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1.
J Acad Nutr Diet ; 2024 Feb 21.
Article in English | MEDLINE | ID: mdl-38395355

ABSTRACT

BACKGROUND: In the Women's Health Initiative Dietary Modification randomized trial, the dietary intervention reduced breast cancer mortality by 21% (P = .02) and increased physical activity as well. OBJECTIVE: Therefore, the aim was to examine whether or not these lifestyle changes attenuated age-related physical functioning decline. DESIGN: In a randomized trial, the influence of 8 years of a low-fat dietary pattern intervention was examined through 20 years of cumulative follow-up. PARTICIPANTS AND SETTING: From 1993 to 1998, 48,835 postmenopausal women, ages 50 to 79 years with no prior breast cancer and negative baseline mammogram were randomized at 40 US clinical centers to dietary intervention or usual diet comparison groups (40 out of 60). The intervention significantly reduced fat intake and increased vegetable, fruit, and grain intake. MAIN OUTCOME MEASURES: In post hoc analyses, physical functioning, assessed using the RAND 36-Item Short Form Health Survey, evaluated quality or limitations of 10 hierarchical physical activities. Longitudinal physical functioning, reported against a disability threshold (when assistance in daily activities is required) was the primary study outcome. STATISTICAL ANALYSES PERFORMED: Semiparametric linear mixed effect models were used to contrast physical functioning trajectories by randomization groups. RESULTS: Physical functioning score, assessed 495,317 times with 11.0 (median) assessments per participant, was significantly higher in the intervention vs comparison groups through 12 years of cumulative follow-up (P = .001), representing a reduction in age-related functional decline. The intervention effect subsequently attenuated and did not delay time to the disability threshold. Among women in the dietary intervention vs comparison groups, aged 50 to 59 years, who were physically inactive at entry, a persistent, statistically significant, favorable influence on physical functioning with associated delay in crossing the disability threshold by approximately a year was seen (P value for interaction = .007). CONCLUSIONS: In the Women's Health Initiative Dietary Modification randomized trial, a dietary intervention that significantly reduced breast cancer mortality also significantly reduced age-related functional decline through 12 years, which was attenuated with longer follow-up.

2.
Stud Health Technol Inform ; 310: 860-864, 2024 Jan 25.
Article in English | MEDLINE | ID: mdl-38269931

ABSTRACT

Post-acute sequelae of SARS CoV-2 (PASC) are a group of conditions in which patients previously infected with COVID-19 experience symptoms weeks/months post-infection. PASC has substantial societal burden, including increased healthcare costs and disabilities. This study presents a natural language processing (NLP) based pipeline for identification of PASC symptoms and demonstrates its ability to estimate the proportion of suspected PASC cases. A manual case review to obtain this estimate indicated our sample incidence of PASC (13%) was representative of the estimated population proportion (95% CI: 19±6.22%). However, the high number of cases classified as indeterminate demonstrates the challenges in classifying PASC even among experienced clinicians. Lastly, this study developed a dashboard to display views of aggregated PASC symptoms and measured its utility using the System Usability Scale. Overall comments related to the dashboard's potential were positive. This pipeline is crucial for monitoring post-COVID-19 patients with potential for use in clinical settings.


Subject(s)
COVID-19 , Humans , COVID-19/epidemiology , Natural Language Processing , SARS-CoV-2 , Disease Progression , Health Care Costs
3.
J Gerontol A Biol Sci Med Sci ; 78(12): 2282-2293, 2023 12 01.
Article in English | MEDLINE | ID: mdl-37463321

ABSTRACT

BACKGROUND: Multimorbidity, defined as the presence of 2 or more chronic health conditions, is increasingly common among older adults. The combination of lifestyle characteristics such as diet quality, smoking status, alcohol intake, physical activity (PA), sleep duration, and body fat as assessed by body mass index (BMI) or waist circumference, and risk of multimorbidity are not well understood. OBJECTIVES: We investigated the association between the healthy lifestyle index (HLI), generated by combining indicators of diet quality, smoking, alcohol, PA, sleep amount, and BMI, and risk of multimorbidity, a composite outcome that included cardiovascular disease (CVD), diabetes, cancer, and fracture. METHODS: We studied 62 037 postmenopausal women aged 50-79 years at enrollment in the Women's Health Initiative, with no reported history of CVD, diabetes, cancer, or fracture at baseline. Lifestyle characteristics measured at baseline were categorized and a score (0-4) was assigned to each category. The combined HLI (0-24) was grouped into quintiles, with higher quintiles indicating a healthier lifestyle. Multivariable adjusted estimates of hazard ratios (HRs) and 95% confidence intervals (95% CIs) for the risk of developing multimorbidity were obtained using Cox proportional hazard models. RESULTS: Over an average follow-up period of 16.3 years, 5 656 women developed multimorbidity. There was an inverse association between the HLI levels and risk of multimorbidity (compared to the HLI_1st quintile: HR_2nd quintile = 0.81 95% CI 0.74-0.83, HR_3rd quintile = 0.77 95% CI 0.71-0.83, HR_4th quintile = 0.70 95% CI 0.64-0.76, and HR_5th quintile = 0.60 95% CI 0.54-0.66; p trend < .001). Similar associations were observed after stratification by age or BMI categories. CONCLUSIONS: Among postmenopausal women, higher levels of the HLI were associated with a reduced risk of developing multimorbidity.


Subject(s)
Cardiovascular Diseases , Diabetes Mellitus , Fractures, Bone , Neoplasms , Humans , Female , Aged , Risk Factors , Multimorbidity , Women's Health , Healthy Lifestyle , Cardiovascular Diseases/epidemiology
4.
Clin Nutr ; 42(9): 1690-1700, 2023 09.
Article in English | MEDLINE | ID: mdl-37523800

ABSTRACT

BACKGROUND & AIMS: Systematic reviews, meta-analyses and Mendelian randomization studies suggest that cardiometabolic diseases may be associated with COVID-19 risk and prognosis, with evidence implicating insulin resistance (IR) as a common biological mechanism. As driving factors for IR, we examined body mass index (BMI) and waist circumference (WC) among postmenopausal women in association with COVID-19 outcomes (positivity and hospitalization), and the role of glucose homeostasis as a mediator of this relationship. METHODS: Associations of BMI and WC at baseline (1993-1998) with COVID-19 outcomes collected at Survey 1 (June-December, 2020) and/or Survey 2 (September-December, 2021) were evaluated among 42,770 Women's Health Initiative (WHI) participants (baseline age: 59.36 years) of whom 16,526 self-reported having taken ≥1 COVID-19 test, with 1242 reporting ≥1 positive COVID-19 test and 362 reporting ≥1 COVID-19 hospitalization. We applied logistic regression and causal mediation analyses to sub-samples with available fasting biomarkers of glucose homeostasis (glucose, insulin, Homeostatic Model Assessment for Insulin Resistance, Homeostasis Model Assessment for ß-cell function, Quantitative Insulin-sensitivity Check Index, Triglyceride-Glucose index (TyG)) at baseline, whereby 57 of 759 reported COVID-19 test positivity and 23 of 1896 reported COVID-19 hospitalization. RESULTS: In fully adjusted models, higher BMI, WC and TyG were associated with COVID-19 test positivity and hospitalization. Glucose concentrations mediated associations of BMI and WC with COVID-19 positivity, whereas TyG mediated BMI and WC's associations with COVID-19 hospitalization. CONCLUSIONS: Obesity and central obesity markers collected an average of 24 years prior were associated with COVID-19 outcomes among postmenopausal women. Glucose concentration and TyG partly mediated these associations.


Subject(s)
COVID-19 , Insulin Resistance , Humans , Female , Middle Aged , Waist Circumference/physiology , Body Mass Index , Blood Glucose/analysis , Postmenopause , Glucose , Insulin , Women's Health , Biomarkers , Obesity , Homeostasis , Triglycerides , Risk Factors
5.
PLoS One ; 18(4): e0283326, 2023.
Article in English | MEDLINE | ID: mdl-37053224

ABSTRACT

IMPORTANCE: The SARS-CoV-2 pandemic has overwhelmed hospital capacity, prioritizing the need to understand factors associated with type of discharge disposition. OBJECTIVE: Characterization of disposition associated factors following SARS-CoV-2. DESIGN: Retrospective study of SARS-CoV-2 positive patients from March 7th, 2020, to May 4th, 2022, requiring hospitalization. SETTING: Midwest academic health-system. PARTICIPANTS: Patients above the age 18 years admitted with PCR + SARS-CoV-2. INTERVENTION: None. MAIN OUTCOMES: Discharge to home versus PAC (inpatient rehabilitation facility (IRF), skilled-nursing facility (SNF), long-term acute care (LTACH)), or died/hospice while hospitalized (DH). RESULTS: We identified 62,279 SARS-CoV-2 PCR+ patients; 6,248 required hospitalizations, of whom 4611(73.8%) were discharged home, 985 (15.8%) to PAC and 652 (10.4%) died in hospital (DH). Patients discharged to PAC had a higher median age (75.7 years, IQR: 65.6-85.1) compared to those discharged home (57.0 years, IQR: 38.2-69.9), and had longer mean length of stay (LOS) 14.7 days, SD: 14.0) compared to discharge home (5.8 days, SD: 5.9). Older age (RRR:1.04, 95% CI:1.041-1.055), and higher Elixhauser comorbidity index [EI] (RRR:1.19, 95% CI:1.168-1.218) were associated with higher rate of discharge to PAC versus home. Older age (RRR:1.069, 95% CI:1.060-1.077) and higher EI (RRR:1.09, 95% CI:1.071-1.126) were associated with more frequent DH versus home. Blacks, Asians, and Hispanics were less likely to be discharged to PAC (RRR, 0.64 CI 0.47-0.88), (RRR 0.48 CI 0.34-0.67) and (RRR 0.586 CI 0.352-0.975). Having alpha variant was associated with less frequent PAC discharge versus home (RRR 0.589 CI 0.444-780). The relative risks for DH were lower with a higher platelet count 0.998 (CI 0.99-0.99) and albumin levels 0.342 (CI 0.26-0.45), and higher with increased CRP (RRR 1.006 CI 1.004-1.007) and D-Dimer (RRR 1.070 CI 1.039-1.101). Increased albumin had lower risk to PAC discharge (RRR 0.630 CI 0.497-0.798. An increase in D-Dimer (RRR1.033 CI 1.002-1.064) and CRP (RRR1.002 CI1.001-1.004) was associated with higher risk of PAC discharge. A breakthrough (BT) infection was associated with lower likelihood of DH and PAC. CONCLUSION: Older age, higher EI, CRP and D-Dimer are associated with PAC and DH discharges following hospitalization with COVID-19 infection. BT infection reduces the likelihood of being discharged to PAC and DH.


Subject(s)
COVID-19 , Hospices , Humans , Aged , Aged, 80 and over , Adolescent , Patient Discharge , Retrospective Studies , COVID-19/epidemiology , SARS-CoV-2/genetics , Hospitalization , Albumins
6.
J Alzheimers Dis ; 91(3): 1107-1119, 2023.
Article in English | MEDLINE | ID: mdl-36565123

ABSTRACT

BACKGROUND: Social support may be a modifiable risk factor for cognitive impairment. However, few long-term, large prospective studies have examined associations of various forms of social support with incident mild cognitive impairment (MCI) and dementia. OBJECTIVE: To examine associations of perceived social support with incident MCI and dementia among community-dwelling older women. METHODS: This prospective cohort study included 6,670 women from the Women's Health Initiative Memory Study who were cognitively unimpaired at enrollment. We used Cox proportional hazards models to assess associations between perceived social support with incident MCI, dementia, or either MCI/dementia during an average 10.7 (SD = 6.1)-year follow-up. Modelling was repeated for emotional/information support, affection support, tangible support, and positive social interaction subscales of social support. RESULTS: Among 6,670 women (average age = 70 years [SD = 3.8]; 97.0% non-Hispanic/Latina; 89.8% White), greater perceived social support was associated with lower risk of MCI/dementia after adjustment for age, ethnicity, race, hormone therapy, education, income, diabetes, hypertension, and body mass index (Tertile [T]3 versus T1: HR = 0.85, 95% CI 0.74-0.99; ptrend = 0.08). Associations were significant for emotional/information support (T3 versus T1: HR = 0.84, 95% CI 0.72-0.97; ptrend = 0.04) and positive social interaction (T3 versus T1: HR = 0.85, 95% CI 0.73-0.99; ptrend = 0.06) subscales. Associations were attenuated and not significant after adjustment for depressive symptom severity. OBJECTIVE: Perceived social support, emotional/information support, and positive social interaction were associated with incident MCI/dementia among older women. Results were not significant after adjustment for depressive symptom severity. Improving social support may reduce risk of MCI and dementia in older women.


Subject(s)
Cognitive Dysfunction , Dementia , Female , Humans , Aged , Prospective Studies , Dementia/diagnosis , Cognitive Dysfunction/diagnosis , Risk Factors , Women's Health , Social Support
7.
Arch Phys Med Rehabil ; 103(10): 2001-2008, 2022 10.
Article in English | MEDLINE | ID: mdl-35569640

ABSTRACT

OBJECTIVE: To examine the frequency of postacute sequelae of SARS-CoV-2 (PASC) and the factors associated with rehabilitation utilization in a large adult population with PASC. DESIGN: Retrospective study. SETTING: Midwest hospital health system. PARTICIPANTS: 19,792 patients with COVID-19 from March 10, 2020, to January 17, 2021. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Descriptive analyses were conducted across the entire cohort along with an adult subgroup analysis. A logistic regression was performed to assess factors associated with PASC development and rehabilitation utilization. RESULTS: In an analysis of 19,792 patients, the frequency of PASC was 42.8% in the adult population. Patients with PASC compared with those without had a higher utilization of rehabilitation services (8.6% vs 3.8%, P<.001). Risk factors for rehabilitation utilization in patients with PASC included younger age (odds ratio [OR], 0.99; 95% confidence interval [CI], 0.98-1.00; P=.01). In addition to several comorbidities and demographics factors, risk factors for rehabilitation utilization solely in the inpatient population included male sex (OR, 1.24; 95% CI, 1.02-1.50; P=.03) with patients on angiotensin-converting-enzyme inhibitors or angiotensin-receptor blockers 3 months prior to COVID-19 infections having a decreased risk of needing rehabilitation (OR, 0.80; 95% CI, 0.64-0.99; P=.04). CONCLUSIONS: Patients with PASC had higher rehabilitation utilization. We identified several clinical and demographic factors associated with the development of PASC and rehabilitation utilization.


Subject(s)
COVID-19 , Adult , Angiotensin-Converting Enzyme Inhibitors , Angiotensins , COVID-19/epidemiology , Humans , Male , Retrospective Studies , SARS-CoV-2
8.
Am J Phys Med Rehabil ; 101(5): 429-432, 2022 05 01.
Article in English | MEDLINE | ID: mdl-35262316

ABSTRACT

OBJECTIVE: The aim of the study was to determine whether stroke patients who receive physical medicine and rehabilitation consultation in acute care setting are more likely to discharge from inpatient rehabilitation facility to a community setting compared with those who do not. DESIGN: This was a retrospective analysis of consecutive patients admitted with stroke to inpatient rehabilitation facility between June and October 2018. The primary outcome measure was discharge disposition. Other variables measured included functional independence measures and length of stay. Analysis of baseline covariates was conducted with t tests and analysis of primary outcome measured with Fisher exact test. RESULTS: We identified 184 consecutive patients, with 62 (33.7%) having and 122 (66.3%) not having a physical medicine and rehabilitation consult; 35 (56.5%) patients versus 51 (41.8%) in physical medicine and rehabilitation consult versus non-physical medicine and rehabilitation group were discharged home (P = 0.042). Between both groups, there were no differences in baseline admission/discharge cognitive or motor functional independence measure scores, total admission/discharge functional independence measure scores, functional independence measure efficiency, or length of stay. However, in both the groups, admission versus discharge overall functional independence measure scores were significantly improved, 71.34 vs. 94.76 and 66.52 vs. 89.94 (P < 0.0001). CONCLUSIONS: Despite no difference in baseline functional scores or length of stay, physical medicine and rehabilitation consultation of poststroke patients in hospital may be associated with discharge home after inpatient rehabilitation facility.


Subject(s)
Stroke Rehabilitation , Stroke , Humans , Inpatients , Length of Stay , Patient Discharge , Recovery of Function , Referral and Consultation , Rehabilitation Centers , Retrospective Studies
9.
J Gerontol A Biol Sci Med Sci ; 77(Suppl 1): S42-S50, 2022 12 06.
Article in English | MEDLINE | ID: mdl-35235646

ABSTRACT

BACKGROUND: The association of cognitive function with symptoms of psychological distress during the coronavirus disease 2019 (COVID-19) pandemic or adherence to COVID-19 protective health behaviors is not well-understood. METHODS: We examined 2 890 older women from the Women's Health Initiative cohort. Prepandemic (ie, within 12 months prior to pandemic onset) and peripandemic global cognitive function scores were assessed with the modified Telephone Interview for Cognitive Status (TICS-m). Anxiety, stress, and depressive symptom severity during the pandemic were assessed using validated questionnaires. We examined adherence to protective behaviors that included safe hygiene, social distancing, mask wearing, and staying home. Multivariable models were adjusted for age, race, ethnicity, education, region of residence, alcohol intake, and comorbidities. RESULTS: Every 5-point lower prepandemic TICS-m score was associated with 0.33-point mean higher (95% confidence interval [CI], 0.20, 0.45) perceived stress and 0.20-point mean higher (95% CI, 0.07, 0.32) depressive symptom severity during the pandemic. Higher depressive symptom severity, but not anxiety or perceived stress, was associated with a 0.69-point (95% CI, -1.13, -0.25) mean decline in TICS-m from the prepandemic to peripandemic period. Every 5-point lower peripandemic TICS-m score was associated with 12% lower odds ratio (OR, 0.88; 95% CI, 0.80, 0.97) of practicing safe hygiene. CONCLUSIONS: Among older women, we observed that: (a) lower prepandemic global cognitive function was associated with higher stress and depressive symptom severity during the pandemic; (b) higher depressive symptom severity during the pandemic was associated with cognitive decline; and (c) lower global cognitive function during the pandemic was associated with lower odds of practicing safe hygiene.


Subject(s)
COVID-19 , Psychological Distress , Female , Humans , Aged , Pandemics/prevention & control , Public Health , SARS-CoV-2 , Women's Health , Cognition , Depression/epidemiology , Depression/psychology , Stress, Psychological/epidemiology
10.
Turk J Phys Med Rehabil ; 65(3): 273-277, 2019 Sep.
Article in English | MEDLINE | ID: mdl-31663076

ABSTRACT

OBJECTIVES: This study aims to evaluate the effects of blood pressure (BP) on functional recovery and length of stay (LOS) in post-stroke patients in an acute rehabilitation facility (ARF). PATIENTS AND METHODS: A total of 116 ischemic stroke patients (60 males, 56 females; mean age 70.0±12.8 years; range, 37 to 93 years) who were admitted to the ARF between January 2012 and September 2012 were included. Daily BP measurements with mean systolic and diastolic BP values and Functional Independent Measure (FIM) scores at the time of admission and discharge were measured. The LOS and systolic and diastolic BP ranges were also recorded. RESULTS: There was no significant correlation between the BP and FIM scores. The mean diastolic BP was positively correlated with admission (rs=0.316, p=0.01) and discharge (rs=0.287, p=0.002), FIM scores, and FIM effectiveness (rs=0.185, p=0.047) and negatively correlated with age (r=-0.449, p<0.001) and LOS (rs=-0.189, p=0.042). The LOS in hospital was negatively correlated with FIM scores at admission (rs=-0.585, p<0.001) and discharge (rs=-0.352, p<0.001) and positively correlated with FIM score changes (rs=0.414, p<0.001). CONCLUSION: Our study results show that diastolic BP in the subacute phase of stroke does not have a major impact on the functional recovery and LOS in post-stroke patients. However, there is a significant correlation between diastolic BP values and FIM efficiency.

11.
J Am Geriatr Soc ; 67(4): 726-733, 2019 04.
Article in English | MEDLINE | ID: mdl-30614525

ABSTRACT

BACKGROUND/OBJECTIVES: A lower risk of falls is commonly cited as a reason to treat hypertension conservatively in older individuals. We examined the effect of hypertension treatment and control status and measured blood pressure (BP) level on the risk of falls in older women. DESIGN/SETTING: Prospective cohort study. PARTICIPANTS: A total of 5971 women (mean age 79 years; 50.4% white, 33.1% black, 16.5% Hispanic/Latina) enrolled in the Women's Health Initiative and Objective Physical Activity and Cardiovascular Health study. MEASUREMENTS: BP was measured by trained nurses, and hypertension treatment was assessed by medication inventory. Participants mailed in monthly calendars to self-report falls for 1 year. RESULTS: Overall, 70% of women had hypertension at baseline (53% treated and controlled, 12% treated and uncontrolled, 5% untreated). There were 2582 women (43%) who reported falls in the 1 year of surveillance. Compared with nonhypertensive women, when adjusted for fall risk factors and lower limb physical function, the incidence rate ratio (IRR) for falls was 0.82 (confidence interval [CI] = 0.74-0.92) in women with treated controlled hypertension (p = .0008) and 0.73 (CI = 0.62-0.87) in women with treated uncontrolled hypertension (p = .0004). Neither measured systolic nor diastolic BP was associated with falls in the overall cohort. In women treated with antihypertensive medication, higher diastolic BP was associated with a lower risk of falls in a model adjusted for fall risk factors (IRR = 0.993 per mm Hg; 95% CI = 0.987-1.000; p = .04). The only class of antihypertensive medication associated with an increased risk of falls compared with all other types of antihypertensive drugs was ß-blockers. CONCLUSION: Women in this long-term research study with treated hypertension had a lower risk of falls compared with nonhypertensive women. Diastolic BP (but not systolic BP) is weakly associated with fall risk in women on antihypertensive treatment (<1% decrease in risk per mm Hg increase). J Am Geriatr Soc, 2019. J Am Geriatr Soc 67:726-733, 2019.


Subject(s)
Accidental Falls/statistics & numerical data , Antihypertensive Agents/therapeutic use , Hypertension/drug therapy , Hypertension/prevention & control , Aged , Female , Humans , Middle Aged , Prospective Studies , Risk Assessment
12.
Neurorehabil Neural Repair ; 29(10): 911-22, 2015.
Article in English | MEDLINE | ID: mdl-25653225

ABSTRACT

BACKGROUND: Evidence supports peroneal nerve functional electrical stimulation (FES) as an effective alternative to ankle foot orthoses (AFO) for treatment of foot drop poststroke, but few long-term, randomized controlled comparisons exist. OBJECTIVE: Compare changes in gait quality and function between FES and AFOs in individuals with foot drop poststroke over a 12-month period. METHODS: Follow-up analysis of an unblinded randomized controlled trial (ClinicalTrials.gov #NCT01087957) conducted at 30 rehabilitation centers comparing FES to AFOs over 6 months. Subjects continued to wear their randomized device for another 6 months to final 12-month assessments. Subjects used study devices for all home and community ambulation. Multiply imputed intention-to-treat analyses were utilized; primary endpoints were tested for noninferiority and secondary endpoints for superiority. Primary endpoints: 10 Meter Walk Test (10MWT) and device-related serious adverse event rate. Secondary endpoints: 6-Minute Walk Test (6MWT), GaitRite Functional Ambulation Profile, and Modified Emory Functional Ambulation Profile (mEFAP). RESULTS: A total of 495 subjects were randomized, and 384 completed the 12-month follow-up. FES proved noninferior to AFOs for all primary endpoints. Both FES and AFO groups showed statistically and clinically significant improvement for 10MWT compared with initial measurement. No statistically significant between-group differences were found for primary or secondary endpoints. The FES group demonstrated statistically significant improvements for 6MWT and mEFAP Stair-time subscore. CONCLUSIONS: At 12 months, both FES and AFOs continue to demonstrate equivalent gains in gait speed. Results suggest that long-term FES use may lead to additional improvements in walking endurance and functional ambulation; further research is needed to confirm these findings.


Subject(s)
Electric Stimulation Therapy/methods , Gait Disorders, Neurologic/etiology , Gait Disorders, Neurologic/therapy , Peroneal Nerve/physiology , Stroke/complications , Aged , Ankle/physiopathology , Chronic Disease , Female , Foot Orthoses , Humans , Longitudinal Studies , Male , Middle Aged , Severity of Illness Index , Time Factors , Treatment Outcome , Walking/physiology
13.
Neurorehabil Neural Repair ; 28(7): 688-97, 2014 Sep.
Article in English | MEDLINE | ID: mdl-24526708

ABSTRACT

BACKGROUND: Evidence supports peroneal nerve functional electrical stimulation (FES) as an effective alternative to ankle-foot orthoses (AFO) for treatment of foot drop poststroke, but few randomized controlled comparisons exist. OBJECTIVE: To compare changes in gait and quality of life (QoL) between FES and an AFO in individuals with foot drop poststroke. METHODS: In a multicenter randomized controlled trial (ClinicalTrials.gov #NCT01087957) with unblinded outcome assessments, 495 Medicare-eligible individuals at least 6 months poststroke wore FES or an AFO for 6 months. Primary endpoints: 10-Meter Walk Test (10MWT), a composite of the Mobility, Activities of Daily Living/Instrumental Activities of Daily Living, and Social Participation subscores on the Stroke Impact Scale (SIS), and device-related serious adverse event rate. Secondary endpoints: 6-Minute Walk Test, GaitRite Functional Ambulation Profile (FAP), Modified Emory Functional Ambulation Profile (mEFAP), Berg Balance Scale (BBS), Timed Up and Go, individual SIS domains, and Stroke-Specific Quality of Life measures. Multiply imputed intention-to-treat analyses were used with primary endpoints tested for noninferiority and secondary endpoints tested for superiority. RESULTS: A total of 399 subjects completed the study. FES proved noninferior to the AFO for all primary endpoints. Both the FES and AFO groups improved significantly on the 10MWT. Within the FES group, significant improvements were found for SIS composite score, total mFEAP score, individual Floor and Obstacle course time scores of the mEFAP, FAP, and BBS, but again, no between-group differences were found. CONCLUSIONS: Use of FES is equivalent to the AFO. Further studies should examine whether FES enables better performance in tasks involving functional mobility, activities of daily living, and balance.


Subject(s)
Electric Stimulation Therapy , Gait Disorders, Neurologic/rehabilitation , Peroneal Nerve/physiopathology , Stroke Rehabilitation , Aged , Ankle/innervation , Ankle/physiopathology , Chronic Disease , Female , Foot/innervation , Foot/physiopathology , Foot Orthoses , Gait Disorders, Neurologic/etiology , Gait Disorders, Neurologic/physiopathology , Humans , Male , Middle Aged , Quality of Life , Recovery of Function , Stroke/complications
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