Dose-response relationship of locomotor training in patients with spinal cord injury : preliminary results

Background: A large proportion of patients with spinal cord injury (SCI) regain ambulatory function. However, during the first 3 months most patients are unable to walk without support. To enable ambulatory training at such an early stage the body weight is partially relieved and leg movement assisted by two therapists. A more recent approach is the application of robotic-based assistance, which allows for longer training duration. From the science of motor learning and studies including patients with stroke, it is known that training effects depend on the duration of the training. Longer training results in a better walking function. Purpose: The aim of the present study is to evaluate whether prolonged robot-assisted walking training leads to a better walking outcome in patients with incomplete SCI, who are initially unable to walk independently (i.e. B and C according to the International Standards for Neurological Classification of SCI-ISNCSCI), and whether such training is feasible or is associated with undesirable effects. Methods: Patients from three sites with an acute incomplete SCI (within 60 days after injury) were randomized to either standard training (session duration 25 minutes) or intensive training (session duration 50 minutes). After 8 weeks of training walking ability (Walking Index for SCI-WISCI, scale 0-20: 0=not able to walk, 20= able to walk independently), the occurrence of adverse events and the rate of perceived exertion (RPE, scale 1-10: 1=very light, 10= very, very hard), as well as patients’ global impression of change (PGIC, scale 0 -10: 0= much better, 5= no change, 10= much worse) were compared between groups. Results: Seventeen patients with incomplete SCI were randomly assigned either to standard training (ISNCSCI B: n=6; C: n=2) or to intensive training (B: n=3; C: n=6). The average duration of training of the standard group was half the length of the intensive group (24.9±0.6 minutes vs. 48.3±3.2 minutes; p=0.01). Both groups performed an equal number of training sessions within 8 weeks (33.8±6.8 and 34.9±6.0; n.s.). The median WISCI changed from 0 to 4 in the standard group (n.s.) and from 0 to 10.5 (p<0.05) in the intensive group. However, the group difference after training did not reach statistical significance. The median RPE (standard: 6.5, range 1-10 and intensive: 6, range 1-10; n.s.) and the PGIC (standard: 3.5, range 0-5; intensive: 2.5, range 1-4; n.s.) did not differ between the standard and intensive training groups. Conclusions: Longer training using a robotic device is feasible and is not associated with undesirable effects in patients with incomplete SCI. Results show a trend towards a positive dose-response relationship. However, there was a larger proportion of patients with a motor incomplete SCI (i.e. ISNCSCI: C) in the intensive training group. Implications: The duration of a standard training session needs to be re-addressed. Results indicate that more intensive training leads to a better outcome

To Explore the Validity of Change Scores of the Children's Hand-use Experience Questionnaire (CHEQ) in Children with Unilateral Cerebral Palsy

© 2018 The Author(s). Aims: To explore the validity of change scores of the Children's Hand-use Experience Questionnaire (CHEQ). Methods: Analysis of the CHEQ included 44 children (15 girls) between 6–16 years (median 9.0; IQR 8–11) with unilateral cerebral palsy, with baseline and post- (two-week intensive) intervention assessments using the Goal Attainment Scale (GAS) as external anchor for change. Hypotheses on the magnitude of expected change were formulated and correlation coefficients and effect sizes calculated. Receiver operating curve analysis was performed and the area under the curve (AUC) calculated to investigate the ability of CHEQ to discriminate between improvement and non-improvement according to GAS. Results: All hypotheses about the magnitude of change were confirmed supporting longitudinal validity of CHEQ scales to measure change in the perception of bimanual performance. AUCs for the Grasp efficacy and the Time utilization were slightly below, and for the Feeling bothered slightly above the threshold. The latter one accurately discriminating between children that improved and did not improve according to the GAS. Conclusions: Evidence was found that CHEQ scales capture change in bimanual performance but with limited accuracy for two out of three scales. The validity of CHEQ change scores needs to be further explored in a wider population

Study protocol for a multicentre randomized controlled trial on effectiveness of an outpatient multimodal rehabilitation program for adolescents with chronic musculoskeletal pain (2B Active)

BACKGROUND: Chronic musculoskeletal pain (CMP) in adolescents can influence functioning and well-being, and has negative consequences for families and society as well. According to the Fear Avoidance Model, fear of movement and pain catastrophizing can influence the occurrence and maintenance of chronic pain complaints and functional disability. Primary objective is to evaluate the effectiveness of a multimodal rehabilitation program in reducing functional disability for adolescents with CMP compared with care as usual. METHODS/DESIGN: Pragmatic multicentre parallel group randomized controlled trial. Randomization by minimization (ratio 1:1) and treatment allocation will be concealed, computer-generated and performed by an independent organization. After randomization, data collection and researchers remain blinded. Inclusion of 124 adolescents and their parents is intended. This sample size is based on a 25 % difference in group mean on the primary outcome, with α = 5 %, β = 80 % and expected 15 % loss to follow up. Study population are adolescents (12-21 years) with CMP with an indication for outpatient rehabilitation treatment in the Netherlands. The intervention group receives a Multimodal Rehabilitation Program (MRP), a multidisciplinary outpatient individual rehabilitation program. MRP consists of 2 different treatment approaches: A graded exposure module or a combination module of graded exposure and physical training. Selection of a module depends on the needs of the patient. To both modules a parent module is added. The control group receives care as usual, which is the care currently provided in Dutch rehabilitation centres. Treatment duration varies between 7 and 16 weeks, depending on treatment allocation. Self-reported measurements are at baseline, and at 2, 4, 10 and 12 months after start of treatment. Intention to treat analysis for between group differences on all outcome variables will be performed. Primary outcome is functional disability (Functional Disability Inventory). Secondary outcome variables are fear of pain, catastrophizing, perceived harmfulness, pain intensity, depressive symptoms, and quality of life. Total direct and indirect costs and health related quality of life will be measured. Process evaluation focuses on protocol adherence, patient centeredness and treatment expectations. DISCUSSION: A pragmatic approach was chosen, to ensure that results obtained are most applicable to daily practice. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT02181725 (7 February 2014). Funded by Fonds Nuts Ohra, Stichting Vooruit, and Adelante

Effectiveness of automated locomotor training in patients with acute incomplete spinal cord injury: A randomized controlled multicenter trial

<p>Abstract</p> <p>Background</p> <p>A large proportion of patients with spinal cord injury (SCI) regain ambulatory function. However, during the first 3 months most of the patients are not able to walk unsupported. To enable ambulatory training at such an early stage the body weight is partially relieved and the leg movements are assisted by two therapists. A more recent approach is the application of robotic based assistance which allows for longer training duration. From motor learning science and studies including patients with stroke, it is known that training effects depend on the duration of the training. Longer trainings result in a better walking function. The aim of the present study is to evaluate if prolonged robot assisted walking training leads to a better walking outcome in patients with incomplete SCI and whether such training is feasible or has undesirable effects.</p> <p>Methods/Design</p> <p>Patients from multiple sites with a subacute incomplete SCI and who are not able to walk independently will be randomized to either standard training (3-5 sessions per week, session duration maximum 25 minutes) or an intensive training (3-5 sessions per week, session duration minimum 50 minutes). After 8 weeks of training and 4 months later the walking ability, the occurrence of adverse events and the perceived rate of exertion as well as the patients' impression of change will be compared between groups.</p> <p>Trial registration</p> <p>This study is registered at clinicaltrials.gov, identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01147185">NCT01147185</a>.</p

Validation of the Orebro musculoskeletal pain screening questionnaire in patients with chronic neck pain

OBJECTIVES To validate the German version of OMPSQ (OMPSQ-G) for patients with chronic neck pain. RESULTS After translating OMPSQ to German, we assessed the discriminant validity between patients and healthy adults. Convergent validity was assessed using Pearson's correlation coefficients between domains of OMPSQ-G and the German version of neck disability index (NDI-G) and visual analogue scale (VAS) of neck pain intensity. Floor and ceiling effects, internal consistency, test-retest and relative reliability were assessed. Fifty patients with chronic neck pain (mean age, 43.6 years; 34 females) and 24 healthy adults (mean age, 50.4 years; 18 females) participated. Mann-Whitney U tests showed significant differences in OMPSQ scores between both groups at the baseline (z = - 4.6; p < 0.001) and second time point (z = - 4.8; p < 0.001). OMPSQ-G scores highly and moderately correlated with NDI-G (ρ = 0.70) and VAS (ρ = 0.41) scores, respectively. There were no floor or ceiling effects. Cronbach's alpha was 0.94. OMPSQ-G showed high reliability (intraclass correlation 2.1: 0.93; standard error of measurement, 6.9; smallest detectable change, 20 points). The Bland-Altman plot indicated no systematic error. OMPSQ-G showed good validity and reliability in patients with neck pain. Trial registration NCT02540343

Patient's Subjective Impression of Cervical Range of Motion: A Mixed-methods Approach

STUDY DESIGN Mixed-method. OBJECTIVE To evaluate the association between objective and subjective cervical range of motion (ROM) among patients with neck pain, and to assess the awareness of impairments. SUMMARY OF BACKGROUND DATA Cervical ROM is frequently used to evaluate neck pain, but it is also important to know what a patient expects from treatment, because this can profoundly affect treatment outcomes and patient satisfaction. METHODS We used a cervical ROM instrument, the Neck Disability Index (NDI), and a self-administered ROM questionnaire for the neck (S-ROM-Neck). Ten patients took part in semi-structured interviews. Correlations were analyzed using Spearman rank order correlations (rs). Differences between patient and assessor were evaluated by the Mann-Whitney U test. Qualitative data were analyzed by content analysis. RESULTS Thirty participants (mean age 43.80 years; 21 females) were included. The correlation (rs) for the S-ROM-Neck between patient and assessor was 0.679 [95% confidence interval (95% CI) 0.404-0.884; P = 0.000]. The correlation between the NDI and S-ROM-Neck was 0.178 (95% CI -0.233 to -0.533; P = 346) for the assessor and -0.116 (95% CI -0.475 to -0.219, P = 0.541) for the patient (U = 448, z = -0.030, P = 0.976). Qualitative analysis revealed that patients had general restrictions in daily life and with specific movements, but that they adjusted their behavior to avoid impairment. CONCLUSION There was a significant correlation between patient and therapist ratings of cervical spine mobility. Although patients experience restriction while moving and are impaired in specific activities, they adjust their lifestyle to accommodate their limitations. LEVEL OF EVIDENCE 4

Validation of the Orebro musculoskeletal pain screening questionnaire in patients with chronic neck pain

Abstract Objectives To validate the German version of OMPSQ (OMPSQ-G) for patients with chronic neck pain. Results After translating OMPSQ to German, we assessed the discriminant validity between patients and healthy adults. Convergent validity was assessed using Pearson’s correlation coefficients between domains of OMPSQ-G and the German version of neck disability index (NDI-G) and visual analogue scale (VAS) of neck pain intensity. Floor and ceiling effects, internal consistency, test–retest and relative reliability were assessed. Fifty patients with chronic neck pain (mean age, 43.6 years; 34 females) and 24 healthy adults (mean age, 50.4 years; 18 females) participated. Mann–Whitney U tests showed significant differences in OMPSQ scores between both groups at the baseline (z = − 4.6; p < 0.001) and second time point (z = − 4.8; p < 0.001). OMPSQ-G scores highly and moderately correlated with NDI-G (ρ = 0.70) and VAS (ρ = 0.41) scores, respectively. There were no floor or ceiling effects. Cronbach’s alpha was 0.94. OMPSQ-G showed high reliability (intraclass correlation 2.1: 0.93; standard error of measurement, 6.9; smallest detectable change, 20 points). The Bland–Altman plot indicated no systematic error. OMPSQ-G showed good validity and reliability in patients with neck pain. Trial registration NCT0254034

The Dutch version of the self-report Child Activity and Limitations Interview in adolescents with chronic pain

Purpose: To assess the factor structure, related constructs and internal consistency of the Child Activity Limitation Interview 21-Child version for use in Dutch-language countries. Methods: Cross-sectional validation study: After forward and back translation of the Dutch version of the Child Activity Limitation Interview 21-Child adolescents (11–21 years old) with chronic musculoskeletal pain completed an assessment. The assessment contained the Dutch Child Activity Limitation Interview, and questionnaires about demographics, pain intensity, functional disability, anxiety and depression. Internal consistency and construct validity were evaluated through exploratory factor analysis (principal axis factoring with oblique rotation) and hypotheses testing using pain intensity, activity limitations, anx- iety and depression as comparative constructs. Results: Seventy-four adolescents completed the assessment. Exploratory factor analysis resulted in a two- factor structure, explaining 50% of the variance. Internal consistency was good (Cronbach’s a 1⁄4 0.91 total scale, a 1⁄4 0.90 Factor 1, a 1⁄4 0.80 Factor 2). All nine hypotheses were confirmed. Conclusion: The Dutch version can be used to assess pain-related disability in Dutch-speaking adolescents comparable to the study sample. Scores on both subscales provide insight into the severity of the pain- related disability in both daily routine and more physically vigorous activities