Condition category
Signs and Symptoms
Date applied
21/05/2010
Date assigned
21/05/2010
Last edited
05/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rebecca Palmer

ORCID ID

Contact details

University of Sheffield
107 Innovation centre
217 Portobello
Sheffield
S1 4DP
United Kingdom
r.l.palmer@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7203

Study information

Scientific title

Evaluating the cost effectiveness of computer therapy compared with usual stimulation for people with long standing aphasia: a feasibility study [Previously known as Computerised Word Finding Therapy for Stroke]

Acronym

CACTUS

Study hypothesis

Aphasia is a communication disorder often caused by stroke. It can affect the ability to understand what is said, the ability to produce correct words and the ability to read and write. People with aphasia rarely receive treatment from NHS speech and language therapists for more than 3 months. It has been established that people with aphasia can continue to improve their communication with prolonged treatment (beyond 12 months). However this is rarely available. Surveys indicate that people with aphasia and their families often feel abandonned when therapy is discontinued and want to continue making efforts to improve (Stroke Survey 2006).

Step-by-Step is a computer program designed to help people to practise exercises to improve their ability to find the correct words when they are talking. This study aims to evaluate the feasibility of carrying out a large study to compare computer therapy with the usual stimulation provided for people with aphasia in stroke clubs or at home to see if use of computer software with assistance from a carer/volunteer can improve the ability of people with aphasia to talk. People who use the computers for treatment will be interviewed to find out how they found working with computers.

This research will test the methods for a randomised controlled trial to help establish whether people with aphasia can continue to improve their ability to talk after completion of traditional NHS therapy, and whether this can be achieved cost-effectively by offering computer treatment at home and in voluntary sector settings. Potential benefits to patients include the opportunity for continued treatment and thus improved ability to talk. It could also give patients independence and control over their therapy. The NHS would benefit by being able to support a long term aphasia treatment service without increasing demand on therapy resources.

Ethics approval

NHS Bradford Research Ethics Committee approved on the 15th April 2009 (ref: 09/H1302/20)

Study design

Multicentre randomised interventional treatment 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

Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Community study

Intervention

Thirty participants with aphasia will be recruited. Participants will be randomly allocated to computer treatment using Step-by-Step word finding software by Jane Mortley (group 1) or usual care (group 2). Group 1 will carry out computer exercises independent of a speech therapist for 5 months. Support will be provided only by stroke volunteers or carers. Structured interviews about the use of computers will be carried out with participants.

Study entry: single randomisation only

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Recruitment rate, measured at baseline, 5 months and 8 months.

Secondary outcome measures

Measured at baseline, 5 months and 8 months:
1. Acceptability of using computer based word finding therapy
2. Change in participation and wellbeing
3. Change in word retrieval
4. Estimation of effect size
5. Quality adjusted life years
6. Resource use data

Overall trial start date

30/10/2009

Overall trial end date

30/09/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of stroke and aphasia with word finding difficulties as one of the predominant features as assessed by the Comprehensive Aphasia Test (CAT)
2. No longer receiving treatment from a speech and language therapist so that the computer treatment can be better isolated and evaluated
3. First stroke and reported by close relatives/friends to have had no speech or language difficulty pre-stroke to isolate cause
4. Both male and female 18 years or above with no upper age limit

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 30; UK sample size: 30

Participant exclusion criteria

Severe visual or cognitive difficulties reducing ability to use the computer program, tested by the ability to see and perform a simple, non-verbally based computer game.

Recruitment start date

30/10/2009

Recruitment end date

30/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Sheffield
Sheffield
S1 4DP
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Sponsor details

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Sponsor type

Government

Website

http://www.sth.nhs.uk/

Funders

Funder type

Government

Funder name

National Insititute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 resutls in http://www.ncbi.nlm.nih.gov/pubmed/22733794

Publication citations

  1. Resutls

    Palmer R, Enderby P, Cooper C, Latimer N, Julious S, Paterson G, Dimairo M, Dixon S, Mortley J, Hilton R, Delaney A, Hughes H, Computer therapy compared with usual care for people with long-standing aphasia poststroke: a pilot randomized controlled trial., Stroke, 2012, 43, 7, 1904-1911, doi: 10.1161/STROKEAHA.112.650671.

Additional files

Editorial Notes