Condition category
Circulatory System
Date applied
04/07/2016
Date assigned
19/12/2016
Last edited
19/12/2016
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 an artery (ischaemic stroke) or a bleed (haemorrhagic stroke). A large proportion of stroke victims suffer from long-term complications depending on the area of the brain that is affected, affecting their ability to speak, think and move. People with severe stroke experience significant muscle weakness which means that they spend much of their time in bed or sitting. This inactivity can cause their muscles to become even weaker and stiffer and may lead them to experience sudden drops in blood pressure when they move from lying to standing (orthostatic hypotension (OH). This further interferes with their ability to participate in intensive stroke rehabilitation, overall recovery and quality of life. Currently physiotherapy for people with severe stroke concentrates on practicing tasks such as getting in and out of bed into a chair that are important for independence and achieving safe discharge home. Standing up early after a stroke may help strengthen muscles, reduce OH and minimise or prevent muscles becoming stiff and weaker. A standing frame has the ability to assist people with severe stroke safely into a supported standing posture, however there are not given to patients when discharged and are not often used in stroke rehabilitation units. This study aims to assess whether it is possible for people with severe stroke to use a standing frame to practice functional movements such as standing and moving between sitting and standing during their hospital-based rehabilitation.

Who can participate?
Adults with severe stroke who are patients in participating Stroke Rehabilitation Units in Cornwall and Devon.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in the functional standing frame programme. This involves a maximum of 30 minutes using the standing frame plus an additional 15 minutes to provide time for usual physiotherapy where participants may practise transfers, arm activities or activities chosen by participants or guided by physiotherapists. Participants will undertake the functional standing frame programme for ideally up to five days per week for a total of three weeks. Those in the second group practice routine physiotherapy stroke rehabilitation for 45 minutes per day (or as long as a tolerated) ideally up to five days per week for three weeks. Participants in both groups complete a range of assessments and questionnaires at the start of the study and then again after three, six and twelve months to assess their function and ability to undertake activities of daily living.

What are the possible benefits and risks of participating?
Participants who use the standing frame may benefit from improvements to their symptoms and enhanced recovery. There are no notable risks involved with participating.

Where is the study run from?
1. Camborne Redruth Community Hospital (UK)
2. Bodmin Community Hospital (UK)
3. Skylark Ward, Stroke Rehabilitation Unit (UK)
4. Elizabeth Ward, Stroke Rehabilitation Unit (UK)

When is the study starting and how long is it expected to run for?
April 2016 to March 2019

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

Who is the main contact?
Miss Angie Logan
angie.logan@plymouth.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Angie Logan

ORCID ID

Contact details

Room S35
Knowledge Spa
Plymouth University
Faculty of Health & Human Sciences
Royal Cornwall Hospital
Truro
TR1 3HD
United Kingdom
+44 7891 336743
angie.logan@plymouth.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ICA-CDRF-2015-01-044

Study information

Scientific title

A randomised controlled feasibility study to investigate the effects of a functional standing frame programme versus usual physiotherapy in people with severe sub-acute stroke on function, quality of life and neuromuscular impairment

Acronym

SPIRES

Study hypothesis

The aim of this study is to find out whether a functional standing frame programme for people with severe stroke is feasible to implement in a sub-acute inpatient rehabilitation setting and if it leads to an improvement in functional ability and quality of life, orthostatic hypotension and a reduction in neuromuscular impairment.

Ethics approval

South West Research Ethics Committee, 03/08/2016, ref: 16/WA/0229

Study design

Multi-centre randomised controlled feasibility trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Stroke

Intervention

Participants will be randomised using a secure web-based system and a minimisation algorithm. The minimisation procedure will minimise group imbalance among the two intervention groups. Groups will be matched for:
1. Fatigue (fatigue Vs. no/minimal fatigue)
2. OH (hypotension Vs. no hypotension)

Functional standing frame programme (intervention group):
The intervention will occur for a period of three weeks and will start as early as possible after randomisation to ensure that the treatment can be completed whilst an inpatient. The functional standing frame programme will occur in a SRU gym/therapy room which is private. The functional standing frame programme involves a maximum of 30 minutes using the standing frame plus an additional 15 minutes to provide time for usual physiotherapy where participants may practise transfers, upper limb activities or activities chosen by participants or guided by physiotherapists. Participants will undertake the functional standing frame programme for ideally up to five days per week which is aligned with the Royal College of Physicians Guidelines.

Usual physiotherapy (control group):
This is defined as routine physiotherapy stroke rehabilitation for 45 minutes per day (or as long as a tolerated) ideally up to five days per week for three weeks, which is aligned with Royal College of Physicians Guidelines.

