Exoskeleton training was generally safe and feasible in a heterogeneous sample of persons with SCI. Results indicate potential benefits on gait function and balance.
Training seemed not to provoke new pain. Spasticity decreased after a single training session. SCIM III and quality of life increased longitudinally for subsets of participants.
This review describes different aspects to consider when developing implantable pressure sensor systems. Measurement of pressure is in general highly important in clinical practice and medical research. Due to the small size, light weight and low energy consumption Micro Electro Mechanical Systems (MEMS) technology represents new possibilities for monitoring of physiological parameters inside the human body. Development of clinical relevant sensors requires close collaboration between technological experts and medical clinicians. Site of operation, size restrictions, patient safety, and required measurement range and resolution, are only some conditions that must be taken into account. An implantable device has to operate under very hostile conditions. Long-term in vivo pressure measurements are particularly demanding because the pressure sensitive part of the sensor must be in direct or indirect physical contact with the medium for which we want to detect the pressure. New sensor packaging concepts are demanded and must be developed through combined effort between scientists in MEMS technology, material science, and biology. Before launching a new medical device on the market, clinical studies must be performed. Regulatory documents and international standards set the premises for how such studies shall be conducted and reported.
Background Systems for monitoring effectiveness and quality of rehabilitation services across health care levels are needed. The purpose of this study was to develop and pilot test a quality indicator set for rehabilitation of rheumatic and musculoskeletal diseases. Methods The set was developed according to the Rand/UCLA Appropriateness Method, which integrates evidence review, in-person multidisciplinary expert panel meetings and repeated anonymous ratings for consensus building. The quality indicators were pilot-tested for overall face validity and feasibility in 15 specialist and 14 primary care rehabilitation units. Pass rates (percentages of “yes”) of the indicators were recorded in telephone interviews with 29 unit managers (structure indicators), and 164 patients (process and outcome indicators). Time use and participants’ numeric rating of face validity (0–10, 10 = high validity) were recorded. Results Nineteen structure, 12 process and five outcome indicators were developed and piloted. Mean (range) sum pass rates for the structure, process and outcome indicators were 59%(84%), 66%(100%) and 84%(100%), respectively. Mean (range) face validity score for managers/patients was 8.3 (8)/7.9 (9), and mean answering time was 6.0/5.5 min. The final indicator set consists of 19 structure, 11 process and three outcome indicators. Conclusion To our knowledge this is the first quality indicator set developed for rehabilitation of rheumatic and musculoskeletal diseases. Good overall face validity and a feasible format indicate a set suitable for monitoring quality in rehabilitation. The variation in pass rates between centers indicates a potential for quality improvement in rheumatic and musculoskeletal rehabilitation in Norway. Electronic supplementary material The online version of this article (10.1186/s12913-019-4091-4) contains supplementary material, which is available to authorized users.
This randomized clinical trial assesses the effects of robot-assisted treadmill training in persons with chronic incomplete spinal cord injury acquired > 2 years earlier. Due to recruitment challenges, it was possible to recruit only 63% of the planned number of participants. The intervention group received gait training 3 days per week for a period of 6 months and the control group received usual care with their local physical therapist. The intervention group showed improvements in lower extremity strength and balance, but no change in walking function. Significant between-group difference was found only in postural control, favouring the control group. Because the target number of study participants was not reached, the study was underpowered and nonsignificant, and thus the findings are inconclusive. This training method may have benefits, but the robotic device is expensive and training effects are limited when the person's baseline function is poor and the training starts late in incomplete spinal cord injury. Objective: To assess the effects of robot-assisted locomotor training in patients with chronic incomplete spinal cord injury. Design: Randomized single-blind controlled clinical trial. Setting: The intervention site was an outpatient clinic, and pre-and post-evaluations were performed in a rehabilitation hospital. Patients: A total of 24 subjects with American Spinal Injury Association Impairment Scale grades C or D, > 2 years post-injury. Interventions: Subjects were randomized to 60 days of robot-assisted locomotor training, or to usual care. Methods: Walking function, lower extremity muscle strength and balance were assessed single-blinded pre-and post-intervention. Results: After a 9-year recruitment period, only 24 of the planned 30 subjects had been enrolled (mean time since injury 17 (standard deviation (SD) 20) years for all subjects). Walking function, lower extremity muscle strength and balance improved modestly in both groups, with no statistically significant group difference in walking function or muscle strength, whereas postural control declined significantly in the intervention group, compared with controls (p = 0.03). Conclusion: Late-onset robot-assisted locomotor training did not re-establish independent walking function. A modest, but non-significant, effect was seen on muscle strength and balance. However, significant between-group differences were found only in postural control in the control group.
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