You'll have to ask your doctor what the results were and what protocols were used to try to get more than 10% of patients 100% recovered. It ended at the end of October so if your doctor doesn't know about this, once again incompetence reigns supreme.
A trial to Evaluate an eXTended RehAbilitation service for Stroke patients (EXTRAS)
ISRCTN45203373 https://doi.org/10.1186/ISRCTN45203373
- Condition category
- Circulatory System
- Date applied
- 08/08/2012
- Date assigned
- 09/08/2012
- Last edited
- 05/10/2018
- Prospective/Retrospective
- Prospectively registered
- Overall trial status
- Completed
- Recruitment status
- No longer recruiting
Plain English Summary
Background and study aimsOne third of patients have long term disability after stoke but specialist stroke rehabilitation usually lasts no more than a few months. Patients who have on going rehabilitation needs once specialist stroke rehabilitation finishes may be referred to a range of other health care professionals or services, but most do not offer specialist stroke rehabilitation. One of the reasons that specialist stroke rehabilitation is not provided over a longer period is because it is not yet known if it is beneficial. This research project is a clinical trial to determine whether a new extended stroke rehabilitation service is beneficial to patients and carers.
Who can participate?
Adults aged over 18 with a new stroke who are being discharged from hospital after their stroke under the care of an Early Supported Discharge team. Carers of stroke patients may also participate. A carer is the main family member or friend, who will provide support after discharge. He/she may not necessarily live with the patient.
What does the study involve?
Stroke patients and carers who agree to participate in the trial will be randomly allocated to either receive a new extended stroke rehabilitation service or to continue with usual NHS care when routine specialist stroke rehabilitation (Early Supported Discharge) ends. The new extended stroke rehabilitation service will involve on going contact, usually by telephone, with a senior Early Supported Discharge (ESD) stroke therapist or nurse for 18 months after ESD finishes. The therapist/nurse will contact patients and carers at 1, 3, 6, 12 and 18 months after discharge from ESD to review their progress and rehabilitation needs. Rehabilitation goals will be agreed and the therapist/nurse will give advice on how to progress towards the goals. The advice may be verbal advice, for example, exercises to practice at home. Or, if required, referral for an additional period of therapy from a service which is available locally may be arranged. Usual NHS care following specialist stroke rehabilitation may involve referral to a range of rehabilitation services in accordance with local clinical practice. The effectiveness of the new extended rehabilitation service will be evaluated by comparing the health (e.g functional abilities and quality of life) of patients and carers who received the new service with those who received usual NHS care.
What are the possible benefits and risks of participating?
We do not know if providing a specialist stroke rehabilitation service over a longer period of time is beneficial. However, we do know that rehabilitation treatments early after stroke improve health and recovery. We believe that rehabilitation over a longer period of time may be beneficial, but this is not yet proven.
Where is the study run from?
The study is being run from Newcastle University, Newcastle upon Tyne, UK. Patients and carers from twelve or more NHS stroke services will be invited to take part.
When is the study starting and how long is it expected to run for?
Recruitment to the study will start on 01 January 2013 and end on 31 May 2015. Study follow up will end on 31 January 2017. The total duration of the study is 5 years.
Who is funding the study?
UK National Institute for Health Research - Health Technology Assessment Programme.
Who is the main contact?
Dr Lisa Shaw
Lisa.Shaw@ncl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Lisa Shaw
ORCID ID
Contact details
Stroke Research Group
Institute for Ageing and Health
3-4 Claremont Terrace
Newcastle Upon Tyne
NE2 4AE
United Kingdom
+44 (0)191 222 6779
lisa.shaw@ncl.ac.uk
Institute for Ageing and Health
3-4 Claremont Terrace
Newcastle Upon Tyne
NE2 4AE
United Kingdom
+44 (0)191 222 6779
lisa.shaw@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12789
Study information
Scientific title
A trial to Evaluate an eXTended RehAbilitation service for Stroke patients (EXTRAS)
Acronym
EXTRAS
Study hypothesis
To determine the clinical and cost effectiveness of an extended stroke rehabilitation service.
Ethics approval
Newcastle and North Tyneside Research Ethics Committee, 25/06/2012, ref: 12/NE/0217
Study design
Randomised interventional phase III study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Stroke Rehabilitation
Intervention
Study intervention: An extended stroke rehabilitation
service provided for 18 months following completion of routine
specialist stroke rehabilitation (Early Supported Discharge). The
extended stroke rehabilitation service will provide on-going contact
with a senior ESD team member who will lead and coordinate further
rehabilitation.
Study control: Usual care post Early Supported Discharge. Usual care may involve referral of patients to a range of rehabilitation services upon completion of ESD in accordance with local clinical practice.
Study control: Usual care post Early Supported Discharge. Usual care may involve referral of patients to a range of rehabilitation services upon completion of ESD in accordance with local clinical practice.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
Nottingham Extended Activities of Daily Living Scale at 24 months post randomisation.
Secondary outcome measures
For patients: health status (Oxford Handicap Scale),
quality of life (Euroqol EQ-5D), mood (Hospital Anxiety and Depression
Scale), experience of services and resource use (adaptation of the
Client Service Receipt Inventory) at 12 and 24 months.
For carers: quality of life (Euroqol EQ-5D), carer stress (Caregiver Strain Index) and experience of services at 12 and 24 months.
For carers: quality of life (Euroqol EQ-5D), carer stress (Caregiver Strain Index) and experience of services at 12 and 24 months.
Overall trial start date
01/01/2013
Overall trial end date
31/10/2018
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