Hand Use and Grasp Sensor System in Monitoring Infant Fine Motor Development.

Objective: To assess the feasibility of a hand use and grasp sensor system in collecting and quantifying fine motor development longitudinally in an infant's home environment. Design: Cohort study. Researchers made home visits monthly to participating families to collect grasp data from infants using a hand use and grasp sensor. Setting: Data collection were conducted in each participant's home. Participants: A convenience sample of 14 typical developmental infants were enrolled from 3 months to 9 months of age. Two infants dropped out. A total of 62 testing sessions involving 12 infants were available for analysis (N=12). Interventions: At each session, the infant was seated in a standardized infant seat. Each instrumented toy was hung on the hand use and grasp sensor structure, presented for 6 minutes in 3 feedback modes: visual, auditory, and vibratory. Main Outcome Measures: Infant grasp frequency and duration, peak grasping force, average grasping force, force coefficient of variation, and proportion of bimanual grasps. Results: A total of 2832 recorded grasp events from 12 infants were analyzed. In linear mixed-effects model analysis, when interacting with each toy, infants' peak grasp force, average grasp force, and accumulated grasp time all increased significantly with age (all P<.001). Bimanual grasps also occupied an increasingly greater percentage of infants' total grasps as they grew older (bar toy P<.001, candy toy P=.021). Conclusions: We observed significant changes in hand use and grasp sensor outcome measures with age that are consistent with maturation of grasp skills. We envision the evolution of hand use and grasp sensor technology into an inexpensive and convenient tool to track infant grasp development for early detection of possible developmental delay and/or cerebral palsy as a supplement to clinical evaluations.

Effects of Intravesical Lactobacillus Rhamnosus GG on Urinary Symptom Burden in People with Neurogenic Lower Urinary Tract Dysfunction.

OBJECTIVE: To test the effectiveness of intravesical Lactobacillus rhamnosus GG (LGG) to reduce the burden of urinary symptoms for individuals with spinal cord injury and disease (SCI/D) with neurogenic lower urinary tract dysfunction (NLUTD) who manage their bladders with intermittent catheterization (IC). DESIGN: A three-phase study (6 months each in baseline, intervention, and washout). Participants self-managed following the Self-Management Protocol using Probiotics (SMP-Pro), completing the online Urinary Symptom Questionnaire for Neurogenic Bladder-IC version (USQNB-IC) weekly. SETTING: Nationwide (United States). PARTICIPANTS: Ninety-six adults and seven children with SCI/D. INTERVENTIONS: In response to one or both of the SMP-Pro trigger urinary symptoms, "cloudier" or "foul smelling" urine, participants self-administered using a clean urinary catheter an LGG+ Normal Saline instillate once or twice in a 30-hour period. MAIN OUTCOME MEASURES: Change in USQNB-IC burden was adjusted individually according to the previous phase for four symptom types. Adjusted changes in burden between the intervention and washout phases were analyzed using one-sample t-tests. Holm correction was applied for the four types of symptoms: A, clinically actionable; B1, bladder function; B2, urine quality; and C, other. RESULTS: During the intervention phase, participants met SMP-Pro instillation criteria 3.83 times on average (range 1-20). An average of 5.6 doses of LGG were instilled. For those who instilled at least once, burdens of type A and B2 symptoms were significantly improved at washout (both adjusted P < .05). CONCLUSIONS: Self-instilled LGG seemed to improve "clinically actionable" (A) and "urine quality" (B2) symptom burden. No changes were observed for those who did not instill. This first-in-human clinical trial supports ongoing research of intravesical LGG, and the SMP-Pro for urinary symptoms.

Clinical Profiles and Symptom Burden Estimates to Support Decision-Making Using the Urinary Symptom Questionnaire for People with Neurogenic Bladder (USQNB) using Intermittent Catheters.

OBJECTIVE: To describe the scoring approach, considering interpretability, validity, and use, of a new patient-centered patient reported outcome (PRO), the Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheter version (USQNB-IC). DESIGN: Subject matter experts (researchers, clinicians, a consumer, a psychometrician) classified USQNB-IC items. Profiles were then composed based on self-management decisions made by patients; patient management decisions made by clinicians; and research-oriented decisions made by investigators. Participants in an 18-month pilot study completed the USQNB-IC every week. Differences in decisions based on traditional 'total scores' and profiles were examined. Validity was defined based on alignment of scoring method with decisions. SETTING: A new set of patient-centered PROs enable monitoring and decision-making around urinary signs and symptoms among people with neurogenic bladder (NB). PARTICIPANTS: Classifications of USQNB-IC items by subject matter experts. Utility of the classifications and profiles that were created was assessed using weekly responses from the 6-month baseline period from 103 participants in a pilot study. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Classification of the 29 symptoms resulted in four categories with exchangeability within-category and nonexchangeability across categories. The burden of each symptom type is one approach to scoring the USQNB-IC. Five profiles, based on these categories, emerged based on, and supportive of, decisions to be made according to symptoms, representing a categorical approach to scoring the USQNB-IC. RESULTS: USQNB-IC items are not all exchangeable. Four symptom classifications comprise within-class exchangeable items. Five profiles emerged to summarize these items to promote decision-making and identification of change over time. Both ways to "score" the USQNB-IC are described and discussed. CONCLUSIONS: "Profiling" promotes valid and interpretable decisions by patients and clinicians, based on a patient's urinary symptoms with the USQNB-IC cross-sectionally and longitudinally. Alternatively, four subsets of the 29 USQNB-IC symptoms can be used as continuous outcomes representing "burden" in clinical management or research.

Conceptualization of Hand-TaPS to measure the subjective experience of dynamic hand orthoses in promoting functional recovery at home after stroke.

BACKGROUND: Dynamic exoskeleton orthoses provide assistance needed to complete movements that would otherwise be impossible after stroke. Beyond the demonstration of their effectiveness, the subjective experience of dynamic orthoses also needs to be considered. OBJECTIVE: To support functional recovery after stroke through the development of Hand-TaPS (Task Practice after Stroke), an instrument to evaluate dynamic hand orthoses in home therapy. METHODS: Dynamic hand orthosis subject matter experts (N = 14), professionals and consumers, considered the items of PYTHEIA, a valid and reliable instrument merging well-tested, assistive technology (AT) assessment items with those tuned to the greater complexity of emerging technologies. Experts reflected on how each item aligned with their personal experience of dynamic orthosis use. Interpretative Phenomenological Analysis guided identification of themes. RESULTS: Four themes (5/20 items) appraised highly relevant for Hand-TaPS. The remaining eight themes (15/20 items) were deemed in need of modification. CONCLUSIONS: Dynamic hand orthoses constitute a special case of AT; the assistance they provide targets therapy, not ADLs. Our work to develop Hand-TaPS provides a clear example of the theoretical difference between rehabilitative and assistive technology and underscores the importance of consideration of how a device is used in its assessment.

Preliminary validation of a Urinary Symptom Questionnaire for individuals with Neuropathic Bladder using Intermittent Catheterization (USQNB-IC): A patient-centered patient reported outcome.

BACKGROUND: We developed a Urinary Symptom Questionnaire for individuals with neurogenic bladder due to spinal cord injury (SCI) and spina bifida (SB) who manage their bladders with intermittent catheterization, the USQNB-IC. This project followed an approach to patient-centered patient reported outcomes development that we created and published in 2017, specifically to ensure the primacy of the patient's perspective and experience. PARTICIPANTS: Two sets of responses were collected from individuals with neurogenic bladder due to either SCI (n = 336) and SB (patients, n = 179; and caregivers of patients with NB, n = 66), and three sets of "controls", individuals with neurogenic bladder who do not have a history of UTIs (n = 49) individuals with chronic mobility impairments (neither SCI nor SB) and without neurogenic bladder (n = 46), and those with no mobility impairment, no neurogenic bladder, and no history of UTIs (n = 64). METHOD: Data were collected from all respondents to estimate these psychometric or measurement domains characterizing a health related PRO: Reliability (minimization of measurement error; internal consistency or interrelatedness of the items; and maximization of variability that is due to "true" difference between levels of the symptoms across patients), and validity (content, reflection of the construct to be measured; face, recognizability of the contents as representing the construct to be measured; structural, the extent to which the instrument captures recognizable dimensions of the construct to be measured; and criterion, association with a gold standard). RESULTS: Evidence from these five groups of respondents suggest the instrument has face, content, criterion, convergent, and divergent validity, as well as reliability. The items were all more descriptive of our patient (focus) groups and were only weakly endorsed by the control groups. CONCLUSIONS: The instrument is unique in its emphasis on, and origination from, the lived experiences of patients with neurogenic bladder who use intermittent catheterization; this preliminary psychometric evidence suggests the instrument could be useful for research and in the clinic. These results justify further development of the instrument, including formal exploration of the scoring and estimation of responsivity of these items to clinical interventions as well as patient-directed self care.

Maintaining primacy of the patient perspective in the development of patient-centered patient reported outcomes.

The objectives of this study were to describe and demonstrate a new model of developing patient reported outcomes (PROs) that are patient-centered, and to test the hypothesis that following this model would result in a qualitatively different PRO than if the typical PRO development model were followed. The typical process of developing PROs begins with an initial list of signs or symptoms originating from clinicians or PRO developers; patient validation of this list ensures that the list (i.e., the new PRO) is interpretable by patients, but not that patient perspectives are central or even represented. The new model begins with elicitation from clinicians and patients independently and separately. These perspectives are formally analyzed qualitatively, and the results are iteratively integrated by researchers, supporting clinical relevance and patient centeredness. We describe the application of this new model to the development of a PRO for urinary signs and symptoms in individuals with neuropathic bladder, and test the hypothesis that the two processes generate qualitatively different instruments using a national validation sample of 300 respondents. Of its 29 items, the new instrument included 13 signs/symptoms derived from existing clinical practice guidelines, with 16 others derived from the patient/focus groups. The three most-endorsed items came from the patients, and the three least-endorsed items came from clinical guidelines. Thematic qualitative analysis of the elicitation process, as well as the results from our national sample, support the conclusion that the new model yields an instrument that is clinically interpretable, but more patient-centered, than the typical model would have done in this context.