A Randomised clinical trial for Rehabilitation intervention in Acute Stroke Patients.
- Conditions
- Other disorders of the nervous system,
- Registration Number
- CTRI/2020/04/024911
- Lead Sponsor
- Australian National Health and Research Medical Council
- Brief Summary
**Aims**
The aim of this study is to define the optimal early intervention regimens that provide the most benefit for people with the ischaemic stroke of mild and moderate severity.
***Hypothesis***
We hypothesise that against a pre-specified control, the optimal dose intervention regimen(s) will result in:
1. More patients experiencing no or little disability at 3 months post-stroke, (primary outcome)
2. Patients experiencing fewer and less severe complications at 14 days
3. Better quality of life at 6 months and
4. More cost-effective care at 6 months
***Method***
We will use a multi-arm, dose-finding, Covariate-Adjusted, Response-Adaptive (CARA) Randomised Clinical Trial in two specified mild and moderate stroke severity strata.
We will test three separate rehabilitation intervention regimens in each strata against a pre-specified control to identify the intervention regimen that results in fewer disabled patients at 3 months post-stroke (mRS 0-2). A sample size of 2,572 patients will allow us to independently observe pre-specified effects in these two strata with power 80% and significance threshold of p=0.025. All analyses will be intention-to-treat. Patients with mild to moderate stroke will be recruited using our global trials network in Australia, New Zealand, Singapore, Malaysia, India and the United Kingdom as well as additional interested collaborators.
***Number of participants***
2,572 stroke patients will be recruited, with 1470 mild severity (National Institute of Health Stroke Scale (NIHSS),15 0-7) and 1102 moderate severity (NIHSS 8-16).
***Stroke Unit Care***
Hospitals with a geographically located stroke unit are selected for this study.
***Inclusion Criteria***
• Ischaemic stroke (first-ever or recurrent)
• Aged ≥ 18 years
• Ability to be enrolled within 48 hours of the onset of stroke symptoms.
• Mild (NIHSS 0-7) to moderate stroke severity (NIHSS 8 -16),
• Pre stroke mRS of 0 – 2
• Meet physiological criteria indicating a stable medical condition (patient rousable, with systolic BP > 120 mmHg and < 180 mmHg, O2 saturation > 92%, HR > 40 and < 100, and temperature < 38.5ºC).
***Exclusion Criteria***
• Pre-stroke mRS of 3, 4 or 5 (indicating moderate to severe pre-morbid disability)
• Haemorrhagic stroke or transient ischaemic attack
• Severe stroke (NIHSS > 16)
• Comorbid progressing neurological conditions
• Severe heart failure or unstable coronary conditions
• Other drug or intervention trial
***Data Collection***
REDCap will be the data management system used. It is a web-based electronic data entry and management system. The electronic Case Report Form (eCRF) will be completed for each study participant summarising all clinical screening and study data.
In addition to the main data set, a number of sub-studies will concurrently run and will include genetic, motor evoked potential and imaging analyses in selected regions.
***Intervention***
The intervention will be provided in both mild and moderate patients (Baseline randomisation NIHSS score). In each group, there will be 4 pre-specified therapy protocols that will be implemented by physiotherapists and nurses. Patients will be randomised to receive one of the 4 treatment protocols for the duration of their acute hospital stay. Time in therapy and frequency of sessions will vary across groups and may require a reorganisation or physiotherapy and nursing care, however, will not require the employment of additional staff to implement. No specialised equipment is required to implement the protocol by the staff.
***Follow up assessments***
Patients will be followed up at 3 and 6 months by an assessor who has been blinded to treatment arm and may occur in the clinic and the community.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 3600
- 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.
- Mild (NIHSS 0-7) or moderate stroke severity (NIHSS 8 ≤ 16) 5.
- Pre stroke mRS of 0 – 2 6.
- Participants are medically stable at the time of recruitment 7.
- Participants may receive thrombolytic and/or ECR.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mRS (score 0-2) 3 months, 6 months
- Secondary Outcome Measures
Name Time Method Recovery of unassisted walking 50 metres and walking speed Quality of life
Trial Locations
- Locations (7)
Christian Medical College
🇮🇳Vellore, TAMIL NADU, India
Christian Medical College and Hospital
🇮🇳Ludhiana, PUNJAB, India
Dr. Ramesh Cardiac & Multispeciality Hospital Pvt. Limited
🇮🇳Guntur, ANDHRA PRADESH, India
GNRC Hospital
🇮🇳Kamrup, ASSAM, India
Kasturba Medical College
🇮🇳Udupi, KARNATAKA, India
Lalitha Super Specialities Hospital
🇮🇳Guntur, ANDHRA PRADESH, India
Sahyadri Hospital
🇮🇳Nashik, MAHARASHTRA, India
Christian Medical College🇮🇳Vellore, TAMIL NADU, IndiaDr Sanjith AaronPrincipal investigator9894022395sanjith@cmcvellore.ac.in