NCT07327645

Brief Summary

Parkinson's disease (PD) is a neurological disease that includes four main findings: resting tremor, bradykinesia, postural instability, and rigidity, in addition to many motor and non-motor symptoms . PD, the most common form of Parkinsonism, is a chronic and progressive disease characterized by the loss of dopaminergic neurons located in the pars compacta region of the substantia nigra. Its degenerative prognosis, characterized by motor and non-motor problems such as bradykinesia, tremor, rigidity, abnormal postural control, gait disorders, depression, and cognitive impairment, makes the management of the disease difficult . The incidence of PD, which typically begins around the ages of 55-60, varies between 15-250/100,000. Studies conducted in Turkey have indicated an incidence of 202/100,000 . In PH, as the disease progresses, there is a decrease in trunk mobility, forward flexion posture, and consequently loss of postural stability, particularly due to axial rigidity. Trunk stiffness and decreased trunk muscle strength are greater in individuals with PH compared to healthy controls. It has been noted that the decrease in trunk mobility impairs both anterior-posterior and lateral balance, and that individuals with PH experiencing these symptoms have difficulty in timing and scaling effective corrective movements, resulting in an increased risk of falls. Gait disorders are considered one of the most disabling aspects of PH and can strongly affect the patient's independence and quality of life. The underlying mechanisms of gait disorders are multifactorial and usually result from a multisystem lesion involving both dopaminergic and non-dopaminergic mechanisms . In addition to the clinical and functional effects of gait disorders, a more important issue is that this impairment in gait can result in falls and trauma. The fact that gait disorders are affected by the motor and non-motor symptoms of the disease, and that they are parallel to longevity and cognitive decline, increases the importance of treatment . Therefore, rehabilitation interventions aimed at treating or alleviating gait disorders should be one of the main focuses in individuals with PH . Falls are one of the most important causes of morbidity for PH . Approximately 60% of PH patients fall at least once a year, and falls are recurrent in at least one-third of these patients . Falls, which occur as a result of various factors, lead to injuries, fear of falling, decreased independence, decreased quality of life, and increased healthcare costs in patients. Fear of falling leads to a decrease in the patient's self-confidence, withdrawal from social life, and the choice of an inactive lifestyle, resulting in an increased risk of falling. This situation becomes a vicious cycle over time. While 28-55% of elderly people living at home fear falling, this rate increases to 50-65% in those who have fallen before . In PH patients, this rate is much higher than in healthy controls and is important in predicting future falls . Therefore, it is stated that fear of falling should be included in the assessment and treatment programs of individuals with PH . Quality of life is a multidimensional outcome measure consisting of three areas: physical, mental, and social, which are influenced by the individual's personal characteristics and environmental factors . Since chronic and progressive diseases affect every aspect of an individual's life, health-related quality of life is taken into consideration in the management of such diseases . PH affects the individual's ability to independently perform almost all daily living activities and causes negative consequences in quality of life. PH affects the individual not only physically, mentally, and socially, but also economically for the individual and their family due to the additional financial burden brought about by care and treatment costs . Therefore, the assessment of quality of life in individuals with PH is important and necessary . Proprioceptive Neuromuscular Facilitation (PNF) is a method frequently used by physiotherapists to facilitate the emergence of motor responses through the stimulation of proprioceptors and to improve voluntary control in the central nervous system . The International PNF Association defines the PNF philosophy under 5 subheadings: positive approach (mental participation in therapy), functional approach (integrating real tasks from daily life), mobilizing reserves (radiation principle), holistic treatment of the individual, motor learning, and control principles using motor learning. PNF fully complies with the International Classification of Functioning, Disability and Health (ICF) because it addresses the relevant patient with their personal and environmental context components of deficiencies, activity limitations, and participation restrictions .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

December 25, 2025

Last Update Submit

January 16, 2026

Conditions

Keywords

Proprioceptive neuromuscular facilitationparkinson diseasetrunk mobilityFunctional abilitiesfear of fallinggait

Outcome Measures

Primary Outcomes (1)

  • The Modified Hoehn and Yahr Scale

    Parkinson's Hoehn and Yahr Staging is a scale developed in 1967 by Margaret M. Hoehn and Melvin D. Yahr that examines the overall clinical condition of individuals with Parkinson's disease according to five stages. Advanced stage indicates an increased stage. It provides information about objective findings and functional impairment of the disease. Although initially designed as a 5-item scale with integer options from 1 to 5, some items with 0.5-point increments were later added.

    10 weeks after the start of treatment

Secondary Outcomes (7)

  • The Movement Disorders Association-Unified Parkinson's Disease Rating Scale (MDS-UPRDS

    10 weeks after the start of treatment

  • Parkinson's Disease Questionnaire (PDQ-39):

    10 weeks after the start of treatment

  • Modified Fall Activity Scale (MFES):

    10 weeks after the start of treatment

  • Modified Schober test

    10 weeks after the start of treatment

  • Timed Up and Go Test (TUG)

    10 weeks after the start of treatment

  • +2 more secondary outcomes

Study Arms (3)

Patients with PD-PNF-1

EXPERIMENTAL

PNF-physiotherapist hand contact group

Other: Proprioceptive Neuromuscular Facilitation (PNF)

Patients with PD-PNF-2

EXPERIMENTAL

PNF-Metronom group

Other: Proprioceptive Neuromuscular Facilitation (PNF)

Patients with PD-PNF-3

EXPERIMENTAL

PNF-Action Observation Group

Other: Proprioceptive Neuromuscular Facilitation (PNF)

Interventions

Group 2 Treatment Program Warm-up exercises combined with breathing Scapula and pelvis PNF patterns Application of the D2 diagonal in the upper extremity and the D1 diagonal in the lower extremity with slow, opposing technique, without physiotherapist hand contact, accompanied by a metronome Cool-down exercises combined with breathing

Patients with PD-PNF-2

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Parkinson's Disease
  • Agreement to participate in the study
  • Age between 40-90 years
  • Score of 21 or higher on the Montreal Cognitive Assessment Scale (MoCA)
  • Hoehn-Yahr stage 1-3 (including 3)

You may not qualify if:

  • Refusal to participate in the study
  • Having vision loss (can wear glasses or contact lenses)
  • Having hearing loss (can wear a hearing aid)
  • Being in Hoehn-Yahr stage 4-5
  • Having accompanying neurological, orthopedic, and rheumatological diseases that prevent the performance of upper and lower extremity patterns.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale Unıversity

Denizli, Kınıklı, 20000, Turkey (Türkiye)

Location

Related Publications (1)

  • Alexandre de Assis IS, Luvizutto GJ, Bruno ACM, Sande de Souza LAP. The Proprioceptive Neuromuscular Facilitation Concept in Parkinson Disease: A Systematic Review and Meta-Analysis. J Chiropr Med. 2020 Sep;19(3):181-187. doi: 10.1016/j.jcm.2020.07.003. Epub 2020 Dec 15.

MeSH Terms

Conditions

Parkinson Disease

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Following a power analysis based on the reference study, a total of 42 individuals with PD were included in the study. Randomized according to age, gender, and Hoehn-Yahr level, the individuals were divided into three study groups. While all groups received PNF treatment, Group 1 performed PNF application with physical contact by the physiotherapist, Group 2 with metronome accompaniment, and Group 3 through action observation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Physiotherapist, PhD Student,Principal Investigator

Study Record Dates

First Submitted

December 25, 2025

First Posted

January 8, 2026

Study Start

August 4, 2023

Primary Completion

July 30, 2025

Study Completion

August 30, 2025

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations