Condition category
Nervous System Diseases
Date applied
11/11/2015
Date assigned
11/11/2015
Last edited
19/11/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Dr Ulrike Hammerbeck

ORCID ID

http://orcid.org/0000-0003-2657-4347

Contact details

Clinical Sciences Building
Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19819

Study information

Scientific title

Does high repetition reaching training early after a stroke promote recovery by strengthening connections from the hemisphere unaffected by the stroke?

Acronym

Study hypothesis

Early after stroke, intensive arm training can promote a functionally useful contribution from the unaffected brain hemisphere.

Ethics approval

1. Ethics Committee North-West – Greater Manchester West research Ethics Committee, 29/09/2015, ref: 15/NW/0703

Study design

Randomised; wait-list controlled trial

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

Topic: Stroke; Subtopic: Rehabilitation; Disease: Therapy type

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

Phase

Drug names

Primary outcome measures

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 trial start date

15/11/2015

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

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

30/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Salford Royal NHS Foundation Trust
Clinical Sciences Building Stott Lane
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

University of Manchester

Sponsor details

University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Stroke Association

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

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.

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes