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Pilot study of Lokomat versus manual-assisted treadmill training for locomotor recovery post-stroke |
Westlake KP, Patten C |
Journal of NeuroEngineering & Rehabilitation 2009 Jun 12;6(18):Epub |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: While manually-assisted body-weight supported treadmill training (BWSTT) has revealed improved locomotor function in persons with post-stroke hemiparesis, outcomes are inconsistent and it is very labor intensive. Thus an alternate treatment approach is desirable. Objectives of this pilot study were to: (1) compare the efficacy of body-weight supported treadmill training (BWSTT) combined with the Lokomat robotic gait orthosis versus manually-assisted BWSTT for locomotor training post-stroke, and (2) assess effects of fast versus slow treadmill training speed. METHODS: Sixteen volunteers with chronic hemiparetic gait (0.62 +/- 0.30 m/s) post-stroke were randomly allocated to Lokomat (n = 8) or manual-BWSTT (n = 8) 3x/wk for 4 weeks. Groups were also stratified by fast (mean 0.92 +/- 0.15 m/s) or slow (0.58 +/- 0.12 m/s) training speeds. The primary outcomes were self-selected overground walking speed and paretic step length ratio. Secondary outcomes included: fast overground walking speed, 6-minute walk test, and a battery of clinical measures. RESULTS: No significant differences in primary outcomes were revealed between Lokomat and manual groups as a result of training. However, within the Lokomat group, self-selected walk speed, paretic step length ratio, and four of the six secondary measures improved (p = 0.040.05, effect sizes = 0.190.60). Within the manual group, only balance scores improved (p = 0.02, effect size = 0.57). Group differences between fast and slow training groups were not revealed (p = 0.28). CONCLUSION: Results suggest that Lokomat training may have advantages over manual-BWSTT following a modest intervention dose in chronic hemiparetic persons and further, that our training speeds produce similar gait improvements. Suggestions for a larger randomized controlled trial with optimal study parameters are provided.
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