scholarly journals Rehabilitation for Children With Dystonic Cerebral Palsy Using Haptic Feedback in Virtual Reality: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Reika Nicole McNish ◽  
Pramod Chembrammel ◽  
Nathaniel Christopher Speidel ◽  
Julian Jwchun Lin ◽  
Citlali López-Ortiz
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Cerebral Palsy ◽  
Muscle Activation ◽  
Haptic Feedback ◽  
Controlled Trial ◽  
Control Group ◽  
Motor Disorder ◽  
Randomized Controlled ◽  
Clinical Measures

BACKGROUND Cerebral palsy (CP) is the most common developmental motor disorder in children. Individuals with CP demonstrate abnormal muscle tone and motor control. Within the population of children with CP, between 4% and 17% present dystonic symptoms that may manifest as large errors in movement tasks, high variability in movement trajectories, and undesired movements at rest. These symptoms of dystonia typically worsen with physical intervention exercises. OBJECTIVE The aim of this study is to establish the effect of haptic feedback in a virtual reality (VR) game intervention on movement outcomes of children with dystonic CP. METHODS The protocol describes a randomized controlled trial that uses a VR game-based intervention incorporating fully automated robotic haptic feedback. The study consists of face-to-face assessments of movement before, after, and 1 month following the completion of the 6-session game-based intervention. Children with dystonic CP, aged between 7 and 17 years, will be recruited for this study through posted fliers and laboratory websites along with a group of typically developing (TD) children in the same age range. We anticipate to recruit a total of 68 participants, 34 each with CP and TD. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method. The primary outcome measure will be the smoothness index of the interaction force with the robot and of the accelerometry signals of sensors placed on the upper limb segments. Secondary outcomes include a battery of clinical tests and a quantitative measure of spasticity. Assessors administering clinical measures will be blinded. All sessions will be administered on-site by research personnel. RESULTS The trial has not started and is pending local institutional review board approval. CONCLUSIONS Movement outcomes will be examined for changes in muscle activation and clinical measures in children with dystonic CP and TD children. Paired t tests will be conducted on movement outcomes for both groups of children independently. Positive and negative results will be reported and addressed. CLINICALTRIAL ClinicalTrials.gov NCT03744884; https://clinicaltrials.gov/ct2/show/NCT03744884 (Archived by WebCite at http://www.webcitation.org/74RSvmbZP) INTERNATIONAL REGISTERED REPOR PRR1-10.2196/11470

scholarly journals Rehabilitation for Children With Dystonic Cerebral Palsy Using Haptic Feedback in Virtual Reality: Protocol for a Randomized Controlled Trial

10.2196/11470 ◽  
2019 ◽  
Vol 8 (1) ◽  
pp. e11470 ◽  
Author(s):  
Reika Nicole McNish ◽  
Pramod Chembrammel ◽  
Nathaniel Christopher Speidel ◽  
Julian Jwchun Lin ◽  
Citlali López-Ortiz
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Cerebral Palsy ◽  
Haptic Feedback ◽  
Controlled Trial ◽  
Randomized Controlled

scholarly journals A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

2020 ◽  
Author(s):  
Raluca Georgescu ◽  
Anca Dobrean ◽  
Cristina Alina Silaghi ◽  
Horațiu Silaghi
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Repeated Measures ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Self Report ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Outcomes ◽  
Before And After

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic effect of traditional non-pharmacological treatments, such as Cognitive Behaviors Therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through Virtual Reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adult patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 30 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment.

scholarly journals A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

2021 ◽  
Author(s):  
Raluca Georgescu ◽  
Anca Dobrean ◽  
Cristina Alina Silaghi ◽  
Horațiu Silaghi
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Repeated Measures ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Self Report ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Outcomes ◽  
Before And After

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic effect of traditional non-pharmacological treatments, such as Cognitive Behaviors Therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through Virtual Reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adult patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 30 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment. Trial registration ClinicalTrials.gov, NCT03776344. Registered on December 14, 2018.

scholarly journals Potential effects of traditional massage on spasticity and gross motor function in children with spastic cerebral palsy: A randomized controlled trial

2019 ◽  
Vol 35 (5) ◽  
Author(s):  
Qamar Mahmood ◽  
Dr. Shaista Habibullah ◽  
Prof. Dr. Muhammad Naveed Babur
Keyword(s):  
Randomized Controlled Trial ◽  
Cerebral Palsy ◽  
Motor Function ◽  
Controlled Trial ◽  
Intervention Group ◽  
Spastic Cerebral Palsy ◽  
Control Group ◽  
Gross Motor ◽  
Gross Motor Function ◽  
Randomized Controlled

