Pilot Study on the Effects of Neuromuscular Taping in Parkinson's Disease Patients (NMT-PD)

Parkinson's disease (PD) is a degenerative disorder characterized by a symptom triad consisting on: tremor, rigidity and bradykinesia . To these symptoms it is often added postural alteration that can stand in two different attitudes, such as the camptocormia and the syndrome of Pisa . Progressing in its evolution, PD becomes increasingly disabling, making it difficult or even impossible daily activities such as washing or dressing.The abnormal posture, with alteration of the limbs, the neck and trunk, is a recurring feature in PD, with a frequency of about 30%. Between 2% and 12.3% are more severe abnormalities such as camptocormia, the syndrome of Pisa and the anterocollis. Several studies disease plug in Neuromuscular Taping technique (NMT) among rehabilitative tools in degenerative neurological syndromes.

To the best of our knowledge, no applications were found in PD. Therefore, the current study was designed to evaluate quantitatively the effects of the NMT intervention on the trunk kinematics during standing position. More specifically, this study aims to compare the trunk kinematic variables of patients with PD who were treated with effective NMT versus those of the subjects who received only the pharmacological treatment.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Neuromuscular taping

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Diagnosis of idiopathic PD by United Kingdom Brain Bank criteria
• No other significant neurological or orthopedic problems
• Age between 55 and 80 years
• MDS-UPDRS item 3.13 Posture between mild and moderate (definite flexion, scoliosis or leaning to one side)
• Patient able to walk independently or with minimal assistance for 10 meters
• Medical treatment for Parkinson's Disease must be stable for at least two weeks prior to inclusion, and during the study. During the study, the dosage of anti-parkinsonian drug treatment should not change, if it is not deemed necessary by the investigator.

Exclusion criteria:

• Disability to understand instructions required by the study (Informed Consent Test of Comprehension)
• primarily wheelchair bound
• Skin abrasions
• sensitive skin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the PD NMT Group; the NMT Group were treated with NMT	Device: Neuromuscular taping; NMT applications: rhomboid major muscle; muscles abdominals; spinal muscles; pectoralis major muscles; gastrocnemius muscle; upper trapezius muscle; anterior muscles of the neck; Other Names: NMT
No Intervention: The PD Group without NMT; The patients received only their usual pharmacological PD therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating scale total score between baseline evaluations and end of treatment	Clinical measures were summarized as means and standard deviations for all the 46 patients.	baseline and end of treatment (1 month)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Parkinson Disease Quality of life 8 total score between baseline evaluations and end of treatment	Clinical measures were summarized as means and standard deviations for all the 46 patients.	baseline and end of treatment (1 month)
Change in the Non Motor Symptoms scale total score between baseline evaluations and end of treatment	Clinical measures were summarized as means and standard deviations for all the 46 patients.	baseline and end of treatment (1 month)
Change in the EuroQol 5 total score between baseline evaluations and end of treatment	Clinical measures were summarized as means and standard deviations for all the 46 patients.	baseline and end of treatment (1 month)
Change in the Freezing of Gait total score between baseline evaluations and end of treatment	Clinical measures were summarized as means and standard deviations for all the 46 patients.	baseline and end of treatment (1 month)

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele Roma
• Collaborators: Politecnico di Milano

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2015
• Primary Completion (Actual): December 18, 2016
• Study Completion (Actual): January 8, 2017

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; Parkinson's Disease; Posture; Trunk; Kinematic; Neuromuscular taping
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: RP 07/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No