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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuromuscular taping
Sponsored by
IRCCS San Raffaele Roma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, Neuromuscular taping, Trunk, Posture, Kinematic, rehabilitation

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    the PD NMT Group

    The PD Group without NMT

    Arm Description

    the NMT Group were treated with NMT

    The patients received only their usual pharmacological PD therapy

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    March 27, 2017
    Last Updated
    October 17, 2022
    Sponsor
    IRCCS San Raffaele Roma
    Collaborators
    Politecnico di Milano
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03104049
    Brief Title
    Pilot Study on the Effects of Neuromuscular Taping in Parkinson's Disease Patients
    Acronym
    NMTPD
    Official Title
    Pilot Study on the Effects of Neuromuscular Taping in Parkinson's Disease Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 20, 2015 (Actual)
    Primary Completion Date
    December 18, 2016 (Actual)
    Study Completion Date
    January 8, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    IRCCS San Raffaele Roma
    Collaborators
    Politecnico di Milano

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Parkinson's Disease, Neuromuscular taping, Trunk, Posture, Kinematic, rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    the PD NMT Group
    Arm Type
    Active Comparator
    Arm Description
    the NMT Group were treated with NMT
    Arm Title
    The PD Group without NMT
    Arm Type
    No Intervention
    Arm Description
    The patients received only their usual pharmacological PD therapy
    Intervention Type
    Device
    Intervention Name(s)
    Neuromuscular taping
    Other Intervention Name(s)
    NMT
    Intervention Description
    NMT applications: rhomboid major muscle muscles abdominals spinal muscles pectoralis major muscles gastrocnemius muscle upper trapezius muscle anterior muscles of the neck
    Primary Outcome Measure Information:
    Title
    Change in the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating scale total score between baseline evaluations and end of treatment
    Description
    Clinical measures were summarized as means and standard deviations for all the 46 patients.
    Time Frame
    baseline and end of treatment (1 month)
    Secondary Outcome Measure Information:
    Title
    Change in the Parkinson Disease Quality of life 8 total score between baseline evaluations and end of treatment
    Description
    Clinical measures were summarized as means and standard deviations for all the 46 patients.
    Time Frame
    baseline and end of treatment (1 month)
    Title
    Change in the Non Motor Symptoms scale total score between baseline evaluations and end of treatment
    Description
    Clinical measures were summarized as means and standard deviations for all the 46 patients.
    Time Frame
    baseline and end of treatment (1 month)
    Title
    Change in the EuroQol 5 total score between baseline evaluations and end of treatment
    Description
    Clinical measures were summarized as means and standard deviations for all the 46 patients.
    Time Frame
    baseline and end of treatment (1 month)
    Title
    Change in the Freezing of Gait total score between baseline evaluations and end of treatment
    Description
    Clinical measures were summarized as means and standard deviations for all the 46 patients.
    Time Frame
    baseline and end of treatment (1 month)

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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