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Parkinson DiseaseNCT06278623

Focal Muscle Vibration in Parkinson's Disease

An observational study of Parkinson Disease and Postural; Defect, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Postural instability has a major impact on the mobility and daily life activities of Parkinson's disease (PD) patients as it often leads to reduced mobility, insecure stance and falls. Read more about this study

Who is it for?
Ages 18 months and older
What is being tested?
Focal Muscle Vibratory Energy (EVM) Treatment
Type of treatment
Medical device
How many people
23 participants
Where
1 siteItaly
Study dates
11 May 2023to 1 Dec 2025
Phase
Observational
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 18 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients affected by Parkinson's disease, who refer to the Physiatry clinic of the Gemelli University Hospital Foundation in Rome.

Who may be able to join

  • diagnosis of Parkinson's disease according to the criteria of the Brain Bank of London;
  • Hoehn and Yahr stage II-III;
  • absence of cognitive impairment
  • (MMSE > 24/30); e
  • effective pharmacological control of the pathology;
  • being part of the PD group-rehabilitation program of our ward for at least one year; -
  • acceptance and signature of informed consent.

Who cannot join

  • comprised: a diagnosis of atypical Parkinsonism;
  • poor pharmacological compensation of the disease;
  • diagnosis of other neurological diseases;
  • diagnosisof neuromuscular diseases;
  • diagnosis of osteo-articular pathologies;
  • cognitive impairment (MMSE < 24);
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  • visual impairment;
  • vestibular disorders;
  • not being part of our PD group-rehabilitation for at least one year;
  • denial of informed consent

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting
  • Gianpaolo Ronconi

    Roma, 00168

    gianpaolo ronconi, +393477123940, gronconi@yahoo.it

    Recruiting

Other trials in Italy

About this study

Official title: Effects of Focal Muscle Vibratory Energy in Patients With Parkinson's Disease: Pilot Prospective Observational Study.

Postural instability has a major impact on the mobility and daily life activities of Parkinson's disease (PD) patients as it often leads to reduced mobility, insecure stance and falls.

The aim of this study was to evaluate the effect of focal vibration on the static and dynamic balance of a group of Parkinson's disease patients with Hoehn and Yahr (HeY) stage II-III. They underwent three weeks of focal muscle vibration applied to the quadriceps, soles of the feet and trapezius muscles bilaterally in addition to conventional physiotherapy . The static and dynamic balance was assessed at baseline (T0), after 3 weeks of treatment (T1) and after 1 month from the last treatment (T2) with the Tinetti scale and stabilometry evaluations.

Read the detailed description

Parkinson's disease (PD) is a chronic, highly disabling neurodegenerative disorder characterized by bradykinesia, resting tremor, rigidity and postural instability . Postural instability has been shown to have a major impact on the autonomy, mobility and quality of life of these patients as it often leads to insecure stance and falls . Balance control is a complex system involving the integration of vestibular, visual and proprioceptive sensory information. Somatosensory information is derived from a variety of sources, most notably the cutaneous mechanoreceptors in the skin and the muscle spindles . It is well known that a decline in skin sensitivity and proprioceptive input naturally occurs with aging. Moreover, kinesthetic sensory deficits may occur due to systemic and neurologic disorders (e.g., diabetes, stroke etc.). Previous studies have demonstrated that the integration of sensory information is abnormal in PD patients with strong repercussions on motor function, posture, static and dynamic balance and greater reliance on visual input for postural control . The effectiveness of current treatments on postural instability and kinesthetic deficits in PD is controversial. Bartolic et al. observed improvement in postural control after treating rigidity with apomorphine. Wright and colleagues [6] suggest that axial kinesthetic sensitivity worsens with levodopa. Furthermore, important side effects and loss of therapeutic efficacy after years of use of dopaminergic agonists represent a major clinical challenge. Muscle vibration is a safe, non-invasive rehabilitation technique that holds promise for improving mobility and balance in moderate to severe PD patients. It consists of local vibrations applied on selected muscles or tendons by means of a mechanical device.

