Effect of functional MRI–guided navigation on surgical outcomes: a prospective controlled trial in patients with arteriovenous malformations

2016 ◽  
Vol 126 (6) ◽  
pp. 1863-1872 ◽  
Author(s):  
Fuxin Lin ◽  
Yuming Jiao ◽  
Jun Wu ◽  
Bing Zhao ◽  
Xianzeng Tong ◽  
...  
Keyword(s):  
Brain Tissue ◽  
Surgical Outcome ◽  
Interim Analysis ◽  
Arteriovenous Malformations ◽  
Controlled Trial ◽  
Standard Procedure ◽  
Control Group ◽  
End Points ◽  
Experimental Group ◽  
Adjacent Brain

OBJECTIVEThe impact of functional MRI (fMRI)–guided navigation on the surgical outcome of patients with arteriovenous malformations (AVMs) is undetermined. This large, randomized controlled trial (RCT) was designed to determine the safety and efficacy of fMRI-guided microsurgery of AVMs. This paper reports the preliminary results of the interim analysis.METHODSBetween September 2012 and June 2015, eligible patients were randomized to the standard microsurgery group (control group) or the fMRI-guided surgery group (experimental group) in a 1:1 ratio. Patients in the control group underwent conventional digital subtraction angiography and MRI before surgery. The surgery was performed according to the standard procedure. However, patients in the experimental group underwent blood oxygen level–dependent (BOLD) fMRI and diffusion tensor imaging within 1 week before surgery. Moreover, preoperative eloquent brain tissue mapping and intraoperative fMRI navigation were performed in addition to the standard procedure. The preliminary end points were the total removal rate of AVMs and postoperative surgical complications. The primary end points were modified Rankin Scale (mRS) score (favorable: mRS Score 0–2; poor: mRS Score 3–6) and surgery-related permanent functional deficits (S-PFD) at the last clinic visit (≥ 6 months). Statistical analysis was performed using the statistical package from SPSS.RESULTSThe interim analysis included 184 participants (93 in the experimental group and 91 in the control group). Patients were equally distributed between the 2 groups. Neither the preliminary nor the primary end points, including postoperative complications (p = 0.781), residual AVM (p = 1.000), last mRS score (p = 0.654), and S-PFD (p = 0.944) showed any significant difference between the control and experimental group. According to the results of the univariate analysis, eloquent adjacent brain tissue (OR 0.14; 95% CI 0.06–0.32; p < 0.001), large size of the nidus (OR 1.05; 95% CI 1.02–1.08; p = 0.002), or diffuse nidus (OR 3.05; 95% CI 1.42–6.58; p = 0.004) were all significantly associated with S-PFD. Additionally, a high Spetzler-Martin score (OR 3.54; 95% CI 2.08–6.02; p < 0.001), no previous hemorrhage (OR 2.35; 95% CI 1.00–5.54; p = 0.05), or a low preoperative mRS score (OR 0.42; 95% CI 0.17–1.00; p = 0.049) were also significantly associated with S-PFD. Multivariate analysis revealed that independent factors correlated with S-PFD were eloquent adjacent brain tissue (OR 0.17; 95% CI 0.04–0.70; p = 0.014) and low preoperative mRS score (OR 0.22; 95% CI 0.07–0.69; p = 0.009).CONCLUSIONSThis preplanned interim analysis revealed no significant differences in the primary end points between the experimental and control group, prompting an early termination of this RCT. The preliminary data indicated that the additional intervention of fMRI navigation is not associated with a more favorable surgical outcome in patients with AVMs. The results indicated that eloquent adjacent brain tissue and a low preoperative mRS score are independent risk factors for S-PFD.Clinical trial registration no.: NCT01758211 (clinicaltrials.gov)

scholarly journals Efficacy of axial TheraTogs on gait pattern in children with dyskinetic cerebral palsy: a randomized controlled trial

2021 ◽  
Vol 26 (1) ◽  
Author(s):  
Shamekh Mohamed El-Shamy ◽  
Ehab Mohamed Abd El Kafy
Keyword(s):  
Cerebral Palsy ◽  
Physical Therapy ◽  
Muscle Tone ◽  
Controlled Trial ◽  
Gait Pattern ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Gait Parameters ◽  
Experimental Group

