Back to resultsBio-Feedback to Improving Stability in Elderly Population
Primary Purpose
Parkinson's Disease Patients
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopes
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease Patients focused on measuring Parkinson's disease, Audio feedback, postural control
Eligibility Criteria
Inclusion Criteria:
- Idiopathic PD for >2 yrs
- Between 50-90 Yrs
- On anti-Parkinsonian medication
- Hoehn & Yahr 2-3 in "ON"
- Free of serious co-morbidities
- Able to walk but reports difficulties in gait
- Can use assistive device
Exclusion Criteria:
- Significant orthopedic disturbances or pain
- Major depression (DSM IV)
- Dementia (MMSE<24)
- Clinically significant hearing problems
- Unstable medical condition (2 wks from meds change)
- Deep Brain Stimulation
Sites / Locations
- Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00716261
First Posted
July 14, 2008
Last Updated
July 15, 2008
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00716261
Brief Title
Bio-Feedback to Improving Stability in Elderly Population
Official Title
Using Bio-Feedback for Improving Stability in Walking and Everyday Activity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
November 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Our hypothesis is that intensive training with positive biofeedback may enhance postural control and stability in Parkinson's disease patients and in elderly fallers.
Detailed Description
The aim of the study is to treat Parkinson's patients and elderly fallers. The intervention is intensive training with Biofeedback to try to correct stooped posture, and to improve stability in standing and in walking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease Patients
Keywords
Parkinson's disease, Audio feedback, postural control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopes
Other Intervention Name(s)
AUDIO-BIOFEEDBACK SYSTEM, DEIS, Università di Bologna, Bologna, Italy(Chiari et al., 2005)
Intervention Description
Training with the Audio-feedback device for about 30 minutes, 3 times per week for 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Idiopathic PD for >2 yrs
Between 50-90 Yrs
On anti-Parkinsonian medication
Hoehn & Yahr 2-3 in "ON"
Free of serious co-morbidities
Able to walk but reports difficulties in gait
Can use assistive device
Exclusion Criteria:
Significant orthopedic disturbances or pain
Major depression (DSM IV)
Dementia (MMSE<24)
Clinically significant hearing problems
Unstable medical condition (2 wks from meds change)
Deep Brain Stimulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M Hausdorff, PhD
Organizational Affiliation
Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Bio-Feedback to Improving Stability in Elderly Population
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