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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM104941 | U.S. NIH Grant/Contract | View source |
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Study activity has initially suspended due to COVID-19 restrictions, but it will not resume due to the confounding influence of the pandemic on the study outcomes. The feasibility of the study protocol is limited with restrictions from the pandemic.
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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Chronic stroke is the leading cause of long-term disability in the United States. Post-stroke health is negatively impacted by two interrelated factors-a substantial risk of falls and limited walking activity. The risk of falling is a barrier to walking activity, with falls self-efficacy mediating the relationship between impaired physical capacity and limited activity. The ability to recover from a fall (i.e. arrest a fall before impact) is a logical, yet untested rehabilitation target to enable walking activity through sustained benefits to falls self-efficacy. Our aim is to demonstrate that fall-recovery training is feasible in stroke survivors with low falls self-efficacy. Five participants will undergo an adapted version of fall-recovery training. We will gather evidence of the implementation, adaptation, and limited efficacy of this intervention in affecting falls self-efficacy and walking activity.
The study aim is to demonstrate that fall-recovery training is feasible in stroke survivors with low falls self-efficacy. We will gather evidence of the adaptation, implementation, and limited efficacy of our intervention. This aim will be addressed with a single-group, interventional study. At baseline, fall-recovery ability will be determined from stepping thresholds in response to treadmill-delivered perturbations. Falls self-efficacy will be determined from questionnaires. Walking activity will be recorded using step counters (StepWatchTM). After three weeks of a non-active control period, we will repeat assessments. Then, participants will attend six training sessions consisting of anterior, posterior, and lateral perturbations. After training, we will repeat all assessments of balance, self-efficacy, and walking activity. We will recruit five participants with chronic stroke (i.e. >6 months after stroke). Falls self-efficacy is recorded upon registry enrollment, allowing us to recruit to our study needs. All participants must have an Activities-Specific Balance Confidence (ABC) score less than 68. Upon enrollment, the Fugl-Meyer Lower Extremity assessment and Stroke Impact Scale will be administered. Fall-recovery ability will be quantified from anterior, posterior, and lateral single-stepping thresholds. Participants will be outfitted with a harness attached to an overhead rail. As they stand on a computer-controlled treadmill (ActiveStep®, Simbex), participants will be instructed to not step in response to rapid belt translations. For each opposing pair of thresholds, a progressively challenging series of perturbations will be delivered. Thresholds are defined as the perturbation magnitudes that consistently elicit one step. Falls self-efficacy will be quantified from the ABC scale and the Falls Efficacy Scale (FES). Walking activity will be quantified as average daily steps, recorded in five-second intervals for one week by a StepWatchTM monitor on the non-paretic ankle.
Our fall-recovery training consists of 6 sessions over 3-4 weeks, each consisting of the following 5-minute series:
The training intensity, as determined by the perturbation size and, if applicable, gait speed, will be small at first, progressing to more challenging levels dependent upon participant performance, safety, and comfort.
As per feasibility-study guidelines, we will gather evidence of adaptation, implementation, and limited efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perturbation-Based Balance Training | Experimental | perturbation-based balance training |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perturbation-based fall-recovery training | Behavioral | Participants will attempt to recover from treadmill-induced balance perturbations as they walk or stand. The size of the perturbations is progressively challenging and dependent upon participant performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Ending Participation | The number of participants who end participation due to adverse events | 6 months |
| Activities Specific Balance Confidence Questionnaire Score. | Balance confidence, as measured by the Activities Specific Balance Confidence questionnaire. Scores range from 0 to 100, and represent the average rating of each question. Higher scores indicate more confidence. Range 0-100 Higher values represent a better outcome. | 6 months |
| Falls Self-Efficacy Scale Score | Falls Self-Efficacy, as measured by the Falls Self-Efficacy Scale. Scores are totaled, ranging from 16-64, with higher scores representing worse self-efficacy. | 6 months |
| Walking Activity | Average steps/day, as measured by a step monitor | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stepping Threshold Assessment of Reactive Balance | Stepping thresholds are the treadmill-induced, standing perturbation magnitudes that elicit anterior, posterior, or lateral steps. These thresholds are determined from a series of progressively challenging perturbations, delivered as participants stand on a computer-controlled treadmill. The thresholds are the size of the perturbation (measured as acceleration) that results in a step for four trial. Participants are instructed to try not to step. One progression consists of forward and backward perturbations to determine anterior and posterior thresholds. A second progression is done with participants facing the side of the treadmill, with the progression identifying left and right stepping thresholds. Anterior, posterior, left, and right thresholds are considered independently (i.e. not averaged or summed). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Delaware | Newark | Delaware | 19711 | United States |
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One participant recruited on 2/21/2020 at University of Delaware campus.
