Valuing Treatments for Parkinson Disease Incorporating Process Utility: Performance of Best-Worst Scaling, Time Trade-Off, and Visual Analogue Scales.

OBJECTIVE: The objective of this study was to compare treatment profiles including both health outcomes and process characteristics in Parkinson disease using best-worst scaling (BWS), time trade-off (TTO), and visual analogue scales (VAS). METHODS: From the model comprising of seven attributes with three levels, six unique profiles were selected representing process-related factors and health outcomes in Parkinson disease. A Web-based survey (N = 613) was conducted in a general population to estimate process-related utilities using profile-based BWS (case 2), multiprofile-based BWS (case 3), TTO, and VAS. The rank order of the six profiles was compared, convergent validity among methods was assessed, and individual analysis focused on the differentiation between pairs of profiles with methods used. RESULTS: The aggregated health-state utilities for the six treatment profiles were highly comparable for all methods and no rank reversals were identified. On the individual level, the convergent validity between all methods was strong; however, respondents differentiated less in the utility of closely related treatment profiles with a VAS or TTO than with BWS. For TTO and VAS, this resulted in nonsignificant differences in mean utilities for closely related treatment profiles. CONCLUSIONS: This study suggests that all methods are equally able to measure process-related utility when the aim is to estimate the overall value of treatments. On an individual level, such as in shared decision making, BWS allows for better prioritization of treatment alternatives, especially if they are closely related. The decision-making problem and the need for explicit trade-off between attributes should determine the choice for a method.

Surface peroneal nerve stimulation in lower limb hemiparesis: effect on quantitative gait parameters.

OBJECTIVE: The objective of this study was to evaluate possible mechanisms for functional improvement and compare ambulation training with surface peroneal nerve stimulation vs. usual care via quantitative gait analysis. DESIGN: This study is a randomized controlled clinical trial. SETTING: The setting of this study is a teaching hospital of an academic medical center. PARTICIPANTS: One hundred ten chronic stroke survivors (>12 wks poststroke) with unilateral hemiparesis participated in this study. INTERVENTIONS: The subjects were randomized to a surface peroneal nerve stimulation device or usual care intervention. The subjects were treated for 12 wks and followed up for 6-mo posttreatment. MAIN OUTCOME MEASURES: Spatiotemporal, kinematic, and kinetic parameters of gait were the main outcome measures. RESULTS: Cadence (F3,153 = 5.81, P = 0.012), stride length (F3,179 = 20.01, P < 0.001), walking speed (F3,167 = 18.2, P < 0.001), anterior-posterior ground reaction force (F3,164 = 6.61, P = 0.004), peak hip power in preswing (F3,156 = 8.76, P < 0.001), and peak ankle power at push-off (F3,149 = 6.38, P = 0.005) all improved with respect to time. However, peak ankle ankle dorsiflexion in swing (F3,184 = 4.99, P = 0.031) worsened. In general, the greatest change for all parameters occurred during the treatment period. There were no significant treatment group × time interaction effects for any of the spatiotemporal, kinematic, or kinetic parameters. CONCLUSIONS: Gait training with peroneal nerve stimulation and usual care was associated with improvements in peak hip power in preswing and peak ankle power at push-off, which may have resulted in improved cadence, stride length, and walking speed; however, there were no differences between treatment groups. Both treatment groups also experienced a decrease in peak ankle ankle dorsiflexion in swing, although the clinical implications of this finding are unclear.

Randomized controlled trial of surface peroneal nerve stimulation for motor relearning in lower limb hemiparesis.

OBJECTIVE: To compare the motor relearning effect of a surface peroneal nerve stimulator (PNS) versus usual care on lower limb motor impairment, activity limitation, and quality of life among chronic stroke survivors. DESIGN: Single-blinded randomized controlled trial. SETTING: Teaching hospital of academic medical center. PARTICIPANTS: Chronic stroke survivors (N=110; >12wk poststroke) with unilateral hemiparesis and dorsiflexion strength of ≤4/5 on the Medical Research Council scale. INTERVENTIONS: Subjects were stratified by motor impairment level and then randomly assigned to ambulation training with either a surface PNS device or usual care (ankle-foot orthosis or no device) intervention. Subjects were treated for 12 weeks and followed up for 6 months posttreatment. MAIN OUTCOME MEASURES: Lower limb portion of the Fugl-Meyer (FM) Assessment (motor impairment), the modified Emory Functional Ambulation Profile (mEFAP) performed without a device (functional ambulation), and the Stroke Specific Quality of Life (SSQOL) scale. RESULTS: There was no significant treatment group main effect or treatment group by time interaction effect on FM, mEFAP, or SSQOL raw scores (P>.05). The time effect was significant for the 3 raw scores (P<.05). However, when comparing average change scores from baseline (t1) to end of treatment (t2, 12wk), and at 12 weeks (t3) and 24 weeks (t4) after end of treatment, significant differences were noted only for the mEFAP and SSQOL scores. The change in the average scores for both mEFAP and SSQOL occurred between t1 and t2, followed by relative stability thereafter. CONCLUSIONS: There was no evidence of a motor relearning effect on lower limb motor impairment in either the PNS or usual-care groups. However, both the PNS and usual-care groups demonstrated significant improvements in functional mobility and quality of life during the treatment period, which were maintained at 6-month follow-up.

Neuromuscular stimulation after stroke: from technology to clinical deployment.

Since the early 1960s, electrical or neuromuscular electrical stimulation (NMES) has been used to support the rehabilitation of stroke patients. One of the earliest applications of NMES included the use of external muscle stimulation to correct drop-foot after stroke. During the last few decades various clinical applications have been used for the upper and lower limb. Despite a growing body of literature on the use of NMES, its application in stroke is still limited to a few clinical groups that provide dedicated clinical services. Some explanations for the limited use are the sometimes conflicting clinical evidence, the size of the effects or the complicated use of the technology itself. This review points out three directions for future research. First, we need to expand our knowledge on brain plasticity and the use of different electrical stimulation strategies to modulate the neural system. Second, we foresee an increase in therapies combining different training principles, for example, the combination of NMES and robotics or neuromodulating drugs. Finally, with the ever-increasing pressure on healthcare budgets, it is expected that clinical and economic evidence will become more relevant in transferring these interventions to a wider community.

Electrical stimulation of the upper extremity in stroke: cyclic versus EMG-triggered stimulation.

OBJECTIVE: To compare the effect of cyclic and electromyography (EMG)-triggered electrical stimulation on motor impairment and function of the affected upper extremity in chronic stroke. DESIGN: Randomized controlled trial. SETTING: Outpatient clinic of a rehabilitation centre. SUBJECTS AND INTERVENTION: Twenty-two subjects in the chronic stage after stroke were randomly assigned to receive either cyclic (n=11) or EMG-triggered electrical stimulation (n=11) of the wrist and finger extensor muscles for a six-week period. OUTCOME MEASURES: The primary outcome measure was the Action Research Arm test (0-57 points) to assess arm function. Grip strength, Fugl-Meyer Motor Assessment and Motricity Index were secondary outcome measures. Assessments were made at the start of the treatment and after 4, 6 and 12 weeks. RESULTS: Both groups improved on the Action Research Arm test. The group receiving cyclic stimulation improved by 2.3 points, and the group receiving EMG-triggered stimulation improved by 4.2 points. The difference in functional gain was not statistically significant. Differences in gain on the secondary outcome measures were not significant either. CONCLUSION: The present study did not detect a significant difference between EMG-triggered and cyclic electrical stimulation with respect to improvement of motor function of the affected arm in chronic stroke.

The use of the analytic hierarchy process to aid decision making in acquired equinovarus deformity.

OBJECTIVE: To increase the transparency of decision making about treatment in patients with equinovarus deformity poststroke. DESIGN: The analytic hierarchy process (AHP) was used as a structured methodology to study the subjective rationale behind choice of treatment. SETTING: An 8-hour meeting at a centrally located rehabilitation center in The Netherlands, during which a patient video was shown to all participants (using a personal computer and a large screen) and the patient details were provided on paper. PARTICIPANTS: A panel of 10 health professionals from different backgrounds. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The performance of the applicable treatments on outcome, impact, comfort, cosmetics, daily effort, and risks and side effects of treatment, as well as the relative importance of criteria in the choice of treatment. RESULTS: According to the model, soft-tissue surgery (.413) ranked first as the preferred treatment, followed by orthopedic footwear (.181), ankle-foot orthosis (.147), surface electrostimulation (.137), and finally implanted electrostimulation (.123). Outcome was the most influential consideration affecting treatment choice (.509), followed by risk and side effects (.194), comfort (.104), daily effort (.098), cosmetics (.065), and impact of treatment (.030). CONCLUSIONS: Soft-tissue surgery was judged best on outcome, daily effort, comfortable shoe wear, and cosmetically acceptable result and was thereby preferred as a treatment alternative by the panel in this study. In contrast, orthosis and orthopedic footwear are usually preferred in daily practice. The AHP method was found to be suitable methodology for eliciting subjective opinions and quantitatively comparing treatments in the absence of scientific evidence.

Therapeutic effect of an implantable peroneal nerve stimulator in subjects with chronic stroke and footdrop: a randomized controlled trial.

BACKGROUND AND PURPOSE: Footdrop, characterized by a person's inability to raise the foot at the ankle, is a common problem in patients with stroke. A randomized controlled trial was performed to determine the therapeutic effect of using a new implantable, 2-channel peroneal nerve stimulator for 6 months versus an ankle-foot orthosis (AFO). SUBJECTS: Twenty-nine patients with chronic stroke and footdrop participated in the study. The mean time from stroke was 7.3 years (SD=7.3), and all subjects were community ambulators. METHODS: The study used a randomized controlled trial design. The functional electrical stimulation (FES) group received the implantable stimulation system for correction of their footdrop. The control group continued using their conventional walking device (ie, AFO, orthopedic shoes, or no walking device). All subjects were measured at baseline and at weeks 4, 8, 12, and 26 in the gait laboratory. The therapeutic effect of FES on the maximum value of the root mean square (RMSmax) of the tibialis anterior (TA) muscle with both flexed and extended knees and walking speed were selected as the primary outcome measures. The RMSmax of the peroneus longus (PL), gastrocnemius (GS), and soleus (SL) muscles with both flexed and extended knees and muscle activity of the TA muscle of the affected leg during the swing phase of gait were selected as secondary outcome measures. RESULTS: A significantly higher RMSmax of the TA muscle with extended knee was found after using FES. No change in walking speed was found when the stimulator was not switched on. A significantly increased RMSmax of the GS muscle with both flexed and extended knees was found after using FES. DISCUSSION AND CONCLUSION: Functionally, no therapeutic effect of implantable peroneal nerve stimulation was found. However, the significantly increased voluntary muscle output of the TA and GS muscles after the use of FES suggests that there was a certain extent of plasticity in the subjects in this study.

A randomized controlled trial of an implantable 2-channel peroneal nerve stimulator on walking speed and activity in poststroke hemiplegia.

OBJECTIVE: To determine the effect of a new implantable 2-channel peroneal nerve stimulator on walking speed and daily activities, in comparison with the usual treatment in chronic stroke survivors with a drop foot. DESIGN: Randomized controlled trial. SETTING: All subjects were measured 5 times in the gait laboratory. PARTICIPANTS: Twenty-nine stroke survivors with chronic hemiplegia with drop foot who fulfill the predefined inclusion and exclusion criteria were included in the study. INTERVENTION: The intervention group received an implantable 2-channel peroneal nerve stimulator for correction of their drop foot. The control group continued using their conventional walking device, consisting of an ankle-foot orthosis, orthopedic shoes, or no device. MAIN OUTCOME MEASURES: Walking speed, assessed both by a six-minute walk test (6MWT) and by using a 10-m walkway, was selected as primary outcome measure and activity monitoring data, consisting of percentage time spent on stepping, standing, and sitting/lying were selected as secondary outcome measure. RESULTS: Functional electric stimulation (FES) resulted in a 23% improvement of walking speed measured with the 6MWT, whereas the improvement in the control group was only 3% (P=.010). Comfortable walking speed measured on a 10-m walkway was also significantly improved in favor of FES (P=.038). The percentage time spent on stepping deteriorated with 3% in the intervention and 0.8% in control group, which was not statistically significant between both groups (P=.13). CONCLUSIONS: The present study shows a clinically relevant effect of the implantable 2-channel peroneal nerve stimulator on walking speed in the sample of stroke survivors included in our study.

A preliminary economic evaluation of percutaneous neuromuscular electrical stimulation in the treatment of hemiplegic shoulder pain.

OBJECTIVE: The objective of this study was to compare the cost-effectiveness of various treatment modalities for hemiplegic shoulder pain. DESIGN: A stage II economic evaluation. MAIN OUTCOME MEASURES: Incremental cost effectiveness ratio of P-NMES, compared to slings and anti-inflammatory injections. RESULTS: The incremental cost effectiveness ratio (ICER) of p-NMES, compared to anti-inflammatory injections is 6,061 euro(+/-3,285). The incremental cost of the first quality-adjusted life year after implantation of the P-NMES device compared to anti-inflammatory injections is 33,007 euro (+/-5,434). This decreases to approximately 7,000 euro after 5 years, and to approximately 5,000 euro after 10 survival years. CONCLUSION: In this early evaluation, P-NMES seems to be cost-effective according to known guidelines. Treatment with P-NMES is recommended for patients with chronic HSP.

Comparison of electric stimulation methods for reduction of triceps surae spasticity in spinal cord injury.

OBJECTIVES: To compare the effect of 3 methods of electric stimulation to reduce spasticity of the triceps surae in patients with complete spinal cord injury (SCI) and to investigate the carryover effect. DESIGN: Placebo-controlled study with repeated measurements after the interventions. SETTING: Research department affiliated with a rehabilitation hospital in the Netherlands. PARTICIPANTS: Ten patients with a complete SCI were recruited from the outpatient population of the rehabilitation hospital. All subjects had American Spinal Injury Association grade A impairment scores, except for one, who had grade C. The patients had no voluntary triceps surae contractibility. INTERVENTIONS: Forty-five minutes of cyclic electric stimulation of the agonist, antagonist, or dermatome of the triceps surae or a placebo approach. MAIN OUTCOME MEASURES: Outcome measures were the Modified Ashworth Scale (MAS), clonus score, and the H-reflex and M wave (H/M) ratio. The electromyographic response to a stretch of the soleus over the whole range of motion was also determined. The magnitude and ankle angle at which the electromyographic response started were calculated. RESULTS: Stimulation of the agonist provided a significant reduction in the MAS compared with the placebo approach (P<.001). There was no significant change in the H/M ratio or the electromyographic response amplitude after any of the stimulation methods, whereas stimulation of the antagonist muscle resulted in a significant reduction in the ankle angle at which the electromyographic response started, compared with the placebo approach (P<.037). CONCLUSIONS: Triceps surae stimulation reduces the MAS for that specific muscle, whereas the angle at which the reflex starts changes after antagonist stimulation.

Relation between stimulation characteristics and clinical outcome in studies using electrical stimulation to improve motor control of the upper extremity in stroke.

OBJECTIVE: Electrical stimulation can be applied in a variety of ways to the hemiparetic upper extremity following stroke. The aim of this review is to explore the relationship between characteristics of stimulation and the effect of electrical stimulation on the recovery of upper limb motor control following stroke. METHODS: A systematic literature search was performed to identify clinical trials evaluating the effect of electrical stimulation on motor control. The reported outcomes were examined to identify a possible relationship between the reported effect and the following characteristics: duration of stimulation, method of stimulation, setting of stimulation parameters, target muscles and stage after stroke. RESULTS: Nineteen clinical trials were included, and the results of 22 patient groups were evaluated. A positive effect of electrical stimulation was reported for 13 patient groups. Positive results were more common when electrical stimulation was triggered by voluntary movement rather than when non-triggered electrical stimulation was used. There was no relation between the effect of electrical stimulation and the other characteristics examined. CONCLUSION: Triggered electrical stimulation may be more effective than non-triggered electrical stimulation in facilitating upper extremity motor recovery following stroke. It appears that the specific stimulus parameters may not be crucial in determining the effect of electrical stimulation.

Gait impairments in a group of patients with incomplete spinal cord injury and their relevance regarding therapeutic approaches using functional electrical stimulation.

The purpose of this study is to determine the most important impairments affecting the gait pattern of the incomplete spinal cord injury (SCI) patient and the potential impact of their treatment. The study consists of two parts. Firstly, a survey amongst 16 professionals was done to find out the impact of the impairments in incomplete-SCI patients. Secondly, gait data from 21 individuals were analyzed to determine the most common impairments. Frequently observed and relevant impairments were: inadequate hip extension (occurrence 76%), limited hip flexion (52%), limited knee flexion (71%), excess of plantar flexion (76%), and impaired foot contact (52%). In conclusion, for gait improvement in incomplete spinal cord injured patients not only ankle movements must be treated, which is done frequently, but also hip extension/flexion and knee flexion are important for gait restoration. The impact on the gait and potential solutions of these impairments are discussed.

A multicriteria decision analysis of augmentative treatment of upper limbs in persons with tetraplegia.

This study supported the evaluation by a rehabilitation team of the performance of two treatment options that improve the arm-hand function in subjects with sixth cervical vertebra (C6) level Motor Group 2 tetraplegia. The analytic hierarchy process, a technique for multicriteria decision analysis, was used by a rehabilitation team and potential recipients to quantitatively compare a new technology, Functional Elec trical Stimulation (FES), with conventional surgery. Perform-ance was measured by functional improvement, treatment load, risks, user-friendliness, and social outcomes. Functional improvement after FES was considered better than that after conventional surgery. However, the rehabilitation team's overall rating for conventional surgery was slightly higher than that for FES (57% vs 44%). Compared with the rehabilitation team, potential recipients gave greater weight to burden of treatment and less weight to functional improvement. This study shows that evaluation of new technology must be more comprehensive than the evaluation of functional improvement alone, and that patient preferences may differ from those of the rehabilitation team.

Percutaneous neuromuscular electrical stimulation (P-NMES) for treating shoulder pain in chronic hemiplegia. Effects on shoulder pain and quality of life.

OBJECTIVE: To evaluate the effect of percutaneous neuromuscular electrical stimulation (P-NMES) of the shoulder muscles on shoulder pain intensity and health-related quality of life in chronic hemiplegia. DESIGN: Prospective, open label design. SETTING: The outpatient services of a large teaching rehabilitation hospital in The Netherlands. SUBJECTS: Fifteen stroke survivors with chronic (> six months) hemiplegia and a therapy-resistant painful shoulder with subluxation. All patients suffered from clinically relevant shoulder pain, as assessed by a score of at least 4 out of 10 on a numerical rating scale. Shoulder subluxation was indicated by at least 1/2 fingerbreadth of glenohumeral separation on palpation. INTERVENTION: Six hours of P-NMES per day for a total of six weeks. MAIN OUTCOME MEASURES: Shoulder pain (Brief Pain Inventory), shoulder subluxation (clinical and radiographic), shoulder pain-free external rotation (hand-held goniometer), motor impairment (Fugl-Meyer Motor test) and quality of life (SF-36) were assessed before treatment, after six weeks of intramuscular stimulation, at three months and six months follow-up. RESULTS: A significant reduction in pain was found on the Brief Pain Inventory. Pain reduction was still present at six months follow-up. All domains, in particular bodily pain, of the SF-36 showed improvement in the short term. After six months of follow-up, bodily pain was still strongly and significantly reduced, whereas social functioning and role physical demonstrated a nonsignificant improvement of more than 10% compared with baseline. CONCLUSION: This pilot suggests that P-NMES potentially reduces shoulder pain in chronic hemiplegia. To establish the clinical value of P-NMES in treating hemiplegic shoulder pain a randomized controlled trial is needed.

The orthotic effect of functional electrical stimulation on the improvement of walking in stroke patients with a dropped foot: a systematic review.

OBJECTIVE: Analysis of the available evidence on the improvement of walking in stroke patients with a dropped foot when using peroneus stimulation. METHODS: A systematic review was performed to identify trials that investigated the orthotic effect of functional electrical stimulation (FES) on walking in stroke patients with a dropped foot. Two independent raters scored the methodological quality of the included articles. Walking speed and physiological cost index (PCI) were selected as the primary outcome measures. Studies that measured walking speed were pooled and a pooled difference including confidence interval was calculated. RESULTS: Eight studies were included in the review, of which one was a randomized controlled trial. Methodological score ranged from 8 to 18 out of 19. Six studies measured walking speed. The pooled improvement in walking speed was 0.13 m/s (0.07-0.2) or 38% (22.18-53.8). CONCLUSIONS: The present review suggests a positive orthotic effect of functional electrical stimulation on walking speed.

Pre-assessment to assess the match between cost-effectiveness results and decision makers' information needs: an illustration using two cases in rehabilitation medicine in The Netherlands.

OBJECTIVE: To determine if a pre-assessment can be used to establish whether cost-effectiveness results would meet the actual information needs of Dutch healthcare decision makers. METHODS: Two recent studies in rehabilitation medicine served as study material. Based on Wholey, a limited pre-assessment was performed in which the potential impact of cost-effectiveness analysis (CEA) results on intended users' decision making was assessed. Desk research and semi-structured interviews with several intended users of CEA results were performed. These included general practitioners, representatives of health insurance companies, the Health Care Insurance Board (CvZ), and medical guidelines committees. RESULTS: In day-to-day decision making of the interviewed decision makers, a cost-effectiveness criterion seemed to be of limited importance. Instead, results from clinical effectiveness studies and budget impact studies appeared to be sufficient. CvZ, however, preferred relative cost-effectiveness to be a criterion for inclusion in future reimbursement guidelines. In both cases the limited pre-assessments changed the expectations of the investigators regarding decision-making impact of an economic evaluation. CONCLUSION: This study revealed that the use of CEA results for Dutch micro- and meso-level healthcare decision making is not self-evident. The main purpose of CEA results is to support health policy making and planning at a macroeconomic level. Pre-assessment can be a valuable tool in designing a CEA to support the actual information needs of the decision makers.