Long-term intervention with Lactobacillus helveticus fermented milk reduces augmentation index in hypertensive subjects.

BACKGROUND: The milk casein-derived biologically active tripeptides, isoleucyl-prolyl-proline (Ile-Pro-Pro) and valyl-prolyl-proline (Val-Pro-Pro), have documented antihypertensive effect probably related to reduced angiotensin formation. It has been suggested that these tripeptides may reduce arterial stiffness and improve endothelial function. Our aim was to evaluate whether the milk-based drink containing Ile-Pro-Pro and Val-Pro-Pro influence arterial stiffness, measured as augmentation index (AIx), and endothelial function in man. METHODS: In a double-blind parallel group intervention study, 89 hypertensive subjects received daily peptide milk containing a low dose of tripeptides (5 mg/day) for 12 weeks and a high dose (50 mg/day) for the following 12 weeks, or a placebo milk drink to titrate the dose-response effect. Arterial stiffness was assessed by pulse wave analysis at the beginning and end of each intervention period. Endothelial function was tested by examining pulse wave reflection response to sublingual nitroglycerin and salbutamol inhalation. Blood pressure was measured by using office and 24-h ambulatory blood pressure measurement. RESULTS: At the end of the second intervention period, AIx decreased significantly in the peptide group compared with the placebo group (peptide group -1.53% (95% confidence interval (CI) -2.95 to -0.12), placebo group 1.20% (95% CI 0.09-2.32), P=0.013). No change in endothelial function index was observed (peptide group 0.02 (95% CI -0.06 to 0.08), placebo group 0.04 (95% CI -0.04 to 0.12), P=0.85). There were no statistically significant differences between the effects of the peptide and placebo treatment on office and 24-h ambulatory blood pressure. CONCLUSIONS: Long-term treatment with Lactobacillus helveticus-fermented milk containing bioactive peptides reduces arterial stiffness expressed as AIx in hypertensive subjects.

Perceived outcomes and utilization of upper extremity surgical reconstruction in individuals with tetraplegia at model spinal cord injury systems.

STUDY DESIGN: Survey. OBJECTIVE: To measure the utilization of upper extremity reconstructive surgery and the clinicians' perceptions of the outcomes provided for persons with tetraplegia across the Model Spinal Cord (SCI) Injury Systems. SETTING: Model SCI Systems. PARTICIPANTS: A clinician from each of the Model Centers. MAIN OUTCOME MEASURE: A mailed survey eliciting responses with respect to: (1) utilization of upper extremity reconstructive procedures and (2) the clinicians' perceived outcomes of these procedures. RESULTS: In all, 76% responded positively about the availability and appropriateness of upper extremity surgical reconstruction at their center. Of the respondents, 75% felt that surgery recipients were generally satisfied with their surgeries, 80% felt that the surgery made a positive impact on recipients' lives, 81% felt that recipients showed increased independence, and 70% reported a positive impact on recipients' occupation. In all, 93% felt insurance companies should pay for the procedures. Compared to the satisfaction of surgery recipients using a similar instrument, clinicians anticipated slightly greater improvements in all areas except occupation. CONCLUSIONS: There is a positive perception of the benefits of reconstructive surgery for tetraplegia; however, procedures are not routinely offered at all centers. The primary reasons reported for this include the misconception that insurance does not remit payment, that a surgeon is not available, and that surgical candidates are referred to another center.

Efficacy of an implanted neuroprosthesis for restoring hand grasp in tetraplegia: a multicenter study.

OBJECTIVE: To evaluate an implanted neuroprosthesis that allows tetraplegic users to control grasp and release in 1 hand. DESIGN: Multicenter cohort trial with at least 3 years of follow-up. Function for each participant was compared before and after implantation, and with and without the neuroprosthesis activated. SETTING: Tertiary spinal cord injury (SCI) care centers, 8 in the United States, 1 in the United Kingdom, and 1 in Australia. PARTICIPANTS: Fifty-one tetraplegic adults with C5 or C6 SCIs. INTERVENTION: An implanted neuroprosthetic system, in which electric stimulation of the grasping muscles of 1 arm are controlled by using contralateral shoulder movements, and concurrent tendon transfer surgery. Assessed participants' ability to grasp, move, and release standardized objects; degree of assistance required to perform activities of daily living (ADLs), device usage; and user satisfaction. MAIN OUTCOME MEASURES: Pinch force; grasp and release tests; ADL abilities test and ADL assessment test; and user satisfaction survey. RESULTS: Pinch force was significantly greater with the neuroprosthesis in all available 50 participants, and grasp-release abilities were improved in 49. All tested participants (49/49) were more independent in performing ADLs with the neuroprosthesis than they were without it. Home use of the device for regular function and exercise was reported by over 90% of the participants, and satisfaction with the neuroprosthesis was high. CONCLUSIONS: The grasping ability provided by the neuroprosthesis is substantial and lasting. The neuroprosthesis is safe, well accepted by users, and offers improved independence for a population without comparable alternatives.

Satisfaction with and usage of a hand neuroprosthesis.

OBJECTIVE: To measure the satisfaction with, clinical impact of, and use of an implantable hand neuroprosthesis. SETTING: Eight different medical centers. PARTICIPANTS: Thirty-four individuals with spinal cord injuries at the C5 or C6 motor level. INTERVENTIONS: Participants were implemented with a hand neuroprosthesis that provides grasp and release. The neuroprosthesis includes a surgically implanted stimulator, implanted electrodes sutured to the hand and forearm muscles, and an externally mounted controller. MAIN OUTCOME MEASURE: A survey was mailed to study participants, who were asked to respond to statements such as "If I had it to do over, I would have the hand system implanted again," using a 5-level Likert scale ("strongly agree" to "strongly disagree"). RESULTS: Eighty-seven percent of participants were very satisfied with the neuroprosthesis, 88% reported a positive impact on their life, 87% reported improvements in activities of daily living, and 81% reported improved independence. Participants reported using the neuroprosthesis a median of 5.5 days per week; 15 participants used the neuroprosthesis 7 days per week, and 5 participants reported not using the device. CONCLUSIONS: The neuroprosthesis was used by most participants. The neuroprosthesis performed satisfactorily, increased users' ability to perform activities of daily living and independence, and improved their quality of life.

Patient selection for an upper extremity neuroprosthesis in tetraplegic individuals.

One hundred and twenty persons with new onset traumatic tetraplegia consecutively admitted to our rehabilitation service were screened for consideration for use of an upper extremity neuroprosthesis. Strict inclusion criteria allowed only for participation of patients with ASIA impairment scale A, B or C injuries at the C5 or C6 level. One hundred and six persons were excluded from participation for the following reasons: five patients died, 27 had central cord syndrome, two had Brown-Sequard syndrome, 12 were injured at too high a level, 42 were injured at too low a level, two were excluded on the basis of motor incompleteness alone, four were excessively denervated, two had limited range of motion, one had overriding medical complications, seven had psychosocial issues making participation impractical, and two elected tendon transfer surgery. In total, 14 patients (representing 11.7% of all tetraplegic individuals and 50% of the C5 or C6 ASIA Impairment Scale A, B or C patients) were found to be candidates for the neuroprosthesis. Given the prevalence of tetraplegia, approximately 12,200 Americans would be candidates for the FES neuroprosthetic hand grasp system under the current research protocols. With both the expansion of current protocols to other diagnostic categories and further research and development, application of this neuroprosthesis to a considerable number of previously excluded subjects will likely be possible.

An implanted upper-extremity neuroprosthesis. Follow-up of five patients.

An implanted neuroprosthesis supplying functional neuromuscular stimulation was used to provide grasp and release to tetraplegic individuals. This article describes the results, at a minimum of three years, for the first five patients to have operative implantation of an eight-channel stimulator-receiver. All of the patients had a clinically complete spinal cord injury with motor function remaining at the level of the fifth or sixth cervical nerve root. In addition to implantation of the stimulator system, each patient had augmentative operations on the hand to improve function. The procedures included tendon transfers, side-to-side tendon anastomoses, arthrodesis of the interphalangeal joint of the thumb, and rotational osteotomy of the radius. The neuroprosthesis provides two grasp patterns controlled by voluntary motion of the shoulder or wrist. Functional evaluations included measurement of pinch force, a grasp-release test, evaluation of the level of functional independence, and usage surveys. Pinch force ranged from eight to twenty-five newtons. All five patients demonstrated functional grasp patterns, had increased independence, and were able to use the neuroprosthesis at home on a regular basis. The implanted stimulator has proved to be safe and reliable, with seven years as the longest time in situ at the time of writing.

Tendon transfers and functional electrical stimulation for restoration of hand function in spinal cord injury.

Spinal cord injury at the C5 and C6 level results in loss of hand function. Electrical stimulation of paralyzed muscles is one approach that has demonstrated significant capacity for restoring grasp and release function. One potential limitation of this approach is that key muscles for stimulation may have lower motor neuron damage, rendering the muscles unexcitable. We have used surgical modification of the biomechanics of the hand to overcome this limitation. Tendon transfer of paralyzed but lower motor neuron intact muscles can compensate for potential function lost owing to muscles with lower motor neuron damage. Such procedures have been performed to provide finger extension, thumb extension, finger flexion, and wrist extension. Additional surgical procedures have been performed to enhance the function provided with electrical stimulation. These are side-to-side synchronization of the finger flexor and extensor tendons, the flexor digitorium superficialis Zancolli-lasso procedure, and thumb interphalangeal joint arthrodesis. These procedures have been performed in 11 patients with C5 and C6 level spinal injuries and functional electrical stimulation neuroprostheses. In these patients, 41 different functional electrical stimulation-related procedures were performed and 38 gave the desired result after surgery. One procedure resulted in no increase or decrease in function or muscle output, and two procedures resulted in a decrease in muscle force or joint range of motion. The issues that must be considered in performing functional electrical stimulation-related tendon transfers are discussed.

Development of a quantitative hand grasp and release test for patients with tetraplegia using a hand neuroprosthesis.

We developed a quantitative grasp and release test for assessing a hand neuroprosthesis in C5 and C6 level tetraplegic patients. The objectives were (1) to determine if a patient's hand performance with the neuroprosthesis exceeded a defined, clinically acceptable baseline, (2) to compare performance with and without the neuroprosthesis, (3) to measure the consistency of performance over time, and (4) to compare performance among patients. In the test, patients grasped, moved, and released one of six different objects as many times as possible in five 30-second trials for each object, with and without the neuroprosthesis. Unlike earlier tests, the objects and the task were chosen to span a range of difficulties appropriate for C5 and C6 tetraplegic patients using a hand neuroprosthesis. Data from five patients showed that performance with the neuroprosthesis was above the baseline; performance improved with the neuroprosthesis, although it was not generally consistent across sessions; and the neuroprosthesis helped C5 patients manipulate most objects and helped C6 patients primarily with more difficult objects.