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Effect of individualized coaching at home on walking capacity in subacute stroke patients: a randomized controlled trial (Ticaa'dom) [with consumer summary] |
Mandigout S, Chaparro D, Borel B, Kammoun B, Salle J-Y, Compagnat M, Daviet J-C |
Annals of Physical and Rehabilitation Medicine 2021 Jul;64(4):101453 |
clinical trial |
6/10 [Eligibility criteria: Yes; 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: Yes; 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: The gains in walking capacity achieved during rehabilitation often plateau, or are lost, when the patient returns home. Moreover, maintaining or increasing the patient's daily physical activity level after a stroke remains challenging. We aimed to evaluate the effectiveness of a six-month individualized coaching program at home on walking capacity, as evaluated by the six-minute walk test in subacute stroke patients. METHODS: Stroke patients in the physical medicine and rehabilitation service participated in a monocentric observer blinded randomized controlled trial with two groups, intervention versus usual care control. The inclusion criteria were: age >= 18 years, first ischemic or hemorrhagic stroke, and stroke within < 6 months. Participants were randomly assigned (blocks of variable size) to an intervention group (EG) receiving individualized coaching on physical activity, or to a control group (CG) receiving standard care. The six-month program was composed of monitored physical activity, home visits and a weekly phone call. Participants were evaluated after hospital discharge (T0), at the end of the six-month program (T1) and six months later (follow-up; T2). The primary outcome was the walking distance performance, as evaluated with the six-minute walk test at T1. RESULTS: Eighty-three participants (age 61 y (IQR 22); time post-stroke 2.4 month (IQR 1.7); Barthel Index 100 (IQR 5)) were included in the study (EG n = 41; CG n = 42). The difference between the two groups was not significant at T1 (418 m (IQR 165) for the EG and 389 m (IQR 188) for the CG; p = 0.168) and at T2 (425m (IQR 121) for the EG versus 382m (IQR 219) for the CG; p = 0.208). CONCLUSION: Our study shows no difference in the six-minute walk test between the two groups of subacute stroke patients after 6 months of the individualized coaching program, combining home visits, feedback on daily performance and weekly telephone calls. http://ClinicalTrials.gov (NCT01822938).
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