NCT00158106

Brief Summary

This study investigates the effectiveness and cost-effectiveness of speech and language therapy for adults who suffer communication difficulties following a stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 12, 2005

Status Verified

September 1, 2005

First QC Date

September 7, 2005

Last Update Submit

September 7, 2005

Conditions

Speech or Language Impairment Following Stroke

Keywords

functional communicative abilitycost effectivenessservice user preferences

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

Speech and Language therapy for dysarthria and/or aphasiaPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with communication impairment following a new stroke

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Communication and Deafness, School of Psychological Sciences, Humanities Devas Street, The University of Manchester

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Speech

Interventions

Language Therapy

Condition Hierarchy (Ancestors)

Verbal BehaviorCommunicationBehavior

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Audrey Bowen, PhD

    The University of Manchester, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

February 1, 2005

Study Completion

August 1, 2005

Last Updated

September 12, 2005

Record last verified: 2005-09

Locations

GB(1)