Computer therapy versus usual stimulation for people with long standing aphasia

ISRCTN ISRCTN91534629
DOI https://doi.org/10.1186/ISRCTN91534629
Secondary identifying numbers 7203
Submission date
21/05/2010
Registration date
21/05/2010
Last edited
27/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rebecca Palmer
Scientific

University of Sheffield
107 Innovation centre
217 Portobello
Sheffield
S1 4DP
United Kingdom

Email r.l.palmer@sheffield.ac.uk

Study information

Study designMulticentre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluating 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]
Study acronymCACTUS
Study objectivesAphasia 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(s)NHS Bradford Research Ethics Committee approved on the 15th April 2009 (ref: 09/H1302/20)
Health condition(s) or problem(s) studiedTopic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Community study
InterventionThirty 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 typeOther
Primary outcome measureRecruitment rate, measured at baseline, 5 months and 8 months.
Secondary outcome measuresMeasured 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 study start date30/10/2009
Completion date30/09/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned sample size: 30; UK sample size: 30
Total final enrolment34
Key inclusion criteria1. 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
Key exclusion criteriaSevere 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.
Date of first enrolment30/10/2009
Date of final enrolment30/09/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Sheffield
Sheffield
S1 4DP
United Kingdom

Sponsor information

Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
England
United Kingdom

Website http://www.sth.nhs.uk/
ROR logo "ROR" https://ror.org/018hjpz25

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/07/2012 Yes No

Editorial Notes

27/10/2022: The total final enrolment has been added.