Andrea L. Behrman

Weight-supported treadmill vs over-ground training for walking after acute incomplete SCI

Objective: To compare the efficacy of step training with body weight support on a treadmill (BWSTT) with over-ground practice to the efficacy of a defined over-ground mobility therapy (CONT) in patients with incomplete spinal cord injury (SCI) admitted for inpatient rehabilitation. Methods: A total of 146 subjects from six regional centers within 8 weeks of SCI were entered in a single-blinded, multicenter, randomized clinical trial (MRCT). Subjects were graded on the American Spinal Injury Association Impairment Scale (ASIA) as B, C, or D with levels from C5 to L3 and had a Functional Independence Measure for locomotion (FIM-L) score <4. They received 12 weeks of equal time of BWSTT or CONT. Primary outcomes were FIM-L for ASIA B and C subjects and walking speed for ASIA C and D subjects 6 months after SCI. Results: No significant differences were found at entry between treatment groups or at 6 months for FIM-L (n = 108) or walking speed and distance (n = 72). In the upper motor neuron (UMN) subjects, 35% of ASIA B, 92% of ASIA C, and all ASIA D subjects walked independently. Velocities for UMN ASIA C and D subjects were not significantly different for BWSTT (1.1 ± 0.6 m/s, n = 30) and CONT (1.1 ± 0.7, n = 25) groups. Conclusions: The physical therapy strategies of body weight support on a treadmill and defined overground mobility therapy did not produce different outcomes. This finding was partly due to the unexpectedly high percentage of American Spinal Injury Association C subjects who achieved functional walking speeds, irrespective of treatment. The results provide new insight into disability after incomplete spinal cord injury and affirm the importance of the multicenter, randomized clinical trial to test rehabilitation strategies.

Body-weight-supported treadmill rehabilitation after stroke.

BACKGROUND Locomotor training, including the use of body-weight support in treadmill stepping, is a physical therapy intervention used to improve recovery of the ability to walk after stroke. The effectiveness and appropriate timing of this intervention have not been established. METHODS We stratified 408 participants who had had a stroke 2 months earlier according to the extent of walking impairment--moderate (able to walk 0.4 to <0.8 m per second) or severe (able to walk <0.4 m per second)--and randomly assigned them to one of three training groups. One group received training on a treadmill with the use of body-weight support 2 months after the stroke had occurred (early locomotor training), the second group received this training 6 months after the stroke had occurred (late locomotor training), and the third group participated in an exercise program at home managed by a physical therapist 2 months after the stroke (home-exercise program). Each intervention included 36 sessions of 90 minutes each for 12 to 16 weeks. The primary outcome was the proportion of participants in each group who had an improvement in functional walking ability 1 year after the stroke. RESULTS At 1 year, 52.0% of all participants had increased functional walking ability. No significant differences in improvement were found between early locomotor training and home exercise (adjusted odds ratio for the primary outcome, 0.83; 95% confidence interval [CI], 0.50 to 1.39) or between late locomotor training and home exercise (adjusted odds ratio, 1.19; 95% CI, 0.72 to 1.99). All groups had similar improvements in walking speed, motor recovery, balance, functional status, and quality of life. Neither the delay in initiating the late locomotor training nor the severity of the initial impairment affected the outcome at 1 year. Ten related serious adverse events were reported (occurring in 2.2% of participants undergoing early locomotor training, 3.5% of those undergoing late locomotor training, and 1.6% of those engaging in home exercise). As compared with the home-exercise group, each of the groups receiving locomotor training had a higher frequency of dizziness or faintness during treatment (P=0.008). Among patients with severe walking impairment, multiple falls were more common in the group receiving early locomotor training than in the other two groups (P=0.02). CONCLUSIONS Locomotor training, including the use of body-weight support in stepping on a treadmill, was not shown to be superior to progressive exercise at home managed by a physical therapist. (Funded by the National Institute of Neurological Disorders and Stroke and the National Center for Medical Rehabilitation Research; LEAPS ClinicalTrials.gov number, NCT00243919.).

Chronic Motor Dysfunction After Stroke Recovering Wrist and Finger Extension by Electromyography-Triggered Neuromuscular Stimulation

BACKGROUND AND PURPOSE After stroke, many individuals have chronic unilateral motor dysfunction in the upper extremity that severely limits their functional movement control. The purpose of this study was to determine the effect of electromyography-triggered neuromuscular electrical stimulation on the wrist and finger extension muscles in individuals who had a stroke > or = 1 year earlier. METHODS Eleven individuals volunteered to participate and were randomly assigned to either the electromyography-triggered neuromuscular stimulation experimental group (7 subjects) or the control group (4 subjects). After completing a pretest involving 5 motor capability tests, the poststroke subjects completed 12 treatment sessions (30 minutes each) according to group assignments. Once the control subjects completed 12 sessions attempting wrist and finger extension without any external assistance and were posttested, they were then given 12 sessions of the rehabilitation treatment. RESULTS The Box and Block test and the force-generation task (sustained muscular contraction) revealed significant findings (P<0. 05). The experimental group moved significantly more blocks and displayed a higher isometric force impulse after the rehabilitation treatment. CONCLUSIONS Two lines of evidence clearly support the use of the electromyography-triggered neuromuscular electrical stimulation treatment to rehabilitate wrist and finger extension movements of hemiparetic individuals > or =1 year after stroke. The treatment program decreased motor dysfunction and improved the motor capabilities in this group of poststroke individuals.

The evolution of walking-related outcomes over the first 12 weeks of rehabilitation for incomplete traumatic spinal cord injury: the multicenter randomized Spinal Cord Injury Locomotor Trial.

Background. The Spinal Cord Injury Locomotor Trial (SCILT) compared 12 weeks of step training with body weight support on a treadmill (BWSTT) that included overground practice to a defined but more conventional overground mobility intervention (CONT) in patients with incomplete traumatic SCI within 8 weeks of onset. No previous studies have reported walking-related outcomes during rehabilitation. Methods. This single-blinded, randomized trial entered 107 American Spinal Injury Association (ASIA) C and D patients and 38 ASIA B patients with lesions between C5 and L3 who were unable to walk on admission for rehabilitation. The Functional Independence Measure (FIM-L) for walking, 15-m walking speed, and lower extremity motor score (LEMS) were collected every 2 weeks. Results. No significant differences were found at entry and during the treatment phase (12-week mean FIM-L = 5, velocity = 0.8 m/s, LEMS = 35, distance walked in 6 min = 250 m). Combining the 2 arms, a FIM-L ≥ 4 was achieved in < 10% of ASIA B patients, 92% of ASIA C patients, and all of ASIA D patients. Walking speed of ≥ 0.6 m/s correlated with a LEMS near 40 or higher. Conclusions. Few ASIA B and most ASIA C and D patients achieved functional walking ability by the end of 12 weeks of BWSTT and CONT, consistent with the primary outcome data at 6 months. Walking-related measures assessed at 2-week intervals reveal that time after SCI is an important variable for entering patients into a trial with mobility outcomes. By about 6 weeks after entry, most patients who will recover have improved their FIM-L to >3 and are improving in walking speed. Future trials may reduce the number needed to treat by entering patients with FIM-L < 4 at > 8 weeks after onset if still graded ASIA B and at > 12 weeks if still ASIA C.

Methods for a Randomized Trial of Weight-Supported Treadmill Training Versus Conventional Training for Walking During Inpatient Rehabilitation after Incomplete Traumatic Spinal Cord Injury

The authors describe the rationale and methodology for the first prospective, multicenter, randomized clinical trial (RCT) of a task-oriented walking intervention for subjects during early rehabilitation for an acute traumatic spinal cord injury (SCI). The experimental strategy, body weight-supported treadmill training (BWSTT), allows physical therapists to systematically train patients to walk on a treadmill at increasing speeds typical of community ambulation with increasing weight bearing. The therapists provide verbal and tactile cues to facilitate the kinematic, kinetic, and temporal features of walking. Subjects were randomly assigned to a conventional therapy program for mobility versus the same intensity and duration of a combination of BWSTT and over-ground locomotor retraining. Subjects had an incomplete SCI (American Spinal Injury Association grades B, C, and D) from C-4 to T-10 (upper motoneuron group) or from T-11 to L-3 (lower motoneuron group). Within 8 weeks of a SCI, 146 subjects were entered for 12 weeks of intervention. The 2 single-blinded primary outcome measures are the level of independence for ambulation and, for those who are able to walk, the maximal speed for walking 50 feet, tested 6 and 12 months after randomization. The trials methodology offers a model for the feasibility of translating neuroscientific experiments into a RCT to develop evidence-based rehabilitation practices.

Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial

BackgroundLocomotor training using body weight support and a treadmill as a therapeutic modality for rehabilitation of walking post-stroke is being rapidly adopted into clinical practice. There is an urgent need for a well-designed trial to determine the effectiveness of this intervention.The objective of the Locomotor Experience Applied Post-Stroke (LEAPS) trial is to determine if there is a difference in the proportion of participants who recover walking ability at one year post-stroke when randomized to a specialized locomotor training program (LTP), conducted at 2- or 6-months post-stroke, or those randomized to a home based non-specific, low intensity exercise intervention (HEP) provided 2 months post-stroke. We will determine if the timing of LTP delivery affects gait speed at 1 year and whether initial impairment severity interacts with the timing of LTP. The effect of number of treatment sessions will be determined by changes in gait speed taken pre-treatment and post-12, -24, and -36 sessions.Methods/DesignWe will recruit 400 adults with moderate or severe walking limitations within 30 days of stroke onset. At two months post stroke, participants are stratified by locomotor impairment severity as determined by overground walking speed and randomly assigned to one of three groups: (a) LTP-Early; (b) LTP-Late or (c) Home Exercise Program -Early. The LTP program includes body weight support on a treadmill and overground training. The LTP and HEP interventions are delivered for 36 sessions over 12 weeks.Primary outcome measure include successful walking recovery defined as the achievement of a 0.4 m/s gait speed or greater by persons with initial severe gait impairment or the achievement of a 0.8 m/s gait speed or greater by persons with initial moderate gait impairment.LEAPS is powered to detect a 20% difference in the proportion of participants achieving successful locomotor recovery between the LTP groups and the HEP group, and a 0.1 m/s mean difference in gait speed change between the two LTP groups.DiscussionThe goal of this single-blinded, phase III randomized clinical trial is to provide evidence to guide post-stroke walking recovery programs.Trial registrationNCT00243919.

Validation of a speed-based classification system using quantitative measures of walking performance poststroke.

Background. For clinical trials in stroke rehabilitation, self-selected walking speed has been used to stratify persons to predict functional walking status and to define clinical meaningfulness of changes. However, this stratification was validated primarily using self-report questionnaires. Objective. This study aims to validate the speed-based classification system with quantitative measures of walking performance. Methods. A total of 59 individuals who had hemiparesis for more than 6 months after stroke participated in this study. Spatiotemporal and kinetic measures included the percentage of total propulsion generated by the paretic leg (Pp), the percentage of the stride length accounted for by the paretic leg step length (PSR), and the percentage of the gait cycle spent in paretic preswing (PPS). Additional measures included the synergy portion of the Fugl-Meyer Assessment and the average number of steps/day in the home and community measured with a step activity monitor. Participants were stratified by self-selected gait speed into 3 groups: household (<0.4 m/s), limited community (0.4-0.8 m/s), and community (>0.8 m/s) ambulators. Group differences were analyzed using a Kruskal—Wallis H test with rank sums test post hoc analyses. Results. Analyses demonstrated a main effect in all measures, but only steps/day and PPS demonstrated a significant difference between all 3 groups. Conclusions. Classifying individuals poststroke by self-selected walking speed is associated with home and community-based walking behavior as quantified by daily step counts. In addition, PPS distinguishes all 3 groups. Pp differentiates the moderate from the fast groups and may represent a contribution to mechanisms of increasing walking speed. Speed classification presents a useful yet simple mechanism to stratify subjects poststroke and may be mechanically linked to changes in PPS.

Active Finger Extension Predicts Outcomes After Constraint-Induced Movement Therapy for Individuals With Hemiparesis After Stroke

Background and Purpose— Constraint-induced movement therapy (CIMT) is a rehabilitative strategy used primarily with the post-stroke population to increase the functional use of the neurologically weaker upper extremity through massed practice while restraining the lesser involved upper extremity. Whereas research evidence supports CIMT, limited evidence exists regarding the characteristics of individuals who benefit most from this intervention. The goal of this study was to investigate the potential of 5 measures to predict functional CIMT outcomes. Methods— A convenience sample of 55 individuals, >6 months after stroke, was recruited that met specific inclusion/exclusion criteria allowing for individuals whose upper extremity was mildly to severely involved. They participated in CIMT 6 hours per day. Pretest, post-test, and follow-up assessments were performed to assess the outcomes for the Wolf Motor Function Test (WMFT). The potential predictors were minimal motor criteria (active extension of the wrist and 3 fingers), active finger extension/grasp release, grip strength, Fugl–Meyer upper extremity motor score, and the Frenchay score. A step-wise regression analysis was used in which the potential predictors were entered in a linear regression model with simultaneous entry of the dependent variables’ pretest score as the covariate. Two regressions models were determined for the dependent variable, for immediate post-test, and for follow-up post-test. Results— Finger extension was the only significant predictor of WMFT outcomes. Conclusions— When using finger extension/grasp release as a predictor in the regression equations, one can predict individual’s follow-up scores for CIMT. This experiment provides the most comprehensive investigation of predictors of CIMT outcomes to date.

Effects of stroke severity and training duration on locomotor recovery after stroke: a pilot study.

Background. Locomotor training using partial body weight-supported treadmill (BWST) walking has been widely investigated for people after stroke, yet there remains a lack of evidence concerning the optimal training duration and the effect of locomotor impairment severity. Previous protocols have not emphasized the transfer of locomotor skills from the BWST environment to overground. Objectives. To assess the feasibility of a program combining locomotor training using BWST with task-specific overground training and to obtain pilot data on the effects of severity and training duration on recovery of locomotion. Methods. Seven adults with chronic poststroke hemiparesis and gait speed less than 0.8 m/s were recruited to participate in a 12-week (36 session) locomotor training program. Each session comprised 20 to 30 minutes of training using BWST with manual assistance, followed by 10 to 15 minutes of overground training to transfer the skills trained in the BWST environment. Gait speed was the primary outcome measure. Results. Six out of the 7 enrolled individuals completed the intervention program; 1 was withdrawn due to transportation difficulties affecting compliance with the training schedule. Four of the 6 participants had a functionally significant improvement in walking speed after 36 sessions, defined as having achieved a 0.4 m/s gait speed or greater for those with initial severe gait speed impairment (<0.4 m/s) or as having achieved a 0.8 m/s gait speed or greater for persons with initial moderate gait speed impairment (≥0.4 m/s and <0.8 m/s). All participants improved in balance and distance walked over 6 minutes, and 5 of the 6 participants showed increases in their daily home and community step activity. Conclusions. A locomotor training program combining walking using BWST and manual assistance with overground practice is feasible for people with chronic poststroke hemiparesis and moderate or severe gait speed impairment. This intervention shows promise for achieving functionally significant improvements in walking speed.

Balance and Ambulation Improvements in Individuals With Chronic Incomplete Spinal Cord Injury Using Locomotor Training–Based Rehabilitation

OBJECTIVE To evaluate the effects of intensive locomotor training on balance and ambulatory function at enrollment and discharge during outpatient rehabilitation after incomplete SCI. DESIGN Prospective observational cohort. SETTING Seven outpatient rehabilitation centers from the Christopher and Dana Reeve Foundation NeuroRecovery Network (NRN). PARTICIPANTS Patients (N=196) with American Spinal Injury Association Impairment Scale (AIS) grade C or D SCI who received at least 20 locomotor training treatment sessions in the NRN. INTERVENTIONS Intensive locomotor training, including step training using body-weight support and manual facilitation on a treadmill followed by overground assessment and community integration. MAIN OUTCOME MEASURES Berg Balance Scale; Six-Minute Walk Test; 10-Meter Walk Test. RESULTS Outcome measures at enrollment showed high variability between patients with AIS grades C and D. Significant improvement from enrollment to final evaluation was observed in balance and walking measures for patients with AIS grades C and D. The magnitude of improvement significantly differed between AIS groups for all measures. Time since SCI was not associated significantly with outcome measures at enrollment, but was related inversely to levels of improvement. CONCLUSIONS Significant variability in baseline values of functional outcome measures is evident after SCI in individuals with AIS grades C and D and significant functional recovery can continue to occur even years after injury when provided with locomotor training. These results indicate that rehabilitation, which provides intensive activity-based therapy, can result in functional improvements in individuals with chronic incomplete SCI.