Clinical trial NCT07014696: ICF-Based Effects of PNF and Kinesio Taping on Hand Function in Hemiplegic Stroke
Official title: Investigation of the Effects of PNF and Kinesiological Taping on Hand Function in Hemiplegic Stroke Patients Based on the ICF Framework
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegia
Hemiplegia Due to Stroke
Hand Functionality
Upper Extremity
Proprioceptive Neuromuscular Facilitation
Kinesio Taping
Keywords: hand functionality
hemiplegia
hemiplegia due to stroke
upper extremity
ICF
Proprioceptive neuromuscular facilitation
kinesio taping
Lead sponsor: Istinye University
Sponsor class: OTHER
Collaborators: name: Ondokuz Mayıs University
First posted: 2025-06-11
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment Method: Patients who continue the rehabilitation program due to hemiplegic stroke and meet the inclusion criteria will be treated. The treatment will be applied in addition to the conventional physiotherapy program for 24 sessions, 3 days a week for 8 weeks.

Group 1: PNF application Group (n: 18): Conventional Physiotherapy + PNF application Group 2: KB application Group (n: 18): Conventional Physiotherapy + KB application Group 3: PNF+KB application Group (n: 18): Conventional Physiotherapy + PNF + KB application
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This clinical trial aims to compare the effects of kinesio taping and PNF on hemiplegic hand functions. In addition, the effects of these applications on body structure, activity, and participation will be examined. The main questions it aims to answer are:

Do kinesio taping and PNF applications have different effects on hemiplegic hand function? Are kinesio taping and PNF applications effective in body structure, activity, and participation? The researchers will compare the advantages of kinesio taping and PNF applications over each other.

Participants:

Kinesio taping and/or PNF applications will be applied 3 days a week for 8 weeks.

Tests will be performed on the first and last day of the study to evaluate hand functions.

Detailed description: This study aims to investigate the effects of proprioceptive neuromuscular facilitation and kinesiology taping on hand functions in hemiplegic stroke patients. In order to evaluate functionality, it will be evaluated with the Box block test, Fugl Meyer upper extremity test, ARAT, and nine-hole peg test. In order to examine the cases within the scope of functionality, disability, and health international classification (ICF), environmental quality scale, upper extremity motor activity diary-28, stroke impact scale, and social adaptation scale will be evaluated.

Stroke is the second leading cause of death and disability among adults over the age of 60 worldwide. Approximately 17 million people have a stroke every year in the world and 140 thousand people in our country. Data from all over the world also reveal that the incidence of stroke will increase in the coming years. By definition, stroke is a clinical condition that develops after focal infarction or hemorrhage in the cerebral cortex, cerebellum and spinal cord, causes focal neurological dysfunction, can last 24 hours or longer and can even result in death. After a stroke, the surrounding brain tissue is deprived of oxygen and essential nutrients, and if left untreated, it can lead to permanent tissue damage, including neuronal cell death. Damages that occur after a stroke cause motor, sensory, and cognitive impairments in individuals; upper extremity dysfunction, balance, and walking difficulties, causing people to be dependent on various degrees in their daily life activities. Post-stroke disability reduces the quality of life of the individual and their relatives, affecting their lives. It also causes both socioeconomic and social problems. Approximately 50-75% of those affected in the early post-stroke period experience upper extremity impairment, and a large portion of them will live with long-term upper extremity impairment. Although most individuals regain walking function after stroke, very few individuals are able to use their upper extremities, especially their hands, at a fully functional level. Upper extremity function after stroke is among the main causes of long-term disability. This is because the natural recovery of upper extremity function is generally more limited than that of the lower extremity. Impaired use of the upper extremity persists in approximately 60% of patients even 6 months after stroke. Exercise interventions are necessary to improve upper extremity motor functions and activities of daily living (ADL) in stroke patients, because persistent upper extremity dysfunction is strongly associated with decreased activities of daily living and poor quality of life after stroke.

