Condition category
Circulatory System
Date applied
25/04/2013
Date assigned
18/06/2013
Last edited
17/12/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Stroke is one the major common causes of severe disability in the UK with over a quarter of a million people living with disability. Stroke is also the third most common cause of death in the UK. It costs society, based on treatment of stroke and productivity loss, £8.9 billion annually. The aim of this study is to find out whether use of the optokinetic chart stimulation protocol (OKCSIB) and conventional activities such as transfers and walking, restore movements, improve function and improve quality of life in new stroke patients who are completely paralysed on their affected side when compared to conventional physiotherapy alone.

Who can participate?
Written informed consent will be obtained from patients who are completely paralysed on one side and are between the ages of 55 and 85 years when they are admitted to the stroke ward at the William Harvey Hospital.

What does the study involve?
The study treatment consists of an optokinetic chart that is moved in front of the patient horizontally, vertically and forwards for three minutes. Sensory interaction for balance will be tested once patients can stand with assistance of, at most, two members of staff. Conventional therapy activities such as sitting, transfers and walking, as appropriate, will continue to be carried out. The control group will receive only the conventional therapy.

What are the possible benefits and risks of participating?
The benefits of participating in the study are not yet fully known as this is a new treatment. However, early studies report improvements in voluntary movements, function and walking. You may feel dizzy and tired during the therapy.

Where is the study run from?
The study will be run from the William Harvey Hospital, UK. This will be the only centre.

When is the study starting and how long is it expected to run for?
The study starts in June 2013 and will run for 18 months.

Who is funding the study?
East Kent Hospitals University NHS Foundation Trust, UK.

Who is the main contact?
Mr Benjamin Chitambira
bchitambira@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Mr Benjamin Chitambira

ORCID ID

Contact details

Richard Stevens Ward
William Harvey Hospital
Kennington Road
Willesborough
Ashford
TN24 0LZ
United Kingdom
+44 (0)12 3361 6242
bchitambira@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OKS4 Version 2.1

Study information

Scientific title

Comparison of the extent of the restoration of voluntary movement, functional abilities and quality of life between dense strokes treated by optokinetic chart stimulation based OKCSIB protocol and those treated by conventional neurophysiotherapy: a prospective single-blind pilot randomised controlled trial

Acronym

OKCSIB

Study hypothesis

It is hypothesised that the optokinetic chart based OKCSIB protocol and conventional activities such as transfers and mobilisation will lead to improved recovery of voluntary movements of affected upper and lower limbs, function, quality of life as well as reduce cost of formal care when compared to conventional neurophysiotherapy.

On 15/09/2014 the overall trial end date was changed from 31/10/2014 to 31/12/2014.
On 07/01/2015 the overall trial end date was changed from 31/12/2014 to 30/06/2015.

Ethics approval

London - Surrey Borders Research Ethics Committee, 10/05/2013, ref: 13/LO/0483

Study design

Single-blind pilot 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 the contact details below to request a patient information sheet

Condition

Stroke

Intervention

1. Optokinetic chart stimulation in three planes (horizontal, vertical and forward) for three minutes in each plane, sensory interaction for balance added once patients can stand with assistance and conventional functional activities VS
2. Conventional neurophysiotherapy as control

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Current primary outcome measures as of 15/09/2014:
STREAM: The outcomes will be taken at 8 weeks, 14 weeks and the 3 months after the 14th week. This is because up to 8 weeks intervention may be in hospital, then 6 weeks intervention in the community, after which the participants are discharged. Follow-up outcomes are then taken 3 months after the final discharge to see if effects are long lasting.

Previous primary outcome measures:
STREAM: The outcomes will be taken at 8 weeks, 14 weeks and the 3 months after the 14th week. This is because 8 weeks intervention will be in hospital, then 6 weeks intervention in the community, after which the participants are discharged. Follow-up outcomes are then taken 3 months after the final discharge to see if effects are long lasting.

Secondary outcome measures

1. Barthel Index
2. Stroke-Specific Quality of Life
3. Modified Ashworth Scale
4. Cost of formal care

Overall trial start date

01/06/2013

Overall trial end date

30/06/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 15/09/2014:
1. Patients with stroke that completely paralyses the affected side with loss of voluntary movement on assessment as signified by 0/5 on the Oxford Scale, 0/20 on the Stroke Rehabilitation Assessment of Movement (STREAM) Scale for each of the affected upper and lower limb or a score of 4/4 on the NIHSS Scale for each affected upper and lower limb
2. Between 55 and 85 years of age
3. Full use of affected limbs before current admission
4. Independently mobile before the stroke
5. Conscious
6. Living within the catchment area of William Harvey Hospital for follow-up purposes
7. Able to consent

Previous inclusion criteria:
1. Patients with stroke that completely paralyses the affected side with loss of voluntary movement on assessment as signified by 0/5 on the Oxford Scale, 0/20 on the Stroke Rehabilitation Assessment of Movement (STREAM) Scale for each of the affected upper and lower limb or a score of 4/4 on the NIHSS Scale for each affected upper and lower limb
2. Between 75 and 85 years of age
3. Full use of affected limbs before current admission
4. Independently mobile before the stroke
5. Conscious
6. Living within the catchment area of William Harvey Hospital for follow-up purposes
7. Able to consent

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

8

Participant exclusion criteria

Current exclusion criteria as of 15/09/2014:
1. Patients with stroke that leads to simultaneous involvement of temporal and parietal lobes.
2. Under 55 years of age and over 85 years of age
3. Pure posterior circulation stroke without middle cerebral artery territory involvement
4. Extensive small vessels disease co-morbidity as reported by an expert neuro-radiologist
5. Partial loss of movement as denoted by scores of 1/5 or above on the Oxford Scale
6. Unconscious
7. Lack of voluntary movements before current stroke
8. Living out of William Harvey Hospital catchment area
9. Dementia and other forms of cognitive impairment
10. Blindness

Previous exclusion criteria:
1. Patients with stroke that leads to simultaneous involvement of temporal and parietal lobes.
2. Under 75 years of age and over 85 years of age
3. Pure posterior circulation stroke without middle cerebral artery territory involvement
4. Extensive small vessels disease co-morbidity as reported by an expert neuro-radiologist
5. Partial loss of movement as denoted by scores of 1/5 or above on the Oxford Scale
6. Unconscious
7. Lack of voluntary movements before current stroke
8. Living out of William Harvey Hospital catchment area
9. Dementia and other forms of cognitive impairment
10. Blindness

Recruitment start date

11/02/2014

Recruitment end date

12/02/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

William Harvey Hospital
Ashford
TN24 0LZ
United Kingdom

Sponsor information

Organisation

East Kent Hospitals University NHS Foundation Trust (UK)

Sponsor details

c/o Dr Art Ationu
Research and Development Directorate
Coombe Valley Road
Buckland Hospital
Dover
CT17 0HD
United Kingdom
+44 (0)13 0422 2561
art.ationu@nhs.net

Sponsor type

Hospital/treatment centre

Website

http://www.ekhuft.nhs.uk/staff/clinical/research-development/

Funders

Funder type

Hospital/treatment centre

Funder name

East Kent Hospitals University NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Internal Project Grant Scheme 2012

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Local NHS Trust conference abstract submission by 19/03/2015
Abstract submission for conference proceedings by 31/05/2015
Scientific journal submission by 31/05/2015
Dissmination to local stroke survivors and carers organisation by 31/07/2015

Intention to publish date

31/05/2015

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.peertechz.com/Novel-Physiotherapy-Physical-Rehabilitation/pdf/JNPPR-2-125.pdf

Publication citations

Additional files

Editorial Notes