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Effects of the robot-assisted gait training device plus physiotherapy in improving ambulatory functions in subacute stroke patients with hemiplegia: an assessor-blinded, randomized controlled trial [with consumer summary]
Thimabut N, Yotnuengnit P, Charoenlimprasert J, Sillapachai T, Hirano S, Saitoh E, Piravej K
Archives of Physical Medicine and Rehabilitation 2022 May;103(5):843-850
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: 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: To investigate the effects of the robot-assisted gait training device (RAGTD) plus physiotherapy versus physiotherapy alone, in improving ambulatory functions in subacute stroke patients with hemiplegia. DESIGN: A prospective, assessor-blinded, randomized controlled trial. SETTING: Subacute stroke patients with hemiplegia admitted at the Rehabilitation Center. PARTICIPANTS: Twenty-six subacute stroke patients with hemiplegia. INTERVENTION: All patients received 30 training sessions (five days/week for six weeks) which included conventional physiotherapy training (60 min) and ambulation training (60 min). In the ambulation training session, the RAGTD group received robotic training (40 min) and ground ambulation training (20 min). The control group received only ground ambulation training (60 min). The outcomes were assessed at the initial session, the end of the 15th and the 30th sessions. Comparisons within group and between the groups were conducted. MAIN OUTCOME MEASURES: Primary outcome variables were the Functional Independence Measure (FIM)-walk score and the efficacy of FIM-walk. RESULTS: The RAGTD group showed greater improvements from baseline than control in: (1) the FIM-walk score, at the end of the 15th session (p = 0.0012), (2) the efficacy of FIM-walk, at the end of the 15th session (p = 0.0008), (3) walking distance in the 6-minute walk test (6MWT), at the end of the 15th session (p = 0.0018), (4) the Barthel Index for Activities of Daily Living (ADL), at the end of the 30th session (p < 0.001), and (5) gait symmetry ratio, at the end of the 30th session (p = 0.0044). Other gait parameters showed tendencies of improvement in the RAGTD group, but there were no significant differences. CONCLUSION: RAGTD plus physiotherapy showed early improvements in walking ability and Barthel ADL index compared to the ground level training plus physiotherapy in subacute stroke patients with hemiplegia.

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