Abnormal synergies occur in the extremities of patients who have had a stroke. The literature has described two main synergies for the upper extremity: Flexion or extension synergy patterns. These synergies in the upper extremity and hand lead to loss of mobility, interfere with activities of daily living including dressing and hygiene, may cause skin breakdown, and may cause pain. Over time, weakness in the hemiparetic hand, motor disorders caused by abnormal synergies, and permanent spasticity begin to cause secondary changes in the musculoskeletal system that may limit the use of the arm and hand and affect functional mobility; soft tissue shortening and contracture formation may be observed. There is a wide range of treatments for upper extremity recovery following stroke. In these methods, integrated treatments are recommended for both the hand and arm. Upper limb rehabilitation aims to provide all possible means to regain lost function and increase the autonomy of stroke patients, taking into account any remaining impairments and disabilities. Carr and Shepherd suggested that poor recovery in the upper limb may result from the direct effects of stroke as well as from inadequate, inappropriate or incorrect therapeutic interventions. However, little information is available to explain what best represents the "optimal treatment". The chosen treatment modality may be directed at a specific impairment (e.g. muscle weakness) or functional movements (e.g. grasping and letting go activity). These treatment modalities may be used separately or combined to address the multifactorial impairments that may arise following stroke, i.e. primary problems and secondary complications. Therefore, it should be noted that upper extremity rehabilitation after stroke will involve a complex intervention that requires the cooperation of the patient, caregivers, and the rehabilitation team.

Neuromuscular therapies, one of the approaches used in the treatment of stroke, include multiple methods. In recent years, activities related to the recovery of motor functions have become the focus of research by scientists dedicated to the development of the topic of brain plasticity, which allows a person to adapt to the environment through learning and self-repair after damage. A typical example of neural plasticity is the recovery process after ischemic stroke, which initiates the reorganization of the central nervous system and the assumption of some functions by undamaged parts of brain structures. Reorganization also involves the expansion of cortical areas that provide the neural substrate for the recovery or adaptation of motor activities after damage. The results of studies on brain plasticity have revealed that the proprioceptive neuromuscular facilitation (PNF) technique, one of the neuromuscular treatments, provides the development of neurorehabilitation. Proprioceptive neuromuscular facilitation (PNF) is a therapeutic approach that provides input with cutaneous, proprioceptive, auditory and visual stimuli to provide functional improvement in motor movement and can play a vital role in the rehabilitation of many injuries. PNF is a special manual technique that combines different planes of movement and is applied by physiotherapists to improve the functional status of the patient. This method plays an effective role in supporting the patient to achieve their goals by making movements more functional. Studies have shown that it is effective in pain management, increasing range of motion, developing muscle strength and endurance, improving balance and coordination, providing proximal stability and supporting functional progress. Neuromuscular reeducation applications are widely preferred in the early rehabilitation processes of acute or subacute periods in order to improve motor functions of paralyzed patients. This method stimulates the proprioceptive organs in the muscles and tendons to improve muscle functions, promotes the emergence of postural reflexes, and regulates muscle contraction to increase strength, flexibility, balance, and coordination. Many articles have revealed that a PNF-based program has the potential to produce positive results on motor function in older adults with acute and chronic paralysis. A 2018 study found that PNF was effective in improving upper extremity motor skills and function in stroke patients in the acute and/or subacute stages, while other studies found that it was effective in reducing spasticity, increasing joint range of motion, and improving self-care function in the chronic stage.

Another neuromuscular treatment method used in stroke patients is kinesiology taping. Kinesiology taping (KT) was introduced by Kenzo Kase in 1996 and is a combination of applying appropriate tension along the elastic therapeutic tape and placing the target muscle in a tense position, and is widely used as an interesting and relatively new method for various clinical treatments. KT is a type of elastic, cotton, adhesive bandage with a 140% extensibility that can mimic the elasticity and tension of human skin, muscle, and fascia. Previous studies have shown that kinesiology taping can increase blood circulation, provide mechanical support and proprioceptive feedback, improve joint range of motion, and activate muscles. KT has gained popularity in clinical practice and has been used in clinical practice worldwide. KT applications may promote functional use of the upper and lower extremities by supporting weak muscles, relaxing overstretched muscles, reducing pain and further improving balance ability. Based on these observations, kinesiology taping is considered a potential treatment for spasticity, motor control and tone regulation, providing prorioceptive input and increasing functions. The International Classification of Functioning, Disability and Health (ICF) is an international and standardized classification system developed by the World Health Organization (WHO) to be applied in many branches of health and to evaluate functionality, disability and health holistically. ICF can be used for many purposes, this classification system is a policy and planning tool for decision makers. In addition to being used to categorize health, ICF can be used to determine functional status and to plan rehabilitation programs and guide goal achievement. An interdisciplinary team approach in stroke treatment, where different specialists work together harmoniously and closely, has been described as the basis for effective stroke rehabilitation programs. Measuring, reporting and comparing outcomes across each treatment approach is important to improve outcomes and make informed choices about how to optimize healthcare and rationalize costs.

Eligibility criteria: Inclusion Criteria:Inclusion criteria for the study (Junior et al., 2019; Kim \& Kim, 2015; Saklecha et al., 2023)

* Stroke diagnosed by MRI or CT, regardless of ischemic or hemorrhagic origin,
* Hemiplegia caused by stroke alone,
* At least 6 and at most 24 months have passed since the stroke was diagnosed
* Being over 18 years of age,
* Volunteering to participate in the study
* Scoring 24 or more on the Standardized Mini Mental State Examination (if illiterate, scoring 18 or more is sufficient)
* Cooperating with evaluation, tests and treatment
* Understanding and speaking Turkish
* Being at least stage 4 according to Brunnstrom staging

Exclusion Criteria:

* Exclusion Criteria (Junior et al., 2019; Kim \& Kim, 2015; Saklecha et al., 2023)
* Individuals with bilateral hemiplegia
* Individuals with unstable vital signs
* Individuals with any open wound in the upper extremity
* Pathological conditions affecting upper extremity sensation (undergoing surgery after fracture, etc.)
* Individuals with a BMI value greater than 29.9 kg/m2
* Individuals with a Standardized Mini Mental Test score below 24 points (18 points)
* Individuals with major neurological or rheumatological disorders affecting the musculoskeletal system other than stroke (Polyneuropathy, Parkinson's, Multiple Sclerosis, Rheumatoid Arthritis, etc.)
* Presence of upper extremity amputation
* Being at less than stage 4 according to Brunnstrom staging

Primary outcomes:
measure: The Fugl Meyer assessment
timeFrame: Beginning of the study and end of week 8 (when 24 sessions are completed)
measure: Action Research Arm Test (ARAT)
timeFrame: Beginning of the study and end of week 8 (when 24 sessions are completed)
measure: The Box-Block Test
timeFrame: Beginning of the study and end of week 8 (when 24 sessions are completed)
measure: Nine hole Peg Test
timeFrame: Beginning of the study and end of week 8 (when 24 sessions are completed)
Secondary outcomes:
measure: Environmental Quality Scale
timeFrame: Beginning of the study and end of week 8 (when 24 sessions are completed)
measure: Upper Extremity Motor Activity Diary-28
timeFrame: Beginning of the study and end of week 8 (when 24 sessions are completed)
measure: Social Adaptation Scale
timeFrame: Beginning of the study and end of week 8 (when 24 sessions are completed)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstinye University, Bahçeşehir Liv Hospital
state: Bahçeşir
city: Samsun
country: Turkey
facility: Ondokuz Mayıs Üniversitesi, SUVAM Havza Fizik Tedavi ve Rehabilitasyon Merkezin
state: Havza
Study officials:
affiliation: Istinye University
name: Berrak Varhan
role: STUDY_DIRECTOR
affiliation: Ondokuz Mayıs University
name: Mahmut Yaran
role: STUDY_DIRECTOR
References:
citation: EFFECTIVENESS OF THE PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION METHOD APPLICATION ON UPPER LIMB FUNCTIONS IN PATIENTS AFTER STROKE: A SYSTEMATIC REVIEW OF LITERATURE