Plain English Summary
Background and study aims
Loss of the ability to use the arm is a common and distressing consequence of stroke. Currently it is unclear how best to provide therapy to improve arm recovery and function. Research suggests that robot-assisted training may be beneficial but this is not yet proven and further research is needed. Robot-assisted training consists of the use of a machine or 'robot' to exercise the arm. The aim of this study is to find out whether robot-assisted training improves arm function after stroke. Robot assisted training is compared to an enhanced upper limb therapy programme consisting of repeated practice of everyday activities using the arm and usual NHS rehabilitation.
Who can participate?
Adults aged over 18 who have had a stroke which has resulted in difficulty using the arm.
What does the study involve?
Participants are randomly allocated to either robot-assisted training, enhanced upper limb therapy or usual NHS rehabilitation. Robot-assisted training and enhanced upper limb therapy are provided for 45 minutes, 3 times per week for 12 weeks. Robot-assisted training uses a machine to exercise the shoulder/elbow, wrist and hand. Enhanced upper limb therapy involves practicing everyday activities. Usual NHS rehabilitation may involve a range of rehabilitation treatments according to individual clinical need. The effects of the treatments are evaluated by comparing the arm function of patients in each group.
What are the possible benefits and risks of participating?
It is not known whether robot assisted training or enhanced upper limb therapy are effective for improving arm function after stroke. However, research has suggested that increasing therapy, in particular repetitive exercise therapy which is used in both robot-assisted training and enhanced upper limb therapy may improve arm function. It is thought that increasing repetitive exercise in rehabilitation 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. Stroke patients from four areas of the UK are invited to take part (Newcastle/Northumbria, Romford, Glasgow and Cambridge).
When is the study starting and how long is it expected to run for?
April 2014 to January 2018
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Helen Bosomworth
helen.bosomworth@ncl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Helen Bosomworth
ORCID ID
Contact details
Stroke Research Group
3-4 Claremont Terrace
Newcastle University
Newcastle Upon Tyne
NE2 4AE
United Kingdom
+44 (0)191 2226322
helen.bosomworth@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15309; HTA 11/26/05
Study information
Scientific title
Robot Assisted Training for the Upper Limb after Stroke (RATULS): a randomised interventional phase III study
Acronym
RATULS
Study hypothesis
To determine whether robot-assisted training with the InMotion robotic gym system (In Motion commercial version) improves upper limb function post stroke.
Ethics approval
National Research Ethics Service Committee North East - Sunderland, 05/11/2013, ref: 13/NE/0274
Study design
Randomised interventional phase III study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Stroke rehabilitation
Intervention
This is a three-group randomised controlled trial.
Group 1: Robot-assisted training
Robot-assisted training will use the InMotion robotic gym system which comprises three modules to exercise the shoulder/elbow, wrist and hand. Treatment will be provided for 45 minutes, 3 times per week for 12 weeks.
Group 2: Enhanced upper limb therapy
Enhanced upper limb therapy will consist of upper limb rehabilitation goal setting followed by practice of everyday activities to work towards the goals. Treatment will be provided for 45 minutes, 3 times per week for 12 weeks
Group 3: Usual NHS rehabilitation
This group will continue with usual NHS rehabilitation in accordance with local clinical practice.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
Upper limb function measured using the Action Research Arm Test (ARAT) at 3 months post randomisation
Secondary outcome measures
1. Upper limb impairment, measured using the Fugl-Meyer Test (motor and sensory arm sections)
2. Activities of daily living (measured using the Barthel ADL Index), quality of life (measured using EQ-5D-5L)
3. Upper limb pain, measured using a numerical rating scale
4. Resource use, measured using an adaption of the Client Services Receipt Inventory
5. Adverse events, measured at 3 and 6 months post randomisation
Overall trial start date
01/04/2014
Overall trial end date
31/08/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adults with a first ever stroke who fulfil the following criteria are eligible:
1. Age 18 years and over
2. Clinical diagnosis of stroke (cerebral infarction, primary intracerebral haemorrhage, subarachnoid haemorrhage)
3. Between one week and five years since stroke
4. Moderate to severe upper limb functional limitation (Action Research Arm Test (ARAT) score 0-39) due to stroke
5. Able to provide consent to take part in the study and to comply with the requirements of the protocol
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 720
Total final enrolment
770
Participant exclusion criteria
1. More than one stroke (patients with previous transient ischaemic attack (TIA) may be invited to participate)
2. Other current significant impairment of the upper limb affected by stroke e.g. fixed contracture, frozen shoulder, severe arthritis, recent fracture
3. Diagnosis likely to interfere with rehabilitation or outcome assessments e.g. registered blind
4. Previous use of the InMotion robotic gym system or other arm rehabilitation robot
5. Current participation in a rehabilitation trial evaluating upper limb rehabilitation after stroke
6. Previous enrolment in this study
Recruitment start date
01/04/2014
Recruitment end date
31/07/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Newcastle University
Newcastle Upon Tyne
NE2 4AE
United Kingdom
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
31/08/2020
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28728602
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31128926 (added 29/05/2019)