Abstract Background TheraTogs promotes proprioceptive sense of a child with cerebral palsy and improves abnormal muscle tone, posture alignment, balance, and gait. Therefore, the aim of this study was to investigate the efficacy of TheraTogs orthotic undergarment on gait pattern in children with dyskinetic cerebral palsy. Thirty children with dyskinetic cerebral palsy were selected for this randomized controlled study. They were randomly assigned to (1) an experimental group that received TheraTogs orthotic undergarment (12 h/day, 3 days/week) plus traditional physical therapy for 3 successive months and (2) a control group that received only traditional physical therapy program for the same time period. Gait parameters were measured at baseline and after 3 months of intervention using Pro-Reflex motion analysis. Results Children in both groups showed significant improvements in the gait parameters (P < 0.05), with significantly greater improvements in the experimental group than in the control group. Conclusions The use of TheraTogs may have a positive effect to improve gait pattern in children with dyskinetic cerebral palsy. Trial registration This trial was registered in the ClinicalTrial.gov PRS (NCT03037697).

Does soft tissue mobilization assist static stretching to improve hamstring flexibility? A randomized controlled trial

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Shibili Nuhmani
Keyword(s):  
Soft Tissue ◽  
Controlled Trial ◽  
Knee Extension ◽  
Repeated Measure ◽  
Control Group ◽  
Static Stretching ◽  
Significant Difference ◽  
Hamstring Flexibility ◽  
Soft Tissue Mobilization ◽  
Experimental Group

AbstractObjectivesObjective of the study is to investigate whether Soft tissue mobilization (STM) can assist with static stretching to improve hamstring flexibly.MethodsThe design of the study was repeated measure design. The study was conducted at the physical therapy laboratory of Jamia Hamdard University, New Delhi. Participants included 78 healthy males with hamstring tightness, randomly assigned to either the control group (static stretching) or the experimental group (STM and static stretching). The experimental group received five sets of four different STM techniques, followed by two sets of 30-s static stretches 3 days per week over the course of 12 weeks. The control group received 5 min of sham ultrasound with an inactive probe prior to static stretching. Active knee extension test (AKE) was the outcome measure.ResultsBoth groups showed significant improvement in AKE compared with the baseline measurements. With ingroup analysis showed a significant difference in AKE across all measured time periods (weeks 4, 8, and 12) with pre-test in both groups (p<0.05). No significant difference in AKE improvement was found between groups (p>0.05).ConclusionThe results of this study show that STM prior to static stretching does not significantly improve hamstring flexibility among healthy individuals. Although this study cannot be generalized, the results may be useful for evidence-based practice in the management of hamstring tightness.

scholarly journals Effect of Microcurrent Stimulation on Pain, Shoulder Function, and Grip Strength in Early Post-Operative Phase after Rotator Cuff Repair

Medicina ◽  
2021 ◽  
Vol 57 (5) ◽  
pp. 491
Author(s):  
Donghyun Yi ◽  
Hwanyong Lim ◽  
Jongeun Yim
Keyword(s):  
Rotator Cuff ◽  
Grip Strength ◽  
Rotator Cuff Repair ◽  
Controlled Trial ◽  
Shoulder Function ◽  
Control Group ◽  
Simple Shoulder Test ◽  
General Physical ◽  
Cuff Repair ◽  
Experimental Group

Background and Objectives: The purpose of this study was to investigate the effects of microcurrent stimulation on pain, shoulder function, and grip strength in patients with rotator cuff repair. Materials and Methods: This randomized single-blind controlled trial was conducted on inpatients of the rehabilitation department, and included 28 patients who underwent rotator cuff repair. Participants were randomly assigned to the experimental group (n = 14), treated with microcurrent stimulation, and the control group (n = 14), treated with false microcurrent stimulation. The microcurrent stimulation administered to the experimental group underwent general physical therapy and microcurrent stimulation three times a week for 4 weeks. Results: Changes in pain, range of motion in shoulder, simple shoulder test, and grip strength were assessed before and after the intervention. Both groups showed a significant decrease in pain and shoulder function (t = 27.412, 22.079, 19.079, and 18.561; p < 0.001), and grip strength showed a significant increase (t = −8.251 and −9.946; p < 0.001). The experimental group that underwent microcurrent stimulation exhibited a significant effect on pain, shoulder function, and grip strength compared with the control group that underwent false microcurrent stimulation (t = −2.17, −2.22, and 2.213; p = 0.039, 0.035, and 0.036). Conclusions: This study confirmed that microcurrent stimulation is effective for the treatment of rotator cuff repair patients.

scholarly journals The effects of transcutaneous electrical nerve stimulation during the first stage of labor: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Anne Njogu ◽  
Si Qin ◽  
Yujie Chen ◽  
Lizhen Hu ◽  
Yang Luo
Keyword(s):  
Transcutaneous Electrical Nerve Stimulation ◽  
Controlled Trial ◽  
Labor Pain ◽  
Control Group ◽  
Electrical Nerve Stimulation ◽  
Randomized Controlled ◽  
Active Labor ◽  
Vas Scores ◽  
Experimental Group ◽  
First Stage Of Labor

Abstract Background Labor pain during childbirth can have devastating effects on the progress of labor, mother, and fetus. Consequently, the management of labor pain is crucial for the well-being of the mother and fetus. Transcutaneous electrical nerve stimulation (TENS) is a non -pharmacological analgesic technique. It uses a low-voltage electrical current to activate descending inhibitory systems in the central nervous system to relieve pain. This study aimed to determine the effects of TENS therapy in the first stage of labor. Methods In this single-blind randomized controlled trial, we screened low-risk pregnant women who anticipated spontaneous vaginal delivery. Women were assigned (1:1) to either the experimental group (received TENS therapy in the first stage of labor) or the control group (received routine obstetric care). The women, midwives, and researchers working in the gynecology and obstetric department were aware of the treatment group, but statisticians analysis the data were blinded. The primary outcome was labor pain intensity, assessed by visual analog scale (VAS) immediately after the randomization, at 30, 60, and 120 min after TENS therapy, and 2–24 h post-delivery. We used SPSS 21.0 software in data analysis. An independent sample t-test compared the mean VAS scores and labor duration between groups. A Chi-square test was employed to compare categorical variables between the groups. A significant level of ≤0.05 was statistically significant. Results A total of 326 pregnant women were eligible: experimental group (n = 161) and control group (n = 165). The experimental group had statistically significantly lower mean VAS scores at a different time (30, 60, and 120 min post-intervention and 2–24 h post-delivery) than the control group (p < 0.001). The experimental group demonstrated a statistically significant shorter duration of the active labor phase than the control group (p < 0.001). Conclusion This study indicates that TENS can be used as a non-pharmacological therapy to reduce pain and shorten the active labor phase. Trial registration ISRCTN registry, ISRCTN23857995. Registered on 11/12/2020, ‘retrospectively registered.

scholarly journals The CARESSES Randomised Controlled Trial: Exploring the Health-Related Impact of Culturally Competent Artificial Intelligence Embedded Into Socially Assistive Robots and Tested in Older Adult Care Homes

2021 ◽  
Author(s):  
Chris Papadopoulos ◽  
Nina Castro ◽  
Abiha Nigath ◽  
Rosemary Davidson ◽  
Nicholas Faulkes ◽  
...  
Keyword(s):  
Older Adult ◽  
Controlled Trial ◽  
Control Group ◽  
Culturally Competent ◽  
Adult Care ◽  
Assistive Robots ◽  
Sf 36 ◽  
Randomised Controlled ◽  
Experimental Group ◽  
Group 1

AbstractThis trial represents the final stage of the CARESSES project which aimed to develop and evaluate a culturally competent artificial intelligent system embedded into social robots to support older adult wellbeing. A parallel group, single-blind randomised controlled trial was conducted across older adult care homes in England and Japan. Participants randomly allocated to the Experimental Group or Control Group 1 received a Pepper robot for up 18 h across 2 weeks. Two versions of the CARESSES artificial intelligence were tested: a fully culturally competent system (Experimental Group) and a more limited version (Control Group 1). Control Group 2 (Care As Usual) participants did not receive a robot. Quantitative outcomes of interest reported in the current paper were health-related quality of life (SF-36), loneliness (ULS-8), and perceptions of robotic cultural competence (CCATool-Robotics). Thirty-three residents completed all procedures. The difference in SF-36 Emotional Wellbeing scores between Experimental Group and Care As Usual participants over time was significant (F[1] = 6.614, sig = .019, ηp2 = .258), as was the comparison between Any Robot used and Care As Usual (F[1] = 5.128, sig = .031, ηp2 = .146). There were no significant changes in SF-36 physical health subscales. ULS-8 loneliness scores slightly improved among Experimental and Control Group 1 participants compared to Care As Usual participants, but this was not significant. This study brings new evidence which cautiously supports the value of culturally competent socially assistive robots in improving the psychological wellbeing of older adults residing in care settings.

A Controlled Trial of Home-Based Acute Psychiatric Services

1993 ◽  
Vol 163 (1) ◽  
pp. 49-54 ◽  
Author(s):  
Tom Burns ◽  
Alan Beadsmoore ◽  
Ashok V. Bhat ◽  
Andrew Oliver ◽  
Carola Mathers
Keyword(s):  
Controlled Trial ◽  
Controlled Study ◽  
Control Group ◽  
Community Based ◽  
Home Based ◽  
Randomised Controlled Study ◽  
One Year ◽  
Randomised Controlled ◽  
Clinical Measures ◽  
Experimental Group

While research has shown community-based psychiatric care to be as good as, or better than, hospital-based care, generalisation to clinical practice has been difficult. This prospective, randomised controlled study examined a community-based approach feasible within NHS conditions. Ninety-four patients were randomly allocated to experimental and 78 to control treatments and followed for one year. The groups were well matched apart from an excess of psychotic control patients. No differences in clinical or social functioning outcome were found. Both groups improved substantially on clinical measures in the first six weeks, with some slow consolidation thereafter. There were three suicides in the control group and one in the experimental group. Access to care was better in the experimental group (93% attended assessment) than in the control group (75% attended assessment).

scholarly journals Effectiveness Of Topical Application Of Chlorhexidine And Prevailing Practices On Episiotomy Wound Among Postnatal Mothers

2014 ◽  
Vol 2 (1) ◽  
Author(s):  
Rincy Michael ◽  
Soney N Toppo ◽  
Varsha Hariharan
Keyword(s):  
Wound Healing ◽  
Topical Application ◽  
Controlled Trial ◽  
Demographic Data ◽  
Assessment Scale ◽  
Research Centre ◽  
Control Group ◽  
Significant Difference ◽  
Postnatal Mothers ◽  
Experimental Group

Puerperium is a period when the mother experiences intense physical and emotional stress due to exhaustion, anxiety and excitement. Each mother has to adjust to physical changes in her own body due to involution and lactation as well as cope up with the new demands on her time and emotions made by the new born baby. Episiotomy, despite evidences that it is an unnecessary intervention, is one of the most common surgical procedures performed during the second stage of labour, especially in primigravida woman. Thus, a randomized controlled trial to assess the effectiveness of topical application of chlorhexidine and prevailing practices on episiotomy wound among postnatal mothers at selected hospital of Indore was undertaken. True experimental approach with pre test post test research design was adopted. Simple random sampling was taken to select 40 postnatal mothers with episiotomy wound and three days postpartum hospital stay in Choithram Hospital & Research Centre, Indore as per the inclusion criteria. Data was collected with help of questionnaire for socio demographic data and obstetrical data and the wound healing was assessed by REEDA wound healing assessment scale. Samples in the experimental group were applied with chlorhexidine on episiotomy wound and the samples in the control group received routine care with betadine or nadoxin. Post assessment score was taken on third day (evening) by REEDA wound assessment scale. Finding of the study related to effectiveness of chlorhexidine among postnatal mothers in experimental group revealed that there was a significant difference in the healing of episiotomy wound by the application of chlorhexidine among postnatal mothers in experimental group at t19 = 11.40 at the level of p< 0.001. Hence it was inferred that topical application of chlorhexidine on episiotomy wound promotes wound healing.

scholarly journals Effectiveness of Abdominal and Gluteus Medius Training in Lumbo-pelvic Stability and Adductor Strength in Women Soccer Players. A Randomized Controlled Study.

2020 ◽  
Author(s):  
Héctor Guerrero-Tapia ◽  
Rodrigo Martín-Baeza ◽  
Rubén Cuesta-Barriuso
Keyword(s):  
Repeated Measures ◽  
Controlled Trial ◽  
Gluteus Medius ◽  
Soccer Players ◽  
Controlled Study ◽  
Control Group ◽  
Extrinsic Factors ◽  
Randomized Controlled ◽  
Limb Injuries ◽  
Experimental Group

