Condition category
Circulatory System
Date applied
04/10/2013
Date assigned
04/10/2013
Last edited
07/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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. This research study is to find out whether robot-assisted training improves arm function after stroke. Robot assisted training will be 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?
Stroke patients with difficulty using their arm who wish to take part in the trial will be randomly assigned to either robot-assisted training, enhanced upper limb therapy or usual NHS rehabilitation. Robot-assisted training and enhanced upper limb therapy will be 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 will be evaluated by comparing the arm function of patients in each group.

What are the possible benefits and risks of participating?
We do not know if 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. We believe 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 will be invited to take part (Newcastle/Northumbria, Romford, Glasgow and Cambridge).

When is study starting and how long is it expected to run for?
Recruitment to the study will start in April 2014 and end in July 2017. Participants will be followed up until 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

Study information

Scientific title

Robot Assisted Training for the Upper Limb after Stroke

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 below 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 measures

Upper limb function measured using the Action Research Arm Test (ARAT) at 3 months post randomisation

Secondary outcome measures

1. Upper limb impairment [Fugl-Meyer Test (motor and sensory arm sections)]
2. Activities of daily living (Barthel ADL Index), quality of life (EQ-5D-5L)
3. Upper limb pain (numerical rating scale)
4. Resource use (adaption of the Client Services Receipt Inventory)
5. Adverse events measured at three and six months post randomisation

Overall trial start date

01/04/2014

Overall trial end date

01/01/2018

Reason abandoned

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

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

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Health Technology Assessment; Grant Codes: 11/26/05

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes