- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07555847
Effect of Kinesiotaping on Tremor in People With Parkinson's Disease
Effect of Kinesiotaping on Hand Tremor in Patients With Parkinson's Disease: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether adding kinesiotaping to a strengthening and stretching home-exercise program can reduce hand tremor and improve hand function in people with Parkinson's disease. The study will also examine how true kinesiotaping compares with sham (placebo) taping and with exercise alone in improving tremor frequency, grip strength, fine motor skills, motor symptoms, daily living activities, and quality of life.
Adults aged 18-80 with Parkinson's disease and hand tremor will be randomly assigned to one of three groups:
Kinesiotaping + Exercise Group: Participants will receive therapeutic kinesiotaping applied to the forearm extensor muscles and wrist for 4 weeks (twice weekly), in addition to a home program of strengthening and stretching exercises.
Sham Taping + Exercise Group: Participants will receive a placebo taping without tension that does not target specific muscles, along with the same exercise program.
Exercise-Only Group: Participants will complete the same home-exercise program without any taping.
Researchers will compare the three groups to see whether kinesiotaping provides additional benefits beyond exercise and whether it performs better than sham taping. Tremor frequency will be measured using an Apple Watch device, and hand strength, dexterity, motor symptoms, and quality of life will be assessed using validated clinical scales.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Resting tremor is one of the main motor symptoms in Parkinson's disease and can significantly limit daily activities, fine motor skills, and upper-extremity function. This clinical trial is designed to evaluate whether adding therapeutic kinesiotaping to a home-based exercise program can reduce hand tremor and improve hand function. The study also aims to compare the effectiveness of true kinesiotaping with sham (placebo) taping and to determine whether either method provides additional benefit beyond exercise alone.
This randomized, controlled, three-arm clinical trial will include participants aged 18 to 80 years who have been diagnosed with Parkinson's disease and experience hand tremor. Participants will be randomly assigned to one of three groups: (1) Kinesiotaping + Exercise, (2) Sham Taping + Exercise, or (3) Exercise Only. All participants will receive a standardized home-exercise program that includes strengthening and stretching exercises targeting forearm muscles. The exercise program will be performed once daily for four weeks.
In the kinesiotaping group, therapeutic taping will be applied to the forearm extensor muscles and wrist using functional taping techniques with appropriate tension and directional application. This approach aims to enhance proprioceptive input, improve muscle activation, and reduce tremor amplitude. In the sham taping group, tape will be applied without therapeutic tension and without following muscle-fiber orientation, providing a placebo intervention. The control group will receive the exercise program only, without any taping.
Tremor severity and frequency will be assessed using accelerometer data from an Apple Watch worn on the affected wrist. Grip strength will be measured with a Jamar dynamometer, and hand dexterity will be evaluated using the Nine Hole Peg Test. Motor symptoms will be assessed with the MDS-UPDRS Part 3, and quality of life will be evaluated using the Parkinson's Disease Questionnaire (PDQ-39). Outcomes will be measured at baseline (T0), at the end of the 4-week intervention (T1), and two weeks after the end of treatment (T2).
The primary objective of this study is to determine whether kinesiotaping provides additional benefit in reducing hand tremor compared with exercise alone. Secondary objectives include evaluating improvements in hand function, changes in grip strength, changes in motor symptoms, and improvements in quality-of-life measures. Kinesiotaping is expected to support tremor control by enhancing proprioceptive feedback. The sham taping group is included to control for placebo effects and to distinguish the specific therapeutic contribution of true kinesiotaping.
This study aims to provide clinical evidence on the usefulness of kinesiotaping as an adjunct to exercise for managing tremor in individuals with Parkinson's disease. The three-arm design will allow clear comparison between true taping, sham taping, and exercise alone, helping to identify the unique effects of kinesiotaping.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Uskudar
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Istanbul, Uskudar, Turkey (Türkiye), 34668
- University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of idiopathic Parkinson's disease
- Hoehn and Yahr stage 1-4
- Presence of hand tremor
- Mini-Mental State Examination (MMSE) score ≥ 23
- Stable medical treatment for at least 3 months prior to enrollment and no planned changes during the study period
- Age between 18 and 80 years
- Ability to understand and provide written informed consent
Exclusion Criteria:
- Diagnosis of essential tremor or tremor due to causes other than Parkinson's disease
- Advanced motor impairment (severe bradykinesia or dyskinesia)
- History of allergic reaction to kinesiotaping materials
- Presence of other neurological disorders causing tremor (e.g., ALS, multiple sclerosis, cerebellar disorders)
- Severe psychiatric disorders (e.g., major depression, psychosis, severe anxiety)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kinesiotaping + Exercise
Participants receive therapeutic kinesiotaping applied to the forearm extensor muscles and wrist twice weekly for 4 weeks, in addition to a daily home-based strengthening and stretching exercise program.
|
Kinesiotaping applied to forearm extensor muscles with therapeutic tension and direction, twice weekly for 4 weeks
Daily strengthening and stretching exercises targeting forearm muscles, performed for 4 weeks.
|
|
Sham Comparator: Sham Taping + Exercise
Participants receive sham taping without therapeutic tension and without following muscle-fiber orientation, applied twice weekly for 4 weeks, along with the same daily home-based exercise program
|
Daily strengthening and stretching exercises targeting forearm muscles, performed for 4 weeks.
Placebo taping applied without therapeutic tension and without muscle alignment, twice weekly for 4 weeks
|
|
Active Comparator: Exercise Only
Participants complete the standardized daily home-based strengthening and stretching exercise program for 4 weeks, with no taping applied
|
Daily strengthening and stretching exercises targeting forearm muscles, performed for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tremor Frequency (Hz)
Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
|
Change in dominant tremor frequency measured using Apple Watch sensors (accelerometer and gyroscope) during a standardized 60-second recording period.
Lower frequency values indicate improvement in tremor severity.
|
Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand Grip Strength (kg)
Time Frame: Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
|
Measured using a Jamar hand dynamometer.
Higher values indicate better muscle strength.
|
Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
|
|
Pinch Strength (kg)
Time Frame: Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
|
Measured using a Jamar pinch meter.
Higher values indicate better finger strength.
|
Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
|
|
Fahn-Tolosa-Marin Tremor Rating Scale Score
Time Frame: Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
|
Clinician-rated scale assessing tremor severity.
Scores range from 0 to 144, with higher scores indicating more severe tremor.
|
Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
|
|
Nine-Hole Peg Test
Time Frame: Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
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Measures fine motor dexterity and hand coordination.
Shorter completion time indicates better performance.
|
Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
|
|
MDS-UPDRS Part III Score
Time Frame: Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
|
Clinician-rated motor examination assessing severity of Parkinsonian motor symptoms.
Scores range from 0 to 132, with higher scores indicating worse motor impairment.
|
Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
|
|
Parkinson's Disease Questionnaire-39 (PDQ-39) Score
Time Frame: Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
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Patient-reported quality of life measure.
Scores range from 0 to 100, with higher scores indicating worse quality of life.
|
Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
|
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Barthel Index Score
Time Frame: Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
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Measures independence in activities of daily living.
Scores range from 0 to 100, with higher scores indicating greater independence.
|
Time Frame: Baseline (Day 0), End of treatment (Week 4), and Follow-up (Week 8; 4 weeks after treatment completion)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mehmet Akif Guler, University of Health Sciences, Sultan 2. Abdulhamid Han Training and Research Hospital
Publications and helpful links
General Publications
- Giray E, Karali-Bingul D, Akyuz G. The Effectiveness of Kinesiotaping, Sham Taping or Exercises Only in Lateral Epicondylitis Treatment: A Randomized Controlled Study. PM R. 2019 Jul;11(7):681-693. doi: 10.1002/pmrj.12067. Epub 2019 Mar 28.
- Dai H, Lin H, Lueth TC. Quantitative assessment of parkinsonian bradykinesia based on an inertial measurement unit. Biomed Eng Online. 2015 Jul 12;14:68. doi: 10.1186/s12938-015-0067-8.
- Shahien M, Elaraby A, Gamal M, Abdelazim E, Abdelazeem B, Ghaith HS, Negida A. Physical therapy interventions for the management of hand tremors in patients with Parkinson's disease: a systematic review. Neurol Sci. 2023 Feb;44(2):461-470. doi: 10.1007/s10072-022-06420-1. Epub 2022 Oct 7.
- Mahadevan N, Demanuele C, Zhang H, Volfson D, Ho B, Erb MK, Patel S. Development of digital biomarkers for resting tremor and bradykinesia using a wrist-worn wearable device. NPJ Digit Med. 2020 Jan 15;3:5. doi: 10.1038/s41746-019-0217-7. eCollection 2020.
- Bravi R, Quarta E, Cohen EJ, Gottard A, Minciacchi D. A little elastic for a better performance: kinesiotaping of the motor effector modulates neural mechanisms for rhythmic movements. Front Syst Neurosci. 2014 Sep 25;8:181. doi: 10.3389/fnsys.2014.00181. eCollection 2014.
- Capecci M, Serpicelli C, Fiorentini L, Censi G, Ferretti M, Orni C, Renzi R, Provinciali L, Ceravolo MG. Postural rehabilitation and Kinesio taping for axial postural disorders in Parkinson's disease. Arch Phys Med Rehabil. 2014 Jun;95(6):1067-75. doi: 10.1016/j.apmr.2014.01.020. Epub 2014 Feb 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Synucleinopathies
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Dyskinesias
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Parkinson Disease
- Tremor
Other Study ID Numbers
- PD-KT-RCT-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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