A Very Early Rehabilitation Trial

Phase 3

Completed

• Conditions: Stroke; Stroke - Ischaemic; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12606000185561
• Lead Sponsor: ational Stroke Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2104

Inclusion Criteria

First or recurrent stroke diagnosis, haemorrhage or infarct, admitted to a stroke unit within 24 hours of onset of stroke symptoms. Patients must at least react to verbal commands.

Exclusion Criteria

Pre stroke mRS of 3,4 or 5 (previous significant disability)Deterioration in patients condition in the first hour resulting in admission to ICU, surgery or documented palliative treatment.Concurrent diagnosis of rapidly deteriorating disease.Unstable coronary or other medical condition which is judged by the investigator to pose a hazard to the patient by involvement in the trial.A confirmed or suspected lower limb fracture preventing implemetation of the protocoltPA patients can be included if the treating physician permits and mobilisation within 24 hours is permitted.Patients cannot be concurrently recruited to drug or other intervention trials. Vital signs not within protocol specified normal limits.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Score[At 3 months]

Secondary Outcome Measures

Name	Time	Method
Death rate and the rate and severity of important medical events [At 3 months];All adverse events during the intervention period. [Day 0 - Day 14];Health related quality of life measure - AQoL[3 and 12 months];Cost effectiveness and cost utility[At 3 and 12 months];mRS [At 12 months];Dose response - Mobilisation dose and outcome. Therapy dose provided by therapists and nurses, and outcome as measured by Modified Rankin Score.[3 months];Staff injury during the intervention period[Day 0 - Day 14];Cognitive function using Montreal Cognitive Assessment (MoCA)[At 3 months];Time (days) to achieve unassisted walking over 50 metres [3 months];Length of hospitalisation (acute+ rehabilitation)[3 months];Mood measured using Irritability, Depression and Anxiety scale[3 and 12 months];Barthel Index [3 and 12 months];Proportion of patients walking unassisted [3 and 12 months]