Objective: To evaluate the effects of traditional massage (TM) on spasticity and gross motor function in children with cerebral palsy (CP). Methods: This randomized control trial (RCT) was conducted with recruitment of 86 children (Dropped out= 11; Analyzed= 75) with spastic CP (diplegia) allocated randomly through sealed envelope method to intervention and control group with ages between 2-10 years from September 2016 to August 2018. Both groups received conventional physical therapy (CPT) once daily, five times a week for a period of three months. However, intervention group received TM additionally. Modified Ashworth Scale (MAS), Gross Motor Function Measure (GMFM-88) and Gross Motor Function Classification System (GMFCS) were used to evaluate spasticity and gross motor function at the beginning, after six and 12 weeks of intervention. Data were compared and analyzed through SPSS-20. Results: Mean age in control and intervention group was 6.81±2.31 and 7.05±2.47 years respectively. No statistically significant differences in MAS, GMFM and GMFCS scores were found at base line. The children in intervention group showed statistically significant reduction in MAS scores in all four limbs after six and 12 weeks of intervention (p < 0.05) in comparison with the control group. However, GMFM scores and GMFCS levels did not change significantly in intervention group as compared to control group. Conclusion: It is concluded that TM can effectively reduce the spasticity, does not have harmful effects, so can be administered safely by mothers at home and making it suitable for the management of spastic CP. However, in order to achieve better gross motor function, it should be practiced in conjunction with CPT, functional skills and task oriented approaches. doi: https://doi.org/10.12669/pjms.35.5.478 How to cite this:Mahmood Q, Habibullah S, Babur MN. Potential effects of traditional massage on spasticity and gross motor function in children with spastic cerebral palsy: A randomized controlled trial. Pak J Med Sci. 2019;35(5):---------. doi: https://doi.org/10.12669/pjms.35.5.478 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

scholarly journals A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

2020 ◽  
Author(s):  
Raluca Georgescu ◽  
Anca Dobrean ◽  
Cristina Alina Silaghi ◽  
Horațiu Silaghi
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Repeated Measures ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Self Report ◽  
Control Group ◽  
Psychological Interventions ◽  
Randomized Controlled ◽  
Pain Outcomes

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for a proper postoperative care. While several trials have investigated the analgesia analgesic effect of traditional non-pharmacological treatments, such as Cognitive Behaviors Therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through Virtual Reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adults patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 27 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation on of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment. Keywords: pain; postsurgical pain; virtual reality; psychological interventions; VR-based interventions; Trial registration status: ClinicalTrials, NCT03776344 . Retrospectively registered in December 14, 2018, https://clinicaltrials.gov/ct2/show/NCT03776344 .

scholarly journals A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

2019 ◽  
Author(s):  
Raluca Georgescu ◽  
Anca Dobrean ◽  
Cristina Alina Silaghi ◽  
Horațiu Silaghi
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Repeated Measures ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Self Report ◽  
Control Group ◽  
Successful Implementation ◽  
Randomized Controlled ◽  
Pain Outcomes

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for a proper postoperative care. While several trials have investigated the analgesia effect of traditional non-pharmacological treatments, such Cognitive Behaviors Therapies for pain after surgery, the newer ways of delivering psychological interventions are paucity investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through Virtual Reality (VR) along with the standard pharmacological treatment return better pain outcomes then standard care in adults patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. In the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. A minimum of 27 patients is intended to be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing in-depth investigation on the effect of VR environments, the estimates of pain intensity will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment. Discussion: It has already been established that VR can improve the outcomes of pain treatment at burn patients. Successful implementation in post-operative settings has the potential to change the recovery trajectory of individuals with surgical interventions. However, the best mode of implementation in terms of efficacy, acceptability, and side effects is still unclear. The present trial will provide guidance for pain interventions to be implemented on large scale and will provide scientific support in discussing treatment options for individual patients. Trial registration status: ClinicalTrials, NCT03776344. Retrospectively registered in December 14, 2018, https://clinicaltrials.gov/ct2/show/NCT03776344.

Stretch-shortening cycle exercises can efficiently optimize gait-symmetry and balance capabilities in children with unilateral cerebral palsy: A randomized controlled trial

2021 ◽  
pp. 1-11
Author(s):  
Ragab K. Elnaggar ◽  
Bader A. Alqahtani ◽  
Saud F. Alsubaie ◽  
Rania R. Mohamed ◽  
Mohammed F. Elbanna
Keyword(s):  
Randomized Controlled Trial ◽  
Cerebral Palsy ◽  
Controlled Trial ◽  
Physical Rehabilitation ◽  
Post Treatment ◽  
Control Group ◽  
Gait Symmetry ◽  
Randomized Controlled ◽  
Unilateral Cerebral Palsy ◽  
Stretch Shortening Cycle

BACKGROUND: Children with unilateral cerebral palsy (UCP) experience an asymmetrical gait pattern and poor balance capabilities. Effective interventions, therefore, are needed to facilitate remediation of these functional issues. OBJECTIVE: This study was set out to investigate the emerging role of stretch-shortening cycle (SSC) exercises on gait-symmetry and balance in children with UCP. METHODS: In this randomized controlled trial, 42 children with UCP (age; 8 –12 years) were enrolled and received either standard physical rehabilitation (control group; n = 21) or the SSC exercise program plus physical rehabilitation (SSC group; n = 21). Spatial- and temporal-gait symmetry index (GSI) and specific balance capabilities [reactive balance, directional control, movement synchronization, and sensory organization] were assessed before and after 16 sessions that were carried out twice/week over non-sequential days in an 8-week program. RESULTS: Using the pre-treatment scores as covariates, the post-treatment spatial- (P = 0.006; η p 2 = 0.17) and temporal- GSI (P <  .001; η p 2 = 0.46) scores reduced significantly in the SSC group as compared to the control group, suggesting favorable improvement of gait symmetry. Also, all measures of balance (P <  0.05; η p 2 ranged between 0.10 and 0.29) improved remarkably, post-treatment, in SSC group in comparison with the control group. CONCLUSION: The evidence from this study suggests that SSC exercises besides standard physical rehabilitation appear to be effective for improving gait symmetry and boosting balance capabilities in children with UCP.

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