Stimulation of Ia afferent fibers from muscle spindles and cutaneous receptors strongly increases the exteroceptive and proprioceptive input to the central nervous system (CNS).

This has been shown to induce a plastic modulation of the primary sensory motor cortex andspinal reflexes, with long lasting positive effects on muscle tone and motor control Despite good results obtained in several other neurological conditions, such as post stroke spatial heminattention, spastic hypertonia and motor control impairment , only a few studies exist on the use of focal vibratory energy for posture and gait disorders in Parkinson's disease. Most of the existing experiments in the literature are about whole-body vibration (WBV) which has shown limited efficacy on stability and movement control In contrast, focal vibration applied over the cervical and soleus muscles , and on quadriceps and paraspinal muscles , in conjunction with conventional physiotherapy, has shown positive effects on the patient's balance, risk of falling and quality of gait.

Despite a consistent body of literature on the use of muscle vibration in rehabilitation, there is currently insufficient evidence regarding its application in patients with Parkinson's disease, including muscle targets, duration and frequency of the treatment and technical parameters. Based on these premises, we aimed to evaluate the effects of focal vibration on static and dynamic balance of patients with Parkinson's disease.

This is a prospective, observational, pilot study. Chronic patients with idiopathic Parkinson's disease were recruited from the Physical and Rehabilitation ward of the Agostino Gemelli Foundation University Hospital of Rome.

Each patient underwent focal muscle vibration in association with conventional physiotherapy three times a week, for three weeks, for a total of nine sessions. The vibration wasapplied via a pneumatic vibration device (EVM, Endomedica, Rome, Italy) at a frequenc of 100 Hz and an amplitude of 0.2 mm. Each session consisted of three stimulation trains of 10 min each, interspersed with 1 min of rest. The stimulus was applied at the level of the upper and lower trapezius, quadriceps femoris and sole of the foot bilaterally with the patient in sitting position . The choice of this last target was based on our clinical judgment and recent literature evidence. The feet provide a direct interface between the body and the environment and represent an important sensory structure in the mechanism of postural control. Plantar skin mechanoreceptors transmit crucial information about pressure variations on the sole of the feet which determine reflex postural reactions through activation of antigravitary muscles . Group rehabilitation was carried out after each focal muscle vibration session. Each group consisted of 5 individuals coordinated by an experienced physiotherapist (DR). The physiotherapy program included several exercises according to the literature :

  • Exercises for the head and trunk control;
  • Strengthening and stabilization of lower limbs and antigravity muscles;
  • Stretching of the posterior kinetic chain muscles;
  • Exercises aimed at recovering and maintaining a correct posture;
  • Coordination and balance exercises;
  • Gait training with and without obstacles. Static balance was assessed through a standardized stabilometry exam performed on a "Prokin PK 254 P" device produced by TecnoBody S.r.l. (Dalmine (BG), Italy). The device consists of a static platform (47 cm of circumference) with four piezoelectric sensors positioned at the extremity of the four cardinal points. The temporal resolution was 0.01 s, and the sampling frequency was set at 20 Hz. The patients were asked to stand on the platform for 60 s in a neutral position with the feet forming a 30-degree angle. The test was performed 30" with the eyes open and 30" with the eyes closed. All data were analyzed by the ProKin 36 software in order to calculate the center of pressure (CoP) sway on the X (anterior-posterior) and Y (medio-lateral) axes (mm), the center of pressure (CoP) velocity on the X (anterior-posterior) (AP-vel) and Y (medio-lateral) (ML-Vel) axes (mm/s), the sway path (Perimeter, total length of CoP trajectory (mm) and the area of the ellipse (mm2).

Lower values reflect greater control in maintaining the static balance. We considered as a primary outcome the reduction of the length of adaptive movements in terms of perimeter and sway area as they represent parameters of global stability of the CoP The patients were evaluated at (T0), after 3 weeks of treatment (T1) and after one month from the last treatment session (T2). A Tinetti scale was used to assess the gait and dynamic balance while consecutive stabilometric examinations were performed to assess the static balance. All patients were tested during the "on phase", 45-90 min after the morning dose of levodopa.

