scholarly journals Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomized controlled trial.

2019 ◽  
Author(s):  
Niccolò Butti ◽  
Emilia Biffi ◽  
Chiara Genova ◽  
Romina Romaniello ◽  
Davide Felice Redaelli ◽  
...  
Keyword(s):  
Social Cognition ◽  
Active Control ◽  
Controlled Trial ◽  
Control Group ◽  
Active Control Group ◽  
Intensive Training ◽  
Randomized Controlled ◽  
Cerebellar Malformations ◽  
Social Prediction ◽  
Social Cognition Training

Abstract Background: Patients with cerebellar malformations exhibit not only movement problems, but also important deficits in social cognition. Thus, rehabilitation approaches should not only involve the recovery of motor function but also of higher-order abilities, such as processing of social stimuli. In keeping with the general role of the cerebellum in anticipating and predicting events, we used a VR-based rehabilitation system to implement a social cognition intensive training specifically tailored to improve predictive abilities in social scenarios (VR-Spirit).Methods: The study is an interventional randomized controlled trial that aims to recruit 42 children, adolescents and young adults with congenital cerebellar malformations, randomly allocated to the experimental or active control group. The experimental group is administered the VR-Spirit, requiring the participants to compete with different avatars in the reaching of recreational equipment and implicitly prompting them to form expectations about their playing preference. The active control group participates to a VR-training with standard games currently adopted for motor rehabilitation. Both trainings are composed by 8 45-minute sessions and are administered in the GRAIL VR-Lab (Motekforce Link, NL), an integrated platform that allows patients to move in natural and attractive VR environments. An evaluation session in VR with the same paradigm used in the VR-Spirit but implemented in a different scenario is administered at the beginning (T0) of the two trainings (T1) and at the end (T2). Moreover, a battery of neurocognitive tests spanning different domains are administered to all participants at T0, T2 and in a follow-up session after two months from the end of the two trainings (T3).Discussion: This study offers a novel approach for rehabilitation based on specific neural mechanisms of the cerebellum. We aim to investigate the feasibility and efficacy of a new intensive social cognition training in a sample of Italian patients aged 7-25 years with congenital cerebellar malformations. We expect that VR-Spirit could enhance social prediction ability and indirectly improve cognitive performance in diverse domains. Moreover, through the comparison with a VR-active control training we aim to verify the specificity of VR-Spirit in improving social perception skills.Trial registration: ISRCTN, ISRCTN 22332873. Retrospectively registered on 12 March 2018. http://www.isrctn.com/ISRCTN22332873Keywords: Virtual reality; Social cognition training; Cerebellum; Paediatric patients; Rehabilitation; Grail.

scholarly journals Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomized controlled trial.

2019 ◽  
Author(s):  
Niccolò Butti ◽  
Emilia Biffi ◽  
Chiara Genova ◽  
Romina Romaniello ◽  
Davide Felice Redaelli ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Social Cognition ◽  
Active Control ◽  
Controlled Trial ◽  
Control Group ◽  
Active Control Group ◽  
Intensive Training ◽  
Randomized Controlled ◽  
Cerebellar Malformations ◽  
Social Prediction

Abstract Background: Patients with cerebellar malformations exhibit not only movement problems, but also important deficits in social cognition. Thus, rehabilitation approaches should not only involve the recovery of motor function but also of higher-order abilities, such as processing of social stimuli. In keeping with the general role of the cerebellum in anticipating and predicting events, we used a VR-based rehabilitation system to implement a social cognition intensive training specifically tailored to improve predictive abilities in social scenarios (VR-Spirit). Methods: The study is an interventional randomized controlled trial that aims to recruit 42 children, adolescents and young adults with congenital cerebellar malformations, randomly allocated to the experimental or active control group. The experimental group is administered the VR-Spirit, requiring the participants to compete with different avatars in the reaching of recreational equipment and implicitly prompting them to form expectations about their playing preference. The active control group participates to a VR-training with standard games currently adopted for motor rehabilitation. Both trainings are composed by 8 45-minute sessions and are administered in the GRAIL VR-Lab (Motekforce Link, NL), an integrated platform that allows patients to move in natural and attractive VR environments. An evaluation session in VR with the same paradigm used in the VR-Spirit but implemented in a different scenario is administered at the beginning (T0) and at the end (T1) of the two trainings. Moreover, a battery of neurocognitive tests spanning different domains are administered to all participants at T0, T1 and in a follow-up session after two months from the end of the two trainings (T2). Discussion: This study offers a novel approach for rehabilitation based on specific neural mechanisms of the cerebellum. We aim to investigate the feasibility and efficacy of a new intensive social cognition training in a sample of Italian patients aged 7-25 years with congenital cerebellar malformations. We expect that VR-Spirit could enhance social prediction ability and indirectly improve cognitive performance in diverse domains. Moreover, through the comparison with a VR-active control training we aim to verify the specificity of VR-Spirit in improving social perception skills.

scholarly journals Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomized controlled trial.

2019 ◽  
Author(s):  
Niccolò Butti ◽  
Emilia Biffi ◽  
Chiara Genova ◽  
Romina Romaniello ◽  
Davide Felice Redaelli ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Social Cognition ◽  
Active Control ◽  
Controlled Trial ◽  
Control Group ◽  
Active Control Group ◽  
Intensive Training ◽  
Randomized Controlled ◽  
Cerebellar Malformations ◽  
Social Prediction

Abstract Background: Patients with cerebellar malformations exhibit not only movement problems, but also important deficits in social cognition. Thus, rehabilitation approaches should not only involve the recovery of motor function but also of higher-order abilities, such as processing of social stimuli. In keeping with the general role of the cerebellum in anticipating and predicting events, we used a VR-based rehabilitation system to implement a social cognition intensive training specifically tailored to improve predictive abilities in social scenarios (VR-Spirit). Methods: The study is an interventional randomized controlled trial that aims to recruit 42 children, adolescents and young adults with congenital cerebellar malformations, randomly allocated to the experimental or active control group. The experimental group is administered the VR-Spirit, requiring the participants to compete with different avatars in the reaching of recreational equipment and implicitly prompting them to form expectations about their playing preference. The active control group participates to a VR-training with standard games currently adopted for motor rehabilitation. Both trainings are composed by 8 45-minute sessions and are administered in the GRAIL VR-Lab (Motekforce Link, NL), an integrated platform that allows patients to move in natural and attractive VR environments. An evaluation session in VR with the same paradigm used in the VR-Spirit but implemented in a different scenario is administered at the beginning (T0) and at the end (T1) of the two trainings. Moreover, a battery of neurocognitive tests spanning different domains are administered to all participants at T0, T1 and in a follow-up session after two months from the end of the two trainings (T2). Discussion: This study offers a novel approach for rehabilitation based on specific neural mechanisms of the cerebellum. We aim to investigate the feasibility and efficacy of a new intensive social cognition training in a sample of Italian patients aged 7-25 years with congenital cerebellar malformations. We expect that VR-Spirit could enhance social prediction ability and indirectly improve cognitive performance in diverse domains. Moreover, through the comparison with a VR-active control training we aim to verify the specificity of VR-Spirit in improving social perception skills.

scholarly journals Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment (PIPCI): Study Protocol of a Randomized Controlled Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Urban Ekman ◽  
Mike K. Kemani ◽  
John Wallert ◽  
Rikard K. Wicksell ◽  
Linda Holmström ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Active Control ◽  
Psychological Health ◽  
Early Phase ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Waiting List ◽  
Control Group ◽  
Active Control Group ◽  
Randomized Controlled

BackgroundIndividuals with early phase cognitive impairment are frequently affected by existential distress, social avoidance and associated health issues (including symptoms of stress, anxiety, and depression). The demand for efficient psychological support is crucial from both an individual and a societal perspective. We have developed a novel psychological intervention (Psychological Intervention tailored for Patients with Cognitive Impairment, PIPCI) manual for providing a non-medical path to enhanced psychological health in the cognitively impaired population. The current article provides specific information on the randomized controlled trial (RCT)-design and methods. The main hypothesis is that participants receiving PIPCI will increase their psychological flexibility (the ability to notice and accept interfering thoughts, emotions, and bodily sensations without acting on them, when this serves action in line with personal values) compared to participants in the active control (cognitive training) group and the waiting list control group. The secondary hypotheses are that participants receiving PIPCI will improve psychological health (stress measures, quality of life, depression, and general health) compared to participants in the active control group and the waiting list control group.Materials and MethodsThis three-arm RCT will recruit participants from the cognitive centers at Karolinska University Hospital in Stockholm and randomize approximately 120 individuals in the early phase of cognitive impairment to either an experimental group (psychological intervention once a week for 10 weeks), an active control group (cognitive training once a week for 10 weeks) or a waiting list control group. Intervention outcome will be evaluated with self-report questionnaires on physical and psychological aspects of health, cognitive assessment, biological markers (obtained from blood and saliva) and health care costs. Assessments will be performed at pre- (1 week before the interventions) and post-intervention (1 week after the interventions), as well as at a 6-month follow-up.DiscussionThe development of a potentially feasible and effective psychological intervention tailored for early phase cognitive impairment (PIPCI) has the potential to advance the non-pharmacological intervention field. This is especially important given the extensive burden for many affected individuals and their families and the current lack of effective treatments. If the psychological intervention discussed here shows feasibility and efficacy, there is potential for far-reaching healthcare implications for patients with early cognitive impairment at risk of developing dementia.Clinical Trial RegistrationClinicalTrials.gov: NCT04356924. Date of registration: April 22, 2020. URL: https://clinicaltrials.gov/ct2/show/NCT04356924.

