Does arm training early after a stroke increase the contribution of the non-affected brain side to recovery?
| ISRCTN | ISRCTN81668376 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81668376 |
| Secondary identifying numbers | 19819 |
- Submission date
- 11/11/2015
- Registration date
- 11/11/2015
- Last edited
- 03/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
A stroke is a serious condition where the blood supply to a part of the brain is cut off, usually by a blood clot blocking an artery or a bleed (haemorrhage). One of the most common complications of a stroke is weakness on one side of the body (hemiparesis). Following a stroke, many patients require extensive rehabilitation so that they can regain movement and keep their independence. Recovering arm movement after a stroke is possible due to the brain's ability to form new connections. By repeating special exercises, the uninjured part of the brain is able to form new connections, leading to short- and long-term improvement in arm function. Animal experiments have shown that early after stroke is the only time that the mechanisms responsible for this can take place. The aim of this study is to find out whether intensive training (arm exercises) is only effective at establishing these new brain connections if given early after stroke.
Who can participate?
Adults who have had a stroke within the past 3 weeks and are suffering from arm weakness.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group complete a course of intensive arm exercises designed to improve movement in their weak arm over 6 days. Those in the second group receive normal care following their stroke and complete the exercises after three months have passed. For participants in both groups, their ability to move and control their arm is measured at the start of the study, after the 6 days of exercise and after three months.
What are the possible benefits and risks of participating?
All participates will have the benefit of receiving or being offered additional arm training either early or later after stroke, which might improve their aim function. They will also have an in-depth assessment, and information about their arm function and any changes throughout the study. The risks associated with single pulse TMS as planned in this trial are very low and patients will be monitored to avoid any possible complications. The arm training may be tiring for participants, however this will also be monitored by the research team.
Where is the study run from?
Salford Royal NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
November 2015 to August 2018
Who is funding the study?
Stroke Association (UK)
Who is the main contact?
Dr Ulrike Hammerbeck
Contact information
Public
Clinical Sciences Building
Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom
 ORCID ID |
0000-0003-2657-4347 |
|---|
Study information
| Study design | Randomised; wait-list controlled trial |
|---|---|
| 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 below to request a patient information sheet |
| Scientific title | Does high repetition reaching training early after a stroke promote recovery by strengthening connections from the hemisphere unaffected by the stroke? |
| Study hypothesis | Early after stroke, intensive arm training can promote a functionally useful contribution from the unaffected brain hemisphere. |
| Ethics approval(s) | Ethics Committee North-West – Greater Manchester West research Ethics Committee, 29/09/2015, ref: 15/NW/0703 |
| Condition | Stroke |
| Intervention | 40 participants with arm weakness are randomly allocated to two groups: Intervention group: Patients will receive early (within the first 6 weeks after stroke) intensive training over 6 days to improve the movement in their arm. Proximal arm training consisting of horizontal reaching movements while gravity is eliminated. A training session consists of 400 repetitions of a 20cm reaching movement. Movement accuracy is measured and rewarded. Control group: Patients receive usual care only for three months, following which they receive the intensive training over 6 days. The way that early reaching training affects the strength of new connections in the brain is measured by using brain stimulation techniques after the intervention. To see if these changes are lasting, the measure will be repeated 3 months after the stroke. |
| Intervention type | Other |
| Primary outcome measure | Motor Evoked Potential to Transcranial Magnetic Stimulation Measures at baseline, 6 and 12 weeks after stroke. |
| Secondary outcome measures | 1. Arm function measured by Motricity Index and Fugl-Meyer score at baseline, 6 and 12 weeks after stroke 2. Reaching accuracy is determined at baseline, 6 and 12 weeks after stroke 3. Feasibility of protocol measured by exit interview at 12 weeks after stroke |
| Overall study start date | 15/11/2015 |
| Overall study end date | 31/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Participant inclusion criteria | 1. Acute stroke patients from Salford Royal Foundation Trust (SRFT) 2. Mild to moderate proximal upper limb weakness (MRC muscle scale 4 or less) 3. Able to reach at least 15cm while supported in the arm-trainer 4. Full upper limb function pre-morbidly |
| Participant exclusion criteria | 1. Contraindications to transcranial magnetic stimulation (TMS), i.e. metal implants or epilepsy. 2. Previous stroke 3. Shoulder pain over 3/10 on visual analogue scale 4. Unable to give informed consent. 5. Severe neglect 6. Complete sensory loss 7. Suspected or confirmed pregnancy |
| Recruitment start date | 15/11/2015 |
| Recruitment end date | 31/10/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Stott Lane
Salford
M6 8HD
United Kingdom
Sponsor information
Hospital/treatment centre
University of Manchester
Oxford Road
Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/027m9bs27 |
|---|
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Preliminary findings of this study will be presented at national (Stroke Forum, Physiotherapy UK) and international conferences (World Congress on Neurorehabilitation, Neural Control of Movement). The final findings will be submitted to peer reviewed journals to demonstrate effectiveness and feasibility of this protocol. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 09/08/2021 | 03/09/2021 | Yes | No | |
| Results article | 04/07/2021 | 03/09/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
03/09/2021: Publication references added.
09/04/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2019 to 31/10/2019
2. The intention to publish date was changed from 31/08/2019 to 31/10/2020
02/04/2019: The condition has been changed from "Topic: Stroke; Subtopic: Rehabilitation; Disease: Therapy type" to "Stroke" following a request from the NIHR.
01/10/2018: The following changes were made to the record:
1. The recruitment end date was changed from 30/04/2018 to 31/03/2019.
2. The intention to publish was updated from 31/12/2018 to 31/08/2019.
3. The overall trial end date was updated from 31/08/2018 to 31/08/2019.
