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Trial registered on ANZCTR


Registration number
ACTRN12613000517774
Ethics application status
Approved
Date submitted
25/02/2013
Date registered
9/05/2013
Date last updated
13/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Telerehabilitation treatment of aphasia across the World Health Organisation International Classification of Functioning Disability and Health (WHO-ICF)
Scientific title
Telerehabilitation treatment of people with aphasia: determining the communication and quality of life outcomes following online treatment
Secondary ID [1] 282022 0
Nil
Universal Trial Number (UTN)
U111111398563
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aphasia 288471 0
Condition category
Condition code
Stroke 288816 288816 0 0
Ischaemic
Stroke 288817 288817 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 289440 289440 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People with aphasia will receive any combination of three aphasia treatments via telerehabilitation including
1) Constraint Induced Language Therapy (CILT)
2) Group aphasia therapy
3) Communication partner training.
The type of treatment received will be determined collaboratively with the client by the treating clinician according to the language difficulties they are experiencing, ability to commit to the time periods required and their support networks.
Telerehabilitation is the delivery of medical rehabilitation services at a distance using electronic information and communication technologies. Telerehabilitation technology allows patients to access assessment and treatment services remotely. In this study, the treatment will be provided via multi-point videoconferencing over the internet using computer based software downloaded onto the participant and clinicians computers.
The first treatment, Constraint Induced Language Therapy (CILT) has been demonstrated to have substantial and stable improvements of language function in people with chronic aphasia with evidence of successful carryover of improved language function to everyday life. Participants will receive 3 hours of therapy a day, 5 days a week for two weeks. Two participants are treated concurrently by one clinician. The primary therapy activity is a dual card game between participants where the objective is to collect matches until the participant has no cards remaining- similar to “Go Fish”. Each participant takes turns verbally requesting a card from the other who must provide a response. The requests are constrained to verbal output only with other forms of communication such as gesture or writing not permitted. The therapy will be delivered online using a web based version of the Go Fish card game developed by the research team and multi-point videoconferencing software to connect video and audio.

In the second treatment, Group Therapy, participants will participate in tasks that incorporate activity and participation level treatment goals. Participants will attend one 1.5 hour treatment session per week for 12 weeks and will be engaged in activities that are functionally relevant and require spoken language to be the main route of communication. Clinician to patient ratios for groups will be one speech pathologist to four patients. The clinician and participants will be connected to each other using web-based videoconferencing software with video and audio. The clinician will use this software to also display electronic treatment materials such as maps, photos and videos.

For the third treatment, Communication Partner Training, participants with aphasia may identify 1 -3 communication partners to be involved in communication partner. The participant and their communication partner will be involved in five 2 hour training sessions, fortnightly over 10 weeks, via the Internet in which they are: provided with education regarding the role of the communication partner in successful communication interactions; recorded participating in a conversation and then provided with feedback; trained in communication strategies and re-recorded and provided with feedback on implementation of the strategies. The strategies that are most relevant and successful with the person with aphasia will be identified and the clinician will provide support to problem solve any difficulties. The clinician will be connected to the participant with aphasia and their communication partner over the internet using web based videoconferencing software.
Intervention code [1] 286606 0
Rehabilitation
Comparator / control treatment
People with aphasia will receive three aphasia treatments face to face
1) Constraint Induced Language Therapy
2) Group aphasia therapy
3) Communication partner training
The type of treatment received will be determined collaboratively with the client by the treating clinician according to the language difficulties they are experiencing, ability to commit to the time periods required and their support networks.
The first treatment, Constraint Induced Language Therapy (CILT) has been demonstrated to have substantial and stable improvements of language function in people with chronic aphasia with evidence of successful carryover of improved language function to everyday life. Participants will receive 3 hours of therapy a day, 5 days a week for two weeks. Two participants are treated concurrently by one clinician. The primary therapy activity is a dual card game between participants where the objective is to collect matches until the participant has no cards remaining- similar to “Go Fish”. Each participant takes turns verbally requesting a card from the other who must provide a response. The requests are constrained to verbal output only with other forms of communication such as gesture or writing not permitted.

In the second treatment, Group Therapy, participants will participate in tasks that incorporate activity and participation level treatment goals. Participants will attend one 1.5 hour treatment session per week over 12 weeks and will be engaged in activities that are functionally relevant and require spoken language to be the main route of communication. Clinician to patient ratios for groups will be one speech pathologist to four patients.

For the third treatment, Communication Partner Training, participants with aphasia may identify 1 -3 communication partners to be involved in communication partner. The participant and their communication partner will be involved in five 2 hour training sessions, fortnightly over 10 weeks, in which they are: provided with education regarding the role of the communication partner in successful communication interactions; recorded participating in a conversation and then provided with feedback; trained in communication strategies and re-recorded and provided with feedback on implementation of the strategies. The strategies that are most relevant and successful with the person with aphasia will be identified and the clinician will provide support to problem solve any difficulties.
Control group
Active

Outcomes
Primary outcome [1] 288956 0
The primary outcome measures is discourse analysis of six connected speech samples. This involves recording participants responses to six stimuli including two static picture descriptions, two sequenced picture descriptions, one request for personal information "What do you like to do on Sundays?" and one request for procedural information "How would you write and send a letter?". These samples are tape recorded and transcribed. The samples are then analysed to determine the number of words, time taken for each sample and the amount of correct information conveyed in each sample.
Timepoint [1] 288956 0
Pre-post intervention
Secondary outcome [1] 301434 0
Assessment of Living with Aphasia (ALA) which is a questionnaire that measures the impact of aphasia on everyday life. The ALA corresponds with the areas of functioning of the World Health Organization International Classification of Functioning and provides information regarding the impact of the communication impairment across a number of domains including language impairments, participation in everyday life, communication environment and personal factors.
Timepoint [1] 301434 0
Pre-post intervention
Secondary outcome [2] 302545 0
Comprehensive Aphasia Test (CAT) which is an assessment battery that includes a cognitive screen, a language battery and a disability questionnaire. The cognitive screen provides information about a range of factors that may affect performance. The language battery provides a profile of performance across all modalities of language production and comprehension. This assessment will provide an outcome measure of the impairment domain in the ICF.
Timepoint [2] 302545 0
Pre-post intervention

Eligibility
Key inclusion criteria
The eligibility criteria are as follows:
Inclusion Criteria
diagnosis of aphasia according to standardised assessment caused by an acquired brain lesion
Eighteen years of age or older
Able to provide consent to participate in the study
English speaking
At least 12 months post stroke and willing to cease any outpatient treatment during the study
Sufficient vision and hearing to operate computer equipment
Broadband Internet connection in their home
Naming and Repetitions scores on Comprehensive Aphasia test > 5 at initial assessment