Promoting Volunteering Among Older Adults in Hong Kong: A Randomized Controlled Trial

2019 ◽  
Vol 60 (5) ◽  
pp. 968-977 ◽  
Author(s):  
Da Jiang ◽  
Lisa M Warner ◽  
Alice Ming-Lin Chong ◽  
Tianyuan Li ◽  
Julia K Wolff ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Hong Kong ◽  
Active Control ◽  
Controlled Trial ◽  
Action Planning ◽  
Control Group ◽  
Active Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background and Objectives Volunteering has consistently been associated with better mental, physical, and cognitive health in older adulthood. However, the volunteering rate of older adults in Hong Kong is much lower than in Western countries. Few studies have examined whether interventions can be effective in motivating older adults to volunteer in Hong Kong. To fill this gap, we conducted a randomized controlled trial to examine the impact of a theory-based social-cognitive intervention on volunteering. Research Design and Methods A total of 264 community-dwelling older adults in Hong Kong (Mage = 69.95 years, SDage = 6.90 years, 81.06% female) were randomly assigned to either an experimental group or an active control group. Participants in the experimental group received 4 weekly 1-hr face-to-face volunteering intervention sessions. Those in the active control group received parallel sessions targeting physical activity instead of volunteering. The time spent on volunteering per month was self-reported and measured at baseline, 6 weeks, 3 months, and 6 months after the intervention. Self-efficacy, intention, action planning, and self-monitoring of volunteering were measured as mediators. Results Monthly volunteering minutes increased among participants in the experimental group when compared with the active control group at 6-week, 3-month, and 6-month follow-ups. Self-efficacy, intention, and action planning consistently mediated the effect of the intervention on volunteering minutes. Discussion and Implications The findings demonstrate the effectiveness of the intervention on volunteering behavior in older adults in Hong Kong through well-established behavior change techniques.

Mindfulness Training and Attentional Control in Older Adults: A Randomized Controlled Trial

2018 ◽  
Author(s):  
Patrick Whitmoyer ◽  
Stephanie Fountain-Zargoza ◽  
Rebecca Andridge ◽  
Keith Bredemeier ◽  
Allison Londerée ◽  
...  
Keyword(s):  
Older Adults ◽  
Working Memory ◽  
Randomized Controlled Trial ◽  
Active Control ◽  
Attentional Control ◽  
Controlled Trial ◽  
Mindfulness Training ◽  
Control Group ◽  
Active Control Group ◽  
Randomized Controlled

Mindfulness-based interventions have been found to improve facets of attentional control. However, comparison with active control groups has been scarce, and few studies have examined mindfulness as a means to ameliorate age-related cognitive deficits. This rigorously-designed, placebo-controlled randomized controlled trial, investigated the effects of mindfulness-based attention training (MBAT) on attentional control in older adults relative to an active control group. Seventy-four community-dwelling older adults were randomized to four weeks of MBAT or an active lifestyle eduction control group. Pre- and post-intervention, participants completed two computerized measures of attentional control with intermittent assessments of self-reported mind-wandering. Although we found some evidence for greater reductions in mind-wandering in the MBAT than the active control group, the MBAT group did not exhibit greater improvements in attentional performance. Exploratory analyses revealed working memory as a significant moderator of the observed effects, such that those in the MBAT group with higher working memory showed greater improvement in attentional control. Thus, we found preliminary evidence for attentional benefits following mindfulness training only in individuals with high working memory. Our results call for more rigorous implementation of RCT methodology in future investigations of mindfulness training’s benefits for cognitive functioning in older adults.

scholarly journals A Randomized Controlled Trial of Illness Management and Recovery With an Active Control Group

2014 ◽  
Vol 65 (8) ◽  
pp. 1005-1011 ◽  
Author(s):  
Michelle P. Salyers ◽  
Alan B. McGuire ◽  
Marina Kukla ◽  
Sadaaki Fukui ◽  
Paul H. Lysaker ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Active Control ◽  
Controlled Trial ◽  
Control Group ◽  
Illness Management ◽  
Active Control Group ◽  
Illness Management And Recovery ◽  
Randomized Controlled

scholarly journals Remotely delivered environmental enrichment intervention for traumatic brain injury: Study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e039767
Author(s):  
Zorry Belchev ◽  
Mary Ellene Boulos ◽  
Julia Rybkina ◽  
Kadeen Johns ◽  
Eliyas Jeffay ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Active Control ◽  
Environmental Enrichment ◽  
Spatial Navigation ◽  
Controlled Trial ◽  
Control Group ◽  
Hippocampal Atrophy ◽  
Active Control Group ◽  
Navigation Group

IntroductionIndividuals with moderate-severe traumatic brain injury (m-sTBI) experience progressive brain and behavioural declines in the chronic stages of injury. Longitudinal studies found that a majority of patients with m-sTBI exhibit significant hippocampal atrophy from 5 to 12 months post-injury, associated with decreased cognitive environmental enrichment (EE). Encouragingly, engaging in EE has been shown to lead to neural improvements, suggesting it is a promising avenue for offsetting hippocampal neurodegeneration in m-sTBI. Allocentric spatial navigation (ie, flexible, bird’s eye view approach), is a good candidate for EE in m-sTBI because it is associated with hippocampal activation and reduced ageing-related volume loss. Efficacy of EE requires intensive daily training, prohibitive within most current health delivery systems. The present protocol is a novel, remotely delivered and self-administered intervention designed to harness principles from EE and allocentric spatial navigation to offset hippocampal atrophy and potentially improve hippocampal functions such as navigation and memory for patients with m-sTBI.Methods and analysisEighty-four participants with chronic m-sTBI are being recruited from an urban rehabilitation hospital and randomised into a 16-week intervention (5 hours/week; total: 80 hours) of either targeted spatial navigation or an active control group. The spatial navigation group engages in structured exploration of different cities using Google Street View that includes daily navigation challenges. The active control group watches and answers subjective questions about educational videos. Following a brief orientation, participants remotely self-administer the intervention on their home computer. In addition to feasibility and compliance measures, clinical and experimental cognitive measures as well as MRI scan data are collected pre-intervention and post-intervention to determine behavioural and neural efficacy.Ethics and disseminationEthics approval has been obtained from ethics boards at the University Health Network and University of Toronto. Findings will be presented at academic conferences and submitted to peer-reviewed journals.Trial registration numberVersion 3, ClinicalTrials.gov Registry (NCT04331392).

Self-Managed Music-Guided Exercise Intervention Improved Upper and Lower Extremity Muscle Strength for ICU Survivors—A Pilot Randomized Controlled Study

2021 ◽  
pp. 109980042110502
Author(s):  
Zhan Liang ◽  
Hilary Yip ◽  
Kimberly Sena Moore ◽  
Tanira Ferreira ◽  
Ming Ji ◽  
...  
Keyword(s):  
Muscle Strength ◽  
Lower Extremity ◽  
Active Control ◽  
Exercise Intervention ◽  
Controlled Study ◽  
Control Group ◽  
Active Control Group ◽  
Randomized Controlled ◽  
Left And Right ◽  
The Mean

Objective The objective of this study was to evaluate effects of a self-managed music-guided exercise intervention on muscle strength among intensive care unit (ICU) survivors. Methods We used a two-arm randomized-controlled trial. Following ICU discharge, eligible participants were assigned to one of two groups: music group ( n = 13) or active control group ( n = 13). The music group was taught to self-manage upper and lower extremity exercise movements by listening to an individualized music-guided playlist twice daily for 5 days. The active control group was provided an exercise brochure and advised to perform the same exercises at the same intervals. Dynamometers were used to measure muscle strength. T-tests and Weighted GEE models were used for testing the intervention effect between groups. Results Twenty-six subjects were enrolled. The mean age was 62.8 ( SD = 13.8), 53.8% were male, 65.4% were Caucasian, and the mean APACHE severity of illness score was 59 ( SD = 23.4). Reasons for ICU admission were mainly cardiac and medical. The music group showed significant improvements in handgrip, plantar flexion, leg extension, elbow flexion, and shoulder adduction strengths on left and right sides. Additionally, left and right leg extensor and left plantar flexor strengths showed significant post-differences, and small to moderately large effect sizes, between the music group and control group. Conclusion These findings suggest that a music-guided exercise intervention has the potential to improve muscle strength in ICU survivors and prevent further post-ICU deterioration in ICU survivors. Future trials should build upon these preliminary findings.

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