Participants in both groups are followed up after 3, 6 and 12 months.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Function/ability to undertake activities of daily living is measured using the Barthel Index of Activities of Daily Living and Edmans Activities of Daily Living Index for Stroke Patients at baseline, 3, 6 and 12 months.

Secondary outcome measures

1. Blood pressure is measured using sphygmomanometer at baseline, 3, 6 and 12 months
2. Knee muscle strength is measured using hand held dynamometer at baseline, 3, 6 and 12 months
3. Length of muscles at hip, knee and ankle is measured using Goniometry at baseline, 3, 6 and 12 months
4. Muscle tone is measured using the Modified Ashworth Scale at baseline, 3, 6 and 12 months
5. Balance/trunk control is measured using the Trunk Control Test at baseline, 3, 6 and 12 months
6. Mood is measured using the PHQ-9/SAD-Q10 at baseline, 3, 6 and 12 months
7. Quality of life is measured using the Stroke & Aphasia Quality of Life Scale-39 at baseline, 3, 6 and 12 months
8. Quality of life is measured using the EQ-5D-5L at baseline, 3, 6 and 12 months
9. Fatigue is measured using the Fatigue Visual Analogue Scale at baseline, 3, 6 and 12 months

Overall trial start date

01/04/2016

Overall trial end date

31/03/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. New (first/recurrent) clinical diagnosis of stroke, cerebral haemorrhage or infarct confirmed by consultant or CT scan leading to admission to the SRU
2. Aged 18 years and over
3. Graded as mRS 4 or 5 and/or NIHSS≥16 (severe or very severe stroke and unable to stand without support/mechanical aid and assistance of two people)
4. Able to give informed consent or assent from a consultee
5. Conscious and responsive to verbal commands

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 in total (25 in each group)

Participant exclusion criteria

1. Systolic blood pressure ≤100mmHg or ≥220mmHg at rest lying or sitting
2. Oxygen saturation ≤87% with or without supplementary oxygen (e.g. severe acute/chronic cardiorespiratory disease)
3. Resting heart rate of ≤40 or ≥110 beats per minute (e.g. cardiovascular instability)
4. Temperature ≥38.5 degrees centigrade or ≤35 degrees centigrade
5. Orthopaedic impairments which prevent full weight bearing in standing
6. Malnutrition Universal Screening Tool score of ≥2, or not meeting nutritional demands for therapeutic interventions
7. Documented clinical decision for receiving end of life care
8. Unstable coronary or other medical condition that is judged by the PI/CI or clinical team to impose a medical risk to the patient by involvement in the study
9. Severe communication and/or cognitive deficit which affects their ability to follow instructions (e.g. assessed functionally by specialist clinicians as being a risk to themselves or others due to their inability to follow non-verbal prompts or are behaving erratically)
10. Immobile and not weight bearing pre-stroke
11. Additional neurological deficits unrelated to the current or past stroke (e.g. peripheral neuropathy or Multiple Sclerosis), because these impairments are not related to the condition of interest
12. Weight of 115kg or more, this is the weight limit on the standing frames
13. Being discharged out of county, e.g. admitted during holiday/visit to Cornwall or Devon because they would be unable to participate in follow-up assessments
14. Already registered in an intervention trial

Recruitment start date

20/12/2016

Recruitment end date

31/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Camborne Redruth Community Hospital
Lanyon Ward, Stroke Rehabilitation Unit Cornwall Partnership Foundation NHS Trust Barncoose Terrace
Redruth, Cornwall
TR15 3ER
United Kingdom

Trial participating centre

Bodmin Community Hospital
Woodfield Ward, Stroke Rehabilitation Unit Cornwall Partnership Foundation NHS Trust Boundary Road
Bodmin, Cornwall
PL31 2QT
United Kingdom

Trial participating centre

Skylark Ward, Stroke Rehabilitation Unit
Mount Gould Community Hospital Livewell Southwest
Plymouth
PL4 7PY
United Kingdom

Trial participating centre

Elizabeth Ward, Stroke Rehabilitation Unit
Bideford Community Hospital North Devon Healthcare Abbotsham Rd
Bideford
EX39 3AG
United Kingdom

Sponsor information

Organisation

Royal Cornwall Hospitals NHS Trust

Sponsor details

Knowledge Spa
Royal Cornwall Hospitals
Truro
TR1 3HD
United Kingdom

Sponsor type

Hospital/treatment centre

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

Planned publication in a high-impact peer reviewed journal.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/03/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes