A Randomized Controlled Trial on the Effects of Cycling With and Without Electrical Stimulation on Cardiorespiratory and Vascular Health in Children With Spinal Cord Injury

Johnston TE, Smith BT, Mulcahey MJ, Betz RR, Lauer RT. A randomized controlled trial on the effects of cycling with and without electrical stimulation on cardiorespiratory and vascular health in children with spinal cord injury.

Objective

To examine the cardiorespiratory/vascular effects of cycling with and without functional electrical stimulation (FES) in children with spinal cord injury (SCI).

Design

Randomized controlled trial.

Setting

Pediatric referral hospital.

Participants

Children with SCI (N=30), ages 5 to 13 years, with injury levels from C4 to T11, and American Spinal Injury Association grades A, B, or C.

Interventions

Children were randomly assigned to 1 of 3 groups: FES leg cycling exercise, passive leg cycling, or noncycling control group receiving electrical stimulation therapy. After receiving instruction on the use of the equipment, children exercised for 1 hour 3 times per week for 6 months at home with parental supervision.

Main Outcome Measures

Oxygen uptake (V̇o₂) during an incremental arm ergometry test, resting heart rate, forced vital capacity, and a fasting lipid profile.

Results

There were no differences (P>.05) between groups after 6 months of exercise when comparing pre- and postvalues. However, there were differences between groups for some variables when examining percent change. The FES cycling group showed an improvement (P=.035) in V̇o₂ (16.2%±25.0%) as compared with the passive cycling group (–28.7%±29.1%). For lipid levels, the electrical stimulation–only group showed declines (P=.032) in cholesterol levels (–17.1%±8.5%) as compared with the FES cycling group (4.4%±20.4%).

Conclusions

Cycling with FES led to gains in V̇o₂, whereas electrical stimulation alone led to improvements in cholesterol.     

Short Versus Long Course of Antibiotics for Catheter-Associated Urinary Tract Infections in Patients With Spinal Cord Injury: A Randomized Controlled Noninferiority Trial

Objective

To assess the applicability of a short-course regimen of antibiotics for managing catheter-associated urinary tract infection (CA-UTI) in patients with spinal cord injury (SCI).

Design

Randomized, controlled, noninferiority trial.

Setting

Medical center.

Participants

Patients with SCI who had CA-UTI (N=61).

Interventions

Patients were randomized to receive either a 5-day regimen of antibiotics after catheter exchange (experimental group) or a 10-day regimen of antibiotics with catheter retention (control group). Noninferiority was prespecified with a margin of 10%.

Main Outcome Measure

Clinical cure at the end of therapy.

Results

Of the 61 patients enrolled in this study, 6 patients were excluded because of bacteremia or absence of urinary symptoms. All patients (100%) achieved clinical cure at the end of therapy. The rates of microbiologic response were 82.1% in the experimental group and 88.9% in the control group (upper boundary 95% confidence interval (CI) for difference, 26%). The rates of resolution of pyuria were 89.3% in the experimental group and 88.9% in the control group (upper boundary 95% CI for difference, 16%). Patients in the experimental group had higher rates of CA-UTI recurrence than the control group. The rates of new CA-UTI, diarrhea, and Clostridium difficile colitis were similar in the 2 treatment arms.

Conclusions

The primary endpoint of the study was met, indicating that the 5-day regimen with catheter exchange was noninferior to the 10-day regimen with catheter retention on the basis of clinical cure. Criteria for noninferiority on the basis of microbiologic response and resolution of pyuria were not met.     

Expiratory Muscle Training in Spinal Cord Injury: A Randomized Controlled Trial

Roth EJ, Stenson KW, Powley S, Oken J, Primack S, Nussbaum SB, Berkowitz M. Expiratory muscle training in spinal cord injury: a randomized controlled trial.

Objective

To assess the effectiveness of expiratory muscle training on the pulmonary function of spinal cord injured patients.

Design

Randomized controlled trial.

Setting

Acute inpatient rehabilitation hospital.

Participants

Patients (N=29, 22 men and 7 women) with recent traumatic, motor complete, spinal cord injury (SCI) at or above level T1 consecutively admitted to an SCI rehabilitation service. Subjects were randomized to either resistance training (n=16) or sham training (n=13).

Interventions

The subjects completed either sham training or expiratory muscle resistive training with maximal expiratory force using a small handheld device, which is a tube with an aperture at the distal end, for 10 repetitions twice a day 5 days a week for a total of 6 weeks.

Main Outcome Measures

Pulmonary function tests were measured before and after the training program and included forced vital capacity (FVC); forced expiratory volume in 1 second (FEV1); maximum expiratory pressure (MEP), which is often referred to as forced expiratory pressure; maximum inspiratory pressure (MIP), which is often referred to as negative inspiratory force; inspiratory capacity (IC); expiratory reserve volume (ERV); total lung capacity (TLC); functional residual capacity (FRC); and residual volume (RV).

Results

FVC, FEV1, and ERV improved in both groups. Although exit values of MEP were improved in both groups compared with entry values, this increase was statistically significant only in the resistance training group. No significant improvements occurred in IC, TLC, FRC, or RV from entry to exit. MIP improved in both groups, but this increase was statistically significant only in the resistance training group. There was also a significant between-group difference in MEP exit values (98cmH₂O for the resistance training group and 59cmH₂O for the sham training group, t=3.45, P=.002). Multivariate analyses failed to reveal significant effects of treatment for any of the pulmonary function tests.

Conclusions

The resistance training group had significantly greater exit MEP values than the sham training group in univariate analysis only. However, improvements in pulmonary function were noted in both the resistance training and sham training groups. Although multivariate analysis failed to reveal a significant difference between groups, these findings offer some indication that expiratory training may benefit people with SCI.     

Hydrophilic Catheters Versus Noncoated Catheters for Reducing the Incidence of Urinary Tract Infections: A Randomized Controlled Trial

Cardenas DD, Hoffman JM. Hydrophilic catheters versus noncoated catheters for reducing the incidence of urinary tract infections: a randomized controlled trial.

Objective

To test the hypotheses that hydrophilic catheters reduce the incidence of symptomatic urinary tract infections (UTIs) in persons with spinal cord injury on self–intermittent catheterization (IC).

Design

Randomized controlled trial.

Setting

Community.

Participants

Subjects (N=56) on IC with recurrent UTIs and who met eligibility criteria.

Intervention

Use of hydrophilic catheters for IC.

Main Outcome Measure

Symptomatic UTIs treated with antibiotics.

Results

Of the 56 subjects enrolled, 45 completed the study (22 in the treatment group, 23 in the control group). There were no significant differences in demographics, including sex, between the treatment group and the controls except for more tetraplegic subjects in the control group (P<.05). Seventy-one percent of the treatment group and 52% of the control group were men. The total number of symptomatic UTIs treated with antibiotics was significantly smaller in the treatment group than in the control group (P<.05). Seventy percent of the control group had at least 1 antibiotic treatment episode compared with only 50% of those with the hydrophilic catheter (P=.18). There was no significant difference in the incidence of bacteriuria or symptomatic UTIs among the 2 groups. Level of injury and years with injury were unrelated to symptomatic UTIs, but being female increased the risk of UTIs (P<.01).

Conclusions

Although there was no difference in the number of symptomatic UTIs in the 2 groups, hydrophilic catheter usage was associated with reduced numbers of treated UTIs as compared with standard nonhydrophilic catheters in persons with spinal cord injury who used self-IC; however, the study is limited by a small sample size. Women on self-IC were more likely to develop UTIs regardless of the catheter type, suggesting that the benefits of the lubrication may be more important in men.     

Health Care Utilization and Barriers Experienced by Individuals With Spinal Cord Injury

Objectives

To identify from whom individuals with spinal cord injury (SCI) seek health care, the percentage who receive preventative care screenings, and the frequency and types of barriers they encounter when accessing primary and specialty care services; and to examine how sociodemographic factors affect access to care and receipt of preventative screenings.

Design

Cross-sectional, observational study using an Internet-based survey.

Setting

Internet based.

Participants

Adults (N=108) with SCI who use a wheelchair as their primary means of mobility in the community.

Interventions

Not applicable.

Main Outcome Measures

Health care utilization during the past year, barriers encountered when accessing health care facilities, and receipt of routine care and preventative screenings.

Results

All but 1 participant had visited a primary care provider within the past 12 months, and 85% had had ≥1 visit to specialty care providers. Accessibility barriers were encountered during both primary care (91.1%) and specialty care (80.2%) visits; most barriers were clustered in the examination room. The most prevalent barriers were inaccessible examination tables (primary care=76.9%; specialty care=51.4%) and lack of transfer aids (primary care=69.4%; specialty care=60.8%). Most participants had not been weighed during their visit (89%) and had remained seated in their wheelchair during their examinations (85.2%). Over one third of individuals aged ≥50 years had not received a screening colonoscopy, 60% of women aged ≥50 years had not had a mammogram within the past year, 39.58% of women had not received a Papanicolaou smear within the previous 3 years, and only 45.37% of respondents had ever received bone density testing.

Conclusions

Individuals with SCI face remediable obstacles to care and receive fewer preventative care screenings than their nondisabled counterparts. We recommend that clinics conduct Americans with Disabilities Act self-assessments, ensure that their clinical staff are properly trained in assisting individuals with mobility disabilities, and take a proactive approach in discussing preventative care screenings with their patients who have SCI.     

Mirror Therapy Enhances Motor Performance in the Paretic Upper Limb After Stroke: A Pilot Randomized Controlled Trial

Objective

To investigate the effectiveness of mirror therapy (MT) combined with bilateral arm training and graded activities to improve motor performance in the paretic upper limb after stroke.

Design

Randomized, controlled, assessor-blinded study.

Setting

Inpatient stroke rehabilitation center of a tertiary care teaching hospital.

Participants

Patients with first-time ischemic or hemorrhagic stroke (N=20), confined to the territory of the middle cerebral artery, occurring <6 months before the commencement of the study.

Intervention

The MT and control group participants underwent a patient-specific multidisciplinary rehabilitation program including conventional occupational therapy, physical therapy, and speech therapy for 5 d/wk, 6 h/d, over 3 weeks. The participants in the MT group received 1 hour of MT in addition to the conventional stroke rehabilitation.

Main Outcome Measures

The Upper Extremity Fugl-Meyer Assessment for motor recovery, Brunnstrom stages of motor recovery for the arm and hand, Box and Block Test for gross manual hand dexterity, and modified Ashworth scale to assess the spasticity.

Results

After 3 weeks of MT, mean change scores were significantly greater in the MT group than in the control group for the Fugl-Meyer Assessment (P=.008), Brunnstrom stages of motor recovery for the arm (P=.003) and hand (P=.003), and the Box and Block Test (P=.022). No significant difference was found between the groups for modified Ashworth scale (P=.647).

Conclusions

MT when combined with bilateral arm training and graded activities was effective in improving motor performance of the paretic upper limb after stroke compared with conventional therapy without MT.     

Additive Effect of Age on Disability for Individuals With Spinal Cord Injuries

Objective

To examine the additive effect of age on disability for adults with spinal cord injury (SCI).

Design

Prospective cohort study.

Setting

SCI Model Systems.

Participants

Individuals with SCI (median age at injury, 32y; range, 6–88y) with a discharge motor FIM score and at least 1 follow-up motor FIM score who also provided measures of other covariates (N=1660). Of the total sample, 79% were men, 72% were white, 16% had incomplete paraplegia, 33% had complete paraplegia, 30% had incomplete tetraplegia, and 21% had complete tetraplegia.

Interventions

Not applicable.

Main Outcome Measures

The primary study outcome was the motor subscale of the FIM. A mixed-models approach was used to examine the additive effect of age on disability for individuals with SCI.

Results

When controlling for motor FIM at discharge from rehabilitation, level and severity of injury, age at injury, sex, race, and the age × time interaction were not significant (P=.07). Age at the time of SCI was significantly associated with motor FIM (F_1,238=22.49, P<.001). Two sensitivity analyses found significant interactions for both age × time (P=.03, P=.02) and age × time-square (P=.01, P=.006) models. Trajectory of motor FIM scores is moderated slightly by age at the time of injury. The older participants were at the time of injury, the greater the curvature and the more rapid decline were found in later years.

Conclusions

These findings indicate that age moderately influences disability for some individuals with SCI: the older the age at the time of injury, the greater the influence age has on disability. The findings serve as an important empirical foundation for the evaluation and development of interventions designed to augment accelerated aging experienced by individuals with SCI.     

Rehabilitation of the Elbow Extension With Motor Imagery in a Patient With Quadriplegia After Tendon Transfer

Grangeon M, Guillot A, Sancho P-O, Picot M, Revol P, Rode G, Collet C. Rehabilitation of the elbow extension with motor imagery in a patient with quadriplegia after tendon transfer.

Objective

To test the effect of a postsurgical motor imagery program in the rehabilitation of a patient with quadriplegia.

Design

Crossover design with kinematic analysis.

Setting

Rehabilitation Hospital of Lyon. Study approved by the local Human Research Ethics Committee.

Participants

C6-level injured patient (American Spinal Injury Association Impairment Scale grade A) with no voluntary elbow extension (triceps brachialis score 1).

Intervention

The surgical procedure was to transfer the distal insertion of the biceps brachii onto the triceps tendon of both arms. The postsurgical intervention on the left arm included 10 sessions of physical rehabilitation followed by 10 motor imagery sessions of 30 minutes each. The patient underwent 5 sessions a week during 2 consecutive weeks. The motor imagery content included mental representations based on elbow extension involved in goal-directed movements. The rehabilitation period of the right arm was reversed, with motor imagery performed first, followed by physical therapy.

Main Outcome Measures

The kinematics of upper-limb movements was recorded (movement time and variability) before and after each type of rehabilitation period. A long-term retention test was performed 1 month later.

Results

Motor imagery training enhanced motor recovery by reducing hand trajectory variability—that is, improving smoothness. Motor performance then remained stable over 1 month.

Conclusions

Motor imagery improved motor recovery when associated with physical therapy, with motor performance remaining stable over the 1-month period. We concluded that motor imagery should be successfully associated with classic rehabilitation procedure after tendon transfer. Physical sessions may thus be shortened if too stressful or painful.     

Periodic Salbutamol in Facioscapulohumeral Muscular Dystrophy: A Randomized Controlled Trial

Payan CA, Hogrel JY, Hammouda EH, Lacomblez L, Ollivier G, Doppler V, Eymard B, Attarian S, Pouget J, Desnuelle C, Laforêt P. Periodic salbutamol in facioscapulohumeral muscular dystrophy: a randomized controlled trial.

Objective

To evaluate the effects on muscle strength of salbutamol administered for 6 months using a periodic regimen in patients presenting with facioscapulohumeral muscular dystrophy (FSHD).

Design

Placebo-controlled double-blind randomized study.

Setting

Three clinical centers involved in neuromuscular disorders.

Participants

Ambulatory patients (N=112), 56 per group, with genetically confirmed FSHD, age 18 to 60 years.

Interventions

Salbutamol (sustained released formulation) administered orally at a daily dose of 16mg using a periodic dosage regimen (3wks on, 1wk off).

Main Outcome Measures

Muscle strength was assessed with quantitative muscle testing (QMT), manual muscle testing (MMT), and timed motor tests. Patients were evaluated at baseline, and 3 and 6 months later. Plasma drug assays were carried out at each visit.

Results

There was no significant change with periodic use of salbutamol in the total composite QMT z-score, MMT score, or timed motor tests. Salbutamol was well tolerated. Lack of efficacy did not seem to be related to plasma concentrations, which were within the expected range.

Conclusions

Results from this study and previous controlled trials preclude at present the use of salbutamol as routine treatment for FSHD, even if we cannot exclude improvement from anabolic effects with a longer duration of treatment.     

Impact of a Wheelchair Education Protocol Based on Practice Guidelines for Preservation of Upper-Limb Function: A Randomized Trial

Objectives

To determine if strict use of the Paralyzed Veterans of America's Clinical Practice Guidelines for Preservation of Upper Limb Function affects wheelchair setup, selection, propulsion biomechanics, pain, satisfaction with life, and participation of individuals with new spinal cord injuries (SCIs).

Design

Single blinded, randomized controlled trial.

Setting

Model SCI systems rehabilitation facility and community.

Participants

Volunteer sample of manual wheelchair users with new SCIs (N=37).

Intervention

The intervention group was strictly educated on the clinical practice guideline by a physical therapist and an occupational therapist in an inpatient rehabilitation facility. The standard of care group received standard therapy services.

Main Outcome Measures

Comparison of wheelchair setup, selection, propulsion biomechanics, pain, and Satisfaction With Life Scale and Craig Handicap Assessment and Reporting Technique scores at the time of discharge from inpatient rehabilitation and at 6 months and 1 year postdischarge.

Results

Participants in the intervention group pushed on tile with significantly lower push frequency (P=.02) at the discharge visit. On the ramp, the intervention group used a significantly larger push length (P=.03) across all time points. No significant differences were found between groups related to wheelchair setup, selection, pain, satisfaction with life, and participation.

Conclusions

The intervention group showed better skills on key wheelchair propulsion biomechanics variables related to upper-limb health. Use of a structured education program may be an effective method of educating new manual wheelchair users to prevent the development of upper-limb impairments in an inpatient setting. Additional follow-up testing is necessary to determine whether the differences seen in propulsion skills translate into decreased pain and improved quality of life in the long term.     

Comparison of Single Bout Effects of Bicycle Training Versus Locomotor Training on Paired Reflex Depression of the Soleus H-Reflex After Motor Incomplete Spinal Cord Injury

Phadke CP, Flynn SM, Thompson FJ, Behrman AL, Trimble MH, Kukulka CG. Comparison of single bout effects of bicycle training versus locomotor training on paired reflex depression of the soleus H-reflex after motor incomplete spinal cord injury.

Objective

To examine paired reflex depression changes post 20-minute bout each of 2 training environments: stationary bicycle ergometer training (bicycle training) and treadmill with body weight support and manual assistance (locomotor training).

Design

Pretest-posttest repeated-measures.

Setting

Locomotor laboratory.

Participants

Motor incomplete SCI (n=12; mean, 44±16y); noninjured subjects (n=11; mean, 30.8±8.3y).

Intervention

All subjects received each type of training on 2 separate days.

Main Outcome Measure

Paired reflex depression at different interstimulus intervals (10s, 1s, 500ms, 200ms, and 100ms) was measured before and after both types of training.

Results

(1) Depression was significantly less post-SCI compared with noninjured subjects at all interstimulus intervals and (2) post-SCI at 100-millisecond interstimulus interval: reflex depression significantly increased postbicycle training in all SCI subjects and in the chronic and spastic subgroups (P<.05).

Conclusions

Phase-dependent regulation of reflex excitability, essential to normal locomotion, coordinated by pre- and postsynaptic inhibitory processes (convergent action of descending and segmental inputs onto spinal circuits) is impaired post-SCI. Paired reflex depression provides a quantitative assay of inhibitory processes contributing to phase-dependent changes in reflex excitability. Because bicycle training normalized reflex depression, we propose that bicycling may have a potential role in walking rehabilitation, and future studies should examine the long-term effects on subclinical measures of reflex activity and its relationship to functional outcomes.     

The Immediate Effects of Mobilization Technique on Pain and Range of Motion in Patients Presenting With Unilateral Neck Pain: A Randomized Controlled Trial

Kanlayanaphotporn R, Chiradejnant A, Vachalathiti R. The immediate effects of mobilization technique on pain and range of motion in patients presenting with unilateral neck pain: a randomized controlled trial.

Objective

To determine the immediate effects on both pain and active range of motion (ROM) of the unilateral posteroanterior (PA) mobilization technique on the painful side in mechanical neck pain patients presenting with unilateral symptoms.

Design

Triple-blind, randomized controlled trial.

Setting

Outpatient physical therapy, institutional clinic.

Participants

Patients (N=60), 2 physical therapists, and 1 assessor involved in this study.

Interventions

The patients were randomly allocated into either preferred or random mobilization group by using an opaque concealed envelope. The first therapist performed the screening, assessing, prescribing the spinal level(s), and the grade of mobilization. The second therapist performed the mobilization treatment according to their allocated group stated in an envelope. The assessor who was blind to the group allocation conducted the measurements of pain and active cervical ROM.

Main Outcome Measures

Pain intensity, active cervical ROM, and global perceived effect were measured at baseline and 5 minutes posttreatment.

Results

After mobilization, there were no apparent differences in pain and active cervical ROM between groups. However, within-group changes showed significant decreases in neck pain at rest and pain on most painful movement (P<0.001) with a significant increase in active cervical ROM after mobilization on most painful movement (P=0.002).

Conclusions

The results of this study did not provide support for the preference of the unilateral PA mobilization on the painful side to the random mobilization.