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
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
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
NCT ID
NCT03104049
First Posted
March 27, 2017
Last Updated
October 17, 2022
Sponsor
IRCCS San Raffaele Roma
Collaborators
Politecnico di Milano
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
Learn more about this trial
Pilot Study on the Effects of Neuromuscular Taping in Parkinson's Disease Patients
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