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   2016| April-June  | Volume 1 | Issue 2  
    Online since July 7, 2016

 
 
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STUDY PROTOCOL
Skill-building through Task-Oriented Motor Practice (STOMP) intervention for activities of daily living in dementia: study protocol for a randomized controlled clinical trial
Carrie A Ciro, Julie A Stoner, Calin Prodan, Linda Hershey
April-June 2016, 1(2):45-50
DOI:10.4103/2468-5658.184743  
Background: Progressive disability in activities of daily living (ADL) is inevitable for people with Alzheimer's disease and related dementias (ADRD). Attempts to slow or prevent ADL disability have been unsuccessful despite making progress in behavioral training methods. Missing from this research is an emphasis on how we maximize a patient's engagement during training and the rigorous examination of implementation protocols (dosing and training methods) which may advantage learning in people with ADRD. Our team addressed this gap with the development of the Skill-building through Task-Oriented Motor Practice (STOMP) intervention which creates methods for obtaining ADL goals that support "personhood" and tests high-intensity protocols that appear to advantage learning and sustained learning over time. Through this study, we aim to evaluate differential outcomes in activities of daily living by two different dose levels of the STOMP intervention. Secondarily, we will assess the moderating effects of participant attention to task during training. Methods/Design: A randomized, single blinded, controlled trial with 32 eligible patients with dementia assigned to either the original, intensive STOMP protocol (3 hours per day, 5 days per week for 2 weeks) or a less-intensive STOMP protocol (1 hour per day, 2 days per week for 2 weeks) delivered by an occupational therapy assistant in the home. ADL training is delivered using motor learning theory techniques of blocked practice, continuous verbal praise, errorless learning and intense dosing schedules. Blinded occupational therapists will complete baseline, post-intervention and 3-month follow-up assessments in the home. Primary outcomes will be examiner and caregiver rated ADL performance. Secondary outcomes will be the amount of time the participant is engaged in the task (e.g., attention to training). Discussion: Through this protocol, we will examine differential ADL outcomes by dose for the STOMP ADL intervention. Our results will inform dosing parameters for future intervention studies for people with ADRD. Trial registration: ClinicalTrials.gov identifier: NCT02356055 Ethics: This study protocol was approved by the University of Oklahoma Health Sciences Center Institutional Review Board (#4648) and will be performed in accordance with the Declaration of Helsinki. Informed consent: Written consent will be obtained by the participant's legally-authorized representative as older adults with dementia are considered a vulnerable population. However, in all cases, assent of the participant will also be obtained at the time of consent.
  9,094 785 2
Long-term effects of Enterprise self-expanding intracranial stent implantation in the treatment of carotid artery stenosis in patients with ischemic stroke: study protocol for a randomized controlled trial
Meng Ji, Wei Wang, Wen-li Hu
April-June 2016, 1(2):38-44
DOI:10.4103/2468-5658.184742  
Background: The Enterprise stent system (Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd., China) is a closed-loop, recoverable self-expanding stent that is effective in the treatment of intracranial aneurysm. However, most studies on the treatment of intracranial aneurysm after ischemic stroke are case series or case reports. Methods/Design: We will perform a single-center, double-blind, randomized parallel-controlled trial at the Department of Neurology, Beijing Chao-yang Hospital, Capital Medical University, China. A cohort of 100 patients with atherosclerotic ischemic stroke will be randomly allocated to undergo either Enterprise self-expanding intracranial stent implantation in combination with antiplatelet medication (stent implantation group, n = 50) or only antiplatelet medication (drug group, n = 50) for treatment of carotid artery stenosis. Four time points (0.5, 1, 2, and 3 years after stent implantation or antiplatelet medication) will be selected for outcome observation and evaluation. The primary outcome will be the National Institutes of Health Stroke Scale score, which is used to evaluate neurologic deficits. The secondary outcomes will be the Barthel index and carotid stenosis rate. Discussion: There is a lack of randomized controlled studies addressing the long-term effects of the Enterprise self-expanding intracranial stent system for carotid artery stenosis in patients with ischemic stroke. This study will investigate and further confirm the clinical significance of the Enterprise stent system in the treatment of carotid artery stenosis in patients with ischemic stroke. Trial registration: This trial was registered at ClinicalTrial.gov (NCT02802072). Ethics: The study protocol has been approved by the Ethics Committee of Beijing Chao-yang Hospital, Captical Medical University, China (approval number: GJCY16012) and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from participants or their guardians prior to inclusion in this study.
  6,064 543 -
Efficacy of Qingxin Huatan therapy in regulating cardiac autonomic nerve function in patients with chronic stable angina: study protocol for a randomized controlled trial
Ping Li, Hong-hao Ma
April-June 2016, 1(2):51-57
DOI:10.4103/2468-5658.184744  
Background: Coronary heart disease is a chronic degenerative disease of the coronary arteries characterized by atherosclerosis. Lianxia Ningxin granules, a traditional Chinese medicine, is a representative preparation of Qingxin Huatan therapy, which has been confirmed to be effective in improving autonomic nerve dysfunction in patients with coronary heart disease. Methods/Design: We herein describe a prospective, single-center, randomized, double-blind, placebo-controlled trial to be performed by the Department of Cardiovascular Medicine, Third Affiliated Hospital of Beijing University of Chinese Medicine, China. Eighty patients with chronic stable angina will be randomly assigned to receive 4 weeks of treatment with either Western medicine plus Lianxia Ningxin granules (traditional Chinese medicine group) or Western medicine plus placebo (control group). All patients will be followed up for 8 weeks. The primary outcome is frequency of angina attacks. The secondary outcomes include heart rate variability, plasma catecholamine concentrations, nitroglycerin consumption, duration of angina, severity of angina pain, efficacy of traditional Chinese medicine treatment, and quality of life. Discussion: This study is designed to assess the efficacy of Qingxin Huatan therapy in treating chronic stable angina, and simultaneously investigate the regulatory effects of this therapy on cardiac autonomic nerve function and related neurotransmitter concentrations. The outcomes will provide information concerning the clinical use of Qingxin Huatan therapy to treat chronic stable angina and its ability to regulate cardiac autonomic nervous function. Trial registration : This protocol was registered at the Chinese Clinical Trial Registry (registration number: ChiCTR-TRC-14004699). Ethics: Written approval has been obtained from the Medical Ethical Committee, Third Affiliated Hospital of Beijing University of Chinese Medicine, China (approval number: KTPJ-BZYSY-2003-003). Informed consent: Written informed consent will be obtained from patients or their guardians prior to inclusion in this study.
  6,018 430 1
REVIEW
Remarkable achievements in multiple sclerosis
Selvarasu Vaitheeshvaran, Manickam Agaath Hedina
April-June 2016, 1(2):77-83
DOI:10.4103/2468-5658.184748  
Multiple sclerosis as a demyelinating disease is characterized by divergent clinical symptoms in the central nervous system. To date, its etiology is still indefinite. Out of the human leukocyte antigen (HLA) region, there are different aspects contributing to multiple sclerosis. Some genome-wide association studies have shown several non-HLA genes play a major role in multiple sclerosis. Additionally, a few single nucleotide polymorphisms in non-HLA genes are likely to be predisposing markers for multiple sclerosis, including rs6897932 in IL7RA, and rs2104286, rs12044852 in IL2RA and CD58 genes, respectively. However, the exact region in the mitochondria is still now indefinite. Given that relevant studies are mostly from Europe, further investigation in different cohorts throughout the world is warranted.
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STUDY PROTOCOL
Relationship between apelin and new-onset atrial fibrillation after coronary artery bypass grafting: a prospective cohort study and retrospective case-control clinical trial
Shu Xu, Zhi Li, Hui Jiang, Hai-bo Wu, Deng-shun Tao, Jin-song Han, Peng Hou, Hui-shan Wang
April-June 2016, 1(2):58-63
DOI:10.4103/2468-5658.184745  
Background: Coronary atherosclerotic heart disease as a chronic degenerative disease is the most common type of organ damage caused by atherosclerosis. Coronary artery bypass grafting is an internationally accepted treatment for coronary atherosclerotic heart disease. However, new-onset atrial fibrillation is a common complication after grafting, and its initiation and maintenance might be associated with levels of the peptide apelin. Methods/Design: A prospective cohort study and retrospective case-control clinical trial will be performed at the Department of Cardiac Surgery, General Hospital of Shenyang Military Region, China. We will recruit 120 patients without a history of atrial fibrillation and scheduled to undergo coronary artery bypass grafting. (1) Cohort study: patients will be assigned to two groups according to preoperative plasma apelin levels: high apelin (> 250 pg/mL) and low apelin (≤ 250 pg/mL). Seven days after surgery, the incidence of new-onset atrial fibrillation will be compared between the two groups. (2) Case-control study: those patients with new-onset atrial fibrillation will comprise the atrial fibrillation group, and those without will form the control group. MRI findings, and levels of plasma apelin, brain natriuretic peptide, and hypersensitive C-reactive protein, will be compared between the two groups 7 days postoperatively. Discussion: This trial is designed to investigate whether apelin can be used as an indicator to predict postoperative atrial fibrillation in patients with coronary atherosclerotic heart disease, and to provide an objective basis for the clinical selection of a preventive intervention program for atrial fibrillation. Trial registration: This trial was registered at ClinicalTrial.gov (NCT02807532). Ethics: The study protocol has acquired written approval from the Chinese Ethics Committee of Registering Clinical Trials (approval No. ChiECRCT-20150011), and will be performed in accordance with the Declaration of Helsinki formulated by the World Medical Association. Informed consent: Written informed consent will be obtained from each subject.
  5,742 372 1
Use of the Smart nitinol stent system for the treatment of severe atherosclerotic carotid stenosis: study protocol for a retrospective, non-randomized, long-term parallel controlled trial
Zhi-gang Ma, Yu-heng Sun, Xiao-xin Peng, Hong-tao Hu
April-June 2016, 1(2):64-70
DOI:10.4103/2468-5658.184746  
Background: The carotid artery should be stented in patients with 70-90% stenosis owing to the high risk of stroke. The self-expanding Smart nitinol stent system is a popular treatment for carotid artery stenosis, because it is easy to manipulate and deploy, and endothelialization is rapid. Methods/Design: We conducted a retrospective, single-center, non-randomized, parallel controlled trial at Beijing Jishuitan Hospital, China. A cohort of 103 patients with severe atherosclerotic carotid stenosis was included in the analysis. Treatment was undertaken according to each patient's wishes after weighing the options: a Smart nitinol stent system (Cordis Corporation, Miami, FL, USA) was used in 40 patients, while 63 were managed conservatively with antiplatelet drugs. The primary outcome is the degree of disability and dependence 2 years after treatment, assessed by the modified Rankin Scale (mRS). The secondary outcomes are mRS score 90 days and 1 year after treatment, recurrence of cerebrovascular events, and severity of neurologic deficit measured using the National Institutes of Health Stroke Scale 1 and 2 years after treatment. Discussion: Previous studies of the Smart nitinol stent system for the treatment of carotid stenosis are mostly self-controlled case series or small cohort studies with short follow-up periods. Consequently, the long-term influence of Smart nitinol stent deployment on the risk of cerebrovascular events and long-term outcomes are not known. This trial illuminates the therapeutic benefits of the Smart nitinol stent system in a 2-year follow-up study of a large cohort of patients with severe atherosclerotic carotid stenosis. Trial registration: This trial was registered at ClinicalTrial.gov (NCT02800174). Ethics: The study protocol was approved by the Ethics Committee of Beijing Jishuitan Hospital, China (approval number: 201605-01) and conducted in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent was obtained from participants or their guardians.
