Parkinson DiseaseNMT-PDNCT03104049
Pilot Study on the Effects of Neuromuscular Taping in Parkinson's Disease Patients
A study testing Neuromuscular taping in people with Parkinson Disease, run by IRCCS San Raffaele Roma.
Trial 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 . Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Neuromuscular taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2015to 8 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Disability to understand instructions required by the study (Informed Consent Test of Comprehension)
- primarily wheelchair bound
- Skin abrasions
- sensitive skin
About this study
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.
- Conditions
- Parkinson Disease
- Being tested
- Neuromuscular taping
- Keywords
- Parkinson's Disease, Neuromuscular taping, Trunk, Posture, Kinematic, rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular tapingDevice
Also called NMT
NMT applications:
- rhomboid major muscle
- muscles abdominals
- spinal muscles
- pectoralis major muscles
- gastrocnemius muscle
- upper trapezius muscle
- anterior muscles of the neck
| Study group | Role | What they receive |
|---|---|---|
| the PD NMT Group | Active comparator | the NMT Group were treated with NMT Receives: Device: Neuromuscular taping |
| The PD Group without NMT | No intervention | The patients received only their usual pharmacological PD therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and end of treatment (1 month)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and end of treatment (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start20 Nov 2015
- Primary completion18 Dec 2016
- Study completion8 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104049
- Sponsor's protocol ID
- RP 07/15
- Acronym
- NMT-PD
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2017
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effects of Neuromuscular Taping in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT03104049
- Acronym / sponsor ID
- NMT-PD / RP 07/15
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Neuromuscular taping, Trunk, Posture, Kinematic, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Collaborators
- Politecnico di Milano
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 18 Dec 2016 (actual)
- Study completion
- 8 Jan 2017 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the PD NMT Group | Active comparator | Device: Neuromuscular tapingthe NMT Group were treated with NMT |
| The PD Group without NMT | No intervention | –The patients received only their usual pharmacological PD therapy |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Disability to understand instructions required by the study (Informed Consent Test of Comprehension)
- primarily wheelchair bound
- Skin abrasions
- sensitive skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular tapingAlso: NMTNMT applications: 1. rhomboid major muscle 2. muscles abdominals 3. spinal muscles 4. pectoralis major muscles 5. gastrocnemius muscle 6. upper trapezius muscle 7. anterior muscles of the neck | Device | the PD NMT Group |
Primary outcome
Change in the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating scale total score between baseline evaluations and end of treatment
Time frame: baseline and end of treatment (1 month)
Clinical measures were summarized as means and standard deviations for all the 46 patients.
4 secondary outcomes
Change in the Parkinson Disease Quality of life 8 total score between baseline evaluations and end of treatment
Time frame: baseline and end of treatment (1 month)
Change in the Non Motor Symptoms scale total score between baseline evaluations and end of treatment
Time frame: baseline and end of treatment (1 month)
Change in the EuroQol 5 total score between baseline evaluations and end of treatment
Time frame: baseline and end of treatment (1 month)
Change in the Freezing of Gait total score between baseline evaluations and end of treatment
Time frame: baseline and end of treatment (1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular taping in people with Parkinson Disease, run by IRCCS San Raffaele Roma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating scale total score between baseline evaluations and end of treatment (time frame: baseline and end of treatment (1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.