Robot assisted training for the upper limb after stroke
| ISRCTN | ISRCTN69371850 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69371850 |
| Secondary identifying numbers | 15309; HTA 11/26/05 |
- Submission date
- 04/10/2013
- Registration date
- 04/10/2013
- Last edited
- 27/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Stroke Research Group
3-4 Claremont Terrace
Newcastle University
Newcastle Upon Tyne
NE2 4AE
United Kingdom
| Phone | +44 (0)191 2226322 |
|---|---|
| helen.bosomworth@ncl.ac.uk |
Study information
| Study design | Randomised interventional phase III study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Robot Assisted Training for the Upper Limb after Stroke (RATULS): a randomised interventional phase III study |
| Study acronym | RATULS |
| Study objectives | To determine whether robot-assisted training with the InMotion robotic gym system (In Motion commercial version) improves upper limb function post stroke. |
| Ethics approval(s) | National Research Ethics Service Committee North East - Sunderland, 05/11/2013, ref: 13/NE/0274 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2014 |
| Completion date | 31/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 720 |
| Total final enrolment | 770 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2014 |
| Date of final enrolment | 31/07/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NE2 4AE
United Kingdom
Sponsor information
Hospital/treatment centre
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom
"ROR" |
https://ror.org/05p40t847 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/08/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/07/2017 | Yes | No | |
| Results article | results | 06/07/2019 | 29/05/2019 | Yes | No |
| Results article | economic evaluation results | 25/05/2021 | 27/05/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
27/05/2021: Publication reference added.
29/05/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
16/01/2019: The intention to publish date has been changed from to 31/08/2020
15/01/2019: The overall trial end date was changed from 01/01/2018 to 31/08/2019.
25/07/2017: Publication reference added.
