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1.

Objective

To assess the benefit of isokinetic strengthening of the upper limb (UL) in patients with chronic stroke as compared to passive mobilization.

Design

Randomized blinded assessor controlled trial.

Setting

Physical Medicine and Rehabilitation departments of 2 university hospitals.

Participants

Patients (N=20) with incomplete hemiplegia (16 men; mean age, 64y; median time since stroke, 32mo).

Interventions

A 6-week comprehensive rehabilitation program, 3d/wk, 3 sessions/d. In addition, a 45-minute session per day was performed using an isokinetic dynamometer, with either isokinetic strengthening of elbow and wrist flexors/extensors (isokinetic strengthening group) or passive joint mobilization (control group).

Main Outcome Measures

The primary endpoint was the increase in Upper Limb Fugl-Meyer Assessment (UL-FMA) score at day 45 (t1). Secondary endpoints were increases in UL-FMA scores, Box and Block Test scores, muscle strength, spasticity, and Barthel Index at t1, t2 (3mo), and t3 (6mo).

Results

Recruitment was stopped early because of excessive fatigue in the isokinetic strengthening group. The increase in UL-FMA score at t1 was 3.5±4.4 in the isokinetic strengthening group versus 6.0±4.5 in the control group (P=.2). Gains in distal UL-FMA scores were larger (3.1±2.8) in the control group versus 0.6±2.5 in the isokinetic strengthening group (P=.05). No significant group difference was observed in secondary endpoints. Mixed models confirmed those results. Regarding the whole sample, gains from baseline were significant for the UL-FMA at t1 (+4.8; P<.001), t2, and t3 and for the Box and Block Test at t1 (+3; P=.013) and t2.

Conclusions

In a comprehensive rehabilitation program, isokinetic strengthening did not show superiority to passive mobilization for UL rehabilitation. Findings also suggest a sustained benefit in impairments and function of late UL rehabilitation programs for patients with stroke.  相似文献   

2.

Objective

To determine whether the early trials in chronic medical conditions demonstrate an effect size that is larger than that in subsequent trials.

Methods

We identified randomized controlled trials (RCTs) evaluating a drug or device in patients with chronic medical conditions through meta-analyses (MAs) published between January 1, 2007, and June 23, 2015, in the 10 general medical journals with highest impact factor. We estimated the prevalence of having the largest effect size or heterogeneity in the first 2 published trials. We evaluated the association of the exaggerated early effect with several a priori hypothesized explanatory variables.

Results

We included 70 MAs that had included a total of 930 trials (average of 13 [range, 5-48] RCTs per MA) with average follow-up of 24 (range, 1-168) months. The prevalence of the exaggerated early effect (ie, proportion of MAs with largest effect or heterogeneity in the first 2 trials) was 37%. These early trials had an effect size that was on average 2.67 times larger than the overall pooled effect size (ratio of relative effects, 2.67; 95% CI, 2.12-3.37). The presence of exaggerated effect was not significantly associated with trial size; number of events; length of follow-up; intervention duration; number of study sites; inpatient versus outpatient setting; funding source; stopping a trial early; adequacy of random sequence generation, allocation concealment, or blinding; loss to follow-up or the test for publication bias.

Conclusion

Trials evaluating treatments of chronic medical conditions published early in the chain of evidence commonly demonstrate an exaggerated treatment effect compared with subsequent trials. At the present time, this phenomenon remains unpredictable. Considering the increasing morbidity and mortality of chronic medical conditions, decision makers should act on early evidence with caution.  相似文献   

3.
Chronic musculoskeletal pain is a common health complaint in Norway and constitutes the largest proportion in terms of those who suffer long-term sickness and are in receipt of disability pensions. The aim of this study was to examine the relation between changes in pain and mental health among men and women with chronic musculoskeletal pain after a rehabilitation program. A total of 201 subjects (132 women and 63 men) with chronic pain (>6 months) and without any manifest organic diseases were referred to the 57-week multidisciplinary rehabilitation program. Measurements of pain (visual analog scale) and mental health (Hospital Anxiety and Depression Scale [HADS]), as well as sociodemographic data, were obtained before and after the rehabilitation period. At baseline, men showed higher HADS scores than women. Both women and men reported significant improvements in pain and mental health. The subjects scored higher on HADS both before and after the rehabilitation compared with a population-based study in the region. Older men and men with low education levels showed less improvement in HADS scores. In women, a significant association was found between change in pain and both change in anxiety and change in depression. The results support the hypothesis that there may be a strong association between change in chronic pain and psychologic factors, but there were gender differences.  相似文献   

4.
Chiu H-T, Wang Y-H, Jeng J-S, Chen B-B, Pan S-L. Effect of functional status on survival in patients with stroke: is independent ambulation a key determinant?ObjectiveTo investigate the effect of functional status, measured using the Modified Rankin Scale (MRS), at 3 months after stroke on survival in patients with stroke.DesignCohort study.SettingReferral medical center.ParticipantsPatients with stroke (N=1032).InterventionsNot applicable.Main Outcome MeasureSurvival after stroke.ResultsThe Kaplan-Meier survival curves stratified by the 3-month MRS score showed 2 clear groups of patients with 3-month MRS scores of 0 to 3 (able to walk without assistance) and 4 or 5 (unable to walk without assistance). Accordingly, we grouped the patients into a high function (HF) group (3-month MRS≦3) and a low function (LF) group (3-month MRS≧4). Multiple Cox regression analysis showed that the LF group had significantly poorer survival (adjusted hazard ratio=4.69; 95% confidence interval [CI], 2.89–7.60; P<.001) than the HF group. Other significant risk factors of higher mortality were older age, history of diabetes mellitus, and heart disease.ConclusionsThis study showed a significant influence of the 3-month MRS score on stroke survival. Moreover, independent ambulation may be a major determinant of a favorable survival prognosis. This finding suggests a potential role of rehabilitation in promoting stroke survival by maximizing ambulation function.  相似文献   

5.
[Purpose] This study examined the effects of an ankle-foot orthosis worn during balance training on lower limb muscle activity and static balance of chronic stroke patients. [Subjects] The subjects were twenty-five inpatients receiving physical therapy for chronic stroke. [Methods] The chronic stroke patients were divided into two groups: thirteen patients were assigned to the ankle-foot orthosis group, while the remaining twelve patients wore only their shoes. Each group performed balance training for 20 minutes, twice per day, 5 days per week, for 6 weeks. The lower limb muscle activities of the paralyzed side tibialis anterior, medial gastrocnemius, and the stability index were measured before and after the 6-week intervention. [Results] Comparison of the groups indicated a significant difference in the muscle activity of the paralyzed side tibialis anterior and the stability index of the eyes-open standing position. After the intervention, the ankle-foot orthosis group evidenced a significant difference in the muscle activities of the paralyzed side tibialis anterior and paralyzed side medial gastrocnemius as well as the stability index of the eyes-open standing position, eyes-closed standing position, eyes-open standing position on a sponge, and eyes-closed standing position on a sponge. The group that only wore their shoes showed significant differences in the stability indexes of eyes-open standing and eyes-open standing on a sponge. [Conclusion] Using the ankle-foot orthosis was effective during the initial training of lower limb muscle activities and the static balance training of chronic stroke patients. However, it was not effective for a variety of dynamic situations.Key words: Ankle-foot orthosis, Lower limb muscle activity, Static balance  相似文献   

6.

Background

Functional electrical stimulation (FES) for patients with stroke and foot drop is an alternative to ankle foot orthoses. Characteristics of FES responders and nonresponders have not been clarified.

Objectives

(1) To investigate the effects of treatment with FES on patients with stroke and foot drop and (2) to determine which factors may relate to responders and nonresponders.

Design

Multicenter, nonrandomized, prospective study.

Setting

Multicenter clinical trial.

Participants

Participants included those who experienced foot drop resulting from stroke, were older than 20 years, and could provide consent to participate; they were enrolled from hospitals between January 2013 and September 2015 and performed rehabilitation with FES.

Methods

Stroke Impairment Assessment Set Foot-Pat Test (SIAS-FP), Fugl-Meyer Assessment for Lower Extremity (FMA-LE), Modified Ashworth scale (MAS) for ankle joint dorsiflexion and plantar flexion muscles, range of motion (ROM) for ankle joint, 10-m walking test (10mWT), Timed Up & Go test (TUG), and 6-minute walking test (6MWT) were evaluated pre- and postintervention. Age, gender, type of stroke, onset times of stroke, paretic side, Brunnstrom stage of the lower extremity (Br. stage-LE), Functional Independence Measure (FIM), Functional Ambulation Category (FAC), poststroke months, number of interventions, total hours of interventions, and whether a brace was used were extracted from patients’ medical records and collected on the physiological examination day.

Main Outcome Measurements

The authors examined 10mWT and age, gender, type of stroke, onset times of stroke, paretic side, Br. stage-LE, FIM, FAC, poststroke months, number of interventions, total hours of interventions, whether a brace was used, SIAS-FP, FMA-LE, MAS, ROM, TUG, and 6MWT before intervention. Participants were divided into nonresponders and responders with a change in 10mWT of <0.1 and ≥0.1 m/s, respectively. Single and multiple regression analyses were used for data analysis. Additionally, the changes between groups were compared.

Results

Fifty-eight responders and 43 nonresponders were enrolled. The between-group differences, compared for changes between pre- and postintervention, were significant in terms of changes in SIAS-FP (P = .02), 10mWT (P < .001), 10-m gait steps (P < .001), TUG (P = .04), and 6MWT (P = .006). In the adjusted regression model, gender (odds ratio [OR], 3.92; 95% confidence interval [CI], 1.426-12.25; P = .007), number of interventions (OR, 1.028; 95% CI, 1.003-1.070; P = .03), and active ankle joint dorsiflexion ROM (OR, 1.047; 95% CI, 1.014-1.088; P = .005) remained significant.

Conclusion

The factors related to 10mWT showing changes beyond the minimal clinically important difference were found to be patient gender, number of interventions, and active ankle joint dorsiflexion ROM before intervention. When patients with stroke who have greater active ankle joint ROM, and are female, use FES positively, they may benefit more from using FES.

Level of Evidence

II  相似文献   

7.
[Purpose] This study was conducted to examine the effects of exercises applied with PNF techniques performed for 30 minutes per session, three times per week, after receipt of radiation therapy following mastectomy on depression and anxiety in patients diagnosed with lymphedema and to prepare basic data for creation of self-directed exercise programs for lymphedema patients that will enable them to perform exercises within the range of no pain. [Methods] The subjects of this study were 45 patients selected from among those diagnosed with breast cancer who showed lymphedema after anti-cancer therapy following mastectomy. [Results] The Beck depression score changed significantly during the five assessment periods however, there was no significant difference between the treatment groups. Post hoc analyses revealed that there was significant improvement in the Beck depression score from 4 weeks in all three groups. The interaction between group and time was also statistically significant. [Conclusion] In conclusion, PNF techniques helped to improve the depression and anxiety rates. Four weeks after the start of therapy, PNF techniques Depression and anxiety to create a greater degree of decline was on display.Key words: Lymphedema, Depression, Anxiety  相似文献   

8.
ObjectivesThe purpose of this study was to provide an updated systematic review and meta-analysis regarding the effectiveness of mobilization with movement (MWM) techniques on range of motion (ROM).MethodsAn electronic search strategy of the Physiotherapy Evidence Database, PubMed, Cochrane Library, Embase, Google Scholar, and CINAHL was performed between August 2008 and January 2018. Two independent reviewers selected the studies. Only randomized controlled trials were included. The methodology was independently assessed by 2 reviewers using the Physiotherapy Evidence Database scale. The Z indicator was considered for the assessment of statistical significance of ROM change, whereas for each meta-analysis referring to a specific joint pathology, the total mean difference (95% confidence interval) was compared against minimum detectable change values from relevant studies conducted in similar populations to assess clinical significance.ResultsIncluded were 18 studies with 753 participants in 10 separate meta-analyses for ROM. All studies were classified as high quality or medium quality. Peripheral joint MWM seems to produce better therapeutic results in comparison to sham, passive, other active, or no therapeutic approach, regarding improvement of joint ROM in specific peripheral joint pathologies, consistently in all movement directions for shoulder adhesive capsulitis (mean improvement 12.30o-26.09o, P < .02) and hip pain (mean improvement 4.50o-14.80o, P < .0001).ConclusionMobilization with movement produced a statistically and clinically significant ROM increase consistently in all movement directions for shoulder adhesive capsulitis and hip pain. However, for shoulder impingement, shoulder pain/dysfunction, hamstring tightness, knee osteoarthritis, and chronic ankle instability pathologies, a therapeutic benefit regarding ROM could not be clearly established. Owing to the small number of individual studies included within the separate groups of pathologies examined in our systematic review, methodologically rigorous studies with longer follow-up periods are warranted to better inform the evidence base on the effects of MWM on ROM.  相似文献   

9.
10.

Objective

To identify key predictors and survival outcomes of new-onset diabetes after transplant (NODAT) in liver transplant (LT) recipients by using the Scientific Registry of Transplant Recipients.

Patients and Methods

Data of all adult LT recipients between October 1, 1987, and March 31, 2016, were analyzed using various machine learning methods. These data were divided into training (70%) and validation (30%) data sets to robustly determine predictors of NODAT. The long-term survival of patients with NODAT relative to transplant recipients with preexisting diabetes and those without diabetes was assessed.

Results

Increasing age (odds ratio [OR], 1.01; 95% CI, 1.00-1.02; P≤.001), male sex (OR, 1.09; 95% CI, 1.05-1.13; P=.03), and obesity (OR, 1.13; 95% CI, 1.08-1.18; P<.001) were significantly associated with NODAT. Sirolimus as a primary immunosuppressant carried a 33% higher risk of NODAT than did tacrolimus (OR, 1.33; 95% CI, 1.22-1.45; P<.001) at 1 year after LT. Patients with NODAT had significantly decreased 10-year survival than did those without diabetes (63.0% vs 74.9%; P<.001), similar to survival in patients with diabetes before LT (58.9%).

Conclusion

Using a machine learning approach, we found that older, male, and obese recipients are at especially higher risk of NODAT. Donor features do not affect risk. In addition, sirolimus-based immunosuppression is associated with a significantly higher risk of NODAT than other immunosuppressants. Most importantly, NODAT adversely affects long-term survival after LT in a manner similar to preexisting diabetes, indicating the need for more aggressive care and closer follow-up.  相似文献   

11.
12.
《Clinical therapeutics》2020,42(9):1750-1761.e7
PurposeAlthough the launch delay of new drugs in China has been a deep concern during the past few years, research on this topic is scarce. The effect of recent regulatory efforts, such as initiating fast review channels to improve access to medical innovations, remains unclear. In this work, we measure the launch delay in China and study whether the fast channels contribute to shorter delays. We also offer an examination of the effect of launch delay on patients’ health.MethodsWe examined the launch delays of 40 new drugs engaged in the 3 national price negotiations in China. Launch delay was defined as the differences between the approval dates of the United States or the European Union and that of China and was measured according to approved indications of every specific drug. Thirty-four health impact models comparing the new drugs and their corresponding comparator therapies were populated with open data from published studies to assess the loss of health attributable to launch delay. The time horizon for each model was the specified delay time.FindingsA total of 40 new drugs with 54 approvals were studied. The median delay was 44.40 months (range, 7.30–196.24 months). For the 20 approvals granted with the fast channels, the median delay was 38.14 months, which was shorter than the 68.25 months of those 34 approvals on the track of standard procedure (P = 0.0276). Moreover, among the 34 health models for 27 new drugs, the largest loss of health was 5.76 life-years and 4.14 quality-adjusted life-years per potential patient, whereas the least loss was 0.006 life-years per head and 0.0035 quality-adjusted life-years per head, respectively.ImplicationsAccess to new drugs is delayed significantly in China, which may undermine patient benefit by causing loss of life-years and quality of life. The fast review procedures in China have appeared to mitigate the launch delay.  相似文献   

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15.
16.

