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COMPLETED PROJECTS Lists of abstracts of the completed projects in alphabetical order of the principal investigator:
Two randomized controlled clinical trials will be conducted concurrently. These studies are identical with respect to objectives, clinical measures and assessments. The studies differ in that one will be conducted in the acute stroke population (<8 weeks post stroke) and one will be conducted in the chronic stroke population (>6 months post-stroke). The primary objective of these concurrent clinical studies was to evaluate the safety and efficacy of the NeuroControl StIM System in reducing inferior shoulder subluxation and diminishing shoulder pain intensity among stoke survivors. Additionally, the clinical impact of the intervention was determined by analysis of a combination of the shoulder inferior subluxation and pain outcomes for each patient. Freedom from device-related complications was the primary safety endpoint. Secondary objectives of the study included assessment of functional independence, changes in pain interference, pain medications, pain-free passive range of motion, upper-extremity motor function, upper extremity muscle spasticity, arm motor ability, and duration of the treatment effect. The progression of shoulder pain was evaluated in both the treatment and control groups via a longitudinal analysis using data from patient diaries. In both the acute and chronic randomized controlled clinical studies, treatment and control patients received conventional shoulder subluxation therapy and a sling. In addition, treatment patients received 6 hours of stimulation per day for a total of 6 weeks. Evaluations were performed within 48 hours prior to System implantation, on the day of implantation, on day 8 when stimulation begins, at an interim treatment phase visit week 4, and at the conclusion of a 6-week period of stimulation when the System is removed. In addition, follow-up evaluations were performed at 3, 6, and 12 months post-removal of the Percutaneous Stimulation System.
Objective Design Setting Patients Interventions Main Outcome Measures Results Conclusion Key Words
Background Methods Results Conclusions
Objective Background Findings Conclusion
We studied the effectiveness of nasal salmon calcitonin (Miacalcin Nasal Spray) in LCS by performing a double blind, randomized, placebo-controlled, parallel group six-week pilot trial. An open-label, six-week extension followed, allowing all patients to receive the active drug. Various outcome measures has been compared to help establish whether Miacalcin is an active agent for the non-surgical treatment of LCS. This was a pilot study to help determine whether Miacalcin Nasal Spray is an active treatment for LCS. The duration of treatment of Phase I is six weeks with an open-label extension (Phase II) for an additional six weeks. This was chosen because it appears from our uncontrolled data that the majority of the treatment response is noted between four and twelve weeks. This study assessed the response to active or placebo treatment during the first 6 weeks followed by an open-label extension in which all patients was offered active treatment for 6 weeks. We were investigating whether a dose of Miacalcin NS 400 IU daily is effective in the treatment of lumbar canal stenosis. The 400 IU daily dose of Miacalcin is twice the standard dose used in the treatment of postmenopausal osteoporosis. However, 400 IU daily has been extensively studied in clinical trials in women with osteoporosis and has an excellent safety profile.
The purposes of this project were to determine the effect of imagined-muscle-contraction training on the strength of human limb muscles and to identify the underlying neural mechanisms for the improved muscle performance due to the imagined-muscle-contraction training. It is well known that the improvement of voluntary muscle strength can be accomplished by an enlargement of muscle mass or by changes that occur in the nervous system. The neural mechanisms underlying the increase in strength, however, are poorly understood. Recent studies have demonstrated that the nervous system is able to increase strength in the absence of muscle exercise and the origin of the neural change associated with strength training appears to be in the brain. Because the imagined contraction training will not involve muscle exercise, any strength improvement after the training will be a result of adaptations in the nervous system. Furthermore, because the training occurs in the brain, any neural changes contributing to the strength increase must be cortical in origin. Changes in brain activation after training were determined by functional magnetic resonance imaging. We found that the strength of the distal (little finger abductor) and proximal (elbow flexors) muscles increased, on average, by 35% and 13.5% respectively. This increase in muscle strength was accompanied with significant increases in brain activity, directly related to the controlling of the maximal muscle contractions as well as in muscle electrical activities. The outcome of this study will be highly relevant to rehabilitation medicine.
Aging is accompanied by a decline in the manipulative capabilities of the hand. Little information is available on interventional strategies, such as hand and finger exercises, that might be used to maintain hand function in older adults. The objective of this study was to determine the effects of training with highly skilled finger-hand movements on the hand function of older adults and to identify the neural mechanisms that mediate the improvement in performance. The training task required independent but coordinated finger movements that require dexterity, coordination, strength, endurance, and continuous sensory feedback. It was expected that the hand function of older adults would significantly improve with training and that this improvement would be associated with training-induced adaptations in the nervous system. Our results indicate that skilled finger-movement training can improve the ability to control submaximal pinch force, hand steadiness, and manual speed in elderly subjects. This exercise may be an inexpensive method to maintain hand functions in elderly.
The phase I project was completed in collaboration with the Cleveland Medical Devices. Inc., members of Rehabilitation Technology and Orthotics and Prosthetics sections of the department. The purpose of this research project was to evaluate the data collection capacity of a newly developed diabetic foot pressure monitor. Data recorded and stored was useful for the clinician to determine the effectiveness of the shoe insert orthosis and the modifications in pressure distributions under the foot of the diabetic patients. Normal subjects were monitored and preliminary indications of normal foot pressure values established. The collected data will help determine the importance of orthotic design, the limits of walking and the time limits of pressure application. A phase II proposal for a wide scale clinical trial has been submitted and is in review.
The objective of the study was to develop a validation test procedure and collect data to classify low air loss support surfaces. Low air loss systems can be defined by their ability to evaporate skin moisture by air flow, thereby decreasing the temperature at the patient-support interface. Therefore, under this classification scheme, the low air loss surface must meet both an established moisture loss threshold and a temperature reduction threshold. Testing was conducted in the laboratory using a heated water bath on a moistened towel to represent the patient’s body temperature, weight, and surface moisture on a set of commercial low air loss support surfaces. Moisture loss and interface temperature measurements were collected over time on both low air loss and standard support surfaces, and correlation between the data and mattress type was determined.
Most of the effort on this project has focused on the refinement of a reproducible and reliable test protocol for simulating the vehicle environment in a laboratory. Testing in a vehicle while traveling in a wheelchair is costly and time consuming, and there are many variables that cannot be controlled. To overcome this, a computer controlled tilt-table has been developed. This concept has since been adopted by the ANSI/RESNA committee developing a standard for transportable mobility aids. To evaluate the effect of driving maneuvers, the mobility aid is secured to the surface of the tilt-table, which represents the vehicle floor, and the occupant is restrained in the mobility aid. The table is then tilted, and as the table and seat orientation changes, the gravity vector develops a force component parallel to the table surface, simulating the lateral or longitudinal inertial forces of the mobility aid and user that occur during turning, braking, or acceleration. The simulated acceleration is equivalent in magnitude (measured in g’s) to the sine of the tilt angle. Although the force perpendicular to the floor is reduced as the table tilts, only a six percent error occurs at tilt angels simulating normal driving maneuvers. Video cameras and load cells record the kinematics and center of gravity locations throughout the test. The test equipment and protocol has been refined, and data has been collected and is being analyzed on 3 able-bodied subjects, and 3 individuals with quadriplegia.
The work was aimed at demonstrating the effect of controlled, passive lateral rotation of immobile patients in bed on the function of internal organ systems. Rotational movement of the patient is introduced by raising and lowering the low air loss support surface under the left and right side to cause up to 40° of axial rotation of the patient in bed. A randomized control group of patients are treated on a low air loss bed of similar design without lateral rotation. Interim results indicated reduction in heart rate and improvement of pressure ulcer wound healing and an excellent nursing staff response to the benefits of passive lateral rotation therapy.
The phase II application was approved for funding at the Cleveland Medical Devices, Inc. after the successful completion of the phase I feasibility study. The project involved testing a modified, previously developed portable device which provides a training and monitoring system to ulcer formation. The Pressure Relief Reminder and Compliance System is capable of providing compliance monitoring and warning via vibration or audible alarm of prolonged periods of the patient immobility. The devices also records the number of warnings received and the response or lack of it by the user. The data will also help the clinician to determine whether the treatment of prescribed time limits are appropriate for pressure sore prevention. The project is also evaluating the lasting effect of the biofeedback for pressure relief and the biofeedback to prevent pressure ulcer formation in consenting wheelchair users. The project has 11 subjects enrolled to study the first objectives and 3 subjects in the second. The initial data analysis is in progress and new enrollment is planned for more data collection. There have been no adverse events in the project.
This project was a collaborative effort with the Greater Cleveland RTA and Flexible Corporation. A conceptual model for an occupant restraint system that can be efficiently used by individuals seated in wheelchairs during transportation was developed as part of a previous project. The occupant restraint design which was further developed through this project is the first system that brings the anchor locations into proximity with the wheelchair seat, thus utilizing the crash worthiness principles used with vehicle seating. Recognizing the service needs of transit providers, particular attention was given to convenience and operation. The project established design criteria, computer modeling, prototype fabrication, laboratory testing, and field demonstrations.
This project demonstrated the feasibility of a mobility aid securement system that specifically addresses the service needs for public transit, private mobility aid transportation providers, and school bus transportation. A prototype of the Cleveland Securement System (CSS) was developed under a previous project and showed significant promise. This system restrains mobility aids without the necessity for a fixed bracket on the mobility aid and without requiring a lengthy strap-down procedure. The CSS operates on all types of mobility aids, and require less than a minute of the operator’s time on mobility aids without any fixed attachment. Mobility aids with a preinstalled attachment can be secured by over 80% of all independent wheelchair users without any driver involvement.
Chronic fatigue syndrome (CFS) patients suffer persistent fatigue that significantly reduces their daily activities. Increasing evidence has emerged to suggest that CFS is a biological illness involving pathology of the central nervous system. The purpose of this study was to determine whether brain activity of CFS patients during voluntary motor activities differs from that of healthy individuals. Eight CFS patients and eight age- and sex-matched healthy volunteers performed isometric handgrip contractions at 50% maximal voluntary contraction level. In the first experiment, they performed 60 contractions with a 10-s rest between adjacent trials – “Non-Fatigue” (NF) task. In the second experiment, the same number of contractions was performed with only a 5-s rest period – “Fatigue” (FT) task. Sixty-four channels of surface EEG were recorded simultaneously from the scalp. In each contraction, the force signal was used as the trigger for EEG averaging to derive motor activity-related cortical potential (MRCP). The amplitude of MRCP for the NF task was greater for the patients group (3.49 ± 1.16 µV) than the control group (3.07 ± 0.51 µV). Similarly, MRCP for the FT task was greater for the patients (4.43 ± 1.10 µV) than for the healthy subjects (3.78 ± 0.94 µV). Spectrum analysis of the EEG signals indicated that there were substantial differences at the delta and theta frequency bands between the two groups. These results support the notion that CFS involves impairments of the central nervous system.
Previously we found a linear relationship between EEG-derived motor activity-related cortical potential (MRCP) and elbow flexor muscle activation (Siemionow et al. Exp Brain Res 133:303, 2000). The purpose of this study was to investigate the relationship between MRCP and voluntary activation of antigravity muscles in a lower extremity. Knowing this relationship is important for assessing the CNS adaptations involving controlling lower limb antigravity muscles under microgravity conditions, such as spaceflight. Eight subjects (six men and 2 woman, age 30±7.6 years) participated in the study. They performed isometric ankle plantar flexions and knee extensions at four intensity levels (10, 30, 50, and 70% MVC). In another session, isokinetic ankle plantar flexions and knee extensions were performed. At each intensity level, 40 contractions were executed while force and EMG signals of the knee extensor and ankle plantar flexor muscles were recorded. EEG signals were acquired with electrodes placed on five scalp locations (Cz, C3, C4, Fz, and Pz). For the location overlying the SMA and leg motor area (Cz), MRCP values for the isometric knee extension at four force levels were: 4.35 ±1.72, 5.20±1.58, 5.83±1.68, and 7.55±1.35 µV, respectively. For the isometric ankle plantar flexion, the four MRCP values (Cz) were 3.15±1.33, 4.32±1.7, 5.29±1.94, and 7.09±2.35 µV, respectively. A similar linear relationship was observed for the dynamic contractions. These results suggest that the MRCP signal represents cortical motor command that scales activation levels of lower extremities antigravity muscles.
The purpose of this study was to investigate changes in finger coordination indices and possible underlying mechanisms related to adaptive cortical reorganization after stroke. Sixteen unilaterally affected stroke patients and sixteen control subjects produced peak forces with different finger from one hand and from two hands simultaneously. Control subjects were divided into two groups: elderly subject (>75, N=8) and young subject (<60, N=8) groups. The peak forces produced by the fingers of the impaired hand were about 36% less than those by the unimpaired hand. In multi-finger tasks, total peak force was smaller than the sum of peak forces in single-finger tasks by the involved fingers (force deficit, FD). Force production by some fingers of a hand was accompanied by involuntary force production by other fingers (enslaving, ENSL). Higher FD and no change in ENSL were observed with age, while stroke resulted in higher ENSL and decreased FD, particularly in IM (index, middle fingers) tasks in the impaired hand. An increase in FD and no change in BD with age suggested that FD and BD are phenomena of different origins. Higher FD could be due to adaptive changes of CNS with age. Decreased FD in the IM task and higher ENSL in the impaired hand was a reflection of higher involvement of index and middle fingers in force production and suggested that less impairment and/or good recovery of these two fingers. Unchanged BD implied that interhemispheric inhibition persisted in unilateral stroke. Changes in finger coordination indices after stroke could probably be associated with adaptive reorganization and incorporated into an earlier introduced hypothesis on cortical organization of multifinger synergy. We conclude that impaired hand function in stroke patients was accompanied not only by a general loss of finger force but also by changes in indices of multi-finger coordination. Changes in multi-effector synergies may be related to adaptive reactions of the CNS to an injury.
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