Clinical trial NCT06967584: Kinesiotaping on HP Patients Pulmonary Parameters
Official title: Effects of Thoracic Kinesio Taping on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Patients With Hemiplegia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegic Patients
Hemiplegia
Keywords: Stroke
Kinesio taping
Chest Physiotherapy
Respiratory test
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether thoracic kinesio taping contributes to the improvement of pulmonary function, the strengthening of respiratory muscles and the enhancement of overall physical ability in stroke patients with hemiplegia. To assess this, a randomized controlled trial will be conducted involving 30 patients aged between 45 and 80 years who have been diagnosed with hemiplegia resulting from a stroke. Participants will be randomly assigned to one of two groups: the Kinesio Taping Group (KTG) or the Sham Kinesio Taping Group (SKTG). The duration of the intervention will be four weeks. During this period, individuals in the KTG will receive thoracic kinesio taping in addition to standard rehabilitation care. In the SKTG, taping will be applied to the same thoracic area but without tension. Measurements will be obtained both before and after the intervention. These assessments will include pulmonary function tests (such as forced vital capacity and forced expiratory volume), evaluations of respiratory muscle strength (specifically maximum inspiratory pressure), and assessments of functional capacity.

Detailed description: Hemiplegia, a condition commonly occurring after a stroke, results in paralysis or significant weakness on one side of the body. Although it is primarily recognized for limiting movement in the limbs, hemiplegia can also profoundly affect respiratory function. Many individuals with hemiplegia experience compromised respiratory performance, which can negatively impact overall health, delay recovery, and reduce quality of life. When a stroke affects brain regions responsible for motor control, it may also impair the muscles involved in breathing. Consequently, individuals with hemiplegia often present with weakened respiratory muscles, restricted thoracic mobility, and diminished lung function. These impairments can lead to insufficient oxygen intake, increased susceptibility to respiratory infections such as pneumonia, and prolonged hospitalization. In addition to muscle weakness, patients may develop stiffness in the chest wall and diaphragm, which limits thoracic expansion during inhalation. This restriction can reduce lung capacity and increase the effort required for breathing. Over time, decreased movement in the thoracic region may result in muscle fibrosis and further loss of flexibility. These changes contribute to symptoms such as dyspnea, fatigue, and reduced functional capacity in daily activities. Furthermore, malnutrition-commonly observed in individuals with neurological conditions like stroke-can exacerbate respiratory muscle weakness and increase the risk of respiratory failure. The interplay between poor nutritional status, weakened respiratory muscles, and compromised lung function may create a detrimental cycle that hinders recovery. To improve pulmonary function in patients with hemiplegia, thoracic kinesio taping may be a promising method. This technique involves applying elastic therapeutic tape to the thoracic region to support muscular function, improve posture, enhance breathing mechanics, and increase proprioceptive awareness.

The present study aims to determine whether thoracic kinesio taping can enhance pulmonary function (i.e., lung performance), strengthen respiratory muscles (particularly those involved in inspiration), and improve overall physical capacity in stroke patients with hemiplegia. To evaluate this, a randomized controlled trial will be conducted involving 30 patients between the ages of 45 and 80 who have been diagnosed with hemiplegia resulting from a stroke. All participants will be medically stable and will have experienced a stroke within the previous six months. Patients with significant cardiac or neurological comorbidities, psychiatric conditions impairing communication, or dermatological sensitivities will be excluded to ensure safety and data integrity.

The intervention will span four weeks. During this period, participants will receive thoracic kinesio taping in addition to standard rehabilitation care. In the control group, sham taping will be applied to the same thoracic region without tension. Assessments will be performed before and after the intervention. These will include pulmonary function tests (e.g., forced vital capacity and forced expiratory volume), measurements of respiratory muscle strength (specifically maximum inspiratory pressure, or MIP), and evaluations of functional capacity. It is anticipated that an improvement in MIP may be observed, suggesting a strengthening of inspiratory muscles due to the intervention. No significant changes are expected in maximum expiratory pressure (MEP), which assesses expiratory muscle strength. Any observed improvements in respiratory parameters and daily functional abilities would support the efficacy of thoracic kinesio taping as a supplementary tool in stroke rehabilitation.

This study holds significance by addressing a frequently overlooked component of stroke recovery: respiratory health. Identifying effective strategies to support pulmonary function may enhance recovery outcomes, reduce complications, and promote greater independence in daily life. The results of this study may also inform the development of more comprehensive rehabilitation protocols for individuals with hemiplegia.

Eligibility criteria: Inclusion Criteria:

* The patients with stroke diagnosis by a neurologist
* 45-80 years old
* Participating to the study in a voluntary basis.
* Patients with clinical setting
* Patient diagnosed at lest stroke attack within 6 months
* They are Medically stable situation

Exclusion Criteria:

* Any Other neurological or orthopedic problems that will affect function other than Stroke
* Patients having unstable
* Severe heart diseases like heart failure, unstable hypertension, previous angina pectoris or myocardial infarction
* Skin sensitivity against kinesio tape
* Lesion or incision in the area of kinesio tape application
* Use of analgesics during study period .
* Mental and cognitive disorders that would affect cooperation.

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: Through study completion, an average of 1 month
measure: Forced Expiratory Volume in the first second (FEV1)
timeFrame: Through study completion, an average of 1 month
measure: Peak Expiratory Flow (PEF)
timeFrame: Through study completion, an average of 1 month
measure: Respiratory Muscle Strength
timeFrame: Through study completion, an average of 1 month
measure: Functional Capacity
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: Symptoms- Dyspnea, Fatigue, pain, cough and sputum
timeFrame: Through study completion, an average of 1 month
measure: Functional Independence Measure
timeFrame: Through study completion, an average of 1 month
measure: Muscle Strength
timeFrame: Through study completion, an average of 1 month
measure: Grip Strength
timeFrame: Through study completion, an average of 1 month
measure: Muscle Tone
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstinye University Bahçeşehir Liv Hospital
Study officials:
affiliation: Istinye University
name: Roya Soltanalizadeh, Specialist
role: STUDY_CHAIR
affiliation: Istinye University
name: Yunus Emre Tütüneken, Pt.MSc.PhD
role: STUDY_CHAIR
References: