NCT06750198

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

26 days

First QC Date

December 20, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

Anterior cruciate ligament RehabilitationHip focused ExercisespainRange of Motion

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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.

    6th week

Study Arms (2)

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.

Other: Hip focusedOther: 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

Other: Standard rehabilitation

Interventions

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

Hip focused exercises

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

Hip focused exercisesStanderd rehab protocol

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehab Clinic

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

  • 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.

    PMID: 11289582BACKGROUND
  • Petersen 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.

    PMID: 10463347BACKGROUND
  • Sanders 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.

    PMID: 26920430BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rabiya Noor, PHD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2024

First Posted

December 27, 2024

Study Start

October 15, 2024

Primary Completion

November 10, 2024

Study Completion

November 20, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations