Preventing falls and freezing in Parkinson�s Disease using a vibration based wearable device
- Conditions
- Health Condition 1: G20- Parkinsons disease
- Registration Number
- CTRI/2022/01/039256
- Lead Sponsor
- ifespark Technologies Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Participants with idiopathic PD
2. Participants who are able to walk independently with or without aid
3. Participants who are moderately severe PD stage (Hoehn and Yahr Stage IIââ?¬â??IV), Patients reporting freezing of gait (according to FOGQ scale)
4. Mental State Examination (HMSE) � 24
5. The participant is expected to remain available (geographically stable) for 2 months after enrollment.
1. Any medical condition compromising the safety or the ability to take part to the study (such as insufficient vision or hearing, inability to participate in therapy session, inability to communicate, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity)
2. Participants with coexisting serious chronic medical illnesses (e.g., orthopedic, psychiatric, or neurological), major depression, or dementia.
3. Participants with gait difficulty other than PD.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in FOG scale score, <br/ ><br>Percentage reduction in TUG test score, <br/ ><br>Percentage change in functional gait scoreTimepoint: 16 sessions, <br/ ><br>16 sessions, <br/ ><br>16 sessions
- Secondary Outcome Measures
Name Time Method Device acceptance according to 5 point Likert scaleTimepoint: 16 sessions