Abstract Background: Abdominal and lumbo-pelvic stability alterations may origin lower limb injuries, such as for example adductor pathology in soccer players. Imbalance can be caused by both intrinsic and extrinsic factors. Methods: This randomized controlled trial conducted over an 8-week period included 25 female footballers randomly allocated to an experimental group (isometric abdominal training and gluteus medius-specific training) or a control group (isometric abdominal training). The exercise protocol in common for both groups included three exercises: Plank, Lateral plank and Bird dog. Specific exercises for the gluteus medius were: Pelvic drop and Stabilization of the gluteus medius in knee valgus. Outcome measures were lumbo-pelvic stability and adductor strength.Results. Lumbo-pelvic stability after surgery was higher in the control group (MD: 4.84 vs MD: 9.58; p < .01) with differences in the analysis of repeated measures (p<.001), but not in group interaction (p =.26). Changes were found in adductor strength in the experimental group (MD: -2.48; p<.001 in the left adductor; MD: -1.48; p<.01 in right adductor) and control group (MD: -1.68; p<.001 in the left adductor; MD: -2.05; p<.001 in the right adductor) after the intervention, with differences in the analysis of repeated measures in left (p<.001) and right (p<.001) adductor strength.Conclusions. An abdominal and gluteal training protocol shows no advantage over a protocol of abdominal training alone for lumbo-pelvic stability and adductor strength and flexibility, while improvements are maintained at four weeks follow-up. Trial Registration Number: NCT03617887.

scholarly journals Effects of Patient-Selected Music Listening on the Pain and Anxiety of Patients Undergoing Hemodialysis: A Randomized Controlled Trial

Healthcare ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. 1437
Author(s):  
SukKyong Kim ◽  
HyeonCheol Jeong
Keyword(s):  
Vascular Access ◽  
Controlled Trial ◽  
Clinical Intervention ◽  
Hemodialysis Patients ◽  
Control Group ◽  
Music Listening ◽  
Anxiety States ◽  
Subjective Pain ◽  
Anxiety Levels ◽  
Experimental Group

This study aimed to analyze the influence of patient-selected music listening on the pain and anxiety levels of hemodialysis patients after undergoing a vascular access operation. Methods: Sixty five patients were randomly assigned to the experimental group (n = 32) or the control group (n = 33). The experimental group was instructed to listen to their favorite music using headphones during their operations at the center. The control group underwent the operations without listening to any music. The pain measurement during vascular access operation was measured by subjective pain and objective pain behavior; anxiety was measured by subjective anxiety and anxiety states. Results: The experimental group reported significantly lower subjective pain levels than the control group (t = 9.36, p = 0.003). Regarding objective pain behaviors, the experimental group had a significantly lower score than the control group (t = 4.59, p = 0.036). The experimental group had significantly lowered subjective anxiety compared to the control group (F = 10.10, p = 0.002). Regarding anxiety states, the experimental group had significantly lower scores than the control group (F = 23.34, p < 0.001). Conclusion: The results suggest that patient-selected music listening reduced hemodialysis patients’ pain and anxiety levels during vascular access operations. Therefore, music medicine can be included as a new clinical intervention.

Cluster Symptoms Reduction via Telephone-Based Intervention in Thai Breast Cancer Patients Undergoing 4-Cycle Adjuvant Chemotherapy: A Randomized-Controlled Trial

2021 ◽  
Vol 104 (6) ◽  
pp. 887-894
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Adjuvant Chemotherapy ◽  
Energy Conservation ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Randomized Controlled ◽  
Experimental Group

Background: Cluster symptoms are a common occurrence in breast cancer patients undergoing chemotherapy. The telephone is a well-recognized, convenient device for reaching out to patients for monitoring and managing their symptoms in an efficient, prompt, and appropriate manner. Objective: To investigate the efficacy of telephone-based intervention to achieve energy conservation among breast cancer patients with the aim of alleviating fatigue, pain, sleep disturbance, and depression. Materials and Methods: The present study was a two-armed, randomized control trial conducted in the university hospital between March and September 2019. Seventy-four breast cancer patients, receiving four courses of adjuvant chemotherapy, were randomly recruited and assigned into the experimental group and the control group. One face-to-face intervention interview for energy conservation was conducted, followed by 20-minutes telephone brief counselling and assessment sessions, scheduled on day 1, 2, 7, and 14. Results: The scores for symptoms of median fatigue and pain in the experimental group were shown to be significantly reduced at the end of the study as compared to those scores within the control group (p<0.05). Similarly, scores for median sleep time and depression were greater at the end of cycle 1 and highest in cycle 2 (p<0.05, 0.001, respectively). Physical activity levels were also higher in the experimental group than in the control group in every cycle, with a statistical significance (p<0.001). Conclusion: The present study intervention demonstrated an effectiveness for the reduction of cluster symptoms. Further studies would be needed in a larger population scale in the customary, randomized controlled trial manner. Keywords: Cancer; Energy conservation; Fatigue; Pain; Sleep; Telephone

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