Parkinson DiseaseEMTPDRNCT03546244
Evaluation of Efficacy of Musical Treadmill in PD Rehabilitation
A study testing musical treadmill and Traditional treadmill in people with Parkinson Disease and Gait Disorders, Neurologic, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial summary
In order to evaluate the effectiveness of musical treadimll on gait parameters in patients with Parkinson's Disease, the investigators compare the outcome measures on two group of patients: one will undergo a 4-week daily musical treadmill training and one will undergo a 4-week daily traditional treadmill training Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic, Treadmill
- What is being tested?
- musical treadmill and Traditional treadmill
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jan 2018to 3 Jan 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stage 2.5-3 according to the Hoehn and Yahr scale (H\&Y);
- Stable pharmacological treatment for the last 6 weeks before the enrolment and during the hospitalization;
- Mini Mental State Examination (MMSE) ≥ 24;
Who cannot join
- Any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous 12 months;
- Drug-induced dyskinesias;
- Disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of UPDRS III;
- Behavioral disturbances (evaluated with Neuropsychiatric Inventory);
- Visual and auditory dysfunctions according to the general clinical evaluation and medical history;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
Gravedona Ed Uniti, Como, 22015
Paola Ortelli, PsyD, +39 0344 82706, ortellipaola73@gmail.com
About this study
Official title: Effects of Musical Treadmill Training vs Traditional Treadmill Training on Gait Parameters in Patinets With Parkinson's Disease
In order to evaluate the effectiveness of musical treadimll on gait parameters in patients with Parkinson's Disease, the investigators compare the outcome measures on two group of patients: one will undergo a 4-week daily musical treadmill training and one will undergo a 4-week daily traditional treadmill training
Read the detailed description
Gait is altered in Parkinson's disease (PD) patients. It has been shown that treadmill training is useful in improving the gait's parameters in patients in early-moderate stages of disease. Moreover, it has been shown that the music, exploiting the entrainment, is effective in order to ameliorate several gait parameters, as step lenghts and cadence. No data are available about the effectiveness of the association between treadmill and music. The aim of this study is to evaluate the effect of a gait training using musical treadmill in patients in stages I-II-III Hoehn \& Yahr (H\&Y).
100 patients with PD in early-moderate stage of disease will be enrolled. All patients will undergo an intensive treatment: 2 session of 20-minutes treadmill training per day, 5 times a week, for 4 weeks. Treadmill speed will be previously set at 20% less the confidence speed and progressively increased of 20%. All patients will be evaluat at the enrolment and at the end of the treatment. The outcome misures are: 6 Minute Walking Test and Timed Up and Go Test.
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic, Treadmill
- Being tested
- musical treadmill, Traditional treadmill
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musical treadmillBehavioural
Patients will undergo a 4-week, 2 daily, incremental session of training with musical treadmill
Traditional treadmillBehavioural
Patients will undergo a 4-week, 2 daily, incremental session of training with traditional treadmill
| Study group | Role | What they receive |
|---|---|---|
| musical treadmill | Experimental | 4-week daily musical treadmill training, consisting in two session, 20 minute per session Receives: Behavioral: musical treadmill |
| traditional session | Active comparator | 4-week daily traditional treadmill training, consisting in two session, 20 minute per session Receives: Behavioral: Traditional treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minutes Walking Test
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes
Measured: 4 week
Timed up and Go Test
The TUG is aimed to measure the ability of patients to perform sequential locomotor tasks that incorporate walking and turning
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start3 Jan 2018
- Primary completion3 Jan 2018
- Study completion3 Jan 2019 (estimated)
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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Sebastianelli, Ospedale Generale Di Zona Moriggia-Pelascini
- Investigators
- Giuseppe Frazzitta, MD, Principal investigator, Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546244
- Sponsor's protocol ID
- Musical Treadmill in PD
- Acronym
- EMTPDR
- Status last verified
- May 2018
- First submitted
- 8 May 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Musical Treadmill Training vs Traditional Treadmill Training on Gait Parameters in Patinets With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03546244
- Acronym / sponsor ID
- EMTPDR / Musical Treadmill in PD
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic, Treadmill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 3 Jan 2018 (actual)
- Study completion
- 3 Jan 2019 (estimated)
- First posted
- 6 Jun 2018 (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.
In order to evaluate the effectiveness of musical treadimll on gait parameters in patients with Parkinson's Disease, the investigators compare the outcome measures on two group of patients: one will undergo a 4-week daily musical treadmill training and one will undergo a 4-week daily traditional treadmill training
Detailed description
Gait is altered in Parkinson's disease (PD) patients. It has been shown that treadmill training is useful in improving the gait's parameters in patients in early-moderate stages of disease. Moreover, it has been shown that the music, exploiting the entrainment, is effective in order to ameliorate several gait parameters, as step lenghts and cadence. No data are available about the effectiveness of the association between treadmill and music. The aim of this study is to evaluate the effect of a gait training using musical treadmill in patients in stages I-II-III Hoehn \& Yahr (H\&Y).
100 patients with PD in early-moderate stage of disease will be enrolled. All patients will undergo an intensive treatment: 2 session of 20-minutes treadmill training per day, 5 times a week, for 4 weeks. Treadmill speed will be previously set at 20% less the confidence speed and progressively increased of 20%. All patients will be evaluat at the enrolment and at the end of the treatment. The outcome misures are: 6 Minute Walking Test and Timed Up and Go Test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| musical treadmill | Experimental | Behavioral: musical treadmill4-week daily musical treadmill training, consisting in two session, 20 minute per session |
| traditional session | Active comparator | Behavioral: Traditional treadmill4-week daily traditional treadmill training, consisting in two session, 20 minute per session |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Stage 2.5-3 according to the Hoehn and Yahr scale (H\&Y);
- Stable pharmacological treatment for the last 6 weeks before the enrolment and during the hospitalization;
- Mini Mental State Examination (MMSE) ≥ 24;
Key exclusion criteria (5 listed)
- Any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous 12 months;
- Drug-induced dyskinesias;
- Disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of UPDRS III;
- Behavioral disturbances (evaluated with Neuropsychiatric Inventory);
- Visual and auditory dysfunctions according to the general clinical evaluation and medical history;
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 |
|---|---|---|
| musical treadmillPatients will undergo a 4-week, 2 daily, incremental session of training with musical treadmill | Behavioural | musical treadmill |
| Traditional treadmillPatients will undergo a 4-week, 2 daily, incremental session of training with traditional treadmill | Behavioural | traditional session |
Primary outcome
6 Minutes Walking Test
Time frame: 4 week
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes
Timed up and Go Test
Time frame: 4 week
The TUG is aimed to measure the ability of patients to perform sequential locomotor tasks that incorporate walking and turning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Giuseppe Frazzitta, MD principal investigator
Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing musical treadmill and Traditional treadmill in people with Parkinson Disease and Gait Disorders, Neurologic, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Ortelli, PsyD (3332974872, ortellipaola73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minutes Walking Test (time frame: 4 week). The study lists 2 primary outcomes in all. 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 6 Jun 2018; AzTrials last refreshed its copy on 8 Nov 2026.