Speech or Language Impairment Following StrokeNCT00158106
Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)
A study testing Speech and Language therapy for dysarthria and/or aphasia in people with Speech or Language Impairment Following Stroke, run by NHS Health Technology Assessment Programme at 1 site in United Kingdom.
Trial summary
This study investigates the effectiveness and cost-effectiveness of speech and language therapy for adults who suffer communication difficulties following a stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Speech or Language Impairment Following Stroke
- What is being tested?
- Speech and Language therapy for dysarthria and/or aphasia
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2005to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with communication impairment following a new stroke
Who cannot join
- Not fluent in the English language
- Subarachnoid haemorrhage
- Pre-existing, progressive dementia or learning disability
- Palliative care only or deceased since admission
- Resident outside the treatment area
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Communication and Deafness, School of Psychological Sciences, Humanities Devas Street, The University of Manchester
Manchester, M13 9PL
About this study
This study investigates the effectiveness and cost-effectiveness of speech and language therapy for adults who suffer communication difficulties following a stroke.
Read the detailed description
Research Question: This is the pilot phase of a two-phase study. Phase 1 - What is the feasibility of conducting a randomised controlled trial of therapy for adults with post-stroke communication impairment? to be followed in 2006 by Phase 2 - What are the effectiveness, costs and service user preferences, for the provision of speech and language therapy for communication difficulties experienced by people in hospital with a stroke? Methodology: Phase 1 - Qualitative (focus groups \& individual interviews) and quantitative (pilot RCT). Phase 2 - Qualitative (focus groups \& individual interviews) and quantitative (a pragmatic, multicentred, randomised controlled trial, stratified by diagnosis and therapist/centre, using an 'intention to treat' approach). Discrete choice experiments will be used to determine cost effectiveness.
Outcome Measures: The primary outcome will be functional communicative ability. The economic analysis will estimate the incremental cost effectiveness and net benefit of the intervention group compared to the control group from a societal perspective. The qualitative study will examine service users' and carers' perspectives on the process and effects of Speech and Language Therapy or the control treatment.
Sample Group: Adults with dysarthria or aphasia, seen early after admission to hospital with a stroke. Exclusions: subarachnoid haemorrhage, progressive dementia, expected recovery without therapy.
- Being tested
- Speech and Language therapy for dysarthria and/or aphasia
- Keywords
- functional communicative ability, cost effectiveness, service user preferences
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech and Language therapy for dysarthria and/or aphasiaProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be functional communicative ability.
Secondary outcomes (1)
The economic analysis to estimate incremental cost effectiveness and net benefit of the intervention. Qualitative study to examine service users' and carers' perspectives Speech and Language Therapy vs control treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech or Language Impairment Following StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- NHS Health Technology Assessment Programme
- Sponsor type
- University, hospital or other
- Investigators
- Audrey Bowen, PhD, Principal investigator, The University of Manchester, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158106
- Sponsor's protocol ID
- HTA ref. 02/11/04
- Other IDs
- ISRCTN78617680, 04/MRE03/30
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 12 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Communication Therapy in the North West (The ACT NoW Pilot Study)
- ClinicalTrials.gov ID
- NCT00158106
- Acronym / sponsor ID
- HTA ref. 02/11/04
- Keywords
- functional communicative ability, cost effectiveness, service user preferences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- NHS Health Technology Assessment ProgrammeUniversity, hospital or other
- Study start
- Feb 2005
- Study completion
- Aug 2005
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effectiveness and cost-effectiveness of speech and language therapy for adults who suffer communication difficulties following a stroke.
Detailed description
Research Question: This is the pilot phase of a two-phase study. Phase 1 - What is the feasibility of conducting a randomised controlled trial of therapy for adults with post-stroke communication impairment? to be followed in 2006 by Phase 2 - What are the effectiveness, costs and service user preferences, for the provision of speech and language therapy for communication difficulties experienced by people in hospital with a stroke? Methodology: Phase 1 - Qualitative (focus groups \& individual interviews) and quantitative (pilot RCT). Phase 2 - Qualitative (focus groups \& individual interviews) and quantitative (a pragmatic, multicentred, randomised controlled trial, stratified by diagnosis and therapist/centre, using an 'intention to treat' approach). Discrete choice experiments will be used to determine cost effectiveness.
Outcome Measures: The primary outcome will be functional communicative ability. The economic analysis will estimate the incremental cost effectiveness and net benefit of the intervention group compared to the control group from a societal perspective. The qualitative study will examine service users' and carers' perspectives on the process and effects of Speech and Language Therapy or the control treatment.
Sample Group: Adults with dysarthria or aphasia, seen early after admission to hospital with a stroke. Exclusions: subarachnoid haemorrhage, progressive dementia, expected recovery without therapy.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with communication impairment following a new stroke
Key exclusion criteria (5 listed)
- Not fluent in the English language
- Subarachnoid haemorrhage
- Pre-existing, progressive dementia or learning disability
- Palliative care only or deceased since admission
- Resident outside the treatment area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech and Language therapy for dysarthria and/or aphasia | Procedure or surgery | – |
Primary outcome
The primary outcome will be functional communicative ability.
1 secondary outcome
The economic analysis to estimate incremental cost effectiveness and net benefit of the intervention. Qualitative study to examine service users' and carers' perspectives Speech and Language Therapy vs control treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2005.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Audrey Bowen, PhD principal investigator
The University of Manchester, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech and Language therapy for dysarthria and/or aphasia in people with Speech or Language Impairment Following Stroke, run by NHS Health Technology Assessment Programme at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be functional communicative ability.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2005.