Pilot Study of AdvanStep in Improving Balance in at Risk Elderly

Impaired Balance in Elderly Clinical Trial

— AdvanStep  

Official title:

Feasibility and Pilot Study of AdvanStep in Improving Balance in Elderly at Risk for Falls

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01059253
• Other study ID #: SHEBA-09-7170-HW-CTIL
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: January 28, 2010
• Last updated: June 14, 2012
• Start date: September 2010
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Elderly individuals are often at increased risks for falls. The AdvanStep is an interactive training exercise and balance device. The use of the AdvanStep will bring about a measurable improvement in the individuals balance in standardized measures.

Description:

1. Feasibility study, assessing usability of the system and receiving feedback from the volunteers.

2. Structured treatment sessions twice per week after an initial assessment of balance and mobility on standardized tests.

3. Reassessment of balance and mobility after completion of 15 treatment sessions.

4. Treatment sessions will be supervised by physical therapists.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 65-80

• History of 2 falls in past 5 years, not requiring medical attention

• No acute orthopedic or neurological disorders

• No cognitive impairment affecting daily function.

• Adequate vision and hearing to see the computer screen and follow verbal commands.

• Unilateral stance test - inability to remain in unilateral stance for 25 seconds

Exclusion Criteria:

• Congestive heart failure or angina that limits physical activity

• Need for interventional medical treatment

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Impaired Balance in Elderly

Intervention

Other:
• AdvanStep training program - Turtle Pop
Balance / mobility exercise program using the AdvanStep in a virtual reality context

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on 4 square step test, Balance Evaluation Systems Test, 25 second unilateral stand test		On completion of treatment	Yes