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Steps Against the Burden of Parkinson's Disease - StepuP

Steps Against the Burden of Parkinson's Disease - StepuP

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06538909
Acronym
StepuP
Enrollment
21
Registered
2024-08-06
Start date
2024-09-30
Completion date
2025-12-31
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief summary

The goals of our StepuP project are: 1. To understand the kinematic and neural mechanisms underlying walking improvements due to treadmill training with and without VR-enabled gait adaptations in people with PD; 2. To assess to what extent improvements in walking due to treadmill training, as measured in the laboratory, transfer to improvements in daily life mobility; 3. To understand the mechanisms underlying the transfer from improvements in walking to improvements in mobility in daily life in people with PD; 4. To understand for whom treadmill training improves walking characteristics in the laboratory and for whom it does not, and to understand for whom treadmill training improves mobility in daily life and for whom it does not.

Interventions

DEVICEVR

Virtual reality that simulates obstacles on the road during walking

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Specific criteria for Parkinson's disease - PD * Diagnosis of Parkinson's disease according to the MDS World Movement Disorders Society criteria Disease severity H&Y I-III * Score section 3.10 (ability to walk) MDS-UPDRS 3.10 ≥ 1 * MoCA cognitive assessment \> 15 * Stable cardiovascular condition, ability to perform aerobic activity at low to moderate intensity * Without orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher.

Exclusion criteria

* Moderate or severe depression (BDI-II ≥18) * Orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher

Design outcomes

Primary

MeasureTime frameDescription
motion capture13 monthsKinematic data will be collected using a Qualisys or Vicon motion capture system at a sampling frequency of 100 Hz.
describe brain activity by EEG cap13 monthsEEG recordings will be made using a 64-channel or 128 channel EEG cap
describe muscles activity by EMG electrodes13 monthsBipolar EMG electrodes will be placed on the leg muscles. EMG data will be recorded at a sample frequency available for each system around 2000 Hz.

Secondary

MeasureTime frameDescription
mGES questionnaire13 monthsmodified gait efficacy scale
FES-i questionnaire13 monthsShort falls efficacy scale international FES-i
FACIT-F questionnaire13 monthsfatigue
EQ-5D questionnaire13 monthshealth-related quality of life
Frailty questionnaire13 monthsFrailty index for physical activity
Fall questionnaires13 monthsFall events (occurrence and frequency) and fall related injuries. (twelve-month retrospective during T0 and during the duration of the trail
clinical trial TUG13 monthsstandard time-up-and-go test
NFOGQ questionnaires13 monthsNFOGQ
aids questionnaires13 monthsUse of mobility aids
cognition questionnaires13 monthsMoCA and trail making test for cognition
Demographics questionnaire ( descriptive measures)13 monthsGeneral descriptive measures : Year of birth, gender, height, weight, shoe size, education, employment, living arrangement, smoking history and alcohol consumption.
Fracture history questionnaire13 monthsFracture history (number and type of fracture, twelve-month retrospective of T0)
MDS-UPDRS test13 monthsMDS-UPDRS
clinical trial walk test13 months2-minute walk test
clinical trial MiniBESTest13 monthsbalance and fall risk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026