Effect of individualized coaching at home on walking capacity in subacute stroke patients: A randomized controlled trial (Ticaa'dom).

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: 61y [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(418m [IQR=165] for the EG and 389m [IQR=188] for the CG; P=0.168) and at T2(425m [IQR=121] for the EG vs. 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).