Clinical Rehabilitation

To systematically review randomized controlled trials of botulinum neurotoxin for limb spasticity to determine whether different injection techniques affect spasticity outcomes.

MEDLINE, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials electronic databases were searched for English language human randomized controlled trials from 1990 to 13 May 2016. Studies were assessed in duplicate for data extraction and risk of bias using the Physiotherapy Evidence Database scale and graded according to Sackett’s levels of evidence.

Nine of 347 studies screened met selection criteria. Four categories of botulinum neurotoxin injection techniques were identified: (1) injection localization technique; (2) injection site selection; (3) injectate volume; (4) injection volume and site selection. There is level 1 evidence that: ultrasound, electromyography, and electrostimulation are superior to manual needle placement; endplate injections improve outcomes vs. multisite quadrant injections; motor point injections are equivalent to multisite injections; high volume injections are similar to low volume injections; and high volume injections distant from the endplate are more efficacious than low volumes closer to the endplate.

Level 1 evidence exists for differences in treatment outcomes using specific botulinum neurotoxin injection techniques. Findings are based on single studies that require independent replication and further study.

To compare efficacy of a web-based multimodal training programme, ‘Move it to improve it’ (Mitii^TM), to usual care on gross motor capacity and performance for children with an acquired brain injury.

Randomized waitlist controlled trial.

Home environment.

A total of 60 independently ambulant children (30 in each group), minimum 12 months post-acquired brain injury were recruited and randomly allocated to receive either 20 weeks of Mitii^TM training (30 minutes/day, six days/week, total 60 hours) immediately, or waitlisted (usual care control group) for 20 weeks. A total of 58 children completed baseline assessments (32 males; age 11 years 11 months ± 2 years 6 months; Gross Motor Function Classification System equivalent I = 29, II = 29).

The Mitii^TM program comprised of gross motor, upper limb and visual perception/cognitive activities.

The primary outcome was 30-second, repetition maximum functional strength tests for the lower limb (sit-to-stand, step-ups, half-kneel to stand). Secondary outcomes were the 6-minute walk test, High-level Mobility Assessment Tool, Timed Up and Go Test and habitual physical activity as captured by four-day accelerometry.

Groups were equivalent at baseline on demographic and clinical measures. The Mitii^TM group demonstrated significantly greater improvements on combined score of functional strength tests (mean difference 10.19 repetitions; 95% confidence interval, 3.26–17.11; p = 0.006) compared with the control group. There were no other between-group differences on secondary outcomes.

Although the Mitii^TM programme demonstrated statistically significant improvements in the functional strength tests of the lower limb, results did not exceed the minimum detectable change and cannot be considered clinically relevant for children with an acquired brain injury.

Australian New Zealand Clinical Trials Registration Number, ANZCTR12613000403730.

To investigate the feasibility, safety and efficacy of extended-release methylphenidate in enhancing processing speed, complex attentional functioning and everyday attentional behaviour after traumatic brain injury.

Seven week randomised, placebo-controlled, double-blind, parallel pilot study.

Inpatient and outpatient Acquired Brain Injury Rehabilitation Program.

Eleven individuals with reduced processing speed and/or attention deficits following complicated mild to severe traumatic brain injury.

Participants were allocated using a blocked randomisation schedule to receive daily extended-release methylphenidate (Ritalin^® LA at a dose of 0.6 mg/kg) or placebo (lactose) in identical capsules.

Tests of processing speed and complex attention, and ratings of everyday attentional behaviour were completed at baseline, week 7 (on-drug), week 8 (off-drug) and 9 months follow-up. Vital signs and side effects were monitored from baseline to week 8.

Three percent (n = 11) of individuals screened participated (mean post-traumatic amnesia duration = 63.80 days, SD = 45.15). Results were analysed for six and four individuals on methylphenidate and placebo, respectively. Groups did not differ on attentional test performance or relative/therapist ratings of everyday attentional behaviour. One methylphenidate participant withdrew due to difficulty sleeping. Methylphenidate was associated with trends towards increased blood pressure and reported anxiety.

Methylphenidate was not associated with enhanced processing speed, attentional functioning or everyday attentional behaviour after traumatic brain injury. Alternative treatments for attention deficits after traumatic brain injury should be explored given the limited feasibility of methylphenidate in this population.

To investigate the effects of a Pilates exercise program on disability, pain, lumbar mobility, flexibility and balance in patients with chronic non-specific low back pain.

Randomized controlled trial.

University laboratory.

A total of 54 patients with chronic non-specific low back pain.

Patients were randomly allocated to an experimental group (n=27) included in a Pilates exercise program or to a control group (n=27) receiving information in a form of a leaflet.

Disability (Roland-Morris Disability Questionnaire and Oswestry Disability Index), current, average and pain at it least and at its worst (Visual Analogue Scales), lumbar mobility (modified Shober test), flexibility (finger-to-floor test) and balance (single limb stance test) were measured at baseline and after the intervention.

A between-group analysis showed significant differences in the intervention group compared to the control group for both disability scores, the Rolland-Morris questionnaire (mean change±standard deviation of 5.31±3.37 and 2.40±6.78 respectively and between-groups mean difference of 3.2 ± 4.12, p=0.003) and the Oswestry Disability Index (p<0.001), current pain (p=0.002) and pain at it least (p=0.033), flexibility (0.032) and balance (0.043).

An 8-week Pilates exercise program is effective in improving disability, pain, flexibility and balance in patients with chronic non-specific low back pain.

To evaluate the effectiveness of inspiratory/expiratory muscle training (IEMT) and neuromuscular electrical stimulation (NMES) to improve dysphagia in stroke.

Prospective, single-blind, randomized-controlled trial.

Tertiary public hospital.

Sixty-two patients with dysphagia were randomly assigned to standard swallow therapy (SST) (Group I, controls, n=21), SST+ IEMT (Group II, n=21) or SST+ sham IEMT+ NMES (Group III, n=20).

All patients followed a 3-week standard multidisciplinary rehabilitation program of SST and speech therapy. The SST+IEMT group’s muscle training consisted of 5 sets/10 repetitions, twice-daily, 5 days/week. Group III’s sham IEMT required no effort; NMES consisted of 40-minute sessions, 5 days/week, at 80Hz.

Dysphagia severity, assessed by Penetration-Aspiration Scale, and respiratory muscle strength (maximal inspiratory and expiratory pressures) at the end of intervention and 3-month follow-up.

Maximal respiratory pressures were most improved in Group II: treatment effect was 12.9 (95% confidence interval 4.5-21.2) and 19.3 (95% confidence interval 8.5-30.3) for maximal inspiratory and expiratory pressures, respectively. Swallowing security signs were improved in Groups II and III at the end of intervention. No differences in Penetration-Aspiration Scale or respiratory complications were detected between the 3 groups at 3-month follow-up.

Adding IEMT to SST was an effective, feasible, and safe approach that improved respiratory muscle strength. Both IEMT and NMES were associated with improvement in pharyngeal swallowing security signs at the end of the intervention, but the effect did not persist at 3-month follow-up and no differences in respiratory complications were detected between treatment groups and controls.

To assess, for people with subacute spinal cord injury, if rehabilitation that is reinforced with the addition of a behavioral intervention to promote physical activity leads to a better health, participation and quality of life.

Randomized controlled trial.

Rehabilitation centers.

A total of 39 participants analyzed (45 included), with subacute spinal cord injury in inpatient rehabilitation, dependent on a manual wheelchair (33% tetraplegia, 62% motor complete, 150 ±74 days postinjury).

A behavioral intervention promoting physical activity after discharge, involving 13 individual sessions delivered by a coach trained in motivational interviewing, beginning two months before and ending six months after discharge from inpatient rehabilitation.

Physical capacity as determined during a maximal exercise test, body mass index, blood pressure, fasting lipid profile, and social participation (IMPACT-S) and quality of life (SF-36) were determined using questionnaires. Measurements were performed two months before discharge, at discharge, and six and 12 months after discharge from inpatient rehabilitation. B represents the between-group difference.

Twelve months after discharge, significant intervention effects were found for diastolic blood pressure (B = –11.35 mmHg, 95% CI = –19.98 to −2.71), total cholesterol (B = –0.89 mmol/L, 95% CI = –1.59 to −0.20), low-density lipoprotein cholesterol (B = −0.63 mmol/L, 95% CI = –1.25 to −0.00) and participation (B = 9.91, 95% CI = 3.34 to 16.48).

A behavioral intervention promoting physical activity after discharge from inpatient rehabilitation improves social participation and seems to reduce risk factors for cardiovascular disease in people with subacute spinal cord injury.

To explore the feasibility of conducting a full trial designed to determine the effectiveness of a model of community-based care for people with spinal cord injury in Bangladesh.

A pilot randomised trial.

Community, Bangladesh.

Participants were 30 people with recent spinal cord injury who were wheelchair-dependent and soon to be discharged from hospital.

Participants randomised to the intervention group received a package of care involving regular telephone contact and three home visits over two years. Participants randomised to the control group received usual care consisting of a telephone call and an optional home visit.

Participants were assessed at baseline and two years after randomization. The primary outcome was mortality and secondary outcomes were measures of complications, depression, participation and quality of life.

A total of 24 participants had a complete spinal cord injury and six participants had an incomplete spinal cord injury. Median (interquartile) age and time since injury at baseline were 31 years (24 to 36) and 7 months (4 to 13), respectively. Two participants, one in each group, died. Five participants had pressure ulcers at two years. There were no notable impediments to the conduct of the trial and no significant protocol violations. The phone calls and home visits were delivered according to the protocol 87% and 100% of the time, respectively. Follow-up data were 99% complete.

This pilot trial demonstrates the feasibility of a full clinical trial of 410 participants, which has recently commenced.

University of Sydney, Australia.

To compare the effects of backward walking training and forward walking training on spatiotemporal gait parameters, and gross motor function measures in children with cerebral palsy.

Randomized controlled clinical trial.

Physical therapy clinics.

A total of 30 children with hemiparetic cerebral palsy of both sexes (10 to 14 years of age, classified as I or II by gross motor function classification system) participated in this study. They were randomly assigned into two equal groups.

Both groups received a conventional physical therapy program for 12 successive weeks (three sessions per week). The experimental group additionally received (25 min) backward walking training. The control group additionally received (25 min) forward walking training.

Baseline, posttreatment, and follow-up assessment for spatiotemporal gait parameters and gross motor functions were evaluated by using three dimensional gait analysis system and gross motor function measures.

There was a significant improvement in step length, walking velocity, cadence, stance phase, and swing phase percentage and gross motor function measures (Dimensions D and E) of the experimental group (0.55 ±0.16, 0.53 ±0.19, 121.73 ±2.89, 54.73 ±1.67, 44.40 ±1.40, 90.20 ±6.44, 82.47 ±12.82), respectively, than the control group (0.39 ±0.13, 0.46 ±0.20, 125.80 ±2.96, 50.27 ±1.62, 49.47 ±1.55, 82.47 ±7.05, 80.47 ±12.61), respectively, (p < 0.05). The significant improvement of all measured outcomes of the experimental group was maintained at 1 month follow-up assessment (p < 0.05).

In addition to a conventional physical therapy program, backward walking training is more effective than forward walking training on spatiotemporal gait parameters, and gross motor function measures in children with hemiparetic cerebral palsy.

(1) To study the effects of providing ankle-foot orthoses in subjects with (sub)acute stroke; and (2) to study whether the point in time at which an ankle-foot orthosis is provided post-stroke (early or delayed) influences these effects.

Randomized controlled trial.

Rehabilitation centre.

Unilateral hemiparetic stroke subjects with indication for use of an ankle-foot orthosis and maximal six weeks post-stroke.

Subjects were randomly assigned to: early provision (at inclusion; Week 1) or delayed provision (eight weeks later; Week 9).

10-metre walk test, 6-minute walk test, Timed Up and Go Test, stairs test, Functional Ambulation Categories, Berg Balance Scale, Rivermead Mobility Index and Barthel Index; assessed in Weeks 1, 3, 9 and 11.

A total of 33 subjects were randomized (16 early, 17 delayed). Positive effects of ankle-foot orthoses were found two weeks after provision, both when provided early (significant effects on all outcomes) or delayed (Berg Balance Scale p = 0.011, Functional Ambulation Categories p = 0.008, 6-minute walk test p = 0.005, Timed Up and Go Test p = 0.028). Comparing effects after early and delayed provision showed that early provision resulted in increased levels of improvement on Berg Balance Scale (+5.1 points, p = 0.002), Barthel Index (+1.9 points, p = 0.002) and non-significant improvements on 10-metre walk test (+0.14 m/s, p = 0.093) and Timed Up and Go Test (–5.4 seconds, p = 0.087), compared with delayed provision.

We found positive effects of providing ankle-foot orthoses in (sub)acute stroke subjects that had not used these orthoses before.

The objectives were to provide an estimate of expected enrolment and attrition rates based on published studies of existing self-management interventions for people with multiple sclerosis, and to identify contributing factors and impact on outcomes.

A systematic literature search was conducted using Ovid MEDLINE, PsychINFO, EMBASE, AMED, CINAHL, OT Seeker, PubMed, and the Cochrane Database of Systematic Reviews databases. Controlled trials with or without randomization using either a between-group or within-person design were included if they met specified criteria. A random-effect meta-regression analysis was conducted to estimate the overall enrolment and attrition proportions, effect of person- and study-related factors, and impact on outcomes.

A total of 48 studies, comprising 4446 persons were identified. The estimated enrolment rate was 50.3% (95% confidence interval (CI): 49.6 to 51.1) and the estimated attrition rates in the intervention and control groups were 16.8% (95% CI: 16.2 to 17.3) and 14.4% (95% CI: 13.8 to 14.9), respectively. The main reported reason for refusing to participate was lack of interest (70.6%), while the reported reasons for dropping out were mainly owing to medical issues (26.1%) and disliking the intervention (17.9%). Trial, programme, and patient-related variables were found to influence the enrolment and/or attrition rates. Studies that had a 10% higher attrition rate had an effect size that was larger by 0.19 (95% CI: 0.17 to 0.24).

Greater understanding of the factors associated with enrolment and attrition rates would help in planning and developing a more appealing self-management intervention that patients can easily accept and incorporate into their everyday lives.

To study whether personal factors (self-efficacy and pain acceptance) mediate the relationship between pain and performance of valued life activities in persons with rheumatoid arthritis.

Persons with rheumatoid arthritis for at least four years (n = 737; 73% women) answered a questionnaire measuring self-efficacy, pain acceptance, performance of valued life activities, and self-rated pain. Relationships among these constructs were explored using univariate and multivariate analyses. Structural equation modelling was then used to examine the mediational role of personal factors on the relationship between pain and performance of valued life activities.

A direct negative association between pain and performance of valued life activities was identified (Beta = .34, P < .001). This suggests that people with rheumatoid arthritis who had higher levels of pain has increased difficulties in performing valued life activities. Self-efficacy and activity engagement component of pain acceptance mediated the relationship between pain and performance of valued life activities, however the pain willingness component of pain acceptance did not influence participation in valued life activities.

These findings highlight the importance of considering personal factors, such as pain acceptance and self-efficacy, in facilitating participation in valued life activities.