Knee Isometric Program (KIP) Home Exercise Programs (HEP) Physical Therapy (PT) Study

NCT ID: NCT06536426

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-02
• Study Completion Date: 2025-09-26

Brief Summary

The purpose of this study is to evaluate the efficacy of a knee isometric program (KIP) as compared to the current gold standard treatment for anterior knee pain (Patellofemoral Clinical Practice Guideline [CPG] - Academy of Orthopedic Physical Therapy).

Detailed Description

Participants will be randomly allocated into the KIP or control intervention via spreadsheet randomization algorithm at the time of consenting. Each patient will have equivalent experiences for the duration of the study regardless of allocation. Time spent with the physical therapist, daily length of exercise program, outcome measures recorded, and home education materials will all be similar for each group. Participants will be asked to refrain from any outside forms of lower extremity strengthening or training. Usage of pain medication (including over-the-counter and prescription drugs) will be documented in the pain journal. Proper use of the pain journal will be explained during consent and again at the initial intake session.

Conditions

Anterior Knee Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Knee Isometric Program (KIP) - Intervention

This group will incorporate the KIP protocol, which is a modified physical therapy regimen that is less time-intensive than the gold standard counterpart. Typical structured/skilled physical therapy occurs over the course of 4-8 weeks with 1-2 visits per week to establish improved lower extremity muscle strength, education, and improve gross function. Home exercise programs (HEP) are utilized in tandem with physical therapy visits so that patients are completing interventions 4-5 days per week. Long-term maintenance is generally provided via a refined comprehensive HEP on completion and discharge from formal physical therapy.

Group Type: EXPERIMENTAL

Knee Isometric Program (KIP)

Intervention Type: BEHAVIORAL

The KIP physical therapy protocol follows the schedule outlined below:

• Session 1 (Completed 4-5 days/week including HEP): Double Leg wall sit 3x30 seconds, Double Leg glute bridge hold 3x30 seconds, Single Leg Stance hold 3x1 minutes, Lunge hold 3x1 minutes
• Session 2 (Completed 4-5 days/week including HEP): Single Leg wall sit 3x20 seconds, Single Leg glute bridge hold 3x20 seconds, Single Leg stance hold 2x1.5 minutes, Lunge hold 2x1.5 minutes
• Session 3 (Completed 4-5 days/week including HEP): Single leg wall sit 3x40 seconds, Single leg glute bridge hold 3x40 seconds, Single leg stance hold 2x3 minutes, Lunge hold 2x3 minutes
• Session 4 (Completed 4-5 days/week including HEP): Single leg wall sit 3x40 seconds, Single leg glute bridge hold 3x40 seconds, Single leg stance hold 2x3 minutes, Lunge hold 2x3 minutes

Patellofemoral Clinical Practice Guideline (CPG) - Control

This group will incorporate the standard of care physical therapy regimen which includes a specific and structured combination of quadriceps and gluteal strengthening as defined in the patellofemoral pain clinical practice guideline. Typical structured/skilled physical therapy occurs over the course of 4-8 weeks with 1-2 visits per week to establish improved lower extremity muscle strength, education, and improve gross function. Home exercise programs (HEP) are utilized in tandem with physical therapy visits so that patients are completing interventions 4-5 days per week. Long-term maintenance is generally provided via a refined comprehensive HEP on completion and discharge from formal physical therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Knee Isometric Program (KIP)

The KIP physical therapy protocol follows the schedule outlined below:

• Session 1 (Completed 4-5 days/week including HEP): Double Leg wall sit 3x30 seconds, Double Leg glute bridge hold 3x30 seconds, Single Leg Stance hold 3x1 minutes, Lunge hold 3x1 minutes
• Session 2 (Completed 4-5 days/week including HEP): Single Leg wall sit 3x20 seconds, Single Leg glute bridge hold 3x20 seconds, Single Leg stance hold 2x1.5 minutes, Lunge hold 2x1.5 minutes
• Session 3 (Completed 4-5 days/week including HEP): Single leg wall sit 3x40 seconds, Single leg glute bridge hold 3x40 seconds, Single leg stance hold 2x3 minutes, Lunge hold 2x3 minutes
• Session 4 (Completed 4-5 days/week including HEP): Single leg wall sit 3x40 seconds, Single leg glute bridge hold 3x40 seconds, Single leg stance hold 2x3 minutes, Lunge hold 2x3 minutes

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Accept all provisions of the study and agree to complete the program in its entirety
• Age between 18-65
• Complaint of anterior knee pain for at least 4 weeks, but no more than 12 months
• Prescribed referral for physical therapy for their knee(s) from one of the investigators

Exclusion Criteria

• Potential participant does not agree to comply with study protocols or does not wish to be subjected to a random group allocation
• Any neurological or degenerative musculoskeletal condition involving the lower extremities
• Ages outside of 18-65
• Surgical history or fracture within the last 12 months on the affected extremity(ies)
• Currently participating in a structured strength training program
• Inability to access clinic for data collection or follow-up sessions
• Significant anatomical anomaly or limb alignment disorder as diagnosed by medical professional (femoral anteversion/retroversion, patella alta/baja, varus/valgus deformities, patella deformities/fractures, osteotomy procedures, limb lengthening procedures)
• Significant cartilage damage as diagnosed by medical professional (grade 3+ chondral defects of the femur or patella)
• Any other condition that limits full weight bearing of the affected lower extremity(ies)
• Vulnerable populations

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Patrick McCulloch,MD

John S. Dunn Chair in Orthopedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Houston Methodist Research Institute

Houston, Texas, United States

Countries

United States

Other Identifiers

PRO00037838

Identifier Type: -

Identifier Source: org_study_id