- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04308239
Reactive Balance Training Targeting Both Slip- and Trip-Induced Falls
Reactive Balance Training Targeting Both Slip- and Trip-Induced Falls Among Older Adults: a Pilot Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Virginia
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Blacksburg, Virginia, United States, 24061
- Virginia Tech - Department of Industrial and Systems Engineering
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1) pass a medical history and screening administered by a physician that excluded participants with osteoporosis of the lumbar spine or proximal femur as assessed by Dual Energy X-ray Absorptiometry (Lunar iDXA, GE Healthcare, Chicago, IL), or any unstable or progressive medical conditions that could contribute to imbalance or falls
Exclusion Criteria:
- smoked
- were in physical therapy
- had a self-reported fragility fracture within the last 10 years
- had an acute lower extremity injury within the last 3 months
- had lower extremity surgery within the last six months
- had an ankle arthroplasty
- had a knee or hip arthroplasty within the last 12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Reactive balance training
Four training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Each session was 0.5-1 hours, with an active training time of 30 minutes for each participant. Reactive balance training involved both slip and trip training. Slip training involved repeatedly stepping onto a low-friction interface (nylon fabric placed over a 0.9 × 0.9 meter polycarbonate sheet) while practicing controlling/decelerating the slipping foot and properly positioning the non-slipping foot under the pelvis. Trip training involved repeatedly practicing recovery from simulated trips on a modified treadmill. While standing on a modified treadmill, the treadmill belt was quickly accelerated posteriorly to elicit a forward loss of balance that mimicked a trip while walking. Participants attempted to step to avert a fall, and to establish a stable gait on the treadmill, after which the treadmill speed was slowed to zero to complete the trial. |
Participants were exposed to simulated trips and slips under safe, controlled conditions in order to practice their reactive response to these common balance perturbations.
|
|
Active Comparator: Control balance training
Four training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Each session was 0.5-1 hours, with an active training time of 30 minutes for each participant. The control intervention involved general balance exercises adapted from the Otago Exercise program. Briefly, all four sessions involved balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support). |
Balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak Slip Speed
Time Frame: during week 1, before the intervention that spanned weeks 2 and 3
|
highest instantaneous speed of slipping foot during actual slip
|
during week 1, before the intervention that spanned weeks 2 and 3
|
|
Peak Slip Speed
Time Frame: during week 4, after the intervention that spanned weeks 2 and 3
|
highest instantaneous speed of slipping foot during actual slip
|
during week 4, after the intervention that spanned weeks 2 and 3
|
|
Trunk Angle at Touchdown After Tripping
Time Frame: during week 1, before the intervention that spanned weeks 2 and 3
|
anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle
|
during week 1, before the intervention that spanned weeks 2 and 3
|
|
Trunk Angle at Touchdown After Tripping
Time Frame: during week 4, after the intervention that spanned weeks 2 and 3
|
anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle
|
during week 4, after the intervention that spanned weeks 2 and 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Slip Distance
Time Frame: during week 1, before the intervention that spanned weeks 2 and 3
|
distance moved by slipping foot during actual slip
|
during week 1, before the intervention that spanned weeks 2 and 3
|
|
Slip Distance
Time Frame: during week 4, after the intervention that spanned weeks 2 and 3
|
distance moved by slipping foot during actual slip
|
during week 4, after the intervention that spanned weeks 2 and 3
|
|
Fall Incidence After a Laboratory-induced Slip
Time Frame: during week 1, before the intervention that spanned weeks 2 and 3
|
the outcome of each slip was categorized as either a: fall, recovery, or harness-assisted
|
during week 1, before the intervention that spanned weeks 2 and 3
|
|
Fall Incidence After a Laboratory-induced Slip
Time Frame: during week 4, after the intervention that spanned weeks 2 and 3
|
the outcome of each slip was categorized as either a: fall, recovery, or harness-assisted
|
during week 4, after the intervention that spanned weeks 2 and 3
|
|
Recovery Step Length After Tripping
Time Frame: during week 1, before the intervention that spanned weeks 2 and 3
|
anterior-posterior step distance of first step over tripping obstacle
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during week 1, before the intervention that spanned weeks 2 and 3
|
|
Recovery Step Length After Tripping
Time Frame: during week 4, after the intervention that spanned weeks 2 and 3
|
anterior-posterior step distance of first step over tripping obstacle
|
during week 4, after the intervention that spanned weeks 2 and 3
|
|
Fall Incidence After a Laboratory-induced Trip
Time Frame: during week 1, before the intervention that spanned weeks 2 and 3
|
the outcome of each trip was categorized as a: fall, recovery, or harness-assisted
|
during week 1, before the intervention that spanned weeks 2 and 3
|
|
Fall Incidence After a Laboratory-induced Trip
Time Frame: during week 4, after the intervention that spanned weeks 2 and 3
|
the outcome of each trip was categorized as a: fall, recovery, or harness-assisted
|
during week 4, after the intervention that spanned weeks 2 and 3
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael L Madigan, PhD, Virginia Polytechnic Institute and State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 18-486
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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