- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411027
Body Awareness-Based Rehabilitation on Physical Psychosocial Status in Patellofemoral Pain Syndrome (BASPR-PFP)
The Effects of Body Awareness-Based Sensorimotor Rehabilitation on Physical Psychosocial Status in Patellofemoral Pain Syndrome
Patellofemoral pain syndrome is a common knee condition that causes pain around or behind the kneecap, especially during activities such as walking, climbing stairs, squatting, or prolonged sitting. This condition can affect daily activities, movement quality, and psychological well-being.
The purpose of this study is to investigate the effects of a body awareness-based sensorimotor rehabilitation program on pain behavior, movement quality, and psychosocial outcomes in individuals with patellofemoral pain syndrome.
Participants will be randomly assigned to either an intervention group receiving body awareness-based sensorimotor rehabilitation or a control group receiving conventional physiotherapy exercises. The rehabilitation program will focus on improving body awareness, posture, balance, and controlled movement patterns.
Outcomes will be assessed before and after the intervention period. The main outcomes include changes in pain-related behaviors, movement quality, and psychosocial status.
The results of this study are expected to provide evidence on whether body awareness-based sensorimotor rehabilitation can be an effective approach for managing patellofemoral pain and improving both physical and psychological aspects of function.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed as a randomized controlled clinical trial to investigate the effects of a body awareness-based sensorimotor rehabilitation program on pain behavior, movement quality, and psychosocial outcomes in individuals with patellofemoral pain syndrome.
Eligible participants diagnosed with patellofemoral pain syndrome will be randomly allocated to either an intervention group or a control group. Randomization will be performed using a computer-generated sequence.
The intervention group will receive a structured body awareness-based sensorimotor rehabilitation program. This program will focus on improving body awareness, postural control, balance, and coordinated movement through guided exercises and movement education. The program aims to enhance participants' ability to perceive and control their body movements during functional activities.
The control group will receive conventional physiotherapy exercises commonly used in the management of patellofemoral pain syndrome. These exercises will focus on strengthening, flexibility, and functional training.
Both groups will participate in their respective programs for a defined intervention period. Outcome assessments will be conducted at baseline and at the end of the intervention period by assessors blinded to group allocation.
Primary outcomes include changes in pain-related behaviors. Secondary outcomes include changes in movement quality and psychosocial status.
The findings of this study will contribute to understanding the role of body awareness-based sensorimotor rehabilitation in the comprehensive management of patellofemoral pain syndrome.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: SEDA KARACA, PHD
- Phone Number: 90 464 444 01 99
- Email: seda.karaca@erdogan.edu.tr
Study Locations
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Rize, Turkey (Türkiye)
- Guneysu Physical Therspy and Rehabilitation School
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Contact:
- SEDA KARACA, PHD
- Email: seda.karaca@erdogan.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18-45 years.
- Clinical diagnosis of patellofemoral pain syndrome with anterior or retropatellar knee pain.
- Knee pain lasting for at least 3 months.
- Pain intensity of at least moderate level during functional activities such as stair climbing, squatting, or prolonged sitting.
- Ability to understand and follow instructions and provide informed consent.
- Willingness to participate in the rehabilitation program.
Exclusion Criteria:
- History of knee surgery within the past 12 months.
- Presence of other knee pathologies (e.g., ligament injury, meniscal tear, osteoarthritis).
- Diagnosis of inflammatory or rheumatological diseases.
- Neurological disorders affecting balance or movement.
- Current pregnancy.
- Participation in another structured physiotherapy or rehabilitation program within the past 3 months.
- Any condition that may prevent safe participation in exercise.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Body Awareness-Based Sensorimotor Rehabilitation
Participants in this group will receive a structured body awareness-based sensorimotor rehabilitation program. The program will consist of guided exercises focusing on increasing body awareness, postural control, balance, and coordinated movement patterns. The intervention aims to enhance participants' ability to perceive, interpret, and control their body movements during functional activities. Exercises will emphasize controlled movement, alignment, breathing, and proprioceptive feedback. The rehabilitation sessions will be supervised by a physiotherapist and will be delivered over a defined intervention period. |
Sensorimotor rehabilitation is a physiotherapy approach that aims to improve the integration of sensory input and motor output to enhance movement control and functional performance. It focuses on optimizing how the nervous system processes sensory information (such as proprioception, balance, and tactile input) to produce efficient and coordinated movements. This approach includes exercises that target postural control, balance, joint position sense, and neuromuscular coordination. The main goal is to restore normal movement patterns, reduce compensatory strategies, and improve functional stability during daily and sports-related activities. Sensorimotor rehabilitation is commonly used in the management of musculoskeletal conditions, particularly those involving movement dysfunction, pain, and impaired motor control, such as knee pain and patellofemoral pain syndrome.
A structured conventional physiotherapy exercise program including strengthening, flexibility, balance, and functional movement exercises based on standard rehabilitation principles.
The program is supervised by a physiotherapist and applied according to routine clinical exercise protocols.
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Active Comparator: Control
Participants in this arm will receive a conventional physiotherapy exercise program focusing on general strengthening, flexibility, balance, and functional movement exercises.
The program reflects standard clinical practice and does not include structured body awareness-based components.
Sessions will be supervised by a physiotherapist and delivered with the same frequency and duration as the experimental group.
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A structured conventional physiotherapy exercise program including strengthening, flexibility, balance, and functional movement exercises based on standard rehabilitation principles.
The program is supervised by a physiotherapist and applied according to routine clinical exercise protocols.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Behavior Score
Time Frame: Baseline (Week 0) and Post-intervention (Week 8)
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Pain behavior refers to observable and self-reported behaviors related to pain experience, including pain intensity, pain-related avoidance, and functional responses to pain during daily activities.
In this study, pain behavior will be evaluated to determine the effect of the intervention on participants' pain-related responses and functional adaptation.
Pain-related behavior will be assessed using the Turkish Pain Behavior Questionnaire total score to evaluate changes in pain-related responses and avoidance behaviors.
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Baseline (Week 0) and Post-intervention (Week 8)
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Movement Quality Assessment Scale Total Score
Time Frame: Baseline (Week 0) and Post-intervention (Week 8)
|
Movement quality refers to the efficiency, control, and coordination of body movements during functional activities.
In this study, movement quality will be assessed to evaluate changes in postural control, balance, and coordinated movement patterns as a result of the rehabilitation program.
Movement quality will be assessed using a standardized movement quality assessment scale evaluating postural control, balance, and coordinated movement patterns.
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Baseline (Week 0) and Post-intervention (Week 8)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patellofemoral Pain Syndrome
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University of North Carolina, Chapel HillCanadian Institutes of Health Research (CIHR)CompletedPatellofemoral Pain Syndrome | Patellofemoral Pain (PFPS) | Patellofemoral Pain | Patellofemoral Pain, PFPUnited States
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Lauren EricksonAmerican College of Sports MedicineCompleted
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Centre Hospitalier de LensCentre National de la Recherche Scientifique, FranceCompleted
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University of Nove de JulhoCompletedPatellofemoral Pain SyndromeBrazil