Aphasia
Conditions
Brief summary
This is a behavioral speech therapy trial for individuals who have suffered a stroke on the left side of the brain and have difficulty speaking. The name of this disorder is called 'aphasia'. Individuals who participate in this study will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).
Detailed description
The study design was a single group (n=26) with repeated testing (3 times) pre- and post-treatment. All participants received the same treatment protocol (described in detail in Appendix A and in Minkina et al. (under review)). In order to control for improvement in language function related to passage of time, and for the effect of repeated exposure to outcome measures, individuals were randomly assigned to one of two conditions: delayed treatment or immediate treatment (Figure 2). Participants who were randomized to the delayed group received repeated testing three times before and three times after a six-week delay. During the delay phase they were permitted to participate in usual speech-language care (e.g., conversation groups and individual therapy). Standardized assessments and outcome measures (described in detail below) were administered prior to the start of treatment (for both immediate and delayed groups), at the end of the delay phase (delayed group only), immediately after treatment termination, and at three months post-treatment.
Interventions
BEHAVIORALspeech therapy
individuals will receive 60 hours of behavioral speech therapy
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* left hemisphere stroke * monolingual English speaking * right handed * presence of aphasia
Exclusion criteria
* preexisting neurological condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Production | Baseline to one week post treatment termination and three months post treatment termination | percent change in the number of untrained words spoken correctly |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Aphasia Therapy Single group, open trail where 28 individuals with aphasia received 60 hours of therapy | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Behavioral Aphasia Therapy |
|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Speech Production
percent change in the number of untrained words spoken correctly
Time frame: Baseline to one week post treatment termination and three months post treatment termination
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Aphasia Therapy | Speech Production | % change immediately post treatment | 5.27 % change score of untrained real words | Standard Deviation 8.09 |
| Behavioral Aphasia Therapy | Speech Production | % change 3 months post treatment | 5.28 % change score of untrained real words | Standard Deviation 7.55 |