A Phase 1 exercise dose escalation study for stroke survivors with impaired walking.

BACKGROUND: Targeted exercise and increased practice can improve the mobility of stroke survivors. However, many stroke survivors continue to have reduced physical work capacity and impaired walking, and experience frequent falls after participating in physical rehabilitation programs. AIM: In this Phase 1 study, we used a dose escalation method, common in pharmaceutical trials, to determine the maximum tolerable dose of multimodal exercise in community-dwelling stroke survivors with mobility impairment. METHODS: Stroke survivors 14-59 months poststroke participated in a 12-week (36 sessions) multimodal exercise program implemented using a cumulative 3 + 3 dose escalation design (featuring increasing doses in successive cohorts of three participants), with set dose-limiting tolerance criteria. The exercise intervention included challenging balance activities, strength, and endurance training. The program was individualized and focused on task-specific requirements for walking in the community. RESULTS: Six survivors participated before escalation was ceased. Four participants were able to tolerate up to 10·5 h/week of exercise, which included 283 min of endurance, 182 min of task practice, 138 min of strengthening, and 28 min resting. The program led to increased walking distance (Six-Minute Walk Test) and faster mobility (4 Square Step Test, Timed Up and Go Test), with pre-postimprovements averaging 23-41%. CONCLUSIONS: This is the first multimodal exercise dose escalation study in stroke. The maximal dose of exercise identified was dramatically higher than the dose typically delivered to stroke survivors in current trials. We now plan to confirm safety and feasibility of this program in a larger Phase II trial.

Over-ground walking on level and sloped surfaces in people with stroke compared to healthy matched adults.

PURPOSE: To investigate the basic spatio-temporal gait characteristics of people with stroke whilst walking on sloped and level terrain, and to compare this performance to healthy matched adults. METHOD: Fifteen community dwelling people with stroke who walked with a hemiplegic gait and a reference group of 15 adults without impairments matched for sex, age and height participated in this descriptive, observational study. Basic gait spatio-temporal measures were recorded at self-selected speed across a GAITRite mat placed on level, uphill and downhill (ramp gradient 1:14 or 4.1°) surfaces. Measures recorded were gait speed, cadence, step length, support base, single and double limb support duration and step length symmetry. Group and walking condition effects were assessed by two separate 2-way (group × slope) repeated measures multivariate analysis of variance. RESULTS: The stroke group walked slower (p < 0.001) than the reference group for all conditions. Within-group analyses found the stroke group decreased their speed and step length when walking downhill compared to level and uphill walking (p < 0.001). In contrast, the reference group maintained speed across all walking conditions. CONCLUSIONS: The findings suggest that walking on slopes affects gait speed in people with stroke and this may have implications when walking in the community. IMPLICATIONS FOR REHABILITATION: • Although a high percentage of people achieve walking independence following a stroke, few achieve independent community mobility. • Walking on slopes is an important aspect of community mobility. • When walking down a standard gradient ramp, people with stroke reduced their speed and step length, relative to level over-ground and uphill walking. • It is recommended that attention be directed to assessment and treatment of walking on slopes as part of stroke rehabilitation, as this may have implications when walking in the community.

Changes in balance and walking from stroke rehabilitation to the community: a follow-up observational study.

OBJECTIVES: To investigate (1) whether clinical test scores at discharge predict falls or limited community mobility after discharge from inpatient stroke rehabilitation; and (2) how walking and dynamic standing balance change after discharge. DESIGN: Follow-up observational study between 6 and 36 months after discharge. SETTING: Rehabilitation setting. PARTICIPANTS: Community-dwelling stroke survivors (N=30) who could walk unassisted when discharged from inpatient rehabilitation. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Six-minute walk test (6MWT), Four Square Step Test (FSST), Step Test (ST), Environmental Analysis of Mobility Questionnaire (EAMQ), Falls Efficacy Scale-International (FES-I), and self-reported falls. RESULTS: Follow-up occurred at a median of 14.5 months postdischarge. Significant improvements occurred between discharge and follow-up for the 6MWT (mean difference [MD]=110.1m; 95% confidence interval [CI], 70.8-149.4; P<.001), ST (MD=1.8 steps; 95% CI, 0.3-3.4; P=.03), and FSST (MD=4.3s; 95% CI, -10.3 to 1.6; P=.05). Despite this, 40% of participants reported falling. The group who fell had lower clinical test scores at discharge and follow-up than nonfallers. Specific cutoff scores for the clinical tests accurately classified falls history in 70% to 78% of participants. The cutoff scores were <250m for the 6MWT, <10 steps on the ST, and a failure or ≥15 seconds to complete the FSST. Participants performing under the cutoff scores reported lower levels of community mobility (EAMQ, P<.04). Concern about falling was only higher for those classified at risk by the FSST (FES-I, P=.008). CONCLUSIONS: The FSST, ST, and 6MWT scores at discharge had good falls prediction. People classified at risk of falls avoided more tasks in their home and community than those not classified at risk.

Clinical identification of multiple fall risk early after unilateral transtibial amputation.

OBJECTIVE: To examine if previously reported clinical tests of stepping and functional mobility could discriminate between multiple-falling and nonmultiple-falling people with unilateral transtibial amputations. DESIGN: Nonrandomized prospective cohort. SETTING: Rehabilitation hospital and general community. PARTICIPANTS: Forty-seven subjects initially recruited and tested at discharge. Forty subjects were retested at 6 months postdischarge and grouped as either multiple fallers (n=13) or nonmultiple fallers (n=27). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Four Square Step Test (FSST), Timed Up & Go (TUG) test, 180 degrees turn test, and the Locomotor Capabilities Index (LCI) advanced score. RESULTS: Significant differences (P<.01) were found between the 2 groups for all of the main outcome measures. The test scores associated with an increased risk of having multiple falls were as follows: TUG test of 19 seconds or more (sensitivity, 85%; specificity, 74%), turn time of 3.7 seconds or more (sensitivity, 85%; specificity, 78%), turn steps 6 steps or more (sensitivity, 100%; specificity, 74%), FSST of 24 seconds or more (sensitivity, 92%; specificity, 93%), and LCI advanced score of 15 or less (sensitivity, 43%; specificity, 91%). CONCLUSIONS: In this study, multiple-falling people with transtibial amputations displayed impaired mobility on the outcome measures reported. These measures offer valuable clinical tests of different and functionally relevant activities and provide good identification of multiple-falls risk.

Additional task-related practice improves mobility and upper limb function early after stroke: a randomised controlled trial.

The purpose of this study was to investigate whether additional practice of either upper limb or mobility tasks improved functional outcome during inpatient stroke rehabilitation. This prospective, randomised, single blind clinical trial recruited 30 stroke subjects into either an Upper Limb or a Mobility Group. All subjects received their usual rehabilitation and an additional session of task-related practice using a circuit class format. Independent assessors, blinded to group allocation, tested all subjects. Outcome measures used were three items of the Jebsen Taylor Hand Function Test (JTHFT), two arm items of the Motor Assessment Scale (MAS), and three mobility measures, the Timed Up and Go Test (TUGT), Step Test, and Six Minute Walk Test (6MWT). Both groups improved significantly between pre- and post-tests on all of the mobility measures, however only the Upper Limb Group made a significant improvement on the JTHFT and MAS upper arm items. Following four weeks training, the Mobility Group had better locomotor ability than the Upper Limb Group (between-group differences in the 6MWT of 116.4 m, 95% CI 31.4 to 201.3 m, Step Test 2.6 repetitions, 95% CI -1.0 to 6.2 repetitions, and TUGT -7.6 sec, 95% CI -15.5 to 0.2 sec). The JTHFT dexterity scores in the Upper Limb Group were 6.5 sec (95% CI -7.4 to 20.4 sec) faster than the Mobility Group. Our findings support the use of additional task-related practice during inpatient stroke rehabilitation. The circuit class format was a practical and effective means to provide supervised additional practice that led to significant and meaningful functional gains.

A clinical test of stepping and change of direction to identify multiple falling older adults.

OBJECTIVES: To establish the reliability and validity of a new clinical test of dynamic standing balance, the Four Square Step Test (FSST), to evaluate its sensitivity, specificity, and predictive value in identifying subjects who fall, and to compare it with 3 established balance and mobility tests. DESIGN: A 3-group comparison performed by using 3 validated tests and 1 new test. SETTING: A rehabilitation center and university medical school in Australia. PARTICIPANTS: Eighty-one community-dwelling adults over the age of 65 years. Subjects were age- and gender-matched to form 3 groups: multiple fallers, nonmultiple fallers, and healthy comparisons. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Time to complete the FSST and Timed Up and Go test and the number of steps to complete the Step Test and Functional Reach Test distance. RESULTS: High reliability was found for interrater (n=30, intraclass correlation coefficient [ICC]=.99) and retest reliability (n=20, ICC=.98). Evidence for validity was found through correlation with other existing balance tests. Validity was supported, with the FSST showing significantly better performance scores (P<.01) for each of the healthier and less impaired groups. The FSST also revealed a sensitivity of 85%, a specificity of 88% to 100%, and a positive predictive value of 86%. CONCLUSION: As a clinical test, the FSST is reliable, valid, easy to score, quick to administer, requires little space, and needs no special equipment. It is unique in that it involves stepping over low objects (2.5cm) and movement in 4 directions. The FSST had higher combined sensitivity and specificity for identifying differences between groups in the selected sample population of older adults than the 3 tests with which it was compared.

Development of a clinical measure of turning for older adults.

OBJECTIVE: The purpose of this study was to identify the characteristics present and observable when older adults safely and efficiently turn while walking and to develop and evaluate a clinical measure of turning based on these characteristics. DESIGN: This was a validation study of balance and mobility tests using a three-group sample of convenience. RESULTS: The reliability of a turn measure consisting of nine movement items was identified. Five of the turn measure items were able to discriminate between multiple faller and the other two groups. The two items dichotomously rated as yes or no were "seems steady throughout the turn" and "moves fluently without hesitation between turn and walk when exiting the turn." Three other items were, total turn score, the time taken to turn, and turn step number. These last two items also achieved strong correlation with existing balance measures and high sensitivity for identifying multiple fallers. These items form an easy-to-use clinical measure of turning for older adults. CONCLUSIONS: The turn measure developed in this investigation was found to be a reliable and valid clinical measure of turning while walking for older adults. Specific turn items were found to discriminate between groups of healthy and impaired older adults and had good sensitivity for identifying multiple fallers. The turn measure is relatively quick to administer and score and uses equipment readily available in most clinical settings.