Fall PreventionNCT03540082
Safe Landing Strategy in Older Adults
A study testing Tuck and Roll Group and Fall Exposure in people with Fall Prevention and Fall Injury, run by University of Illinois at Urbana-Champaign.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall Prevention, Fall Injury, Fall Safety
- What is being tested?
- Tuck and Roll Group and Fall Exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 19 Jan 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI 18.5-30 kg/m2
- Healthy bone mass (2.5 SD of young)
- No tumbling experience
Who cannot join
- > 70 years old
- Bone fracture within 3 years
- Osteoporosis
- Blood thinners
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Fall Prevention, Fall Injury, Fall Safety
- Being tested
- Tuck and Roll Group, Fall Exposure
- Keywords
- Aging, Older Adults, Fall prevention, Fall safety, Safe landing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuck and Roll GroupOther
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.
Fall ExposureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Tuck and Roll Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Forceplate measurements (CueFors2, Motek Medical)
- Motion capture (VICON, Oxford Metrics)
- Inertial sensor (BioStampRC, MC10)
- Short-term skill acquisition (Aim 1) will be quantified as change in hip impact force between baseline and post assessments on visit 4
Measured: 1-week and 3-months post
Secondary outcomes (1)
Retention effects
Examine retention effect of fall strategy training through a composite score from the following:
- Participant questionnaire
- Track and review which participants attend all four study visits
Measured: 3-months post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start19 Jan 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540082
- Sponsor's protocol ID
- 17577
- Status last verified
- Apr 2019
- First submitted
- 23 Mar 2018
- Last updated
- 14 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Landing Strategy in Older Adults
- ClinicalTrials.gov ID
- NCT03540082
- Acronym / sponsor ID
- 17577
- Conditions
- Fall Prevention, Fall Injury, Fall Safety
- Keywords
- Aging, Older Adults, Fall prevention, Fall safety, Safe landing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 19 Jan 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 30 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fall Exposure | Active comparator | Other: Fall ExposureAn 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. |
| Control | No intervention | –Written instructions will be provided on the correct way to fall without physical practice. |
| Tuck and Roll Group | Other | Other: Tuck and Roll GroupAn 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. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI 18.5-30 kg/m2
- Healthy bone mass (2.5 SD of young)
- No tumbling experience
Key exclusion criteria (4 listed)
- > 70 years old
- Bone fracture within 3 years
- Osteoporosis
- Blood thinners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuck and Roll GroupAn 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 |
| Fall ExposureAn 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 |
Primary outcome
Safe Landing Strategy
Time frame: 1-week and 3-months post
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 secondary outcome
Retention effects
Time frame: 3-months post
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Tuck and Roll Group and Fall Exposure in people with Fall Prevention and Fall Injury, run by University of Illinois at Urbana-Champaign.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily Pike (2172447006, epike@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safe Landing Strategy (time frame: 1-week and 3-months post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.