Focal Muscle Vibration in Parkinson's Disease

NCT06278623 | Unknown

• 1 other identifier: 4935
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson Disease; Postural; Defect; Rehabilitation

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (3)

• NRS numeric rating scale of pain

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

• Stabilometric Test

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

• Mc Gill Pain questionnaire

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

Interventions

Focal Muscle Vibratory Energy (EVM) Treatment DEVICE

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.

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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);
• visual impairment;
• vestibular disorders;
• not being part of our PD group-rehabilitation for at least one year;
• denial of informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Gianpaolo Ronconi

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• gianpaolo ronconi

  Catholic University of the Sacred Heart

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gianpaolo ronconi

CONTACT

3477123940; gianpaolo.ronconi@unicatt.it

gianpaolo ronconi

CONTACT

3477123940; gianpaolo.ronconi@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: February 26, 2024
• Study Start: May 11, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 26, 2024

Record last verified: 2023-08

Locations

IT (1)