How to cite this article:
Shendkar CV, Arya BK, Lenka P, Kumar R, Mahadevappa M. Conception, Development, and Clinical Trial Design of Point-of-care Technologies: A Case of Improved FES Device Development. Indian J Phy Med Rehab 2016; 27 (1):2-9.
This article presents a case study on the development of an indigenous stimulator device, including the design of its clinical trials and the process of its clinical trial registration in the newly launched clinical trial registry- India (CTRI). The ethical and regulatory issues involved in medical device clinical trials in India are also discussed.
Design and Methods
The entire development and trial cycle of a new medical device from ideation to technology transfer is explained in this case of a newly developed indigenous FES device. The primary emphasis is on how to systematically analyse the global trial registry databases to adequately frame a medical device trial. With this case study, we present how to shortlist relevant trials; we then compare them and explain the valid methods for registering a trial protocol in the CTRI.
Our work can act as a model or guide for rehabilitation researchers in India, facilitating there work in the medical device design and trial protocol development. Though our trial has been designed for and registered in the Indian CTRI trial registry, our work can be equally useful for researchers abroad who desire to conduct their medical device trials in India.
There may be change in clinical spectrum of cerebral palsy (CP) due to improvement in maternal and child care health service. The clinical profi le, aetiological factors and comorbidities of children with CP attending Department of PMR, VMMC & Safdarjang Hospital during the years 1981- 1989 and 2008 - 2012 were therefore compared and analysis done.
Four hundred and ten (group B) children with CP registered in last 4 years (2008 - 2012) at PMR Department of VMMC & Safdarjang Hospital were compared with previous study of 544 (group A) children during year 1981 - 1989 from same centre.
Spastic CP remained most common in both the groups. Diplegia is commonest type of CP (38.78%) as compared to previous group where quadriplegia (34.9%) was most common. The mixed type showed a statistical signifi cant increase in percentage (group A: 0.18 % versus group B: 3.7 %).
In aetiology, there is decrease in prenatal and postnatal causes and increase in natal causes which were statistically signifi cant. Birth asphyxia (50.3 %) remains the main aetiological factor as earlier (24.5%). Speech problems (59.7%), mental retardation (31.7%) and seizures (26.8%) are common comorbidities as compared to previous studies where mental retardation (47.2 %) was found to be most common followed by speech impairment (37%), visual impairment (9%) and seizures (8.8%).
Clinical profile of CP has evolved with an increase in diplegic and a decrease in quadriplegic CP.
How to cite this article:
Das SP, Sahu M, Parida PK. Management of Sacral Pressure Sore by Clinically Isolated Superior Gluteal Artery Perforator-based Fasciocutaneus Flap in Patients with Spinal Cord Injury. Indian J Phy Med Rehab 2016; 27 (1):14-18.
Observation on management of sacral pressure sore by superior gluteal arterial perforatorbased flap using anatomical land marks in the absence of facility of Doppler probe for isolation of superior gluteal arterial perforators.
Materials and methods
Thirteen patients of spinal cord injury presented with sacral pressure sore were managed surgically using superior gluteal artery perforator-based flap coverage. The location of the artery was identifi ed using anatomical land marks. In 10 patients the flap was heeled uneventfully, one had signifi cant complication with wound dehiscence.
Management of sacral pressure sore by superior gluteal arterial perforator-based flap using anatomical land marks is a simple and reliable procedure. The learning curve is not that stiff. Sophisticated instruments are not required for this procedure.
Charles Wow Karech
With an increased awareness to maintain physical fitness, weight training has become increasingly popular. Neurologic injuries are one of many injuries which can occur accidentally or with improper technique. We present a case of an isolated right medial pectoral nerve mononeuropathy in a 48-year-old male weightlifter.
Complex regional pain syndrome (CRPS) of the lower limb is a relatively uncommon entity as compared to CRPS of the upper extremity. Literature search has revealed only 2 retrospective case series and a single case report of lower extremity CRPS type I from 1975 to 2014 on Pubmed, isolated cases of CRPS type I of lower extremity have also been reported following knee surgeries and arthroscopies. This report presents a case of lower limb CRPS type I following blunt trauma to right foot, treatment of which was directed towards management of allodynia, vasomotor symptoms and surgical correction of deformity which had developed because of the disease, coping mechanisms were also reinforced through counselling and relaxation training. The individual responded well to treatment with a reported 75% reduction in the disabling symptoms and improvement in ambulatory status.