Fall Recovery Training for Older Adults in Continuous Care Facilities

NCT02173015 | Completed

• 2 other identifiers: 13-000605UL1TR000135
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect that a new fall prevention training program has on the fall incidence of long-term care facility residents at high-risk of falling.

Conditions

Accidental Falls

Keywords

accidental falls; older adults; long-term care; nursing home; postural balance

Outcome Measures

Primary Outcomes (1)

• Fall Incidence

  The fall incidence (fallers / total group size) of low-risk residents, high-risk residents who do not complete training, and high-risk residents who complete training.

  up to 6 months

Study Arms (3)

Low Fall Risk

NO INTERVENTION

Individuals who have a functional reach greater than 8" and a unipedal stance time greater than 5 s.

High Fall Risk, No Training

NO INTERVENTION

Individuals who have a functional reach of 8" or less OR a unipedal stance time of 5 s or less, but do not qualify for compensatory step training due to health concerns.

High Fall Risk, Training

EXPERIMENTAL

Individuals who have a functional reach of 8" or less OR a unipedal stance time of 5 s or less, and qualify for compensatory step training.

Other: Compensatory step training

Interventions

Compensatory step training OTHER

The training consists of a progression of anterior or posterior treadmill belt movements applied as the subject is standing or walking. This training specifically focuses on aspects important to trip and slip recovery. Subjects will participate in up to 6 sessions in 7 to 30 days. The training intensity (magnitude of disturbance delivered) is progressive and dependent on subject performance. Subjects will be instructed to respond with single or multiple steps in order to prevent a fall. All subjects will be outfitted with a safety harness to prevent injury. Up to 72 disturbances will be delivered each session.

High Fall Risk, Training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be 50 years or older, living in continuous-care retirement facilities.

You may not qualify if:

• For participation in study:
• Three or more errors on the Six-Item Screener for Cognitive Impairment
• Individuals who cannot provide consent for themselves
• For participation in compensatory step training:
• Physician or nurse practitioner approval to participate in the study with the guidelines that subjects should not participate if any of the following is applicable:
• Unable to walk one block without stopping or using a walking aid (self-reported)
• Acute illness at the time of functional assessment or training
• Body mass greater than 114 kg
• Body size too large for wearing a safety harness
• Lower extremity joint replacement within a year prior to participation
• Femoral neck or total hip bone mineral density t-score less than -2.5
• Based on a dual-energy X-ray absorptiometry (DXA) scan in the Mayo Clinic Charlton Clinical Research Unit (CRU), with no medication changes that may affect bone mineral density at the hip (e.g. starting prednisone). During the visit to the CRU, the subject's height and weight will be measured.
• If the subject has had bilateral hip replacement, then the subject will not qualify for compensatory step training.
• Dementia
• Parkinson's disease

Sponsors & Collaborators

• Mayo Clinic: lead
• University of Illinois at Chicago: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Kenton R Kaufman, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: W Hall Wendel Jr Musculoskeletal Research Professor

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: June 24, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 4, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)