject can transfer to phase 2
| Study group | Role | What they receive |
|---|---|---|
| Hip focused exercises | Experimental | will receive hip focused exercises and standard rehabilitation protocol with the frequency of 2 sets and 10 repetitions thrice per week for a total of 12 weeks. Pre and post intervention values will be taken on 1st day and after 12 weeks. Receives: Other: Hip focused; Other: Standard rehabilitation |
| Standerd rehab protocol | Active comparator | will receive only standard rehabilitation protocol with the frequency of 2 sets and 10 repetitions thrice per week for a total of 12 weeks. Pre and post intervention values will be taken on 1st day and after 12 weeks Receives: Other: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) is commonly used in the clinical setting and is convenient to administer and interpret. The NPRS is a numbered scale that begins with zero and ends at ten. Zero indicates no pain, while ten is the worst intensity of pain that individual can imagine
Measured: 6 WEEK
Universal Goniometer
The goniometer is used to objectively assess active and passive joint ROM. The universal or standard plastic, long armed, 360 degree goniometer is frequently recommended for measurement of knee ROM as the longer arm is thought to reduce error resulting from incorrect placement of the goniometric axis
Measured: 6th week
WOMAC
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to measure the physical function of the knee. This scale was shown to be a valid and reliable tool, which was utilized to assess the physical function in patients with knee surgery. This tool comprises 24 questions: 5 questions about pain (0-20 points), 2 questions about stiffness (0-8 points), and 17 questions about physical functions difficulty (0-68 points), which may be completed in less than 5 minutes.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start15 Oct 2024
- Primary completion10 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Operative Anterior Cruciate Ligament RehabilitationStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Participant
- Enrolment
- 47 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
- NCT06750198
- Sponsor's protocol ID
- REC/RCR & AHS/24/0109
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matsumoto H, Suda Y, Otani T, Niki Y, Seedhom BB, Fujikawa K. Roles of the anterior cruciate ligament and the medial collateral ligament in preventing valgus instability. J Orthop Sci. 2001;6(1):28-32. doi: 10.1007/s007760170021.
PubMed 11289582Petersen W, Tillmann B. Structure and vascularization of the cruciate ligaments of the human knee joint. Anat Embryol (Berl). 1999 Sep;200(3):325-34. doi: 10.1007/s004290050283.
PubMed 10463347Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/0363546516629944. Epub 2016 Feb 26.
PubMed 26920430
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hip Focused Exercises on Pain, Range of Motion, Functional Disability, Muscle Strength and Endurance in Patients With Post Operative Anterior Cruciate Ligament Rehabilitation
- ClinicalTrials.gov ID
- NCT06750198
- Acronym / sponsor ID
- REC/RCR & AHS/24/0109
- Keywords
- Anterior cruciate ligament Rehabilitation, Hip focused Exercises, pain, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 27 Dec 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.
A Randomized Controlled Trial will be conducted at Mahaban Medical and Research Hospital through consecutive sampling technique on 66 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with hip focused exercises and standard rehabilitation protocol while Group B will be treated with traditional exercises at the frequency of 2 sets with 10 repetitions and thrice a week. Outcome measures will be conducted through pain, range of motion, functional disability, muscle strength and endurance after 12 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non- parametric test will be used within a group or between two groups.
Detailed description
Anterior cruciate ligament plays an important role in knee stability and is prone to contact and and non-contact injuries. ACL reconstruction followed by proper rehabilitation is the most successful procedure to restore knee stability and ROM. Keeping in mind the lower limb kinematics and biomechanics the aim of this study will be to see the effects of hip focused exercises on pain, range of motion, functional disability, muscle strength and endurance in patients with post-operative ACL rehabilitation. A Randomized Controlled Trial will be conducted at Mahaban Medical and Research Hospital through consecutive sampling technique on 66 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with hip focused exercises and standard rehabilitation protocol while Group B will be treated with traditional exercises at the frequency of 2 sets with 10 repetitions and thrice a week. Outcome measures will be conducted through pain, range of motion, functional disability, muscle strength and endurance after 12 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non- parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip focused exercises | Experimental | Other: Hip focused, Other: Standard rehabilitationwill receive hip focused exercises and standard rehabilitation protocol with the frequency of 2 sets and 10 repetitions thrice per week for a total of 12 weeks. Pre and post intervention values will be taken on 1st day and after 12 weeks. |
| Standerd rehab protocol | Active comparator | Other: Standard rehabilitationwill receive only standard rehabilitation protocol with the frequency of 2 sets and 10 repetitions thrice per week for a total of 12 weeks. Pre and post intervention values will be taken on 1st day and after 12 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Both males and females of age group between 18 and 45 years
- Patients with ACL reconstruction in early rehabilitation phase.
- Physically or recreationally active a minimum of three times per week.(26)
- 1-5 day post operatively(26)
- Physically healthy and without patients with other medical history or joint deformities
Key exclusion criteria (10 listed)
- Patients with multiple ligament injuries in the knee joint
- Patients with knee osteoarthritis
- Patients with joint infection (27)
- An associated chondral defect requiring surgical intervention
- A meniscus tear requiring a repair.
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 |
|---|---|---|
| Hip focusedGroup A will be treated with hip focused exercises and standard rehabilitation protocol. Hip focused exercises will be comprised of following exercises in phase 1 will be Side lying hip abduction, Hip abduction in standing, Hip extension from prone, Single leg bridge, Side lying clam with resistance while exercises in phase 2 will be same with more repetitions in addition to Side lunges, Forward lunges | Other | Hip focused exercises |
| Standard rehabilitationGroup B will be only be treated with standard rehabilitation protocol. When participant reach full ROM of knee, perform four sets of 20 repetitions of straight leg raising with full extension, and maintain one minute single leg balance on a solid surface with the affected side, subject can transfer to phase 2 | Other | Hip focused exercises, Standerd rehab protocol |
Primary outcome
The Numeric Pain Rating Scale (NPRS)
Time frame: 6 WEEK
The Numeric Pain Rating Scale (NPRS) is commonly used in the clinical setting and is convenient to administer and interpret. The NPRS is a numbered scale that begins with zero and ends at ten. Zero indicates no pain, while ten is the worst intensity of pain that individual can imagine
Universal Goniometer
Time frame: 6th week
The goniometer is used to objectively assess active and passive joint ROM. The universal or standard plastic, long armed, 360 degree goniometer is frequently recommended for measurement of knee ROM as the longer arm is thought to reduce error resulting from incorrect placement of the goniometric axis
WOMAC
Time frame: 6th week
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) was used to measure the physical function of the knee. This scale was shown to be a valid and reliable tool, which was utilized to assess the physical function in patients with knee surgery. This tool comprises 24 questions: 5 questions about pain (0-20 points), 2 questions about stiffness (0-8 points), and 17 questions about physical functions difficulty (0-68 points), which may be completed in less than 5 minutes.
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 2024.
- Background: PubMed 11289582Matsumoto H, Suda Y, Otani T, Niki Y, Seedhom BB, Fujikawa K. Roles of the anterior cruciate ligament and the medial collateral ligament in preventing valgus instability. J Orthop Sci. 2001;6(1):28-32. doi: 10.1007/s007760170021.
- Background: PubMed 10463347Petersen W, Tillmann B. Structure and vascularization of the cruciate ligaments of the human knee joint. Anat Embryol (Berl). 1999 Sep;200(3):325-34. doi: 10.1007/s004290050283.
- Background: PubMed 26920430Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/0363546516629944. Epub 2016 Feb 26.
- Individual participant dataSharing planned: No
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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 Hip focused and Standard rehabilitation in people with Post Operative Anterior Cruciate Ligament Rehabilitation, 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 7 inclusion and 10 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 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?
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?
The Numeric Pain Rating Scale (NPRS) (time frame: 6 WEEK). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06750198, which also lists 3 linked publications.
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 2024.