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A Randomised clinical trial for Rehabilitation intervention in Acute Stroke Patients.

A Phase 3, Multi-Arm Multi-Stage Covariate-Adjusted Response-Adaptive Randomised Trial to Determine Optimal Early Mobility Training after Stroke (AVERT DOSE) - AVERT DOSE

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024911
Enrollment
3600
Registered
2020-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G89-G99- Other disorders of the nervous system

Interventions

Intervention1: Mobility training dose: Mild stroke patients randomized to one of the four PT treatment group Control Intervention1: Mobility training dose: Moderate stroke patients randomized to one o

Sponsors

Australian National Health and Research Medical Council
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients admitted to a stroke unit with: 1. Ischemic stroke (first-ever or recurrent) 2. Aged >= 18 years 3. Ability to be enrolled within 48 hours of the onset of stroke symptoms. 4. Mild (NIHSS 0-7) or moderate stroke severity (NIHSS 8 5. Pre stroke mRS of 0 â?? 2 6. Participants are medically stable at the time of recruitment 7. Participants may receive thrombolytic and/or ECR

Exclusion criteria

Exclusion criteria: 1. Pre-stroke mRS of 3, 4 or 5 (indicating moderate to severe pre-morbid disability) 2. Diagnosis of hemorrhagic stroke or transient ischemic attack 3. Severe stroke (NIHSS > 16) 4.Co-morbid progressive neurological conditions 5. Severe heart failure or unstable coronary conditions that may pose a hazard to the participant 6. Concurrent diagnosis of rapidly deteriorating disease (e.g. terminal cancer) 7.Deterioration following admission, resulting in palliation or immediate surgery 8. A lower limb fracture/disability resulting in the participant unable to take part in mobility training 9. Patients with no evident mobility problems 10. Patients expected to be discharged within 3 days post enrollment. 11.Current participation in a drug or other intervention trial

Design outcomes

Primary

MeasureTime frame
mRS (score 0-2)Timepoint: 3 months, 6 months

Secondary

MeasureTime frame
Recovery of unassisted walking 50 metres and walking speed Quality of life EQ-5DTimepoint: at 3 months, 6 months

Countries

Australia, India, Ireland, Malaysia, Singapore, United Kingdom

Contacts

Public ContactDr Dimple Dawar

Christian Medical College and Hospital Ludhiana

jeyarajpandian@hotmail.com9915784750

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026