Condition category
Nervous System Diseases
Date applied
23/12/2015
Date assigned
23/12/2015
Last edited
19/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer 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 blood flow (ischemia) or a bleed in the brain (intracerebral haemorrhage). The majority of strokes are ischemic strokes, in which the arteries that supply the brain with oxygen (carotid arteries) become narrowed or blocked. Intracerebral haemorrhages (ICH) are much less common than ischemic strokes, and occur when a diseased blood vessel in the brain bursts, causing bleeding which causes a sudden increase of pressure on the brain. One of the most common complications of a stroke is weakness on one side of the body (hemiparesis). This can involve weakness in the arms and/or legs, as well as loss of control over the torso (trunk deficit). Previous studies have shown that in individuals with poor trunk control, such as the ability to sit unsupported (poor sitting balance), are less likely to regain their mobility at six months. Despite this, physiotherapy that specifically targets trunk performance is often neglected during early rehabilitation. It is well recognized that more extensive physical rehabilitation following stroke significantly improves a person’s chance of regaining their mobility. Given that trunk function is a good predictor of future mobility, including specific trunk training in early physiotherapy could play an important role. The aim of this study is to look at the effects of providing additional trunk training during early rehabilitation after stroke in order to find out whether a large-scale study would be possible.

Who can participate?
Adults who have suffered a stroke three to seven days previously who are experiencing hemiparesis in the arm and leg and are unable to sit unsupported for 30 seconds (severe trunk deficit). Adults who have suffered a stroke three to seven days previously who are experiencing hemiparesis in the arm and leg and are unable to sit unsupported for 30 seconds and are unable to make their own decisions (lacking mental capacity).

What does the study involve?
All participants undergo 16 additional hours of trunk training over a period of six to eight weeks as well as standard physiotherapy. This involves functional exercises, such as moving in bed, sitting up and standing, as well as exercises designed to strengthen muscles. At the start of the study, and then again after the trunk training programme and six months later, participants complete a number of questionnaires and movement tests in order to find out whether their condition has improved. The amount of participants who could be recruited to take part is also recorded to find out if it is feasible to conduct a larger study. In a sub-study, ten participants who lack the mental capacity (ability to make decisions) to decide if they want to take part who meet the other inclusion criteria also complete the same training program and follow up assessments, to see if there is any difference.

What are the possible benefits and risks of participating?
Participants benefit from receiving additional therapy sessions which could help to improve their recovery. There are no notable risks of participating, although the extra exercise sessions could make participants feel tired.

Where is the study run from?
Mark ward, St Thomas’ Hospital (UK)

When is the study starting and how long is it expected to run for?
December 2015 to June 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Isaac Sorinola
isaac.2.sorinola@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Isaac Sorinola

ORCID ID

Contact details

Faculty of Life Sciences & Medicine
Room 3.24 Shepherd's House
Guy's Campus
King's College London
London
SE1 1UL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20256

Study information

Scientific title

Additional Trunk Training in Early Stroke Trial (ATTEST): A mixed method feasibility study

Acronym

ATTEST

Study hypothesis

The aim of this study is to carry out a study to determine the feasibility and acceptability of delivering additional trunk training during early rehabilitation after stroke for adults with significant trunk weakness 72 hours post stroke.

Ethics approval

East of England-Essex NHS committee, 13/11/2015, ref: 15/EE/0317
Significant amendment approved 21/06/2016 (HRA approval received 04/08/2016).

Study design

Non-randomised feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

See additional files

Condition

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

Intervention

The patient will receive a minimum of 16 hours of additional trunk training over a 6-8 week period, focussing on strengthening and functional exercises. Specific trunk strength training exercises will be prescribed following an initial assessment of muscle strength. The functional training element will consist of practising functional movements such as bed mobility, lying to sitting, independent sitting, standing and transitions. Sessions will take place daily (as far as possible) and will last for approximately 30 minutes. The training will be in addition to the patient’s usual physiotherapy and take place on the stroke ward, in the hospital gym or in the patient’s place of residence if discharged from acute care before the training is completed.

Participants will be followed up post intervention and at six months.