  5,268 350 -
Transcription factor Runx2 in necrotic femoral head tissue: study protocol for a retrospective non-randomized parallel-controlled trial
Li-qing Yang, Cheng-jian Dong, Shu Zhu
April-June 2016, 1(2):71-76
DOI:10.4103/2468-5658.184747  
Background: Osteonecrosis of the femoral head (ONFH) results from an interruption of the blood supply to the femoral head or injury-caused death of chondrocytes and bone marrow components. Many osteogenesis-related factors, such as Runt-related transcription factor 2 (Runx2), bone morphogenetic protein (BMP), osteoprotegerin and osteocalcin, are involved in the subsequent repair process. Runx2 is an important transcription factor responsible for osteoblast differentiation and maturation of bone marrow stromal stem cells during bone development. The Runx2 gene has been shown to control osteoblast differentiation and formation by upregulating the transcription of various mineralization-related protein genes in chondrocytes, allowing chondrocyte differentiation into osteoblasts, and playing a key role in bone repair. Methods/Design: A retrospective, single-center, non-randomized, parallel-controlled trial was performed at Shengjing Hospital of China Medical University, China. Fifteen patients with ONFH and 15 patients with osteoarthritis were scheduled to undergo total hip replacement. Primary measure is Runx2 messenger RNA (mRNA) expression in femoral head and neck tissue, and secondary measures include BMP-2, BMP-7 and osteoprotegerin mRNA expression, as well as osteocalcin immunoreactivity. Discussion: During 2010-2011, this study first detected mRNA expression of several bone repair-related genes, including Runx2, in the femoral head and neck of patients with ONFH. Runx2 expression was compared with that of bone tissue from osteoarthritis patients to identify expression in necrotic femoral head tissue, which help clarify the role and possible clinical significance of Runx2 in femoral head necrosis, bone repair and reconstruction. Trial registration: This trial was registered at ClinicalTrial.gov identifier: NCT02735538. Ethics: This study protocol was approved by the Ethics Committee of Shengjing Hospital of China Medical University (approval No. 2016PS222K) and was performed in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent was obtained from each included patient.
  4,859 326 -
COMMENTARY
Commentary on "Safety and efficacy of human umbilical cord-derived mesenchymal stem cells in patients with Alzheimer's disease: study protocol for an open-label self-control trial"
Bianca Gutfilen, Gianluca Valentini
April-June 2016, 1(2):84-85
DOI:10.4103/2468-5658.184749  
  4,218 335 -
PERSPECTIVE
A new integrative approach to evaluate pathological gait: locomotor rehabilitation index
Leonardo Alexandre Peyré-Tartaruga, Elren Passos Monteiro
April-June 2016, 1(2):86-90
DOI:10.4103/2468-5658.184750  
This article reviews the concept of locomotor rehabilitation index (LRI) from the principle of dynamical similarities and the theory of mechanism minimizing the energy expenditure in pathological walking. This index is defined as the percentage ratio between self-selected speed and optimum speed (algebraically LRI = 100 × self-selected speed/optimum walking speed). First, we analyze the mechanical foundations of human walking especially focusing on general size effects. Then, we discuss the descriptive physiology of pendular mechanism, evidencing the path that leads to the view of reductionist and extremely descriptive view of pathological gait. Integrative models, generated by the first evidence presented in our previous papers around the LRI, represent a crucial change of perspective. This model is discussed in details and criticized concerning the ensuing experimental findings. Finally, we discuss the case of Parkinson's disease using the Nordic walking as a neat example of application of LRI on pathological locomotion. To conclude , the concept of LRI is reinforced by the substantial evidence, showing that this new proposal for assessing the gait functionality is extremely promising and should be stimulated in studies that examine the effects of therapies on gait functionality in degenerative diseases.
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