Condition category
Nervous System Diseases
Date applied
09/08/2018
Date assigned
13/08/2018
Last edited
13/08/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Many stroke survivors have difficulty using their arm or hand, which can affect them and their carers in many different ways. Many people need rehabilitation to improve arm function after a stroke. We already know that therapy that promotes using the affected arm in daily activities is most likely to help. A growing number of studies suggest that more therapy is needed to improve arm function after stroke than what is provided routinely. Stroke survivors, carers and health care professionals have indicated that further research on arm rehabilitation is a top priority.
More research is needed into the amount of extra arm therapy is required to make a difference, along with when is best to give this extra arm therapy. This study aims to look at the effectiveness of a new arm rehabilitation programme for people who have difficulties using their arm or hand after a recent stroke.

Who can participate?
Adults who have had a stroke in the previous 3 weeks and have difficulty using their arm and/or hand as a result of their stroke

What does the study involve?
All participants will receive the usual care and will be randomised into 3 groups:
1. Extra arm physiotherapy early after stroke (within 3 weeks after stroke) and usual care (early group)
2. Extra arm physiotherapy later after stroke (starting 3 months after stroke) and usual care (later group)
3. Usual care only (control group)
For all participants, the intervention will last for a total of 27 hours over 6 weeks. This will be 45 minutes per day, divided depending on each participant's tolerance (e.g. 15 minutes 3 times per day), 6 days per week over 6 weeks.

What are the possible benefits and risks of participating?
The possible benefit to participants is that those in the groups allocated to receive extra arm physiotherapy may see more improvement in their arm/hand function as a result; however, this cannot be guaranteed. The only risks associated with this study are standard risks associated with arm physiotherapy. The extra amount of arm physiotherapy may lead to tiredness or soreness during or after therapy; however, this should only be short-lived.

Where is the study run from?
Glasgow Caledonian University and includes 5 sites across NHS Lanarkshire and NHS Greater Glasgow & Clyde in the UK, where participants will be recruited from.

When is the study starting and how long is it expected to run for?
July 2013 to August 2018

Who is funding the study?
The Charitable Trust of the Chartered Society of Physiotherapy (UK)

Who is the main contact?
Prof. Frederike van Wijck
frederike.vanwijck@gcu.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Frederike van Wijck

ORCID ID

http://orcid.org/0000-0003-0855-799X

Contact details

Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
+441413318967
Frederike.vanWijck@gcu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3

Study information

Scientific title

Early VERsus Later Augmented Physiotherapy compared with usual upper limb physiotherapy: an exploratory randomised controlled trial of arm function after stroke

Acronym

EVERLAP

Study hypothesis

The aim of this study is to test the feasibility of conducting a definitive three-arm randomised controlled trial of arm physiotherapy after stroke, and to determine its methodology, size and cost.

Ethics approval

West of Scotland Research Ethics Committee 5, 26/11/2014, 14/WS/1136

Study design

Interventional multi-centre single-blinded three-armed exploratory randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Stroke

Intervention

Participants will be randomly allocated into 3 groups. The Glasgow Clinical Trials Unit (UKCRC-registered, no. 16) provides a telephone randomisation service for this study. Participants are allocated to groups in equal numbers, minimised by baseline severity based on ARAT scores (severe: 0 ≤ ARAT ≤ 3; moderate: 4 ≤ ARAT ≤ 28; mild: 29 ≤ ARAT ≤ 56) 17. Randomisation takes place after baseline assessments, by telephone to an interactive voice response system to conceal future allocations. A minimisation schedule ensures equal allocation to each group within each stratum. At randomisation, each participant is allocated a unique participant code which is used to identify their study data. Participants’ personal data are not used in any study documentation or study data.
All 3 groups will receive usual arm physiotherapy, and 2 of the 3 groups will receive additional, augmented arm physiotherapy delivered at different time points after stroke. The 3 groups will receive the following treatment:
1. The early group will receive early intervention treatment, in addition to usual arm physiotherapy. Participants in the early group will receive augmented arm physiotherapy, involving tailored strategies primarily aimed at improving functional activity of the affected arm and hand within 3 weeks after stroke. Therefore, these participants receive an extra 27 hours of physiotherapy over 6 weeks, with each session lasting for 45 minutes per day (divided depending on individual tolerance, e.g. 15 minutes, 3 times per day), 6 days per week, over a period of 6 weeks. To enhance self-management, research physiotherapists will provide participants with a choice of a home upper limb activity DVD, a workbook, or a novel mobile phone/tablet reminder service to remind participants to increase upper limb activity.
2. The later group will receive late intervention treatment, in addition to usual arm physiotherapy. Participants in the later group will receive the same treatment as the early group; however instead, they will receive this 3 months after their stroke.
3. The control group will receive usual arm physiotherapy only, which consists of routine interventions delivered after a stroke, including those targeting positioning, sensory awareness, pain, hypertonia, and shoulder complications, along with function. Participants in the control group will not be offered the DVD/workbook/mobile phone reminder service
Participants in all 3 groups will be assessed at 4 timepoints - the baseline (3 weeks after stroke), 9 weeks, 16 weeks and at the follow-up (24 weeks). This includes assessments before and after the intervention for the early and later intervention groups. All 3 groups will be assessed at these same 4 timepoints to explore immediate and longer term intervention effects and compare recovery curves.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Action Research Arm Test (ARAT)

Secondary outcome measures

Secondary outcome measures 1-12 will be assessed at the baseline (3 weeks after stroke), 9 weeks, 16 weeks and at the follow-up (24 weeks):
1. Arm activity in free-living conditions, assessed using body worn triaxial accelerometers
2. Self-reported arm activity, assessed using the 14-item Motor Activity Log (MAL 14)
3. Patient-selected goals and goal attainment, assessed using the Canadian Occupational Performance Measure (COPM)
4. Independence in activities of daily living, assessed using the Barthel Index of Activities of Daily Living
5. Motor performance, assessed during the Action Research Arm Test (ARAT):
5.1. Movement duration
5.2. Trunk movement
6. Grip strength, assessed using a Jamar dynamometer
7. Muscle strength, assessed using the arm section of Motricity Index
8. Mood, assessed using the Hospital Anxiety and Depression Scale (HADS)
9. Self-reported impairment, participation and health-related quality of life, assessed using the Stroke Impact Scale (SIS)
10. Self-reported health-related quality of life, assessed using the EuroQol-5D (EQ-5D)
11. Carer burden, assessed using Caregiver’s Burden Scale
12. Resource impacts:
12.1. Capital (space and equipment)
12.2. Labour (physiotherapy whole time equivalents, employed in the usual and augmented arm physiotherapy)
12.3. Consumables
12.4. Private costs, assessed using a bespoke participant questionnaire
13. Acceptability, assessed through exit interviews with participants in the intervention groups (augmented arm physiotherapy groups) only at the end of the augmented arm physiotherapy intervention
14. Recruitment, retention and adherence rates, assessed by the number of patients approached, deemed eligible and recruited, the number of dropouts (including withdrawals) and the number of therapy sessions taken, recorded from the first approach about the study by clinical staff through to the follow-up (24 weeks)
15. Safety, assessed from the baseline through to the follow-up (24 weeks):
15.1. Participants will be asked at each visit about any adverse events since the previous visit. Only those classed as serious will be recorded (e.g. events that result in permanent impairment, or in-patient hospitalisation), 15.2. Pain, assessed using a numeric pain rating scale (NPRS)
16. Resource impacts

Overall trial start date

17/07/2013

Overall trial end date

17/08/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged at least 18 years
2. Diagnosis of stroke, as confirmed by CT/MRI scans
3. Stoke-related upper limb impairment (score 0-56 on the Action Research Arm Test (ARAT))
4. Capable of undertaking the allocated physiotherapy intervention and adhering to the study protocol, as per judgement of the treating clinician
5. Able to provide informed consent to participate in the study
6. Living within the community services catchment area of a participating study centre

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75

Participant exclusion criteria

Any factors likely to interfere with participation in the intervention, including:
1. Medically unstable
2. Severe cognitive/communication impairment (e.g. unable to follow a 2 step command)
3. Severe depression/anxiety
4. Other upper limb impairment:
4.1. Fixed contracture
4.2. Frozen shoulder
4.3. Severe arthritis
4.4. Upper limb pain that inhibits participation
5. Registered blind
6. Terminal cancer

Recruitment start date

20/04/2016

Recruitment end date

14/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Monklands Hospital
Monkscourt Avenue
Airdrie
ML6 0JS
United Kingdom

Trial participating centre

Hairmyres Hospital
Eaglesham Road
East Kilbride
G75 8RG
United Kingdom

Trial participating centre

Wishaw General Hospital
50 Netherton Street
Wishaw
ML2 0DP
United Kingdom

Trial participating centre

Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom

Trial participating centre

Western Infirmary
Dumbarton Road
Glasgow
G11 6NT
United Kingdom

Trial participating centre

Glasgow Caledonian University
Cowcaddens Road
Glasgow
G0 4BA
United Kingdom

Sponsor information

Organisation

Glasgow Caledonian University

Sponsor details

Cowcaddens Road
Glasgow
G4 0BA
United Kingdom

Sponsor type

University/education

Website

www.gcu.ac.uk

Funders

Funder type

Not defined

Funder name

Chartered Society of Physiotherapy Charitable Trust

Alternative name(s)

CSP Charitable Trust, The Chartered Society Of Physiotherapy Charitable Trust, CSPCT

Funding Body Type

private sector organisation

Funding Body Subtype

Associations and societies (private and public)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in Physiotherapy and other high-impact, peer-reviewed journals in 2019

Intention to publish date

31/07/2019

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes