Parkinson Disease Clinical Trial
Official title:
Effects of Focal Muscle Vibratory Energy in Patients With Parkinson's Disease: Pilot Prospective Observational Study.
NCT number | NCT06278623 |
Other study ID # | 4935 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 11, 2023 |
Est. completion date | December 1, 2025 |
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.
Status | Recruiting |
Enrollment | 23 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Months and older |
Eligibility | Inclusion criteria: - 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. Exclusion criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Gianpaolo Ronconi | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | NRS numeric rating scale of pain | ranges from 0 to 10 with 0 indicating no pain to 10 maximum pain | Evaluation was performed at (T0), after 3 weeks of treatment (T1) and after one month from the last treatment session (T2) | |
Secondary | 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. |
Evaluation was performed at (T0), after 3 weeks of treatment (T1) and after one month from the last treatment session (T2) | |
Secondary | 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 | Evaluation was performed at (T0), after 3 weeks of treatment (T1) and after one month from the last treatment session (T2) |
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