- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07525115
Effects of Proprioceptive Neuromuscular Facilitation-Based Lower Extremity Training on Balance, Gait, and Functional Independence in Individuals With Stroke (PNF-STROKE)
The Effects of Proprioceptive Neuromuscular Facilitation-Based Lower Extremity Rehabilitation on Balance, Gait Performance, Functional Independence, and Quality of Life in Individuals With Stroke: A Randomized Controlled Study
This study aims to investigate the effects of a proprioceptive neuromuscular facilitation (PNF)-based lower extremity rehabilitation program on balance, gait performance, functional independence, and quality of life in individuals with stroke.
Stroke is a leading cause of long-term disability and is commonly associated with impairments in motor control, balance, and walking ability, which negatively affect independence and daily functioning.
In this randomized controlled trial, participants with stroke will be randomly assigned to either a PNF-based rehabilitation group or a control group receiving conventional physiotherapy. The intervention will focus on lower extremity PNF techniques to improve motor control, balance, and gait performance.
Assessments will be conducted at baseline and at the end of the intervention period.
The findings are expected to contribute to the development of evidence-based rehabilitation strategies for individuals with stroke.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed as a prospective, randomized, parallel-group controlled trial to evaluate a PNF-based lower extremity rehabilitation program in individuals with stroke.
A total of 60 participants will be randomly allocated in a 1:1 ratio to either an intervention group or a control group using a computer-generated randomization sequence.
The intervention group will receive a structured rehabilitation program based on proprioceptive neuromuscular facilitation principles. The program will incorporate techniques such as rhythmic initiation, dynamic reversals, stabilizing reversals, and rhythmic stabilization. These techniques will be applied through lower extremity diagonal movement patterns (D1 and D2) in functional positions including supine, sitting, and standing. The intervention will be individualized and progressively adjusted according to participant performance and tolerance.
The control group will receive a conventional physiotherapy program consisting of range of motion exercises, muscle strengthening, balance training, and gait-related activities consistent with standard rehabilitation practice.
Both groups will receive interventions with equivalent duration and frequency.
Outcome assessments will be performed by an independent assessor who is blinded to group allocation.
Statistical analyses will be conducted to evaluate changes over time and differences between groups.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mehmet Salih Tan, Doctora
- Phone Number: +905467266876 Türkiye
- Email: mstan@medipol.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of stroke confirmed by a neurologist
- Age between 40 and 80 years
- Ability to walk with or without an assistive device
- Medically stable condition
- Ability to understand and follow verbal instructions
- Willingness to participate and provide informed consent
Exclusion Criteria:
- Severe cognitive impairment preventing participation
- Other neurological disorders affecting mobility
- Severe musculoskeletal disorders affecting lower extremity function
- Severe cardiovascular conditions contraindicating exercise
- Participation in another rehabilitation study
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: PNF Training Group
Participants in this group will receive a proprioceptive neuromuscular facilitation (PNF)-based lower extremity rehabilitation program.
The intervention will include specific PNF techniques such as rhythmic initiation, dynamic reversals, stabilizing reversals, and rhythmic stabilization aimed at improving balance, gait performance, and lower extremity motor control in individuals with stroke.
|
No drug or medical device is used as part of the intervention. The study involves only physiotherapy-based rehabilitation programs. A structured PNF-based exercise program targeting lower extremity motor function, balance, and gait performance. The intervention will include techniques such as rhythmic initiation, dynamic reversals, stabilizing reversals, and rhythmic stabilization applied using diagonal movement patterns (D1 and D2). Exercises will be performed in functional positions (supine, sitting, standing) and progressively adjusted according to patient tolerance. |
|
Active Comparator: Conventional Physiotherapy Group
Participants in the control group will receive conventional physiotherapy exercises focusing on lower extremity strengthening, balance training, and functional mobility exercises commonly used in stroke rehabilitation.
|
Standard physiotherapy exercises including balance training, gait training, and strengthening exercises for individuals with stroke.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale
Time Frame: Baseline and 8 weeks
|
The Berg Balance Scale (BBS) is a 14-item scale used to assess functional balance.
Each item is scored from 0 to 4, with a total score ranging from 0 to 56.
Higher scores indicate better balance performance.
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go Test
Time Frame: Baseline and 8 weeks
|
The Timed Up and Go Test (TUG) measures functional mobility and dynamic balance.
It records the time (in seconds) required to stand up from a chair, walk 3 meters, turn, walk back, and sit down.
Lower values indicate better performance.
|
Baseline and 8 weeks
|
|
Fugl-Meyer Motor Assessment (Lower Extremity)
Time Frame: Baseline and 8 weeks
|
The Fugl-Meyer Assessment (Lower Extremity section) evaluates motor recovery after stroke.
Scores range from 0 to 34, with higher scores indicating better motor function.
|
Baseline and 8 weeks
|
|
10-Meter Walk Test
Time Frame: Baseline and 8 weeks
|
The 10-Meter Walk Test assesses walking speed (m/s).
Higher walking speed indicates better gait performance.
|
Baseline and 8 weeks
|
|
6-Minute Walk Test
Time Frame: Baseline and 8 weeks
|
The 6-Minute Walk Test measures walking endurance and functional exercise capacity as the total distance walked in meters.
Higher values indicate better performance.
|
Baseline and 8 weeks
|
|
Stroke Specific Quality of Life Scale
Time Frame: Baseline and 8 weeks
|
The Stroke-Specific Quality of Life Scale (SS-QOL) evaluates health-related quality of life.
Scores range from 49 to 245, with higher scores indicating better quality of life.
|
Baseline and 8 weeks
|
Collaborators and Investigators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PNF-REHAB-STROKE-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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