Idiopathic Parkinson's Disease, Progressive Supranuclear Palsy
Conditions
Brief summary
The purpose of this research study is to evaluate safety and effectiveness of Foot Mechanical stimulation to improving Gait and Gait Related Disorders in Parkinson Disease and Progressive Supranuclear Palsy both stable and with motor fluctuation.
Interventions
DEVICEFoot Mechanical Stimulation (GONDOLA)
Sponsors
IRCCS San Raffaele Roma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of idiopathic PD or PSP by UK Brain Bank criteria, * Able to walk 25 feet unassisted or with minimal assistance; * On stable doses of Parkinson's medications for at least 2 weeks prior to study onset; * Endurance sufficient to stand at least 20 minutes unassisted per patient report.
Exclusion criteria
* Other significant neurological or orthopedic problems.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go. | Change from Baseline in Timed Up and Go test at 1 month follow up. | Time Up and Go test will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 minuts walking test. | Change from Baseline in gait speed at 1 month follow up | 6 minuts walking test will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13). |
| Gait Parameters | Change from Baseline in Gait Parameters at 1 month follow up | Gait Analysis will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13). |
| FREEZING OF GAIT QUESTIONNAIRES | Change from Baseline in FREEZING OF GAIT QUESTIONNAIRES at 1 month follow up. | — |
| THE PARKINSON'S DISEASE QUESTIONNAIRE (PDQ-39) | Change from Baseline in PDQ-39 at 1 month follow up | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS). | Change from Baseline in UPDRS scores at 1 month follow up | — |
| PROGRESSIVE SUPRANUCLEAR PALSY RATING SCALE (PSP RATING SCALES) | Change from Baseline in PSP RATING SCALES scores at 1 month follow up | — |
| Functional Ambulation classification (FAC) | Change from Baseline in FAC scores at 1 month follow up | — |
| Walking handicap Scale (WHS) | Change from Baseline in WHS scores at 1 month follow up | — |
| BOLD signal response to gondola treatment | Change from Baseline in UPDRS scores at 1 month follow up | BOLD signal will be collected in OFF state 4 hour after oral assumption of levodopa at baseline (inclusion) (T0), before (T1-T3-T5-T7-T9-T11) and after all stimulation (T2-T4-T6-T8-T10) and endpoint (after 6 stimulation) (T12) at the follow-up examination after 1 months from the treatments conclusion (T13). |
Countries
Italy
Outcome results
None listed