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NCT Number: NCT07525115

Effects of Proprioceptive Neuromuscular Facilitation-Based Lower Extremity Training on Balance, Gait, and Functional Independence in Individuals With Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Proprioceptive Neuromuscular Facilitation Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proprioceptive Neuromuscular Facilitation Training

Other

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.

Conventional Physiotherapy

Other

Standard physiotherapy exercises including balance training, gait training, and strengthening exercises for individuals with stroke.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet Salih Tan, Doctora

CONTACT

[email protected]

Türkiye ext. +905467266876

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

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

Acronym: PNF-STROKE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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