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Gait training in subacute non-ambulatory stroke patients using a full weight-bearing gait-assistance robot: a prospective, randomized, open, blinded-endpoint trial |
Ochi M, Wada F, Saeki S, Hachisuka K |
Journal of the Neurological Sciences 2015 Jun 15;353(1-2):130-136 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; 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: This study was a prospective, randomized, open, blinded-endpoint trial with the aim of examining whether gait training with a gait-assistance robot (GAR) improves gait disturbances in subacute non-ambulatory hemiplegic stroke patients more than overground conventional gait training. The GAR adopts a robot arm control system with full weight bearing and foot pressure visual biofeedback. METHODS: Twenty-six hemiplegic patients were randomly assigned to either the GAR-assisted gait training (GAGT) group or the overground conventional gait training (OCGT) group. Both groups underwent 60 min of standard physical therapy and 20 min of GAGT or OCGT 5 days a week for 4 weeks. The primary outcome measure was the Functional Ambulation Classification (FAC). The secondary outcome measures were the peak torque of the extensor muscles in the lower extremities and a 10-m walking test. The lower extremity function was evaluated using the Fugl-Meyer Assessment, and activities of daily living were assessed using the Functional Independence Measure. RESULTS: The GAGT group demonstrated significantly greater improvements in FAC and peak torque on the unaffected side (p = 0.02) than the OCGT group. Additionally, gait speed tended to be faster (p = 0.07) in the GAGT group. CONCLUSIONS: GAGT combined with standard physical therapy in subacute non-ambulatory hemiplegic patients led to significant improvements in gait and peak torque on the unaffected side compared to OCGT.
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