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The goal of this study was to evaluate the effects of reactive balance training (RBT) targeting slipping and tripping on laboratory-induced slips and trips. In an effort to build upon prior work, the present study included: 1) a control group receiving an alternative balance training intervention; 2) separate training and assessment sessions; 3) alternative RBT methods that may be more amenable to work outside the lab compared to prior methods, and 4) older adult participants receiving individualized training to reduce drop-out. The investigators hypothesized that slips after RBT would result in improved reactive balance kinematics, and a lower incidence of falls, compared to either initial slips before any intervention or after a control intervention. The investigators also hypothesized that trips after RBT would result in improved reactive balance kinematics, and a lower incidence of falls, compared to either initial trips before any intervention or after a control intervention. Results were intended to contribute to knowledge regarding the efficacy of alternative methods for RBT, and provide additional evidence regarding its efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reactive balance training | Experimental | 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. |
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| Control balance training | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reactive balance training | Behavioral | Participants were exposed to simulated trips and slips under safe, controlled conditions in order to practice their reactive response to these common balance perturbations. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Slip Speed | highest instantaneous speed of slipping foot during actual slip | during week 1, before the intervention that spanned weeks 2 and 3 |
| Peak Slip Speed | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Slip Distance | distance moved by slipping foot during actual slip | during week 1, before the intervention that spanned weeks 2 and 3 |
| Slip Distance | distance moved by slipping foot during actual slip |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Michael L Madigan, PhD | Virginia Polytechnic Institute and State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Tech - Department of Industrial and Systems Engineering | Blacksburg | Virginia | 24061 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32532221 | Derived | Allin LJ, Brolinson PG, Beach BM, Kim S, Nussbaum MA, Roberto KA, Madigan ML. Perturbation-based balance training targeting both slip- and trip-induced falls among older adults: a randomized controlled trial. BMC Geriatr. 2020 Jun 12;20(1):205. doi: 10.1186/s12877-020-01605-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reactive Balance Training | Four training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Training in each session was 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. |
| FG001 | 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). Otago Balance Training: 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-intervention Evaluation (1 Week) |
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| Intervention (2 Weeks) |
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| Post-intervention Evaluation (1 Week) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Reactive Balance Training | Group of participants who were assigned to reactive balance training. |
| BG001 | Control Balance Training | Group of participants who were assigned to control balance training. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Peak Slip Speed | highest instantaneous speed of slipping foot during actual slip | Posted | Mean | Standard Deviation | meters/sec | during week 1, before the intervention that spanned weeks 2 and 3 |
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The period of time over which adverse event data were collected was 4 weeks. This included week 1 of pre-intervention evaluation, weeks 2-3 of intervention, and week 4 of post-intervention evaluation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reactive Balance Training | Participants assigned to the reactive balance training. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Baker's cyst | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Not believed to have resulted from reactive balance training or testing involved in this study. |
All training and assessment sessions were conducted by a single investigator who was not blinded to participant group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Madigan | Virginia Tech | (540) 231-3543 | mlm@vt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 31, 2019 | May 4, 2020 | Prot_SAP_ICF_000.pdf |
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A two-group, pretest-posttest parallel design was employed. Participants were first assigned to either the reactive balance training or control intervention using minimization. During the first week, participants completed a pre-intervention assessment involving exposure to a single laboratory-induced slip or trip based upon random assignment. During the second and third weeks, participants completed a total of four sessions of their assigned intervention (two sessions per week for two weeks). During the fourth week, participants completed a post-intervention assessment involving exposure to the other perturbation (slip or trip) that they did not experience during the pre-intervention assessment. This design was selected to evaluate gait and reactive balance prior to any training intervention, and to avoid any unintended training effects induced by exposing participants to the same perturbation more than once.
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| Otago Balance Training | Behavioral | 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). |
|
| during week 4, after the intervention that spanned weeks 2 and 3 |
| Fall Incidence After a Laboratory-induced Slip | 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 | 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 | anterior-posterior step distance of first step over tripping obstacle | during week 1, before the intervention that spanned weeks 2 and 3 |
| Recovery Step Length After Tripping | 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 | 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 | 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 |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Mass | Mean | Standard Deviation | kilograms |
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| Primary | Peak Slip Speed | highest instantaneous speed of slipping foot during actual slip | Posted | Mean | Standard Deviation | meters/sec | during week 4, after the intervention that spanned weeks 2 and 3 |
|
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| Primary | Trunk Angle at Touchdown After Tripping | anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle | Posted | Mean | Standard Deviation | degrees | during week 1, before the intervention that spanned weeks 2 and 3 |
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| Primary | Trunk Angle at Touchdown After Tripping | anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle | Posted | Mean | Standard Deviation | degrees | during week 4, after the intervention that spanned weeks 2 and 3 |
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| Secondary | Slip Distance | distance moved by slipping foot during actual slip | Posted | Mean | Standard Deviation | centimeters | during week 1, before the intervention that spanned weeks 2 and 3 |
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| Secondary | Slip Distance | distance moved by slipping foot during actual slip | Posted | Mean | Standard Deviation | centimeters | during week 4, after the intervention that spanned weeks 2 and 3 |
|
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| Secondary | Fall Incidence After a Laboratory-induced Slip | the outcome of each slip was categorized as either a: fall, recovery, or harness-assisted | Posted | Count of Participants | Participants | during week 1, before the intervention that spanned weeks 2 and 3 |
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| Secondary | Fall Incidence After a Laboratory-induced Slip | the outcome of each slip was categorized as either a: fall, recovery, or harness-assisted | Posted | Count of Participants | Participants | during week 4, after the intervention that spanned weeks 2 and 3 |
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| Secondary | Recovery Step Length After Tripping | anterior-posterior step distance of first step over tripping obstacle | Posted | Mean | Standard Deviation | percent body height | during week 1, before the intervention that spanned weeks 2 and 3 |
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| Secondary | Recovery Step Length After Tripping | anterior-posterior step distance of first step over tripping obstacle | Posted | Mean | Standard Deviation | percent body height | during week 4, after the intervention that spanned weeks 2 and 3 |
|
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| Secondary | Fall Incidence After a Laboratory-induced Trip | the outcome of each trip was categorized as a: fall, recovery, or harness-assisted | Posted | Count of Participants | Participants | during week 1, before the intervention that spanned weeks 2 and 3 |
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| Secondary | Fall Incidence After a Laboratory-induced Trip | the outcome of each trip was categorized as a: fall, recovery, or harness-assisted | Posted | Count of Participants | Participants | during week 4, after the intervention that spanned weeks 2 and 3 |
|
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|
| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Control Balance Training | Participants assigned to the control balance training. | 0 | 5 | 0 | 5 | 1 | 5 |
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| Arthritis pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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