Immediate Effect of Scalp Acupuncture on the Gait of Patients with Subacute Intracerebral Haemorrhage Analysed by Three-Dimensional Motion: Secondary Analysis of a Randomised Controlled Trial

Objective To investigate the immediate effect of scalp acupuncture on walking pattern, using three-dimensional gait analysis (3D-GA), among patients in the subacute stage of intracerebral haemorrhage (ICH). Methods A subset of 30 patients with subacute ICH participating in a recently published randomised controlled trial who were able to walk independently were assessed by 3D-GA before and immediately after scalp acupuncture treatment (treatment group) or no intervention (control group) and the results presented here as a secondary analysis. The acupuncture manipulation was repeated three times with an interval of 5 min. Spatiotemporal and kinematic parameters during walking were collected and analysed using a 3D motion analysis system. Results After treatment, there were significant differences between the treatment and control groups in the spatiotemporal parameters of step length, velocity and cadence (p<0.05) and double-limb support. No significant difference was found in step width. When kinematic parameters were evaluated, the treatment group showed a significantly decreased peak pelvic anterior tilt angle and an increased hip extension angle after scalp acupuncture treatment, whereas the control group demonstrated no temporal changes. There were no significant changes in any other kinematic parameters in either group. Conclusions As the first exploratory study to investigate the effect of the scalp acupuncture on gait performance in patients with subacute ICH, this secondary analysis of a recent randomised trial suggested an immediate effect of treatment on spatiotemporal parameters. Improvement in gait pattern may be associated with a decreased anterior tilt of the pelvis and augmented hip joint motion during walking. Trial Registration Number ChiCTR-TRC-08000225; Post-results.

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Acute effects of calcium supplements on blood pressure and blood coagulation: secondary analysis of a randomised controlled trial in post-menopausal women

British Journal Of Nutrition ◽

10.1017/s0007114515003694 ◽

2015 ◽

Vol 114 (11) ◽

pp. 1868-1874 ◽

Cited By ~ 18

Author(s):

Sarah M. Bristow ◽

Greg D. Gamble ◽

Angela Stewart ◽

Anne M. Horne ◽

Ian R. Reid

Keyword(s):

Blood Pressure ◽

Blood Coagulation ◽

Controlled Trial ◽

Secondary Analysis ◽

Control Group ◽

Calcium Citrate ◽

Acute Effects ◽

Menopausal Women ◽

Post Menopausal ◽

Randomised Controlled

AbstractRecent evidence suggests that Ca supplements increase the risk of cardiovascular events, but the mechanism(s) by which this occurs is uncertain. In a study primarily assessing the effects of various Ca supplements on blood Ca levels, we also investigated the effects of Ca supplements on blood pressure and their acute effects on blood coagulation. We randomised 100 post-menopausal women to 1 g/d of Ca or a placebo containing no Ca. Blood pressure was measured at baseline and every 2 h up to 8 h after their first dose and after 3 months of supplementation. Blood coagulation was measured by thromboelastography (TEG) in a subgroup of participants (n 40) up to 8 h only. Blood pressure declined over 8 h in both the groups, consistent with its normal diurnal rhythm. The reduction in systolic blood pressure was smaller in the Ca group compared with the control group by >5 mmHg between 2 and 6 h (P≤0·02), and the reduction in diastolic blood pressure was smaller at 2 h (between-groups difference 4·5 mmHg, P=0·004). Blood coagulability, assessed by TEG, increased from baseline over 8 h in the calcium citrate and control groups. At 4 h, the increase in the coagulation index was greater in the calcium citrate group compared with the control group (P=0·03), which appeared to be due to a greater reduction in the time to clot initiation. These data suggest that Ca supplements may acutely influence blood pressure and blood coagulation. Further investigation of this possibility is required.

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Evaluation of the Effectiveness of Nordic Walking Training in Improving the Gait of Persons with Down Syndrome

BioMed Research International ◽

10.1155/2019/6353292 ◽

2019 ◽

Vol 2019 ◽

pp. 1-11

Author(s):

Agnieszka Skiba ◽

Jakub Marchewka ◽

Amadeusz Skiba ◽

Szymon Podsiadło ◽

Iwona Sulowska ◽

...

Keyword(s):

Down Syndrome ◽

Three Dimensional ◽

Training Group ◽

Step Length ◽

Positive Influence ◽

Control Group ◽

Kinematic Parameters ◽

Nordic Walking ◽

Infrared Video ◽

Spatiotemporal Parameters

People with Down syndrome (DS) show dysfunction of gait, expressed by disturbed character of angular changes and values of the spatiotemporal parameters as compared to the physiological norm. It is known that exercises and various activities have positive effect on balance and gait, but there are only a few scientific proofs concerning above-mentioned in people with DS. Furthermore, the effect of Nordic Walking (NW) training on gait in people with DS is unexplored. We enrolled 22 subjects with DS, aged 25-40 years, with moderate intellectual disability. Participants were randomly divided into 2 groups: NW training group which underwent 10 weeks of training at a frequency of 3 times a week and control group with no specific intervention. Subjects were examined twice: 1 week before training and a week immediately after intervention. Gait was evaluated by the Vicon 250: a computerized system of three-dimensional analysis of motion, connected to 5 infrared video cameras. We conducted mixed-design ANOVA model to assess the effects of time and type of training on spatiotemporal parameters. We found significant favorable time by group interaction in the following parameters: step length in right leg: F(1,15) =14,47, p=0.002; left leg accordingly F(1,15) =5,15, p=0.038, cycle length in right leg: F(1,15) =14,48, p=0.002; left leg accordingly F(1,15) =15,09, p=0.001; and gait standardised speed F(1,15) =5,35, p=0.035. Statistically significant changes were observed in numerous kinematic parameters of ankle, knee, pelvis, and shoulder in NW group. Regular NW training has positive influence on selected spatiotemporal and kinematic parameters in people with Down Syndrome and may be an attractive and safe form of rehabilitation.

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RelAte: pilot study of the effects of a mealtime intervention on social cognitive factors and energy intake among older adults living alone

British Journal Of Nutrition ◽

10.1017/s000711451600369x ◽

2016 ◽

Vol 116 (9) ◽

pp. 1573-1581 ◽

Cited By ~ 8

Author(s):

Joanna E. McHugh Power ◽

Olga Lee ◽

Niamh Aspell ◽

Emma McCormack ◽

Michelle Loftus ◽

...

Keyword(s):

Older Adults ◽

Treatment Group ◽

Energy Intake ◽

Self Efficacy ◽

Controlled Trial ◽

Complex Interventions ◽

Living Alone ◽

Control Group ◽

Nutritional Interventions ◽

Randomised Controlled

AbstractMealtime interventions typically focus on institutionalised older adults, but we wanted to investigate whether they may also be effective among those living independently. Using a randomised controlled trial design, we assessed the effects of a novel mealtime intervention on self-efficacy, food enjoyment and energy intake. A total of 100 adults living alone aged over 60 years were randomised to the treatment or control conditions: all received a guidebook on nutrition and culinary skills. Treatment group participants received a weekly visit from a trained volunteer who prepared and shared a meal with them. Participants in the treatment group showed improvements relative to those in the control group at borderline significance (P=0·054) for self-efficacy and at significance for food enjoyment. Significant improvements were observed in female participants in the treatment but not in the control group in energy intake (although following corrections for multiple comparisons, only the effect on food enjoyment remained significant). These findings will inform the design of future complex interventions. For this type of intervention to be successful, more focus has to be placed on making interventions more personalised, potentially according to sex. Findings are important for nutritional sciences as they indicate that, in order to improve energy intake and food enjoyment among older adults, multimodal nutritional interventions including social components may be successful.

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Acupuncture treatment on the motor area of the scalp for motor dysfunction in children with cerebral palsy: study protocol for a multicenter randomized controlled trial

10.21203/rs.2.12483/v2 ◽

2019 ◽

Author(s):

Jun Wang ◽

Wei Shi ◽

Dhiaedin Khiati ◽

Bingpei Shi ◽

Xiaojuan Shi ◽

...

Keyword(s):

Cerebral Palsy ◽

Acupuncture Treatment ◽

Controlled Trial ◽

Scalp Acupuncture ◽

Motor Dysfunction ◽

Control Group ◽

Rehabilitation Treatment ◽

Randomized Controlled ◽

Children With Cerebral Palsy ◽

Function Measure

Abstract Background: Scalp acupuncture has been widely used as treatment for motor dysfunction in children with cerebral palsy in China. Previous studies have failed to provide high quality evidence to demonstrate the effectiveness of this treatment in children with cerebral palsy. No high quality randomized controlled trials on scalp acupuncture have been published. The aim of this study is to evaluate the effectiveness of jiao’ scalp acupuncture when combined with routine rehabilitation treatment versus routine rehabilitation treatment alone for motor dysfunction in children with cerebral palsy. Methods/design: This is a four-centred randomized controlled trial. One hundred cerebral palsy patients with motor dysfunction were enrolled. Patients will be allocated in a 1:1 ratio into either an acupuncture treatment group or a control group. Cerebral palsy patients in the control group will receive conventional rehabilitation treatment, whereas patients in the acupuncture group will receive a combination of scalp acupuncture and conventional rehabilitation treatment. Thirty-six treatment sessions will be performed over a 12-week period. The Gross Motor Function Measure and the Fine Motor Function Measure Scale will be assessed as the primary outcome measure. The Pediatric Evaluation of Disability Inventory, and the Cerebral Palsy Quality of Life Questionnaire for Children will be selected as secondary outcome measures. All assessments will be conducted at baseline, week 4 (treatment 12), week 8 ( treatment 24 ), week 12 (treatment 36), and week 24 (follow-up). Discussion: This is the first trial evaluating the efficacy and safety of scalp acupuncture as a treatment for motor dysfunction in children with cerebral palsy. The results of this trial are expected to provide relevant evidence demonstrating that scalp acupuncture can be used as an effective rehabilitation treatment method for improving motor dysfunction in children with cerebral palsy.

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Scalp acupuncture treatment for motor dysfunction in children with cerebral palsy: study protocol for a multicenter randomized controlled Trial

10.21203/rs.2.12483/v1 ◽

2019 ◽

Cited By ~ 1

Author(s):

Jun Wang ◽

Wei Shi ◽

Dhiaedin Khiati ◽

Bingpei Shi ◽

Xiaojuan Shi ◽

...

Keyword(s):

Cerebral Palsy ◽

Acupuncture Treatment ◽

Controlled Trial ◽

Scalp Acupuncture ◽

Motor Dysfunction ◽

Control Group ◽

Rehabilitation Treatment ◽

Randomized Controlled ◽

Children With Cerebral Palsy ◽

Function Measure

Abstract Abstract Background: Scalp acupuncture has shown a remarkable treatment efficacy on motor dysfunction in children with cerebral palsy, especially when performed on the motor area of Jiao’s scalp acupuncture, which is the most widely used treatment. However, previous studies have summarized that the clinical curative effect of acupuncture treatment for children with cerebral palsy remains uncertain. Meanwhile, no randomized controlled trials on scalp acupuncture have been performed. The aim of this study is to evaluate the efficacy and safety of scalp acupuncture for motor dysfunction in children with cerebral palsy. Methods/design: This is an assessor and analyst blinded, randomized controlled trial. One hundred cerebral palsy patients with motor dysfunction meeting the inclusion criteria will be allocated by a 1:1 ratio into either an acupuncture treatment group or a control group. Cerebral palsy in the control group will receive conventional rehabilitation treatment, whereas a combination of scalp acupuncture and conventional rehabilitation treatment will be applied to the acupuncture group. Thirty-six treatment sessions will be performed over a 12-week period. The Gross Motor Function Measure and the Fine Motor Function Measure Scale will be assessed as the primary outcome measure. The Pediatric Evaluation of Disability Inventory, and the Cerebral Palsy Quality of Life Questionnaire for Children will be selected as secondary outcome measurements. All assessments will be conducted at baseline, week 4 (treatment 12), week 8 (treatment 24), week 12 (treatment 36), and week 24 (follow-up). Discussion: This is the first trial evaluating the efficacy and safety of scalp acupuncture for motor dysfunction in children with cerebral palsy. The results of this trial are expected to provide relevant evidence demonstrating that scalp acupuncture can be used as an effective rehabilitation treatment method for improving motor dysfunction in children with cerebral palsy.

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Clinical effects of high-intensity laser therapy on patients with chronic refractory wounds: a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-045866 ◽

2021 ◽

Vol 11 (7) ◽

pp. e045866

Author(s):

Qian Lu ◽

Zhifei Yin ◽

Xuefeng Shen ◽

Jinhua Li ◽

Panpan Su ◽

...

Keyword(s):

Treatment Group ◽

Randomised Controlled Trial ◽

High Intensity ◽

Wound Dressing ◽

Wound Care ◽

Controlled Trial ◽

Control Group ◽

High Intensity Laser ◽

Randomised Controlled ◽

Intensity Laser

ObjectiveTo investigate the effectiveness of high-intensity laser therapy (HILT) on chronic refractory wounds.DesignRandomised controlled trial.SettingThe outpatient wound care department of the Affiliated Jiangsu Shengze Hospital of Nanjing Medical University from August 2019 to June 2020.ParticipantsSixty patients were enrolled in this study and were randomised into control (n=30) and treatment (n=30) groups.Interventions and outcome measuresThe control group was treated only with conventional wound dressing, whereas the treatment group received irradiation with HILT in addition to standard wound care, such as debridement, wound irrigation with normal saline solution and application of dressing and sterile gauze. Patient scores on the Bates-Jensen Wound Assessment Tool (BWAT) and Pressure Ulcer Scale for Healing (PUSH) were evaluated before and after 1, 2 and 3 weeks of treatment.ResultsOne patient was excluded from the control group, and a total of 59 subjects completed the trial. The BWAT scores significantly decreased in the treatment group compared with the control group at the end of 3-week treatment (difference=−3.6; 95% CI −6.3 to–0.8; p<0.01). Similarly, patients in treatment group showed a significant reduction of PUSH scores compared with the control group (difference=−5.3; 95% CI −8.1 to –2.6; p<0.01).ConclusionsThe therapeutic effects of HILT on chronic refractory wounds are significant and far more superior to those of conventional wound dressing.Trial registration numberChinese Clinical Trial Registry; ChiCTR1900023157. URL: http://www.chictr.org.cn/showproj.aspx?proj=38866

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Hyperbaric oxygen as an adjuvant treatment for patients with COVID-19 severe hypoxaemia: a randomised controlled trial

Emergency Medicine Journal ◽

10.1136/emermed-2021-211253 ◽

2021 ◽

pp. emermed-2021-211253

Author(s):

Mariana Cannellotto ◽

Mariano Duarte ◽

Guillermo Keller ◽

Ramiro Larrea ◽

Eleonora Cunto ◽

...

Keyword(s):

Acute Respiratory Distress Syndrome ◽

Treatment Group ◽

Randomised Controlled Trial ◽

Interim Analysis ◽

Distress Syndrome ◽

Controlled Trial ◽

Control Group ◽

Safety And Efficacy ◽

Severe Hypoxaemia ◽

Randomised Controlled

BackgroundHyperbaric oxygen (HBO2) therapy has been proposed to treat hypoxaemia and reduce inflammation in COVID-19. Our objective was to analyse safety and efficacy of HBO2 in treatment of hypoxaemia in patients with COVID-19 and evaluate time to hypoxaemia correction.MethodsThis was a multicentre, open-label randomised controlled trial conducted in Buenos Aires, Argentina, between July and November 2020. Patients with COVID-19 and severe hypoxaemia (SpO2 ≤90% despite oxygen supplementation) were assigned to receive either HBO2 treatment or the standard treatment for respiratory symptoms for 7 days. HBO2 treatment was planned for ≥5 sessions (1 /day) for 90 min at 1.45 atmosphere absolute (ATA). Outcomes were time to normalise oxygen requirement to SpO2 ≥93%, need for mechanical respiratory assistance, development of acute respiratory distress syndrome and mortality within 30 days. A sample size of 80 patients was estimated, with a planned interim analysis after determining outcomes on 50% of patients.ResultsThe trial was stopped after the interim analysis. 40 patients were randomised, 20 in each group, age was 55.2±9.2 years. At admission, frequent symptoms were dyspnoea, fever and odynophagia; SpO2 was 85.1%±4.3% for the whole group. Patients in the treatment group received an average of 6.2±1.2 HBO2 sessions. Time to correct hypoxaemia was shorter in treatment group versus control group; median 3 days (IQR 1.0–4.5) versus median 9 days (IQR 5.5–12.5), respectively (p<0.010). OR for recovery from hypoxaemia in the HBO2 group at day 3 compared with the control group was 23.2 (95% CI 1.6 to 329.6; p=0.001) Treatment had no statistically significant effect on acute respiratory distress syndrome, mechanical ventilation or death within 30 days after admission.ConclusionOur findings support the safety and efficacy of HBO2 in the treatment of COVID-19 and severe hypoxaemia.Trial registration numberNCT04477954.

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Reality orientation therapy combined with cholinesterase inhibitors in Alzheimer's disease: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.187.5.450 ◽

2005 ◽

Vol 187 (5) ◽

pp. 450-455 ◽

Cited By ~ 94

Author(s):

Graziano Onder ◽

Orazio Zanetti ◽

Ezio Giacobini ◽

Giovanni B. Frisoni ◽

Luisa Bartorelli ◽

...

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Treatment Group ◽

Cholinesterase Inhibitors ◽

Controlled Trial ◽

Disease Assessment ◽

Control Group ◽

Randomised Controlled ◽

Reality Orientation ◽

State Examination

BackgroundReality orientation therapy combined with cholinesterase inhibitors has not been evaluated in patients with Alzheimer's disease.AimsTo perform such an evaluation.MethodWe randomly assigned 79 of 156 patients treated with donepezil to receive a reality orientation programme. Caregivers of the treatment group were trained to offer the programme at home 3 days a week, 30 min/day for 25 consecutive weeks, and were invited to stimulate and involve patients in reality-based communication.ResultsThe treatment group showed a slight improvement in Mini-Mental State Examination (MMSE) scores (mean change + 0.2, s.e. = 0.4) compared with a decline in the control group (mean change −1.1, s.e. =0.4; P=0.02). Similarly for the Alzheimer's Disease Assessment Scale – Cognition (treatment group mean change +0.4, s.e.=0.8; control group –2.5, s.e.=0.8; P = 0.01). The intervention had an equal effect on cognition in those with mild (MMSE score ⩾20) and moderate (score < 20) dementia. No significant effect was observed for behavioural and functional outcomes.ConclusionsReality orientation enhances the effects of donepezil on cognition in Alzheimer's disease.

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Acupuncture treatment on the motor area of the scalp for motor dysfunction in children with cerebral palsy: study protocol for a multicenter randomized controlled trial

Trials ◽

10.1186/s13063-019-3986-z ◽

2020 ◽

Vol 21 (1) ◽

Cited By ~ 1

Author(s):

Jun Wang ◽

Wei Shi ◽

Dhiaedin Khiati ◽

Bingpei Shi ◽

Xiaojuan Shi ◽

...

