Bio-Feedback to Improving Stability in Elderly Population | NCT00716261

Studies
Bio-Feedback to Improving Stability in Elderly Population

NCT00716261

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Jul 16, 2008Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Parkinson's Disease Patients

Interventions

McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopes

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Sep 2009Estimated

Completion Date

Nov 2009Estimated

First Submitted Date

Jul 14, 2008

First Submission Date that Met QC Criteria

Jul 15, 2008

First Posted Date

Jul 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2008

Last Update Posted Date

Jul 16, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopes	Device	Training with the Audio-feedback device for about 30 minutes, 3 times per week for 6 weeks		AUDIO-BIOFEEDBACK SYSTEM DEIS, Università di Bologna Bologna, Italy(Chiari et al., 2005)

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey M Hausdorff, PhD	Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center		Tel Aviv		64239	Israel

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided