Fall Prevention Program for Older Adults

Accidental Falls Clinical Trial

Official title:

Fall Prevention Program for Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00714051
• Other study ID #: E4955-R
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 8, 2008
• Last updated: October 2, 2014
• Start date: October 2008
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill.

Description:

The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill. The training program will last for 4 weeks. Upon completion, participants will complete a test where a trip is simulated. Those assigned to the intervention group will test one additional time as well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2014
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

• 65-80 yr old,

• normal reflexes and muscle tone

Exclusion Criteria:

• lower extremity fracture or surgery last 5 yrs

• back surgery or disc herniation last 5 yrs

• noticeable gait impairment,

• low back pain,

• decreased disease-related vision,

• dizziness,

• history of heart problems,

• bone mineral density <.65,

• mini-mental score <24

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Accidental Falls

Intervention

Behavioral:
• fall prevention training
Training on a specialized treadmill that produced trip-simulating perturbations (movements.
• Attention Control
Participants walked on a treadmill at a self-selected speed once per week for four weeks.

Locations

Country	Name	City	State
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Fell on a Tripping Test	Participants completed a tripping test upon completion of the 4 weeks training period. Participants walked along a platform while harnessed to an overhead rail. Participants walked at a self-selected pace knowing that they will be tripped but do not know how or when the trip will be induced. The trip is induced by an obstruction that deploys from the floor. A decoy rope was laid across the pathway about 3 meters before the trip to intentionally mislead the participant to expect the trip at that point. This expectation affects gait and response to a trip. The participant was tripped on the 3rd set of 10 walking trials.	4 weeks	No