Keyword(s):

Cerebral Palsy ◽

Acupuncture Treatment ◽

Controlled Trial ◽

Scalp Acupuncture ◽

Motor Dysfunction ◽

Control Group ◽

Rehabilitation Treatment ◽

Randomized Controlled ◽

Children With Cerebral Palsy ◽

Function Measure

Abstract Background Scalp acupuncture has been widely used as treatment for motor dysfunction in children with cerebral palsy in China. Previous studies have failed to provide high-quality evidence to demonstrate the effectiveness of this treatment in children with cerebral palsy. No high-quality randomized controlled trials on scalp acupuncture have been published. The aim of this study is to evaluate the effectiveness of Jiao’s scalp acupuncture when combined with routine rehabilitation treatment versus routine rehabilitation treatment alone for motor dysfunction in children with cerebral palsy. Methods/Design This is a four-centre randomized controlled trial. One hundred cerebral palsy patients with motor dysfunction were enrolled. Patients will be allocated in a 1:1 ratio into either an acupuncture treatment group or a control group. Cerebral palsy patients in the control group will receive conventional rehabilitation treatment, whereas patients in the acupuncture group will receive a combination of scalp acupuncture and conventional rehabilitation treatment. Thirty-six treatment sessions will be performed over a 12-week period. The Gross Motor Function Measure and the Fine Motor Function Measure Scale will be assessed as the primary outcome measures. The Paediatric Evaluation of Disability Inventory and the Cerebral Palsy Quality of Life Questionnaire for Children will be selected as secondary outcome measures. All assessments will be conducted at baseline, week 4 (treatment 12), week 8 (treatment 24), week 12 (treatment 36) and week 24 (follow-up). Discussion This is the first trial evaluating the efficacy and safety of scalp acupuncture as a treatment for motor dysfunction in children with cerebral palsy. The results of this trial are expected to provide relevant evidence demonstrating that scalp acupuncture can be used as an effective rehabilitation treatment method for improving motor dysfunction in children with cerebral palsy. Trial registration ClinicalTrials.gov, NCT03921281. Registered on 19 April 2019.

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Chinese medicine (Q-14) in the Treatment of Patients with Coronavirus Disease 2019 (COVID-19): A Single-center, Open label, Randomised Controlled Trial

10.1101/2021.01.25.21249417 ◽

2021 ◽

Author(s):

Jia Liu ◽

Wei Yang ◽

Yue Liu ◽

Cheng Lv ◽

Lianguo Ruan ◽

...

Keyword(s):

Treatment Group ◽

Standard Care ◽

Controlled Trial ◽

Control Group ◽

Chest Discomfort ◽

Open Label ◽

Conversion Time ◽

Q 14 ◽

Randomised Controlled ◽

And Control

ABSTRACTOBJECTIVETo evaluate the efficacy and safety of Chinese medicine (Q-14) plus standard care compared with standard care alone in adult with coronavirus disease 2019 (COVID-19).Study DESIGNSingle-center, open label, randomised controlled trial.SETTINGWuhan Jinyintan Hospital, Wuhan, China, February 27 to March 27, 2020.PARTICIPANTS204 patients with laboratory confirmed COVID-19 were randomised in to treatment group and control group, which was 102 patients each group.INTERVENTIONSIn treatment group, Q-14 was administrated at 10g (granules), twice daily for 14 days and plus standard care. In control group, patients were given standard care alone for 14 days.MAIN OUTCOME MEASUREThe primary outcome was conversion time of SARS-CoV-2 viral assay. Adverse events were analyzed in the safety population.RESULTSAmong 204 patients, 195 were analyzed according to the intention to treat principle. There were 149 patients (71 vs. 78 in treatment group and control group respectively) turning to negative via SARS-CoV-2 viral assay. No statistically significance showed in conversion time between treatment group and control group (FAS: Median (IQR): 10.00 (9.00-11.00) vs. 10.00 (9.00-11.00); Mean rank: 67.92 vs. 81.44; P=0.051.). Time to recovery of fever was shorter in treatment group as compared in control group. The disappearance rate of symptom in cough, fatigue, chest discomfort was significantly higher in treatment group. In chest computed tomography (Chest CT) examinations, overall evaluation of chest CT examination after treatment compared with baseline showed more patients improved in treatment group .There were no significant differences in the other outcomes.CONCLUSIONAdministration of Q-14 on standard care for COVID-19 was useful for improvement of symptoms (such as fever, cough, fatigue and chest discomfort), while did not result in a significantly higher probability of negative conversion of SARS-CoV-2 viral assay. No serious adverse events were reported.TRIAL REGISTRATIONChiCTR2000030288

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