Combined arm stretch positioning and neuromuscular electrical stimulation during rehabilitation does not improve range of motion, shoulder pain or function in patients after stroke: a randomised trial.

QUESTION: Does static stretch positioning combined with simultaneous neuromuscular electrical stimulation (NMES) in the subacute phase after stroke have beneficial effects on basic arm body functions and activities? DESIGN: Multicentre randomised trial with concealed allocation, assessor blinding, and intention-to-treat analysis. PARTICIPANTS: Forty-six people in the subacute phase after stroke with severe arm motor deficits (initial Fugl-Meyer Assessment arm score ≤ 18). INTERVENTION: In addition to conventional stroke rehabilitation, participants in the experimental group received arm stretch positioning combined with motor amplitude NMES for two 45-minute sessions a day, five days a week, for eight weeks. Control participants received sham arm positioning (ie, no stretch) and sham NMES (ie, transcutaneous electrical nerve stimulation with no motor effect) to the forearm only, at a similar frequency and duration. OUTCOME MEASURES: The primary outcome measures were passive range of arm motion and the presence of pain in the hemiplegic shoulder. Secondary outcome measures were severity of shoulder pain, restrictions in performance of activities of daily living, hypertonia, spasticity, motor control and shoulder subluxation. Outcomes were assessed at baseline, mid-treatment, at the end of the treatment period (8 weeks) and at follow-up (20 weeks). RESULTS: Multilevel regression analysis showed no significant group effects nor significant time × group interactions on any of the passive range of arm motions. The relative risk of shoulder pain in the experimental group was non-significant at 1.44 (95% CI 0.80 to 2.62). CONCLUSION: In people with poor arm motor control in the subacute phase after stroke, static stretch positioning combined with simultaneous NMES has no statistically significant effects on range of motion, shoulder pain, basic arm function, or activities of daily living. TRIAL REGISTRATION: NTR1748.

Reconsidering evidence-based practice in prosthetic rehabilitation: a shared enterprise.

BACKGROUND: A divide is experienced between producers and users of evidence in prosthetic rehabilitation. OBJECTIVE: To discuss the complexity inherent in establishing evidence-based practice in a prosthetic rehabilitation team illustrated by the case of prosthetic prescription for elderly dysvascular transfemoral amputee patients. STUDY DESIGN: A qualitative research design was used, in which data from multiple sources was triangulated to extract themes for discussion. METHODS: This discussion paper draws on empirical material gathered by individual and focus-group interviews with members of a prosthetic rehabilitation team, information on technological advancements presented on websites of orthopaedic industry, guidelines and literature study. RESULTS: A prosthetic rehabilitation team needs to deal with lack of evidence, contradictory results, various classification systems, diverging interests of different stakeholders and many modifying factors, and all of this in a continuous technological changing environment. Integrating research designs with different strengths but not sharing the same biases may help researchers to deal with the multimorbidity and multifaceted disability of the target group. Articulating clinical knowledge, patients' needs and values in a systematic way provides depth, detail, nuance and context for evidence-based practice issues in prosthetic rehabilitation. CONCLUSIONS: Reconsidering the relationship between evidence, technology and rehabilitation practice is an imperative shared enterprise for clinicians and researchers. Scientific, clinical and patient-related knowledge are seen as important knowledge practices that should inform and strengthen each other. CLINICAL RELEVANCE: This discussion paper puts the academic clinical debate on evidence-based practice in prosthetics and orthotics in another light. By demonstrating the complexities surrounding evidence-based practice, it is argued and illustrated how both researchers and clinicians can contribute to optimal patient care in which evidence, technology and rehabilitation practice are integrated.

Manipulative therapy in addition to usual medical care accelerates recovery of shoulder complaints at higher costs: economic outcomes of a randomized trial.

BACKGROUND: Shoulder complaints are common in primary care and have unfavourable long term prognosis. Our objective was to evaluate the clinical effectiveness of manipulative therapy of the cervicothoracic spine and the adjacent ribs in addition to usual medical care (UMC) by the general practitioner in the treatment of shoulder complaints. METHODS: This economic evaluation was conducted alongside a randomized trial in primary care. Included were 150 patients with shoulder complaints and a dysfunction of the cervicothoracic spine and adjacent ribs. Patients were treated with UMC (NSAID's, corticosteroid injection or referral to physical therapy) and were allocated at random (yes/no) to manipulative therapy (manipulation and mobilization). Patient perceived recovery, severity of main complaint, shoulder pain, disability and general health were outcome measures. Data about direct and indirect costs were collected by means of a cost diary. RESULTS: Manipulative therapy as add-on to UMC accelerated recovery on all outcome measures included. At 26 weeks after randomization, both groups reported similar recovery rates (41% vs. 38%), but the difference between groups in improvement of severity of the main complaint, shoulder pain and disability sustained. Compared to the UMC group the total costs were higher in the manipulative group (€1167 vs. €555). This is explained mainly by the costs of the manipulative therapy itself and the higher costs due sick leave from work. The cost effectiveness ratio showed that additional manipulative treatment is more costly but also more effective than UMC alone. The cost-effectiveness acceptability curve shows that a 50%-probability of recovery with AMT within 6 months after initiation of treatment is achieved at €2876. CONCLUSION: Manipulative therapy in addition to UMC accelerates recovery and is more effective than UMC alone on the long term, but is associated with higher costs. INTERNATIONAL STANDARD RANDOMIZED CONTROLLED TRIAL NUMBER REGISTER: ISRCTN11216.

Manipulative therapy in addition to usual care for patients with shoulder complaints: results of physical examination outcomes in a randomized controlled trial.

OBJECTIVE: The purpose of this study was to examine the effect of manipulative therapy on the shoulder girdle, in addition to usual care provided by the general practitioner, on the outcomes of physical examination tests for the treatment of shoulder complaints. METHODS: This was a randomized controlled trial in a primary care setting in the Netherlands. A total of 150 participants were recruited from December 2000 until December 2002. All patients received usual care by the general practitioner. Usual care included one or more of the following depending on the needs of the patient: information/advice, oral analgesics or nonsteroidal antiinflammatory drugs, corticosteroid injections, exercises, and massage. In addition to usual care, the intervention group received manipulative therapy, up to 6 treatment sessions in a 12-week period. Twenty-four physical examination tests were done at baseline and after 6, 12, and 26 weeks. Factor analysis was done to reduce the number of outcome measures. RESULTS: The factor analysis resulted in 4 factors: "shoulder pain," "neck pain," "shoulder mobility," and "neck mobility." At 6 weeks, no significant differences between groups were found. At 12 weeks, the mean changes of all 4 factors favored the intervention group; the factors "shoulder pain" and "neck pain" reached statistical significance (95% confidence interval [CI], 0.1-2.1). At 26 weeks, differences in the factors "shoulder pain" (95% CI, 0.0-2.6), "shoulder mobility" (95% CI, 0.2-1.7), and "mobility neck" (95% CI, 0.2-1.3) statistically favored the intervention group. CONCLUSION: In this pragmatic study, manipulative therapy, in addition to usual care by the general practitioner, diminished severity of shoulder pain and neck pain and improved shoulder and neck mobility.

Goal setting in Dutch paediatric rehabilitation. Are the needs and principal problems of children with cerebral palsy integrated into their rehabilitation goals?

OBJECTIVE: To evaluate whether the needs and principal problems of children with cerebral palsy (CP) as formulated in their interdisciplinary rehabilitation reports are integrated into the goal descriptions and whether this depends on the nature of the needs and problems. DESIGN: Descriptive multiple-case study. SETTING: Five Dutch paediatric rehabilitation facilities. SUBJECTS: The rehabilitation profiles of 41 children with cerebral palsy aged between 4 and 8 years. METHODS: The raw text data were extracted and organized, after which two raters independently linked the extracted content to the categories of the International Classification of Functioning, Disability and Health for Children and Youth (ICF-CY). Matches between needs, problems and goals were identified by ICF-CY code comparisons. RESULTS: The Cohen's kappas for ICF-CY encoding were all in the range of "fair to good" (0.52-0.78). For five children (12%) no needs had been formulated and the reports of 10 (24%) were excluded from further analyses as they lacked a principal goal. In the 31 reports analysed, 29 (23%) need constructs and 46 (46%) problem constructs were incorporated into the goals. Of the total of 95 goal constructs 49 (52%) were not related to either a need or a problem construct. No clear relationship could be established between the type of needs and problems and their inclusion or exclusion in the principal goals. CONCLUSION: Overall, the integration of the needs and principal problems of children with their rehabilitation goals was not optimal. However, integration was difficult to objectify because needs, problems and goals were poorly documented.

Effects of vibrating insoles on standing balance in diabetic neuropathy.

This study investigated the effects on standing balance of random vibrations applied to the plantar side of the feet by vibrating insoles in subjects with neuropathy and nondisabled subjects. In four different conditions (eyes open or closed and with or without an attention-demanding task [ATD]), subjects with neuropathy secondary to diabetes mellitus (n = 17) and nondisabled subjects (n = 15) stood for 60 s on vibrating insoles placed on a force plate. During each condition, the insoles were turned on for 30 s and off for 30 s (random order). The calculated balance measures were mean velocity of the center of pressure displacements and root-mean-square of the velocity of these displacements in the anteroposterior and mediolateral directions. In subjects with neuropathy, an interaction effect between vibration and an ADT was found for balance. No effects of vibration on balance were found in nondisabled subjects. Vibrating insoles improved standing balance in subjects with neuropathy only when attention was distracted. Improvement of the insoles and their activation is needed to make their implementation in daily living possible and effective.

Development of vibrating insoles.

The objective of this study was to describe the development of vibrating insoles. Insoles, providing a subsensory mechanical noise signal to the plantar side of the feet, may improve balance in healthy young and older people and in patients with stroke or diabetic neuropathy. This study describes the requirements for the tactors, (tactile actuators) insole material and noise generator. A search for the components of vibrating insoles providing mechanical noise to the plantar side of the feet was performed. The mechanical noise signal should be provided by tactors built in an insole or shoe and should obtain an input signal from a noise generator and an amplifier. Possible tactors are electromechanical tactors, a piezo actuator or the VBW32 skin transducer. The Minirator MR1 of NTI, a portable MP3 player or a custom-made noise generator can provide these tactors with input. The tactors can be built in foam, silicone or cork insoles. In conclusion, a C2 electromechanical tactor, a piezo actuator or the VBW32 skin transducer, activated by a custom-made noise generator, built in a cork insole covered with a leather layer seems the ideal solution.

A randomised controlled trial of cardiac rehabilitation after revascularisation.

BACKGROUND: It is unclear if psycho-education on top of physical training is of additional value regarding quality of life in revascularised patients. DESIGN: Prospective randomised study comparing two types of cardiac rehabilitation: exercise based versus a more comprehensive approach including psychological therapy. METHODS: One hundred and thirty-seven male patients who underwent an uncomplicated coronary revascularisation procedure and who were mentally in a good condition, were randomised to one of two types of cardiac rehabilitation: physical training plus information about their disease ('Fit' program) during 6 weeks or comprehensive cardiac rehabilitation which, on top of the Fit-program, included weekly psycho-education sessions and relaxation therapy ('Fit-Plus' program) for 8 weeks. One hundred and four patients were analysed. Quality of life was measured by the 'Leiden Quality of Life questionnaire' and by the RAND-36 (quality of life) questionnaire. RESULTS: Quality of life improved in both treatment groups in the course of time up to 9 months after cardiac rehabilitation and there was no difference between the two types of cardiac rehabilitation. Exercise capacity improved likewise, blood lipid profile was unaffected and energy intake decreased in each treatment group but, again, there were no inter-group differences. CONCLUSION: After an uncomplicated revascularisation procedure, physical training plus information results in a comparable outcome on quality of life when compared to a more comprehensive program including additional psycho-education and relaxation therapy.

Interobserver reliability of neck-mobility measurement by means of the flock-of-birds electromagnetic tracking system.

