NCT03540082

Brief Summary

The purposes of this project to examine whether older adults can learn safe landing strategy during a fall. The research hypotheses are three-fold: 1) To determine whether older adults can learn a safe landing strategy to reduce impact severity of falling; 2) To examine whether the training effect on the right side falls can be transferred to the left side falls; and 3) To examine 1-week and 3-month retention effect of fall strategy training in older adults.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 19, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 14, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

March 23, 2018

Last Update Submit

May 13, 2019

Conditions

Keywords

AgingOlder AdultsFall preventionFall safetySafe landing

Outcome Measures

Primary Outcomes (1)

  • Safe Landing Strategy

    To determine whether older adults can learn a safe landing strategy to reduce impact severity of falling through a composite outcome from the following measures: 1. Forceplate measurements (CueFors2, Motek Medical) 2. Motion capture (VICON, Oxford Metrics) 3. Inertial sensor (BioStampRC, MC10) 4. Short-term skill acquisition (Aim 1) will be quantified as change in hip impact force between baseline and post assessments on visit 4

    1-week and 3-months post

Secondary Outcomes (1)

  • Retention effects

    3-months post

Study Arms (3)

Fall Exposure

ACTIVE COMPARATOR

An instructor will implicitly be exposed to the falling technique. Each group will have 4 sessions to physically practice the skills with each practice session lasting about an hour.

Other: Fall Exposure

Control

NO INTERVENTION

Written instructions will be provided on the correct way to fall without physical practice.

Tuck and Roll Group

OTHER

An instructor will explicitly verbally and visually demonstrate the falling technique and provide feedback on participant performance. Each group will have 4 sessions to physically practice the skills with each practice session lasting about an hour.

Other: Tuck and Roll Group

Interventions

An instructor will explicitly verbally and visually demonstrate the falling technique and provide feedback on participant performance. Each group will have 4 sessions to physically practice the skills with each practice session lasting about an hour.

Tuck and Roll Group

An instructor will implicitly be exposed to the falling technique. Each group will have 4 sessions to physically practice the skills with each practice session lasting about an hour.

Fall Exposure

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 18.5-30 kg/m2
  • Healthy bone mass (2.5 SD of young)
  • No tumbling experience

You may not qualify if:

  • \> 70 years old
  • Bone fracture within 3 years
  • Osteoporosis
  • Blood thinners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2018

First Posted

May 30, 2018

Study Start

January 19, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

May 14, 2019

Record last verified: 2019-04