Background

Lumbar stabilization exercise programs (LSEP) produce positive effects on clinical outcomes, but the underlying mechanisms remain relatively unexplored. Psychological and neuromuscular mechanisms can be involved, such as a better activation of the lumbar multifidus, which represents one possibility.

Objectives

To determine the following: (1) the effect of an LSEP on lumbar multifidus muscle thickness and activation, as measured with rehabilitative ultrasound imaging (RUSI), in patients with low back pain (LBP); (2) the correlation between RUSI measures and any change in clinical outcomes following the LSEP; and (3) the reliability of RUSI measures in control subjects over 8 weeks.

Design

One-arm clinical trial with healthy subjects as a control group; reliability study.

Setting

LSEP delivered in a clinical setting; outcomes measured in a laboratory setting.

Participants

A total of 34 patients with nonacute LBP and 28 healthy control subjects.

Methods

Outcomes were measured before and after an 8-week LSEP in patients with LBP, and at the same time interval (without treatment, to assess reliability) in control subjects.

Main Outcome Measurements

Pain numeric rating scale, Oswestry Disability Index (function), as well as RUSI measures for the lumbar multifidus (LM) muscles at 3 vertebral levels (L5-S1, L4-5, and L3-4) during rest (static) and dynamic contractions (percent thickness change).

Results

Patients did not show systematic changes in RUSI measures relative to controls, even though RUSI impairments were observed at baseline (dynamic measure at L5-S1) and even though patients had significant improvements in pain and disability. Correlational analyses with these clinical outcomes suggested that patients had reduced muscle thickness at baseline that was associated with a greater reduction in disability following LSEP; however, LM activation measured at baseline showed the opposite. Static RUSI measures showed excellent reliability at the L4-5 and L3-4 levels, whereas dynamic measures were not reliable.

Conclusions

Patients showed less muscle activation than controls at baseline (L5-S1 level), but the LSEP did not normalize this impairment. The links between RUSI measures and the change in clinical outcomes during LSEP should be further explored.This clinical trial has been recorded in the International Standard Registered Clinical/soCial sTudy Number (ISRCTN) registry (ID: ISRCTN94152969).

Level of Evidence

II  相似文献   

17.
18.
19.

Purpose

The present study was to examine the effect of a meditation-based exercise program on the motor and non-motor symptoms of Parkinson’s disease (PD).

Methods

Sixty three PD patients who were recruited from a university hospital were randomly assigned to the experimental group (n = 33) and to the control group (n = 30). Participants completed an 8-week Mindfulness Meditation-based Complex Exercise Program (MMBCEP) that included 6 sessions. Before and after the intervention, the Six-Minute Walk Test (6MWT), elastic band pull, chair stand test, and 2.45-meter walk test were administered for the motor symptoms and the Korean Version of Geriatric Depression Scale, The State-Trait Anxiety Inventory (STAI), the Korean-Montreal Cognitive Assessment, Parkinson’s Disease Sleep Scale (PDSS), Activities of Daily Living (ADL), and the Quality of Life of Patients with Parkinson's Disease (PDQL) were administered for non-motor symptoms.

Results

Significant improvements in the motor symptoms (i.e., muscle strength (lower and upper extremity), balance, and muscle endurance) and in the non-motor symptoms (i.e., anxiety, depression, cognitive functions, sleep disturbance, quality of life, and activities of daily living) were observed.

Conclusions

MMBCEP, a complex exercise program-based on mindfulness meditation, is associated with increased motor symptoms, decreased emotional disturbances (anxiety and depression) and sleep disturbance, and improved cognitive functions, quality of life, and activities of daily living. Future research should test the effects of MMBCEP with more representative PD patients.  相似文献   

20.
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