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Effects of gait rehabilitation with a footpad-type locomotion interface in patients with chronic post-stroke hemiparesis: a pilot study [with consumer summary]
Tanaka N, Saitou H, Takao T, Iizuka N, Okuno J, Yano H, Tamaoka A, Yanagi H
Clinical Rehabilitation 2012 Aug;26(8):686-695
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; 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*

OBJECTIVE: We developed a footpad-type locomotion interface called the GaitMaster. The purpose of this pilot study was to examine the effects of gait rehabilitation using the GaitMaster in chronic stroke patients. DESIGN: Randomized cross-over design. SETTING: An outpatient department. SUBJECTS: Twelve patients with chronic post-stroke hemiparesis. INTERVENTION: In group A, patients underwent an 'intervention phase' followed by a 'non-intervention phase', whereas in group B, patients underwent the non-intervention phase first, followed by the intervention phase. In the four- or six-week intervention phase, participants underwent twelve 20-minute sessions of gait rehabilitation using the GaitMaster4. MAIN OUTCOME MEASURES: We measured gait speed and timed up-and-go test. RESULTS: No differences between the two groups were observed in the baseline clinical data. For the combined groups A and B, the maximum gait and timed up-and-go test speeds improved significantly only in the intervention phase (p = 0.0001 and p = 0.003, respectively). The percentages of improvement from baseline at the end of GaitMaster training were 16.6% for the maximum gait speed and 8.3% for the timed up-and-go test. The effect size for GaitMaster4 training was 0.58 on the maximum gait speed and 0.43 on the timed up-and-go test. CONCLUSIONS: This pilot study showed that gait rehabilitation using the GaitMaster4 was a feasible training method for chronic stroke patients. Calculation of the sample size indicated that a sample size of 38 participants would be adequate to test a null hypothesis of nil benefit additional to routine rehabilitation for chronic stroke patients in a future randomized controlled trial.

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