Steps Against the Burden of Parkinson's Disease - StepuP
- Conditions
- Parkinson Disease
- Interventions
- Device: VR
- Registration Number
- NCT06538909
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 21
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.
- Moderate or severe depression (BDI-II ≥18)
- Orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PD with VR int. VR Parkinson's disease patients using Virtual reality intervention that include physical activity and cognitive
- Primary Outcome Measures
Name Time Method motion capture 13 months Kinematic data will be collected using a Qualisys or Vicon motion capture system at a sampling frequency of 100 Hz.
describe muscles activity by EMG electrodes 13 months Bipolar 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.
describe brain activity by EEG cap 13 months EEG recordings will be made using a 64-channel or 128 channel EEG cap
- Secondary Outcome Measures
Name Time Method NFOGQ questionnaires 13 months NFOGQ
MDS-UPDRS test 13 months MDS-UPDRS
clinical trial MiniBESTest 13 months balance and fall risk
mGES questionnaire 13 months modified gait efficacy scale
Frailty questionnaire 13 months Frailty index for physical activity
Fracture history questionnaire 13 months Fracture history (number and type of fracture, twelve-month retrospective of T0)
clinical trial TUG 13 months standard time-up-and-go test
clinical trial walk test 13 months 2-minute walk test
FES-i questionnaire 13 months Short falls efficacy scale international FES-i
FACIT-F questionnaire 13 months fatigue
EQ-5D questionnaire 13 months health-related quality of life
cognition questionnaires 13 months MoCA and trail making test for cognition
Demographics questionnaire ( descriptive measures) 13 months General descriptive measures : Year of birth, gender, height, weight, shoe size, education, employment, living arrangement, smoking history and alcohol consumption.
Fall questionnaires 13 months Fall events (occurrence and frequency) and fall related injuries. (twelve-month retrospective during T0 and during the duration of the trail
aids questionnaires 13 months Use of mobility aids
Related Research Topics
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