The Tinetti scale, also known as performance-oriented mobility assessment (POMA), is a standardized screening modality for gait and balance disorders. It is applied to screen different patient populations including elderly patients and patients with Parkinson's disease. The test assesses a patient's balance and gait using a standardized scoring system comprising 16 items with a maximal score of 28. A score ≤ 18, a score between 19-24 and a score ≥ 25 reflect an overall high, medium and low risk of falls, respectively Numeric rating scale and Mc Gill pain questionaire were used to measure pain at each timing evaluation.

Descriptive analysis was performed using standard procedures for the calculation of frequencies, measure of average position (arithmetic mean) and dispersion indicators.

The differences between pretreatment and post-treatment measures at each timing were analyzed with Student's t-test for paired samples. A p-value < 0.05 for two side test was considered statistically significant. Data analysis was conducted with the software SPSS 1.4

Being tested
Focal Muscle Vibratory Energy (EVM) Treatment
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Focal Muscle Vibratory Energy (EVM) TreatmentDevice

    The patients involved in the study will undergo muscle vibratory stimulation in association with conventional rehabilitation treatment three times a week, for three weeks for a total duration of 9 sessions in association with conventional treatment.

    The vibration will be applied at a frequency of 100 Hz and an amplitude of 0.2 cm for 30 minutes (three sessions of 10 min each with 1 min break in between) three times a week for three weeks at the level of the quadriceps femoris and triceps surae bilaterally for balance improvement and stimulation of proprioception and in the trapezius and trunk extensor muscles bilaterally for pain relief.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tinetti scale

    balance and deambulation scale. The Tinetti scale, also known as performance-oriented mobility assessment (POMA), It is a standardized screening modality for gait and balance disorders. It is applied to screen different patient populations including elderly patients and patients with Parkinson's disease. The test assesses a patient's balance and gait using a standardized scoring system comprising 16 items with a maximal score of 28. A score ≤ 18, a score between 19-24 and a score ≥ 25 reflect an overall high, medium and low risk of falls, respectively

    Measured: Evaluation was performed at (T0), after 3 weeks of treatment (T1) and after one month from the last treatment session (T2)

Secondary outcomes (3)
  1. NRS numeric rating scale of pain

    ranges from 0 to 10 with 0 indicating no pain to 10 maximum pain

    Measured: Evaluation was performed at (T0), after 3 weeks of treatment (T1) and after one month from the last treatment session (T2)

  2. Stabilometric Test

    Static balance evaluation. Static balance was assessed through a standardized stabilometry exam performed on a "Prokin PK 254 P" device produced by TecnoBody S.r.l. (Dalmine (BG), Italy).Data analysed were the center of pressure (CoP) sway on the X (anterior-posterior) and Y (medio-lateral) axes (mm), the center of pressure (CoP) velocity on the X (anterior-posterior) (AP-vel) and Y (medio-lateral) (ML-Vel) axes (mm/s), the sway path (Perimeter, total length of CoP trajectory (mm) and the area of the ellipse (mm2

    ).Lower values reflect greater control in maintaining the static balance.

    Measured: Evaluation was performed at (T0), after 3 weeks of treatment (T1) and after one month from the last treatment session (T2)

  3. Mc Gill Pain questionnaire

    evaluation of pain. It is composed of 78 words. Respondents choose those that best describe their experience of pain. Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain). Qualitative differences in pain may be reflected in respondent's word choice

    Measured: Evaluation was performed at (T0), after 3 weeks of treatment (T1) and after one month from the last treatment session (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2024
  2. Study start11 May 2023
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06278623
Sponsor's protocol ID
4935
Status last verified
Aug 2023
First submitted
10 Mar 2023
Last updated
26 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease and Postural; Defect, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 7 inclusion and 10 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 26 Feb 2024. 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 gianpaolo ronconi (3477123940, gianpaolo.ronconi@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tinetti scale (time frame: Evaluation was performed at (T0), after 3 weeks of treatment (T1) and after one month from the last treatment session (T2)). 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 26 Feb 2024.

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