OBJECTIVE: The aim of this study is to evaluate the safety and efficacy of NeuroAiD amongst people who sustain SCI in the study setting.
METHODS: Spinal Cord Injury-Assessing Tolerability and Use of Combined Rehabilitation and NeuroAiD (SATURN) is a prospective cohort study of patients with moderately severe to severe SCI, defined as American Spinal Injury Association (ASIA) Impairment Scale (AIS) A and B. These patients will be treated with open-label NeuroAiD for 6 months in addition to standard care and followed for 24 months. Anonymized data will be prospectively collected at baseline and months 1, 3, 6, 12, 18, and 24 and will include information on demographics; main diagnostics; and neurological and functional state assessed by the Spinal Cord Independence Measure, ASIA-International Standard for Neurological Classification Spinal Cord Injury, and Short Form (SF-8) Health Survey. In addition, NeuroAiD treatment, compliance, concomitant therapies, and side effects, if any, will be collected. Investigators will use a secured online system for data entry. The study is approved by the ethics committee of Hospital University Kebangsaan Malaysia.
RESULTS: The coprimary endpoints are safety, AIS grade, and improvement in ASIA motor score at 6 months. Secondary endpoints are AIS grade, ASIA motor scores and sensory scores, Spinal Cord Independence Measure (SCIM), SF-8 Health Survey, and compliance at other time points.
CONCLUSIONS: SATURN investigates the promising role of NeuroAiD in SCI especially given its excellent safety profile. We described here the protocol and online data collection tool we will use for this prospective cohort study. The selection of moderately severe to severe SCI provides an opportunity to investigate the role of NeuroAiD in addition to standard rehabilitation in patients with poor prognosis. The results will provide important information on the feasibility of conducting larger controlled trials to improve long-term outcome of patients with SCI.
TRIAL REGISTRATION: Clinicaltrials.gov NCT02537899; https://clinicaltrials.gov/ct2/show/NCT02537899 (Archived by WebCite at http://www.webcitation.org/6m2pncVTG).
MATERIAL AND METHODS: Patients with Spastic CP with Gross Motor Function Classification System (GMFCS) I-III that underwent lower limb surgical intervention in our centre from 2008-2018 were retrospectively reviewed for The Spinal Alignment and Range of Motion Measure ROM subscale (SAROMM) scores and Functional Mobility Scale (FMS) 18 months after surgery. Changes in SAROMM, FMS scores and minimal clinically important difference (MCID) were determined.
RESULTS: 19 patients were included in the study with mean age of 12.58. All patients underwent muscle tendon procedures. Box plot analysis of SAROMM showed reduction of median scores at 6(26.3%) and 12(47.4%) months which plateaus at 18 months post-surgery. Repeated measure ANOVA analysis showed there was a statistically significant effect of time on SAROMM scores (p <0.001) with MCID of 13.4. Improvement of FMS scores was the most at 50m with 13 children (p < 0.05), one at 5m and five at 500m. None reported worsening of FMS scores at 18 months. There were no changes of GMFCS levels by the end of 18 months.
CONCLUSION: Surgeries performed on GMFCS I-III patients with the aim of gait improvement translates into improved mobility with results comparable to other countries.
CONCLUSION: MyDerm is an alternative option for the treatment of a massive skin defect in patients who desire removal of only a negligible amount of skin from the donor site and when use of an autograft is insufficient.
METHODS: This was a prospective non randomized clinical trial conducted on 31 patients with diabetes mellitus with high risk foot (King's classification stage II) over a 12 weeks period. Dynamic foot plantar pressure reading was recorded at day 0, 6 weeks and 12 weeks intervals, both barefoot and with StepEase™, using Novel Pedar-X system (Novel GmbH, Munich, Germany). Patients' satisfaction and usage practice were assessed by a questionnaire.
RESULTS: The mean age of subjects was 57.9 years with mean body mass index (BMI) of 26 kg/m2. The mean duration of diagnosis with diabetes mellitus was 10.2 years. The mean peak plantar pressure was found to be highest at the right forefoot and left heel region, 267.6 kPa (SD113.5 kPa) and 266.3 kPa (SD 94.6 kPa) respectively. There was a statistically significant reduction of mean peak pressure (P
METHODS: This randomised controlled trial was undertaken in a tertiary hospital in Malaysia from July 2019 until July 2020. Thirty patients were randomised into a group undergoing purely conventional rehabilitation (Group 1) and a group undergoing both conventional rehabilitation and immersive virtual reality assisted rehabilitation (Group 2). The immersive virtual reality assisted rehabilitation was started at 3 months post operatively for 3 months duration. Limb loading, balance, range of motion, functional hop tests of the knee, pain and subjective scoring of the knee with the International Knee Documentation Committee (IKDC) Scores were measured preoperatively and at 6 months.
RESULTS: There were significant differences in terms of improvement of pain scores (p = 0.012) as well as IKDC Scores (p = 0.024) in Group 2 as compared to Group 1. However, there were no significant differences with regards to limb loading, balance, range of motion and functional hop tests of the knee (p > 0.05). No adverse events were observed during the study period.
CONCLUSION: Immersive virtual reality can be used as an adjunct in rehabilitation of patients after ACL reconstruction in terms of improving their pain as well as their subjective knee evaluation. Large randomised control trial is recommended to further investigate the efficacy.
EVIDENCE ACQUISITION: In this systematic review, an electronic search through three primary databases, including Medline (PubMed), Scopus and Web of Science (WOS) was conducted to identify original studies reporting on barriers and facilitators for rehabilitation service organization in low-and middle-income countries. Date of search: 25th April 2021 (PubMed), 3rd May 2021 (Scopus and Web of Science). All studies including barriers or/and facilitators for rehabilitation services in low- and middle income countries which were written in English were included in the review. The articles written in other languages and grey literature, were excluded from this review.
EVIDENCE SYNTHESIS: Total of 42 articles were included from year 1989 to 2021. Numerous barriers were identified that related to education, resources, leadership, policy, technology and advanced treatment, community-based rehabilitation (CBR), social support, cultural influences, political issues, registries and standards of care. National health insurance including rehabilitation and funding from government and NGOs are some of the facilitators to strengthen rehabilitation service organization. Availability of CBR programs, academic rehabilitation training programs for allied health professionals, collaboration between Ministry of Heath (MOH) and Non-governmental Organizations (NGOs) on telerehabilitation services are amongst other facilitators.
CONCLUSIONS: Recommendations for improving and expanding rehabilitation service organization include funding, training, education, and sharing of resources.