Sub-study:
Ten participants meeting the main study inclusion/exclusion criteria as detailed above, but who do not have mental capacity to give informed consent will be recruited to participate in this sub-study. Participants will be assessed for capacity by the research nurse as detailed below to comply with the Mental Capacity Act, 2005. If a participant does not have capacity to consent, a personal or nominated consultee will be sought to make a decision on their behalf in their interest.
All other aspects of the study will be identical to the main study.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Feasibility measures of recruitment, retention and attrition will be determined through screening and completion data to measure the number of admitted patients that fulfil the study inclusion/exclusion criteria; consent to take part in the study; complete the trunk training intervention; and complete baseline, post intervention and 6 month follow up assessments of the secondary outcome measures.

Secondary outcome measures

1. Trunk impairment is measured using the Trunk Impairment Scale at baseline, post intervention and at 6 months follow-up
2. Mobility is measured using the Modified Rivermead Mobility Index at baseline, post intervention and at 6 months follow-up
3. Quality of life is measured using the Stroke Specific Quality of Life Scale and SF-6D at baseline, post intervention and at 6 months follow-up
4. Quality of life and health costs (QALYs) are measured using the EQ5D-5L at baseline, post intervention and at 6 months follow-up

Overall trial start date

01/12/2015

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria (updated on 19/09/2016):
1. Aged 18 years or over
2. Between day 3 and day 7 of a supra tentorial lesion associated with an ischaemic or haemorrhagic stroke
3. With hemiparesis involving the arm and leg
4. Able to understand and follow a one-stage command
5. With significant trunk deficit evidenced by an inability to sit independently for 30 seconds
6. Able to provide informed consent in accordance with the Mental Capacity Act (2005)
7. Patients with mild aphasia can be included, the consent procedure will be facilitated using pictorial aphasia-friendly participant information booklets and communication other than spoken language (for example, gestures, strategic use of environmental cues) in line with Connect recommendations
8. Non-English speakers will be included if the aid of an interpreter is available via the NHS

Sub-study:
1. Those meeting inclusion criteria (above)
2. Lacking mental capacity to give informed consent

Original inclusion criteria:
1. Aged 18 years or over
2. Between day 3 and day 7 of a first supra tentorial lesion associated with an ischaemic or haemorrhagic stroke
3. With hemiparesis involving the arm and leg
4. Able to understand and follow a two-stage command
5. With significant trunk deficit evidenced by an inability to sit independently for 30 seconds
6. Able to provide informed consent in accordance with the Mental Capacity Act (2005)
7. Patients with mild aphasia can be included, the consent procedure will be facilitated using pictorial aphasia-friendly participant information booklets and communication other than spoken language (for example, gestures, strategic use of environmental cues) in line with Connect recommendations
8. Non-English speakers will be included if the aid of an interpreter is available via the NHS

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 20; UK Sample Size: 20

Participant exclusion criteria

Exclusion criteria (updated on 19/09/2016):
1. Individuals with brainstem or cerebellar strokes associated with severe symptoms of dizziness or positional vertigo exacerbated by exercise. Screening for severe dizziness will be ascertained by the medical staff before recruiting.
2. Clinically significant pre-morbid levels of disability
3. Not medically stable as defined by the medical team

Original exclusion criteria:
1. Individuals with brain stem, cerebellar or multiple stroke lesion
2. Previous neurological disease affecting motor performance
3. Not medically stable

Recruitment start date

01/02/2016

Recruitment end date

30/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Thomas’ Hospital
Mark ward Guy’s and St Thomas’ NHS Foundation Trust Westminster Bridge Road
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Keith Brennan
Director of Research Management
Director of Administration (Health Schools)
K0.58 King’s Building Strand Campus
London
WC2R 2LS
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. Protocol paper - intend to submit to Trials (BMC) early-mid 2016
2. Feasibility paper- aim to submit late 2017

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/09/2016: The ethics approval, inclusion and exclusion criteria have been updated. In addition, information about a sub-study with patients lacking mental capacity to consent has been added to the inclusion criteria, interventions and plain English summary. 22/04/2016: Verified study information with principal investigator.