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| ID | Title | Description |
|---|---|---|
| FG000 | Perturbation-based Balance Training | perturbation-based balance training perturbation-based fall-recovery training: Participants will attempt to recover from treadmill-induced balance perturbations as they walk or stand. The size of the perturbations is progressively challenging and dependent upon participant performance. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | perturbation-based balance training perturbation-based fall-recovery training: Participants will attempt to recover from treadmill-induced balance perturbations as they walk or stand. The size of the perturbations is progressively challenging and dependent upon participant performance. |
| 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 | Median |
| 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 | Adverse Events Ending Participation | The number of participants who end participation due to adverse events | The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded. | Posted | 6 months |
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1 month (from study start date: February 21, 2020 to the day the study was halted: March 13, 2020).
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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 | Intervention | perturbation-based balance training perturbation-based fall-recovery training: Participants will attempt to recover from treadmill-induced balance perturbations as they walk or stand. The size of the perturbations is progressively challenging and dependent upon participant performance. |
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The study was halted due to the COVID-10 pandemic after one participant was enrolled and completed baseline assessments. The study did not resume and participation was terminated by the investigator.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy Crenshaw, Ph.D. | University of Delaware | 302-831-4795 | crenshaw@udel.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 | Sep 18, 2019 | Jul 14, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 10, 2020 | Sep 5, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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single-group, observational study
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|
| 6 months |
| years |
|
| 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 |
|
| Balance Confidence | The Activities- Specific Balance Confidence (ABC) Scale is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Range 0-100 Higher values represent a better outcome. | Number | units on a scale |
|
| Lower Extremity Fugl-Meyer | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia Scores range from 0-34 Higher values represent a better outcome. | Number | units on a scale |
|
| Stroke Impact Scale | The stroke impact scale is a self-report questionnaire that evaluates disability and health-related quality of life after stroke. Range for each domain (0-100) Domain scores are averaged for total score. Higher values represent a better outcome. | Number | units on a scale |
|
| Anteroposterior stepping thresholds | As participants stand on a computer-controlled treadmill, sudden belt accelerations perturb balance. Perturbations are delivered in forward and backward directions, and participants are instructed to not step. The size of the perturbations is increased until the participant steps in response to the movement. Thresholds are defined as the acceleration of the treadmill belt (in units of m/s^2) that consistently elicited an anterior or posterior step. | Number | m/s^2 |
|
| Falls Efficacy Scale | A 16-item self-administered questionnaire designed to assess fear of falling Range: 16-64 Lower values represent a better outcome. | Number | units on a scale |
|
| Participants |
|
| Primary | Activities Specific Balance Confidence Questionnaire Score. | Balance confidence, as measured by the Activities Specific Balance Confidence questionnaire. Scores range from 0 to 100, and represent the average rating of each question. Higher scores indicate more confidence. Range 0-100 Higher values represent a better outcome. | The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded. | Posted | 6 months |
|
|
| Primary | Falls Self-Efficacy Scale Score | Falls Self-Efficacy, as measured by the Falls Self-Efficacy Scale. Scores are totaled, ranging from 16-64, with higher scores representing worse self-efficacy. | The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded. | Posted | 6 months |
|
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| Primary | Walking Activity | Average steps/day, as measured by a step monitor | The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded. | Posted | 6 months |
|
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| Secondary | Stepping Threshold Assessment of Reactive Balance | Stepping thresholds are the treadmill-induced, standing perturbation magnitudes that elicit anterior, posterior, or lateral steps. These thresholds are determined from a series of progressively challenging perturbations, delivered as participants stand on a computer-controlled treadmill. The thresholds are the size of the perturbation (measured as acceleration) that results in a step for four trial. Participants are instructed to try not to step. One progression consists of forward and backward perturbations to determine anterior and posterior thresholds. A second progression is done with participants facing the side of the treadmill, with the progression identifying left and right stepping thresholds. Anterior, posterior, left, and right thresholds are considered independently (i.e. not averaged or summed). | The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded. | Posted | 6 months |
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| 0 |
| 1 |
| 0 |
| 1 |
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| 1 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |