scholarly journals Functional electrical stimulation+iPad-based music therapy for upper limb recovery after stroke: Study protocol for a mixed methods randomised controlled trial

2020 ◽  
pp. 1-24
Author(s):  
Tanya Marie Silveira ◽  
Simone Dorsch ◽  
Grace Thompson ◽  
Jeanette Tamplin
Keyword(s):  
Electrical Stimulation ◽  
Mixed Methods ◽  
Randomised Controlled Trial ◽  
Music Therapy ◽  
Study Protocol ◽  
Upper Limb ◽  
Functional Electrical Stimulation ◽  
Controlled Trial ◽  
Stroke Study ◽  
Randomised Controlled

scholarly journals Functional electrical stimulation‐assisted cycle ergometry-based progressive mobility programme for mechanically ventilated patients: randomised controlled trial with 6 months follow-up

Thorax ◽  
2021 ◽  
pp. thoraxjnl-2020-215755
Author(s):  
Petr Waldauf ◽  
Natália Hrušková ◽  
Barbora Blahutova ◽  
Jan Gojda ◽  
Tomáš Urban ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Randomised Controlled Trial ◽  
Functional Electrical Stimulation ◽  
Controlled Trial ◽  
Cycle Ergometry ◽  
Control Group ◽  
Mechanically Ventilated ◽  
Icu Discharge ◽  
Randomised Controlled

PurposeFunctional electrical stimulation-assisted cycle ergometry (FESCE) enables in-bed leg exercise independently of patients’ volition. We hypothesised that early use of FESCE-based progressive mobility programme improves physical function in survivors of critical care after 6 months.MethodsWe enrolled mechanically ventilated adults estimated to need >7 days of intensive care unit (ICU) stay into an assessor-blinded single centre randomised controlled trial to receive either FESCE-based protocolised or standard rehabilitation that continued up to day 28 or ICU discharge.ResultsWe randomised in 1:1 ratio 150 patients (age 61±15 years, Acute Physiology and Chronic Health Evaluation II 21±7) at a median of 21 (IQR 19–43) hours after admission to ICU. Mean rehabilitation duration of rehabilitation delivered to intervention versus control group was 82 (IQR 66–97) versus 53 (IQR 50–57) min per treatment day, p<0.001. At 6 months 42 (56%) and 46 (61%) patients in interventional and control groups, respectively, were alive and available to follow-up (81.5% of prespecified sample size). Their Physical Component Summary of SF-36 (primary outcome) was not different at 6 months (50 (IQR 21–69) vs 49 (IQR 26–77); p=0.26). At ICU discharge, there were no differences in the ICU length of stay, functional performance, rectus femoris cross-sectional diameter or muscle power despite the daily nitrogen balance was being 0.6 (95% CI 0.2 to 1.0; p=0.004) gN/m2 less negative in the intervention group.ConclusionEarly delivery of FESCE-based protocolised rehabilitation to ICU patients does not improve physical functioning at 6 months in survivors.Trial registration numberNCT02864745.

scholarly journals The effectiveness of peroneal nerve functional electrical simulation for the reduction of bradykinesia in Parkinson’s disease: A feasibility study for a randomised control trial

2020 ◽  
pp. 026921552097251
Author(s):  
Paul N Taylor ◽  
Trish Sampson ◽  
Ben Beare ◽  
Maggie Donavon-Hall ◽  
Peter W Thomas ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Electrical Stimulation ◽  
Randomised Controlled Trial ◽  
Study Design ◽  
Functional Electrical Stimulation ◽  
Standard Care ◽  
Peroneal Nerve ◽  
Controlled Trial ◽  
Randomised Controlled

Objectives: To assess the feasibility of a multi-site randomised controlled trial to evaluate the effect of functional electrical stimulation on bradykinesia in people with Parkinson’s disease. Design: A two-arm assessor blinded randomised controlled trial with an 18 weeks intervention period and 4 weeks post-intervention follow-up. Setting: Two UK hospitals; a therapy outpatient department in a district general hospital and a specialist neuroscience centre. Participants: A total of 64 participants with idiopathic Parkinson’s disease and slow gait <1.25 ms−1. Interventions: Functional electrical stimulation delivered to the common peroneal nerve while walking in addition to standard care compared with standard care alone. Main measures: Feasibility aims included the determination of sample size, recruitment and retention rates, acceptability of the protocol and confirmation of the primary outcome measure. The outcome measures were 10 m walking speed, Unified Parkinson’s Disease Rating Scale (UPDRS), Mini Balance Evaluation Systems Test, Parkinson’s Disease Questionnaire-39, EuroQol 5-dimension 5-level, New Freezing of Gait questionnaire, Falls Efficacy Score International and falls diary. Participants opinion on the study design and relevance of outcome measures were evaluated using an embedded qualitative study. Results: There was a mean difference between groups of 0.14 ms−1 (CI 0.03, 0.26) at week 18 in favour of the treatment group, which was maintained at week 22, 0.10 ms−1 (CI –0.05, 0.25). There was a mean difference in UPDRS motor examination score of –3.65 (CI –4.35, 0.54) at week 18 which was lost at week 22 –0.91 (CI –2.19, 2.26). Conclusion: The study design and intervention were feasible and supportive for a definitive trial. While both the study protocol and intervention were acceptable, recommendations for modifications are made.

scholarly journals A Dep ression Re cognition and T reatment package for families living with Stroke (DepReT-Stroke): study protocol for a randomised controlled trial

Trials ◽  
2011 ◽  
Vol 12 (1) ◽  
Author(s):  
Richard J Gray ◽  
Phyo K Myint ◽  
Frances Elender ◽  
Garry Barton ◽  
Michael Pfeil ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Stroke Study ◽  
Randomised Controlled

scholarly journals Robotic-based ACTive somatoSENSory (Act.Sens) retraining on upper limb functions with chronic stroke survivors: study protocol for a pilot randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Ananda Sidarta ◽  
Yu Chin Lim ◽  
Christopher Wee Keong Kuah ◽  
Yong Joo Loh ◽  
Wei Tech Ang
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Upper Limb ◽  
Controlled Trial ◽  
Chronic Stroke ◽  
Community Dwelling ◽  
Control Group ◽  
Stroke Survivors ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Abstract Background Prior studies have established that senses of the limb position in space (proprioception and kinaesthesia) are important for motor control and learning. Although nearly one-half of stroke patients have impairment in the ability to sense their movements, somatosensory retraining focusing on proprioception and kinaesthesia is often overlooked. Interventions that simultaneously target motor and somatosensory components are thought to be useful for relearning somatosensory functions while increasing mobility of the affected limb. For over a decade, robotic technology has been incorporated in stroke rehabilitation for more controlled therapy intensity, duration, and frequency. This pilot randomised controlled trial introduces a compact robotic-based upper-limb reaching task that retrains proprioception and kinaesthesia concurrently. Methods Thirty first-ever chronic stroke survivors (> 6-month post-stroke) will be randomly assigned to either a treatment or a control group. Over a 5-week period, the treatment group will receive 15 training sessions for about an hour per session. Robot-generated haptic guidance will be provided along the movement path as somatosensory cues while moving. Audio-visual feedback will appear following every successful movement as a reward. For the same duration, the control group will complete similar robotic training but without the vision occluded and robot-generated cues. Baseline, post-day 1, and post-day 30 assessments will be performed, where the last two sessions will be conducted after the last training session. Robotic-based performance indices and clinical assessments of upper limb functions after stroke will be used to acquire primary and secondary outcome measures respectively. This work will provide insights into the feasibility of such robot-assisted training clinically. Discussion The current work presents a study protocol to retrain upper-limb somatosensory and motor functions using robot-based rehabilitation for community-dwelling stroke survivors. The training promotes active use of the affected arm while at the same time enhances somatosensory input through augmented feedback. The outcomes of this study will provide preliminary data and help inform the clinicians on the feasibility and practicality of the proposed exercise. Trial registration ClinicalTrials.gov NCT04490655. Registered 29 July 2020.

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