Development of the Parkinson's sensory stimulator shoe for improvement of freezing of gait among Parkinson's disease patients with unresponsive freezing of gait
Phase 1
- Conditions
- nresponsive freezing of gait in patients with Parkinson's diseaseFreezing of gait, Parkinson's disease, vibration, pressure, shoes
- Registration Number
- TCTR20210419001
- Lead Sponsor
- Second century fund, Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1. Diagnosis of idiopathic PD by UKPDSBB criteria.
2. Age 40-80 years
3.Presenting of regular FOG episodes
4.Capability to walk, unassisted or with minimal assistance for 25 feet.
5.Stable drug therapy since at least 30 days before the start of the study.
6.Thai Mental State Examination (TMSE) >=25.
7.Able to give informed consent.
Exclusion Criteria
1.Any other neurological condition, including sensory neuropathy from previous medical history or abnormal sensation at feet from history or physical examination.
2.Receiving any medications (For examples, sedative drugs) or having any musculoskeletal or cardiovascular condition affecting locomotion.
3.Severe dyskinesias or dystonias affecting locomotion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Freezing episodes immediate post intervention Video rated by movement disorder specialists
- Secondary Outcome Measures
Name Time Method gait parameters immediate post intervention standard gait mat sensors