NCT06967584

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2025

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

April 19, 2025

Last Update Submit

July 24, 2025

Conditions

Keywords

StrokeKinesio tapingChest PhysiotherapyRespiratory test

Outcome Measures

Primary Outcomes (5)

  • Forced Vital Capacity (FVC)

    Pulmonary function testing will be performed in a sitting position using a portable spirometer according to American Thoracic Society guidelines. Spirometry is a standard pulmonary function test used to assess how effectively the lungs are operating. The test will calculate FVC (The volume delivered during an expiration made as forcefully and completely as possible starting from full inspiration)

    Through study completion, an average of 1 month

  • Forced Expiratory Volume in the first second (FEV1)

    Pulmonary function testing will be performed in a sitting position using a portable spirometer according to American Thoracic Society guidelines. Spirometry is a standard pulmonary function test used to assess how effectively the lungs are operating. The test will calculate FEV1 (The volume delivered in the first second of a FVC maneuver.)

    Through study completion, an average of 1 month

  • Peak Expiratory Flow (PEF)

    Pulmonary function testing will be performed in a sitting position using a portable spirometer according to American Thoracic Society guidelines. Spirometry is a standard pulmonary function test used to assess how effectively the lungs are operating. The test will calculate PEF (The highest forced expiratory flow measured with a peak flow meter. In other word, this measures the maximum speed at which the patient can exhale air.)

    Through study completion, an average of 1 month

  • Respiratory Muscle Strength

    Respiratory muscle strength, including maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), will be evaluated using an electronic pressure transducer (MicroRPM; Micro Medical Ltd., Kent, United Kingdom). For the MIP measurement, the patient will be seated comfortably. Following a maximal exhalation, the nose will be occluded using a nasal clip, and a maximal inhalation will be performed through a mouthpiece. For the MEP measurement, after a maximal inhalation in the same seated position, the nose will again be closed with a clip, and a maximal exhalation will be carried out through the mouthpiece. Each measurement will be repeated three times, and the highest value will be recorded. Assessments will be performed twice: once at baseline and once at the end of the approximately one-month intervention period.

    Through study completion, an average of 1 month

  • Functional Capacity

    Functional capacity will be assessed using the Functional Bridge Test (FBT). In this test, the patient lies in a supine position on a bed and performs a bridge movement, which involves lifting the hips and extending the trunk against gravity, thereby engaging the hip and trunk extensor muscles. This maneuver is intended to evaluate the postural control function of the proximal lower-extremity and trunk muscles, which are essential for bed mobility. The test is graded on a four-point scale to assess functional capacity: Grade 1: Difficulty initiating lift-off Grade 2: Insufficient hip elevation Grade 3: Slightly insufficient hip elevation Grade 4: Sufficient hip elevation Assessments will be conducted twice: once at baseline and once at the end of the one-month intervention period.

    Through study completion, an average of 1 month

Secondary Outcomes (5)

  • Symptoms- Dyspnea, Fatigue, pain, cough and sputum

    Through study completion, an average of 1 month

  • Functional Independence Measure

    Through study completion, an average of 1 month

  • Muscle Strength

    Through study completion, an average of 1 month

  • Grip Strength

    Through study completion, an average of 1 month

  • Muscle Tone

    Through study completion, an average of 1 month

Study Arms (2)

Kinesio Taping group

EXPERIMENTAL
Other: Kinesio Taping

Sham Kinesio Taping group

SHAM COMPARATOR
Other: Sham Kinesio Taping

Interventions

The Kinesio tape will be applied anteriorly and posteriorly along the subcostal region to facilitate the respiratory muscles. Anteriorly, an "I"-shaped Kinesio tape will be applied with the base anchored on the xiphoid process, stretched to 50-75% tension, applied only to the linea alba. The ends of the tape will be applied without tension toward the subcostal curvature. Posteriorly, a second "I"-shaped Kinesio tape will be applied. The base of the tape will be anchored on the spinous process of the 12th thoracic vertebra with 50-75% tension, and the tails will be applied without tension toward the ribs

Kinesio Taping group

The Kinesio tape will be applied anteriorly and posteriorly along the subcostal region but without tension

Sham Kinesio Taping group

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients with stroke diagnosis by a neurologist
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstinye University Bahçeşehir Liv Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HemiplegiaStroke

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Roya Soltanalizadeh, Specialist

    Istinye University

    STUDY CHAIR
  • Yunus Emre Tütüneken, Pt.MSc.PhD

    Istinye University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

April 19, 2025

First Posted

May 13, 2025

Study Start

November 11, 2024

Primary Completion

July 23, 2025

Study Completion

July 23, 2025

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations