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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06536426
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The Methodist Hospital Research Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Anterior Knee Pain Syndrome

Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

No Intervention: 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.

Interventions

Behavioral: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Houston Methodist Research Institute, Houston, Texas

Status

Recruiting

Address

Houston Methodist Research Institute

Houston, Texas, 77030

Site Contact

Haley Goble

[email protected]

713-441-3930

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