Allied rehabilitation using caregiver-mediated exercises combined with telerehabilitation for stroke (ARMed4Stroke): A randomised controlled trial.

Objective: To assess the added value of caregiver-mediated exercises combined with telerehabilitation in addition to usual care compared to usual care alone on the self-reported mobility outcome after subacute stroke.

Design: Multicentre, observer-blinded, parallel randomised controlled trial. An off-site researcher allocated treatments using minimisation.

Setting: Four rehabilitation centres in the Netherlands.

Participants: Forty-one patient-caregiver dyads within 3 months poststroke.

Intervention: Eight-week blended care program with caregiver-mediated mobility exercises for 2.5 h per week supported by telerehabilitation and four face-to-face sessions in addition to usual care.

Main measures: Self-reported mobility domain of the Stroke Impact Scale postintervention. Secondary outcomes were functional outcome, dyads' psychosocial wellbeing, care transition to the community postintervention and after 6 months.

Results: Forty-one dyads (21 intervention, 20 control) were randomised, and 37 (N = 18; N = 19) were analysed following intention-to-treat. The Stroke Impact Scale mobility was not significantly different between groups postintervention (B 0.8, 95% CI -6.8-8.5, p = 0.826). The secondary outcomes, namely, (a) caregivers' quality of life postintervention (p = 0.013), (b) caregivers' symptoms of depression postintervention (p = 0.025), and (c) independence in leisurely activities at 6 months (p = 0.024), showed significant benefits in favour of caregiver-mediated exercises with telerehabilitation. A significant difference favouring controls was found in self-reported muscle strength at 6 months (p = 0.002).

Conclusions: Caregiver-mediated exercises combined with telerehabilitation yielded no differential effect on our primary outcome self-reported mobility. Although the trial is underpowered, current findings are in line with previous trials. Future studies should further explore beneficial effects of caregiver involvement in stroke rehabilitation targeting psychosocial wellbeing.