Clinical effectiveness of peroneal nerve functional electrical stimulation in chronic stroke patients with hemiplegia (PLEASURE): A multicentre, prospective, randomised controlled trial

2020 ◽  
pp. 026921552096670
Author(s):  
Kenji Hachisuka ◽  
Mitsuhiro Ochi ◽  
Takashi Kikuchi ◽  
Satoru Saeki
Keyword(s):  
Peroneal Nerve ◽  
Controlled Trial ◽  
Gait Training ◽  
Foot Drop ◽  
Control Group ◽  
Walk Test ◽  
Stroke Patients ◽  
Control Groups ◽  
Secondary Endpoints ◽  
And Control

Objective: To compare the effectiveness of gait training using a peroneal nerve stimulation device with the effectiveness of gait training without the device in improving gait ability and ankle-specific body functions. Design: Multicentre, prospective, randomised, open-label trial. Setting: Twenty-three hospitals. Subjects: In total, 119 stroke patients with foot drop were randomly assigned to the experimental (with the device) or control (without the device) group. Intervention: Subjects underwent 480-minute self-directed training over four weeks, followed by 260-minute physical therapist-assisted gait training with or without the device. Main measures: The primary endpoint was a change in the six-minute walk test (6MWT) without the device from baseline to after the four-week intervention. The secondary endpoints were changes in the 10-metre walk test (10MWT) without the device, Fugl-Meyer Assessment, range of motion, muscle strength, Modified Ashworth Scale, Stroke Impact Scale Japanese edition (J-SIS) and adverse events. Results: Fifty-six experimental and 59 control group participants, with an average age of 59 years (SD 12) completed the trial. The 6MWT distance changes (m) for the experimental and control groups were 14.7 (SD 37.6) and 22.2 (SD 49.3), respectively. The 10MWT speed changes (m/sec) for the experimental and control groups were 0.06 (SD 0.12) and 0.07 (SD 0.17), respectively. No significant differences were observed in these changes between both groups, and no differences were found in the other secondary endpoints, except for the J-SIS patient’s subjective assessment ( P = 0.048). Conclusion: The improvement in gait ability and body functions were equivalent with or without the use of the device.

scholarly journals Alleviating psychological distress associated with a positive cervical cancer screening result: a randomized control trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yukari Isaka ◽  
Ai Hori ◽  
Rie Tanaka ◽  
Masao Ichikawa
Keyword(s):  
Cervical Cancer ◽  
Psychological Distress ◽  
Cancer Screening ◽  
Cervical Cancer Screening ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
And Control ◽  
Screening Result

Abstract Background The method of communicating a positive cancer screening result should seek to alleviate psychological distress associated with a positive result. We evaluated whether the provision of information through a leaflet would help reduce psychological distress in a randomized controlled trial. Methods The participants were women aged 20–69 years who were about to undergo cervical cancer screening at health centers. Before the screening, they received hypothetical screening results, with a leaflet (intervention group, n = 493) or without it (control group, n = 479), randomly. Their psychological distress and intention to undergo further examination were then compared between the intervention and control groups. Results After the intervention (providing a leaflet with hypothetical screening results), psychological distress appeared to be higher in the control group than in the intervention group among those who received a hypothetical positive screening result (odds ratio: 2.57, 95% confidence interval: 1.87–3.54), while 95% and 97% of those in the intervention and control groups, respectively, reported that they would undergo further examination. Conclusions Information provision might help reduce psychological distress but not hinder further examination among women who screen positive for cervical cancer. Trial registration: UMIN Clinical Trials Registry UMIN000029894. Date of Registration: November 2017.

The Efficacy of Silver-Ion Implanted Catheters in Reducing Peritoneal Dialysis-Related Infections

2003 ◽  
Vol 23 (4) ◽  
pp. 368-374 ◽  
Author(s):  
John H. Crabtree ◽  
Raoul J. Burchette ◽  
Rukhsana A. Siddiqi ◽  
Isan T. Huen ◽  
Linda L Hadnott ◽  
...  
Keyword(s):  
Ion Beam ◽  
Controlled Trial ◽  
Silver Ion ◽  
Control Group ◽  
Site Infection ◽  
Control Groups ◽  
Exit Site ◽  
Exit Site Infection ◽  
Catheter Survival ◽  
And Control

♦ Background Dialysis-related infections are the commonest cause of catheter loss and transfer to hemodialysis. Surface modifications of the catheter that reduce infections are of major importance. ♦ Objective The efficacy of silver-ion treated catheters in reducing dialysis-related infections was tested. ♦ Methods The study design was a prospective, randomized controlled trial. Patients were implanted with either a silver-treated study catheter or a control catheter. Prospective collection of data included infectious complications and catheter survival. ♦ Results The subject groups were comprised of 67 silver-treated catheters and 72 control catheters. Demographic characteristics of the study and control groups were equal. Exit-site infection rates for the study group and control group (0.52 and 0.45 episodes/patient-year of dialysis respectively) were not different by Poisson regression analysis ( p > 0.4). Peritonitis rates were identical for the two groups (0.37 episodes/patient-year) and were not different by Poisson analysis ( p > 0.9). Antibiotic-free intervals between infections for the study and control groups were not significantly different for exit-site infections ( p = 0.58), peritonitis ( p = 0.44), or both infections combined ( p = 0.47). Actuarial analyses showed no differences between the groups in the probability of remaining free of exit-site infection ( p> 0.2) or peritonitis ( p > 0.7). Similarly, catheter survival was not significantly different between the groups ( p > 0.6). ♦ Conclusion Surface modification of catheters with ion beam implantation of silver produced no clinical effect with respect to reducing dialysis-related infections.

scholarly journals Pengaruh Terapi AIUEO terhadap Kemampuan Bicara Pasien Stroke yang Mengalami Afasia Motorik

2019 ◽  
Vol 1 (2) ◽  
pp. 226-235
Author(s):  
Afnijar Wahyu ◽  
Liza Wati ◽  
Murad Fajri
Keyword(s):  
Wilcoxon Test ◽  
Control Group ◽  
Stroke Patients ◽  
Control Groups ◽  
Control Group Design ◽  
Treatment Groups ◽  
Group Design ◽  
Motor Aphasia ◽  
A Value ◽  
And Control

The purpose of this study was to determine the effect of AIUEO therapy on the speech ability of stroke patients who have motor aphasia in Raja Ahmad Thabib Hospital Tanjungpinang. The research design used was quasi experiment with the Nonequivalent Control Group Design approach to 9 respondents who were divided into 9 treatment groups and 9 control groups. The results showed that there were significant differences in the functional ability of communication between the control and treatment groups with a value of p <0.05 (p = 0.007 at a = 0.05) using the Wilcoxon Test statistical test. Conclusion, the influence of AIUEO therapy on the speech ability of stroke patients with motor aphasia in the treatment and control groups at Ahmad Thabib Hospital Tanjungpinang.   Keywords: Speech Ability, Motor Aphasia Stroke, AIUEO Therapy

Effect of buddy-style intervention on exercise adherence in community-dwelling disabled older adults: A pilot randomized controlled trial

2021 ◽  
pp. 026921552110411
Author(s):  
Hiromichi Takeda ◽  
Katsuhiko Takatori
Keyword(s):  
Older Adults ◽  
Controlled Trial ◽  
Intervention Group ◽  
Exercise Adherence ◽  
Control Group ◽  
Adult Day Care ◽  
Control Groups ◽  
Randomized Controlled ◽  
And Control ◽  
Pilot Randomized Controlled Trial

Objective To assess the preliminary effects of a buddy-style intervention to improve exercise adherence. Design A parallel-group, open-label, pilot randomized controlled trial. Setting Adult day-care centers. Participants Sixty-five disabled older adults. Interventions All participants underwent a 12-week home exercise program, and the intervention group received a 5–10 min buddy-style intervention between older adults in the intervention group once weekly at an adult day-care center. Main measures Based on the exercise log calendar, the number of days of exercise was assessed for each of the three phases: 1–4 weeks, 5–8 weeks, and 9–12 weeks. Short physical performance battery was measured at baseline and after 12 weeks. Results Of the 590 screened older adults, 65 were recruited and 33 were assigned to the intervention group. One participant in each group withdrew before the program began, and four and five patients in the intervention and control groups, respectively, dropped out by the 12-week assessment. Analysis of covariance of the 28 and 26 patients in the intervention and control groups, respectively, for whom exercise log calendars could be retrieved, showed that the intervention group (24.4/28 days) exercised significantly more days than the control group (20.6/28 days) at 9–12 weeks ( P = 0.009). In the between-group effect of the intention-to-treat analysis of short physical performance battery, walking and standing test ( P = 0.790, P = 0.829) were not significantly different, and balance test ( P = 0.049) was significantly better in the control group. Conclusions There was a preliminary effect of the buddy-style intervention to improve exercise adherence.

scholarly journals Effect of Exercise Program on Fatigue and Depression among Geriatric Patients Undergoing Hemodialysis

2019 ◽  
Vol 8 (2) ◽  
pp. 23
Author(s):  
Soad Hassan Abd Elhameed ◽  
Doaa El Sayed Fadila
Keyword(s):  
Geriatric Patients ◽  
Controlled Trial ◽  
Geriatric Depression Scale ◽  
Depression Scale ◽  
Exercise Program ◽  
Structured Interview ◽  
University Hospital ◽  
Control Group ◽  
Control Groups ◽  
And Control

Background: Fatigue is one of the foremost common complications faced the hemodialysis elderly patients. Fatigue not only impact the daily lives and activities of patients but it conjointly influences their quality of life, which can afterwards result in magnified depression, tiny social interactions and increase dependency on others.Aim: Determine the effect of exercise program on fatigue and depression among geriatric patients undergoing hemodialysis.Design: Randomized controlled trial (pretest post-test) design was used.Setting: The study was carried out in the dialysis units of Mansoura University Hospital and New Mansoura General Hospital.Subjects: A purposive sample of 62 geriatric patients undergoing hemodialysis was selected and randomly allocated into two equal groups, study group (n = 31) and control group (n =31).Tools: Three tools were used; Structured interview questionnaire sheet, Multidimensional Fatigue Inventory Scale and Geriatric Depression Scale Short Form.Results: The mean age of the study and control groups was 63.45±4.49 and 64.7±5.25 respectively. A high statistically significant change in fatigue and depression score (pre and post 2 months) between the study and the control groups was observed (P=0.000). Moreover, a statistically significant relation was observed between fatigue and age of the hemodialysis geriatric patients after implementation of the exercise program (P= 0.002).Conclusion: Implementation of the exercise program proved to be effective in improving the level of fatigue and depression among geriatric patients undergoing hemodialysis in the study group.Recommendation: Encourage geriatric patients undergoing hemodialysis to perform regularly range of motion and relaxation exercises in order to alleviate fatigue and overcome depression.  

scholarly journals Cryotherapy Reduced Postoperative Pain in Gynecologic Surgery: A Randomized Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-6 ◽  
Author(s):  
Apisada Chumkam ◽  
Densak Pongrojpaw ◽  
Athita Chanthasenanont ◽  
Junya Pattaraarchachai ◽  
Kornkarn Bhamarapravatana ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Statistical Difference ◽  
Controlled Trial ◽  
Exploratory Laparotomy ◽  
Gynecologic Surgery ◽  
Control Group ◽  
Study Group ◽  
Control Groups ◽  
Vas Score ◽  
And Control

Objective. To examine the effectiveness of cryotherapy for reducing postoperative pain in patients who underwent exploratory laparotomy for gynecologic surgery. Materials and Methods. Patients who had indication for an exploratory laparotomy gynecologic procedure were selected by attending physicians to undergo abdominal surgery via low transverse skin incision. The participants were randomized into study and control groups with simple random sampling methods. Cold packs were applied at two hours after operation for 6 hours. The visual analog scale (VAS) score was recorded at two, 6, and 12 hours after operation. Result. One hundred cases were recruited and then divided into study and control groups equally. The mean age of both groups was 43 years. There was no difference in demographics data of both groups. Half of the participants in both groups underwent hysterectomies. At two hours after surgery, both groups had similar VAS scores. The study group had a lower VAS score at 6 and 12 hours after surgery than the control group with statistical difference. Morphine consumption within 24 hours after surgery in both the study and control groups was 2.8±3.4 and 3.0±4.4 mg, respectively, with no statistical difference. However the registration time of the first morphine requirement in the study group was statistically more prolonged than that of the control group. The lengths of hospital stay in both groups were similar. There was no complication reported in this study. Conclusion. Cryotherapy can reduce postoperative pain. In this presented study the patients who underwent gynecologic surgery had improved pain relief and prolonged time for the first dose of the analgesic drug.

Comparison of the effects of Buteyko and pranayama breathing techniques on quality of life in patients with asthma – a randomized controlled trial

2012 ◽  
Vol 27 (2) ◽  
pp. 133-141 ◽  
Author(s):  
Venkatesan Prem ◽  
Ramesh Chandra Sahoo ◽  
Prabha Adhikari
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Control Group ◽  
Life Questionnaire ◽  
Control Groups ◽  
Quality Of Life Questionnaire ◽  
Randomized Controlled ◽  
Questionnaire Score ◽  
And Control

Objective: To compare two breathing exercises (Buteyko and pranayama) with a control group in patients with asthma. Design: Randomized controlled trial. Subjects: One hundred and twenty subjects were randomized to three groups through block randomization. Subjects with an Asthma Quality of Life Questionnaire score <5.5 participated in the study. Setting: Outpatient pulmonary medicine department. Interventions: Subjects in the Buteyko and pranayama groups were trained for 3–5 days and instructed to practise the exercises for 15 minutes twice daily, and for three months duration. The control group underwent routine pharmacological management during the study period. Outcome measures: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire and pulmonary function test. Results: The baseline characteristics were similar in all three groups. Post intervention, the Buteyko group showed better trends of improvement (mean (95% confidence interval), P-value) in total Asthma Quality of Life Questionnaire score than the pranayama (0.47 (–0.008–0.95), P = 0.056) and control groups (0.97 (0.48–1.46), P = 0.0001). In comparison between the pranayama and control groups, pranayama showed significant improvement (0.50 (0.01–0.98), P = 0.042) in total Asthma Quality of Life Questionnaire score. Conclusion: The Buteyko group showed better trends of improvement in quality of life and asthma control than the group performing the pranayama breathing exercise.

scholarly journals Efficacy of a herbal toothpaste on patients with established gingivitis: a randomized controlled trial

2006 ◽  
Vol 20 (2) ◽  
pp. 172-177 ◽  
Author(s):  
Fabiana Ozaki ◽  
Claudio Mendes Pannuti ◽  
Ana Vitória Imbronito ◽  
Wellington Pessotti ◽  
Luciana Saraiva ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Controlled Trial ◽  
Test Group ◽  
Experimental Period ◽  
Positive Control ◽  
Control Group ◽  
Control Groups ◽  
Double Blind ◽  
Significant Difference ◽  
And Control

The aim of this randomised, double blind controlled trial was to verify the efficacy of a herbal dentifrice on the reduction of plaque and gingivitis. Forty eight volunteers with established gingivitis were randomly assigned to either a test group (herbal dentifrice) or positive control group (dentifrice with triclosan and fluoride). The dentifrices were distributed in plain white tubes by an independent pharmacy, which revealed the contents of each tube only after the experimental period. Plaque and gingivitis assessments were carried out on baseline and after 28 days of product use. All examinations were conducted by the same calibrated investigator. Subjects were instructed to brush their teeth three times daily using their assigned dentifrice for 28 days. There was a significant reduction in plaque levels in both the test and control groups. However, there was no significant difference between the groups. A significant reduction in gingivitis was observed in both groups, although there was no significant difference between them. No adverse reactions were reported. The authors concluded that both dentifrices were effective in reducing plaque and gingivitis in subjects with established gingivitis.

scholarly journals Staphylococcal sepsis in mothers and newborn babies

1962 ◽  
Vol 60 (1) ◽  
pp. 105-112 ◽  
Author(s):  
M. S. Spink
Keyword(s):  
Nasal Mucosa ◽  
Controlled Trial ◽  
Bacterial Flora ◽  
Phage Type ◽  
Test Group ◽  
Cross Infection ◽  
Control Group ◽  
Control Groups ◽  
Peak Period ◽  
And Control

A serious outbreak of staphylococcal infections in the maternity units in Blackburn was investigated. There were considerably more than one hundred cases of breast abscesses altogether, well over half of which occurred in primiparae. Staphylococcus aureus, phage type 80, was the predominating organism throughout the outbreak and at the peak period during the early part of the outbreak this type was responsible for nearly 80% of the infections.After the introduction of a number of procedures for the general reduction of cross-infection the incidence of breast abscess fell markedly and a controlled trial of an antibacterial cream, containing neomycin and hibitane, which was applied to the nasal mucosa of all infants and mothers in the test group of patients, was undertaken. The conditions obtaining in the test and control groups were identical in every way except that the control patients did not receive the neomycin-hibitane cream. There were about 1250 mothers and infants each in the test and control groups; the incidence of breast abscesses in the test group was 0·8% and in the control group it was 2·7%. The method adopted for the detection and treatment of carriers among the nursing staff broke down on two occasions; this fact and the emergence of an unforeseen source resulted in a larger number of infections than should have occurred. Had it not been for these incidents there is little doubt that the trial would have shown more conclusively the effectiveness of the neomycinhibitane cream, by the method laid down, in reducing cross-infection.Investigation of the bacterial flora on the nasal mucosa of over 1000 infants in the control group yielded results of considerable interest. Of 300 cases where there was early colonization by Staph. albus, this organism established its dominating position in 70% of the cases and it was not subsequently displaced by Staph. aureus. The significance of this observation and the evidence favouring nasal dissemination of Staph.aureus as the most important cause of hospital cross-infection are discussed.

scholarly journals Breast Microecology Improvement Using Probiotics Following Needle Aspiration in Patients With Lactational Breast Abscess: a Multi-center Randomized Double-blind Controlled Trial

2021 ◽  
Author(s):  
Yi Zhang ◽  
Yajun Gao ◽  
Jing Qin ◽  
Xiaoting Li ◽  
Fei Jiang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Reaction Rates ◽  
Needle Aspiration ◽  
Healing Time ◽  
Control Group ◽  
Cure Rate ◽  
Control Groups ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
And Control

Abstract Background: Studies show that oral probiotics can improve the breast microecology and thus alleviate the inflammatory response; however, there is a lack of experimental data corresponding to cases with existing abscesses. We aimed to investigate the effect of Lactobacillus fermentum CECT5716 during needle aspiration in patients with lactational breast abscesses.Methods: Patients (aged 20–41 years) with lactational single-cavity breast abscesses (diameter 3–6 cm) from 12 hospitals were randomly assigned to the experimental (n=51) and control groups (n=50). Outcome measures included the abscess cure rate on day-5 of treatment, delactation rate, relieving pain rate, and the number of needle aspirations until day-28.Results: The experimental group’s 5-day cure rate (43.1%, 22/51) was significantly higher (p<0.05). The breastfeeding continuation on day-5 did not differ significantly (experimental group: 88.2%, 45/51; control group: 96.0%, 48/50; p=0.269). In the experimental and control groups, 19.6% and 14.0% of patients experienced moderate to severe pain on day-5, respectively, with no statistically significant differences (p=0.451). The median number of needle aspirations up to day-28 was two in the experimental (1–3 times) and control (1–4 times) groups, with no statistically significant differences (Mann–Whitney U test, p=0.322). Four patients in each group developed diarrhea, with adverse reaction rates of 7.84% (4/51) and 8.0% (4/50), respectively. No adverse reactions were reported in the infants.Conclusion: L. fermentum can shorten the healing time in patients with lactational breast abscesses.Trial registration: This study was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn), registration number: ChiCTR2000032682, registration date: May 6, 2020.

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