For the intensive therapy participants there is this additional inclusion criteria:
Able to commit to a 2 week block of intensive aphasia treatment involving 3 hours of therapy per day for 5 days of the week
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
Diagnosis of any concomitant cognitive disorders such as dementia or progressive aphasia
Concomitant severe apraxia or dysarthria of speech as identified on initial screening assessment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be concealed by using consecutively numbered, sealed, opaque envelopes which are stored centrally
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation process will be performed by a researcher not involved in the treatment of participants and will employ an off-site, computer-generated random number sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Both intention-to-treat and per-protocol analyses will be performed as per CONSORT guidelines for non-inferiority trials. Non-inferiority of the telerehabilitation intervention will determined by computing the within-group differences from baseline and the 95% confidence interval (CI) of these differences. Treatment effects will be calculated pre- to post-treatment. In addition to intention-to-treat and per-protocol analyses, a sensitivity analysis to account for missing data and their potential effect on the observed results will be performed. In this analysis a last observation carried forward approach will be used to replace missing data at either baseline or post-treatment assessment points. Where data from both post-treatment assessments are missing, the participant’s existing data will be excluded from the study. Consistent results between the initial and sensitivity analyses will be indicative of robust findings. Further analyses of the clinical treatment effect of each intervention group will be conducted using a linear mixed model which is appropriate for comparing means in independent samples and has the added advantage of adjusting for baseline differences and being tolerant of missing data. As baseline differences are adjusted for with this approach, it is possible to compare pre and post-treatment scores between groups, rather than their change scores. The statistic will be computed with observed outcomes as the dependent variables and with fixed factors of treatment group (Tele, FTF) and assessment time (pre- and post-intervention). Interactions among these factors will also be determined. Fixed predicted values and residuals from these analyses will be used for data inspection purposes. The outcome of primary interest is the interaction effect between groups and time. An alpha level of 0.05 will be used for this analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
1/10/2012
Date of last participant enrolment
Anticipated
31/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 671 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [2] 672 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [3] 673 0
Caboolture Hospital - Caboolture
Recruitment hospital [4] 674 0
Warwick Hospital - Warwick
Recruitment hospital [5] 675 0
Dalby Hospital Health Service - Dalby
Recruitment postcode(s) [1] 6409 0
4055 - Ferny Grove
Recruitment postcode(s) [2] 6410 0
4005 - New Farm
Recruitment postcode(s) [3] 6411 0
4000 - Brisbane
Recruitment postcode(s) [4] 6412 0
4070 - Moggill
Recruitment postcode(s) [5] 6413 0
4011 - Clayfield
Recruitment postcode(s) [6] 6414 0
4030 - Wooloowin
Recruitment postcode(s) [7] 6415 0
4059 - Kelvin Grove Bc
Recruitment postcode(s) [8] 6417 0
4020 - Redcliffe
Recruitment postcode(s) [9] 6419 0
4350 - Clifford Gardens
Recruitment postcode(s) [10] 6420 0
4370 - Leslie Dam
Recruitment postcode(s) [11] 6421 0
4361 - Clifton
Recruitment postcode(s) [12] 6422 0
4360 - Nobby
Recruitment postcode(s) [13] 6425 0
4510 - Caboolture

Funding & Sponsors
Funding source category [1] 286799 0
University
Name [1] 286799 0
The University of Queensland
Country [1] 286799 0
Australia
Primary sponsor type
Individual
Name
Rachelle Pitt
Address
University of Queensland
Sir Fred Schonell Drive
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 285589 0
None
Name [1] 285589 0
Address [1] 285589 0
Country [1] 285589 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288866 0
University of Queensland Behavioural and Social Sciences Ethical Review Committee
Ethics committee address [1] 288866 0
Ethics committee country [1] 288866 0
Australia
Date submitted for ethics approval [1] 288866 0
Approval date [1] 288866 0
14/03/2011
Ethics approval number [1] 288866 0
20050000530

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38130 0
Mrs Rachelle Pitt
Address 38130 0
School of Health and Rehabilitation Sciences
University of Queensland
Sir Fred Schonell Drive
St Lucia QLD 4072
Country 38130 0
Australia
Phone 38130 0
61411789490
Fax 38130 0
Email 38130 0
[email protected]
Contact person for public queries
Name 38131 0
Rachelle Pitt
Address 38131 0
School of Health and Rehabilitation Sciences
University of Queensland
Sir Fred Schonell Drive
St Lucia QLD 4072
Country 38131 0
Australia
Phone 38131 0
61411789490
Fax 38131 0
Email 38131 0
[email protected]
Contact person for scientific queries
Name 38132 0
Rachelle Pitt
Address 38132 0
School of Health and Rehabilitation Sciences
University of Queensland
Sir Fred Schonell Drive
St Lucia QLD 4072
Country 38132 0
Australia
Phone 38132 0
61411789490
Fax 38132 0
Email 38132 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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