OBJECTIVE: To establish the interobserver reliability for measuring neck mobility in human subjects by means of an electromagnetic tracking device, the Flock-of-Birds system. METHODS: Two observers independently and in random order assessed the cervical range-of-motion in 30 subjects with a dysfunction in the neck and shoulder region (symptomatic subjects) and 30 subjects without known pathology (asymptomatic subjects). Measurements included rotation in neutral position, in flexed position and in extended position, flexion-extension, and lateral bending (all active and passive). Reliability was analyzed by intraclass correlation coefficient (ICC) and agreement by limits of agreement and percentage of paired observations within 5 degrees, 10 degrees, and 15 degrees. RESULTS: For asymptomatic subjects, the ICC varied from 0.57 to 0.85, and the limits of agreement varied between 14.5 degrees and 27.0 degrees. The percentage of paired observations within 5 degrees, 10 degrees, and 15 degrees ranged from 31% to 57%, 58% to 90%, and 78% to 93%, respectively. For symptomatic subjects, the ICC varied from 0.36 to 0.91, and the limits of agreement varied between 9.6 degrees and 37.8 degrees. The percentage of paired observations within 5 degrees, 10 degrees, and 15 degrees ranged from 17% to 60%, 33% to 93%, and 50% to 97%, respectively. CONCLUSIONS: Despite the use of a standardized protocol and a sophisticated measurement system, the interobserver reliability of neck mobility was variable in quality, with reliability being good in rotation in neutral position, flexion-extension, and lateral bending.

Manipulative therapy in addition to usual medical care for patients with shoulder dysfunction and pain: a randomized, controlled trial.

BACKGROUND: Dysfunction of the cervicothoracic spine and the adjacent ribs (also called the shoulder girdle) is considered to predict occurrence and poor outcome of shoulder symptoms. It can be treated with manipulative therapy, but scientific evidence for the effectiveness of such therapy is lacking. OBJECTIVE: To study the effectiveness of manipulative therapy for the shoulder girdle in addition to usual medical care for relief of shoulder pain and dysfunction. DESIGN: Randomized, controlled trial. SETTING: General practices in Groningen, the Netherlands. PATIENTS: 150 patients with shoulder symptoms and dysfunction of the shoulder girdle. INTERVENTIONS: All patients received usual medical care from their general practitioners. Only the intervention group received additional manipulative therapy, up to 6 treatment sessions in a 12-week period. MEASUREMENTS: Patient-perceived recovery, severity of the main complaint, shoulder pain, shoulder disability, and general health. Data were collected during and at the end of the treatment period (at 6 and 12 weeks) and during the follow-up period (at 26 and 52 weeks). RESULTS: During treatment (6 weeks), no significant differences were found between study groups. After completion of treatment (12 weeks), 43% of the intervention group and 21% of the control group reported full recovery. After 52 weeks, approximately the same difference in recovery rate (17 percentage points) was seen between groups. During the intervention and follow-up periods, a consistent between-group difference in severity of the main complaint, shoulder pain and disability, and general health favored additional manipulative therapy. LIMITATIONS: The sample size was small, and assessment of end points was subjective. CONCLUSION: Manipulative therapy for the shoulder girdle in addition to usual medical care accelerates recovery of shoulder symptoms.

Groningen Manipulation Study. The effect of manipulation of the structures of the shoulder girdle as additional treatment for symptom relief and for prevention of chronicity or recurrence of shoulder symptoms. Design of a randomized controlled trial within a comprehensive prognostic cohort study.

BACKGROUND: We present the design of the Groningen Manipulation Study. This randomized controlled trial is part of the Dutch Shoulder Disability Study, a comprehensive prognostic cohort study on shoulder disorders, with randomized controlled interventions in subcohorts. OBJECTIVE: To evaluate the effectiveness of manipulative treatment of the structures of the shoulder girdle, in addition to standard treatment by the general practitioner for relief of shoulder symptoms and prevention of persistent or recurrent shoulder symptoms. METHODS: A total of 250 patients with shoulder symptoms and a functional limitation of the shoulder girdle will be included from 30 general practices in Groningen, The Netherlands. All participating patients receive standard treatment by the general practitioner and will be randomly allocated to additional manipulative treatment. Evaluation measurements take place 6, 12, 26, and 52 weeks after randomization. CONCLUSION: The short-term primary outcome measure is the proportion of patients with relief of shoulder complaints and the long-term primary outcome is the proportion of patients without persistent or recurrent shoulder symptoms. Dependent and independent variables include a structured medical history, a physical examination of the shoulder and shoulder girdle, and a measure of the mobility of the cervico-thoracic spine with a 6-degree-of-freedom electromagnetic tracking device.