Stroke Clinical Trial
Official title:
Fall-recovery Training for Those With Chronic Stroke and Low Falls Self-efficacy
Verified date | September 2023 |
Source | University of Delaware |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | March 13, 2020 |
Est. primary completion date | March 13, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Participants must be 18 years or older - Participants must have had a single stroke of non-cerebellar origin, occurring six or more months prior to study enrollment. - An Activities-Specific Balance Confidence (ABC) score less than 68. Exclusion Criteria: - More than one stroke - Acute illness at the time of functional assessment or training - Body mass greater than 136 kg (300 lbs) to ensure that the treadmill accelerates accurately - Lower extremity joint replacement or shoulder joint replacement within a year prior to participation - Dementia - Parkinson's disease - A history of back surgery - A history of neck surgery - More than one occurrence of back or neck pain in the month prior to participation - Current back or neck pain at the time of participant enrollment - Bulging vertebral discs - Spine, hip, or lower extremity fracture within a year prior to participation - Open lesions on the lower extremity - Insulin-dependent diabetes - Use of a pacemaker - Use of an ostomy pouch - Pregnancy - Osteoporosis - Doctor recommendation to avoid moderate physical activity or exercise - Any neural, muscular, or skeletal condition or injury that precludes safe participation in the training or introduces a confounding factor on the study, at the discretion of the clinician or study staff |
Country | Name | City | State |
---|---|---|---|
United States | University of Delaware | Newark | Delaware |
Lead Sponsor | Collaborator |
---|---|
University of Delaware | National Institute of General Medical Sciences (NIGMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse Events Ending Participation | The number of participants who end participation due to adverse events | 6 months | |
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. |
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. | 6 months | |
Primary | Walking Activity | Average steps/day, as measured by a step monitor | 6 months | |
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). | 6 months |
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