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The goal of this clinical trial is to evaluate a novel and pragmatic (i.e., not requiring specialized equipment) task-specific step training regimen that aims to improve reactive balance after tripping. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| step training | Experimental | Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated volitional and reactive stepping movements that mimic the movements necessary to recover balance after tripping while walking. |
|
| treadmill training | Experimental | Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated exposure to simulated trips on a treadmill. To simulate a trip, participants first stand on the stationary treadmill belt. A sudden and unexpected increase in backward treadmill belt speed induces a forward loss of balance similar to when tripping. Participants are then required to take steps to recover balance and establish a stable gait pattern before the trial ends. Trials are repeated using pseudo-random speeds that provide variability and are individualized to each participant's capabilities. |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| step training | Behavioral | Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trunk Angle at Touchdown of the First Recovery Step | After a laboratory-induced trip: Angle from vertical of a line connecting midpoint of greater trochanter markers and midpoint of the acromion markers | 1 week after the 3-week intervention |
| Trip Outcome | This is a binary variable that has a value of either "fall" or "recovery." After a laboratory-induced trip, trip outcome will be assign to one of the following two values: "fall" if a participant is fully and continuously supported by the harness as observed from video, or if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is greater than 40% of body weight * seconds. The harness force will be measured by a uniaxial load cell. "recovery" if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is less than 40% of body weight * seconds. The harness force will be measured by a uniaxial load cell. | 1 week after the 3-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery Step Length | After a laboratory-induced trip, the distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping foot at touchdown | 1 week after the 3-week intervention |
| Sacrum Height at Touchdown of the First Recovery Step |
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Inclusion Criteria:
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 | Blacksburg | Virginia | 24061 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Step Training | Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated volitional and reactive stepping movements that mimic the movements necessary to recover balance after tripping while walking. step training: Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping. |
| FG001 | Treadmill Training | Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated exposure to simulated trips on a treadmill. To simulate a trip, participants first stand on the stationary treadmill belt. A sudden and unexpected increase in backward treadmill belt speed induces a forward loss of balance similar to when tripping. Participants are then required to take steps to recover balance and establish a stable gait pattern before the trial ends. Trials are repeated using pseudo-random speeds that provide variability and are individualized to each participant's capabilities. treadmill training: Sudden treadmill changes in speed (from standing) induce trip-like losses of balance, after which participants take steps to recover balance and establish a stable gait pattern. This is repeated over a range of speeds to both provide training variability and to individualize training to each participant's capability. |
| FG002 | Control | Received no training. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Step Training | Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated volitional and reactive stepping movements that mimic the movements necessary to recover balance after tripping while walking. step training: Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping. |
| 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 | Trunk Angle at Touchdown of the First Recovery Step | After a laboratory-induced trip: Angle from vertical of a line connecting midpoint of greater trochanter markers and midpoint of the acromion markers | Posted | Mean | Standard Deviation | degrees | 1 week after the 3-week intervention | trips | trips |
|
1 week after the 3-week intervention
Definitions did not differ from clinicaltrials.gov
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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 | Step Training | Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated volitional and reactive stepping movements that mimic the movements necessary to recover balance after tripping while walking. step training: Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Madigan | Virginia Tech | 5402313543 | 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 | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2025 | Mar 24, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2025 | Mar 24, 2025 | ICF_001.pdf |
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| treadmill training | Behavioral | Sudden treadmill changes in speed (from standing) induce trip-like losses of balance, after which participants take steps to recover balance and establish a stable gait pattern. This is repeated over a range of speeds to both provide training variability and to individualize training to each participant's capability. |
|
After a laboratory-induced trip, the minimum distance between the walkway and the greater trochanter marker on the non-tripping limb during trip recovery. |
| 1 week after the 3-week intervention |
| Gait Speed | The average forward speed of the participant prior to the laboratory-induced trip. | 1 week after the 3-week intervention |
| Average Step Speed | After a laboratory-induced trip, the distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping foot at touchdown divided by the time from impact with the trip obstacle and touchdown of the initial recovery step. | 1 week after the 3-week intervention |
| Trip Recovery Strategy | This is a binary variable that has a value of either "elevating" or "lowering." Elevating or lowering, depending upon how the participant uses the foot that trips on the obstacle after the laboratory-induced trip. If the foot is elevated over the obstacle, then this will be elevating. If the foot is lowered to the ground and the opposite foot first steps over the obstacle, then this will be lowering. The measurement tool to determine this outcome is a video recording of the trip, and this outcome has no units. | 1 week after the 3-week intervention |
| BG001 | Treadmill Training | Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated exposure to simulated trips on a treadmill. To simulate a trip, participants first stand on the stationary treadmill belt. A sudden and unexpected increase in backward treadmill belt speed induces a forward loss of balance similar to when tripping. Participants are then required to take steps to recover balance and establish a stable gait pattern before the trial ends. Trials are repeated using pseudo-random speeds that provide variability and are individualized to each participant's capabilities. treadmill training: Sudden treadmill changes in speed (from standing) induce trip-like losses of balance, after which participants take steps to recover balance and establish a stable gait pattern. This is repeated over a range of speeds to both provide training variability and to individualize training to each participant's capability. |
| BG002 | Control | Received no training. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| body height | Mean | Standard Deviation | meters |
|
| body mass | Mean | Standard Deviation | kilograms |
|
| unipedal stance time (seconds) | Mean | Standard Deviation | seconds |
|
| Treadmill Training |
Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated exposure to simulated trips on a treadmill. To simulate a trip, participants first stand on the stationary treadmill belt. A sudden and unexpected increase in backward treadmill belt speed induces a forward loss of balance similar to when tripping. Participants are then required to take steps to recover balance and establish a stable gait pattern before the trial ends. Trials are repeated using pseudo-random speeds that provide variability and are individualized to each participant's capabilities. treadmill training: Sudden treadmill changes in speed (from standing) induce trip-like losses of balance, after which participants take steps to recover balance and establish a stable gait pattern. This is repeated over a range of speeds to both provide training variability and to individualize training to each participant's capability. |
| OG002 | Control | Received no training. |
|
|
| Primary | Trip Outcome | This is a binary variable that has a value of either "fall" or "recovery." After a laboratory-induced trip, trip outcome will be assign to one of the following two values: "fall" if a participant is fully and continuously supported by the harness as observed from video, or if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is greater than 40% of body weight * seconds. The harness force will be measured by a uniaxial load cell. "recovery" if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is less than 40% of body weight * seconds. The harness force will be measured by a uniaxial load cell. | Posted | Number | number of falls | 1 week after the 3-week intervention | trips | trips |
|
|
|
| Secondary | Recovery Step Length | After a laboratory-induced trip, the distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping foot at touchdown | Posted | Mean | Standard Deviation | % body height | 1 week after the 3-week intervention | trips | trips |
|
|
|
| Secondary | Sacrum Height at Touchdown of the First Recovery Step | After a laboratory-induced trip, the minimum distance between the walkway and the greater trochanter marker on the non-tripping limb during trip recovery. | Posted | Mean | Standard Deviation | % of sacrum height while standing | 1 week after the 3-week intervention | trips | trips |
|
|
|
| Secondary | Gait Speed | The average forward speed of the participant prior to the laboratory-induced trip. | Posted | Mean | Standard Deviation | meters per second | 1 week after the 3-week intervention | trips | trips |
|
|
|
| Secondary | Average Step Speed | After a laboratory-induced trip, the distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping foot at touchdown divided by the time from impact with the trip obstacle and touchdown of the initial recovery step. | Posted | Mean | Standard Deviation | meters per second | 1 week after the 3-week intervention | trips | trips |
|
|
|
| Secondary | Trip Recovery Strategy | This is a binary variable that has a value of either "elevating" or "lowering." Elevating or lowering, depending upon how the participant uses the foot that trips on the obstacle after the laboratory-induced trip. If the foot is elevated over the obstacle, then this will be elevating. If the foot is lowered to the ground and the opposite foot first steps over the obstacle, then this will be lowering. The measurement tool to determine this outcome is a video recording of the trip, and this outcome has no units. | Posted | Number | number of trips using lowering strategy | 1 week after the 3-week intervention | trips | trips |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Treadmill Training | Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated exposure to simulated trips on a treadmill. To simulate a trip, participants first stand on the stationary treadmill belt. A sudden and unexpected increase in backward treadmill belt speed induces a forward loss of balance similar to when tripping. Participants are then required to take steps to recover balance and establish a stable gait pattern before the trial ends. Trials are repeated using pseudo-random speeds that provide variability and are individualized to each participant's capabilities. treadmill training: Sudden treadmill changes in speed (from standing) induce trip-like losses of balance, after which participants take steps to recover balance and establish a stable gait pattern. This is repeated over a range of speeds to both provide training variability and to individualize training to each participant's capability. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Control | Received no training. | 0 | 10 | 0 | 10 | 0 | 10 |
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