Family-led rehabilitation after stroke in India: the ATTEND trial, study protocol for a randomized controlled trial

Abstract

BackgroundGlobally, most strokes occur in low- and middle-income countries, such as India, with many affected people having no or limited access to rehabilitation services. Western models of stroke rehabilitation are often unaffordable in many populations but evidence from systematic reviews of stroke unit care and early supported discharge rehabilitation trials suggest that some components might form the basis of affordable interventions in low-resource settings. We describe the background, history and design of the ATTEND trial, a complex intervention centred on family-led stroke rehabilitation in India.Methods/designThe ATTEND trial aims to test the hypothesis that a family-led caregiver-delivered home-based rehabilitation intervention, designed for the Indian context, will reduce the composite poor outcome of death or dependency at 6 months after stroke, in a multicentre, individually randomized controlled trial with blinded outcome assessment, involving 1200 patients across 14 hospital sites in India.DiscussionThe ATTEND trial is testing the effectiveness of a low-cost rehabilitation intervention that could be widely generalizable to other low- and middle-income countries.Trial registrationClinical Trials Registry-India CTRI/2013/04/003557. Australian New Zealand Clinical Trials Registry ACTRN12613000078752. Universal Trial Number U1111-1138-6707.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1129-8) contains supplementary material, which is available to authorized users.

Family-led rehabilitation after stroke in India (ATTEND): a randomised controlled trial

“…26 piloted in Ludhiana 11 and the protocol was published. 10 The steering committee designed the study, collected the data (in collaboration with the hospital sites), made the decision to submit the manuscript for publication and vouch for the fidelity of the study to the protocol. The writing committee wrote the manuscript and vouch for the completeness and accuracy of the data and analyses.…”

“…The training was designed to occur for approximately one hour a day in hospital, for about three days, with the intention of expediting early supported discharge. 10 There was a written intervention guide for the coordinators and an intervention manual for the patient and caregiver. To reduce potential contamination, the manual was given to participants on the first home visit to prevent access by control participants in hospital.…”

Physiotherapy in Indian communities: a brief review

“…32 FibromyalgiaTo compare physiotherapy and amitriptyline for disability reduction in patients with fibromyalgia & to determine which clinical features at baseline would predict benefit with either therapyDifferent treatment allocation to both groupsn=156(82: amitriptyline; 74: physiotherapy)Structured physical training-relaxation, stretching and strengthening exercises, Aerobic exercises, At least 10 minutes of home exercises daily, Monthly follow ups for 6 monthsDecreased scores on Fibromyalgia Impact questionnaire in both groups after 6 monthsSmall sample sizeNo control groupFAmily-Led RehabiliTaTion aftEr Stroke in INDia: the ATTEND pilot study 4 StrokeTo check the feasibility of conducting a large-scale study of family-led, trained caregiver-delivered, home-based stroke rehabilitation Randomized controlled trialn = 104Control group: usual community careIntervention group: a stroke rehabilitation package of care that starts in hospital and continues at home by the caregiver who is trained by an experienced nurse or physiotherapist, including regular home visits for 2 months- telephone follow ups if home visits are not possibleIt is feasible to conduct a trial using an intervention of an empowered caregiver to give home-based rehabilitation after stroke *Family-led rehabilitation after stroke in India: the ATTEND trial, study protocol for a randomized controlled trial 3 StrokeTo test the effectiveness of a family-led caregiver-delivered home-based low-cost rehabilitation intervention for stroke patients in IndiaRandomized controlled trial n = 2400Same as aboveHome based rehabilitation after hospital discharge will be safe and cost effective Impact of physical therapy on burden of caregivers of individuals with functional disability 33 Chronic disabling health conditionsTo evaluate the effects of a tailored physical therapy intervention, or caregiver education, on the caregivers’ burdenRandomized controlled trialn=66(Control: 24, intervention:21; caregiver education: 21)Control group: no treatmentIntervention group:1 month tailored intervention-3-5 days a week for 20-60 minutesCaregiver education: only caregiver education; 2 days a week-10-30 minutesSignificant reduction in all three groups; no significant findings between groups however trends of reduced caregiver stress and burden in intervention groupHeterogenous groups, Telephone interviews for follow up may have biased resultsEffect of CDT and home program on health- related quality of life in post mastectomy lymphedema patients …”

Facilitação Neuromuscular Proprioceptiva Na Marcha Em Pacientes Com Sequela De Acidente Vascular Encefalico

“…Considerada a doença vascular mais incapacitante que acomete a parte central do sistema nervoso, aproximadamente 20 a 30% dos indivíduos tornam-se dependentes na marcha e necessitam de auxilio em suas atividades básicas de vida diária (ABVD). Após o AVE, apresentam lesões residuais, não apenas motoras e cognitivas, mas também metabólicas e psicossociais, cardiovasculares e na acuidade visual (5) . A sequela mais frequente é a hemeparesia, que aumenta a probabilidade de quedas, altera a velocidade de execuções de atividades comuns, automáticas e a autonomia dos portadores.…”