Stimulation of the tibial nerve-a randomised trial for urinary problems associated with Parkinson's-the STARTUP trial.

BACKGROUND: non-motor symptoms such as bladder dysfunction are common (80%) in people with Parkinson's increasing the risk for falls with a negative impact on health-related costs and quality of life.We undertook STARTUP to evaluate the clinical and cost-effectiveness of using an adhesive electrode to stimulate the transcutaneous tibial nerve stimulation (TTNS) to treat bladder dysfunction in people with Parkinson's disease (PD).Study design, materials and methods: STARTUP was a parallel two-arm, multi-centre, pragmatic, double-blind, randomised controlled trial. Each participant attended one clinic visit to complete consent, be randomised using a computer-generated system and to be shown how to use the device.The trial had two co-primary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score (IPSS). These were completed at baseline, 6 and 12 weeks. A bladder frequency chart and resource questionnaire were also completed. RESULTS: two hundred forty two participants were randomised. About 59% of participants were male, the mean age was 69 years and mean time since diagnosis was 6 years. Questionnaire return rate was between 79 and 90%.There was a statistically significantly lower score in the active group at 6 weeks in the IPSS questionnaire (mean difference (Standard deviation, SD) 12.5 (6.5) vs 10.9 (5.5), effect size -1.49, 95% CI -2.72, -0.25). There was no statistically significant change in any other outcome. CONCLUSION: TTNS was demonstrated to be safe with a high level of compliance. There was a significant change in one of the co-primary outcome measures at the end of the treatment period (i.e. 6 weeks), which could indicate a benefit. Further fully powered RCTs are required to determine effective treatments.

Agreement of the activPAL3 and activPAL for characterising posture and stepping in adults and children.

Characterisation of physical activity and sedentary behaviour under free-living conditions is becoming increasingly important in light of growing evidence for the health implications of these behaviours. The integrity of long-term follow-up and the ability to compare outcomes between studies is critically dependent on the agreement of outcomes from successive generations of monitors. This study evaluated the agreement of the activPAL and second generation activPAL3 devices. Agreement was assessed in both adults (median 27.6y IQR 22.6) (n=20) and young people (median 12.0y IQR 4.1) (n=8) during standardised and daily living (ADL) test activities. During standardised activities; sedentary duration, upright duration, stepping duration and overall number of steps were all detected within small limits of agreement (≤5%). However, the activPAL characterised more steps during jogging than the activPAL3 (adults +8.36%, young people +6.80%). Also during ADL differences arose due to different posture characterisation in young people and lower step detection in the activPAL than the activPAL3 (adults -20.58%, young people -11.43%). Second-by-second posture analysis demonstrated high levels (>90%) of agreement for all activities between monitors. However, sensitivity (68.7%) and positive predictive value (78.8%) for adult stepping demonstrated disagreement between monitor interpretation of movement patterns during ADL. Agreement between monitor outcomes for standardised activities provides confidence that these outcomes can be considered almost equivalent. However, for characterisation of jogging and smaller movements during ADL, it is likely that significant differences between monitor outcomes will arise.

Validity and reliability of the activPAL3 for measuring posture and stepping in adults and young people.

Characterisation of free-living physical activity requires the use of validated and reliable monitors. This study reports an evaluation of the validity and reliability of the activPAL3 monitor for the detection of posture and stepping in both adults and young people. Twenty adults (median 27.6y; IQR22.6y) and 8 young people (12.0y; IQR4.1y) performed standardised activities and activities of daily living (ADL) incorporating sedentary, upright and stepping activity. Agreement, specificity and positive predictive value were calculated between activPAL3 outcomes and the gold-standard of video observation. Inter-device reliability was calculated between 4 monitors. Sedentary and upright times for standardised activities were within ±5% of video observation as was step count (excluding jogging) for both adults and young people. Jogging step detection accuracy reduced with increasing cadence >150stepsmin(-1). For ADLs, sensitivity to stepping was very low for adults (40.4%) but higher for young people (76.1%). Inter-device reliability was either good (ICC(1,1)>0.75) or excellent (ICC(1,1)>0.90) for all outcomes. An excellent level of detection of standardised postures was demonstrated by the activPAL3. Postures such as seat-perching, kneeling and crouching were misclassified when compared to video observation. The activPAL3 appeared to accurately detect 'purposeful' stepping during ADL, but detection of smaller stepping movements was poor. Small variations in outcomes between monitors indicated that differences in monitor placement or hardware may affect outcomes. In general, the detection of posture and purposeful stepping with the activPAL3 was excellent indicating that it is a suitable monitor for characterising free-living posture and purposeful stepping activity in healthy adults and young people.