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AphasiaPATDNCT04610346

Assessing an Animal-Assisted Treatment Program for Adults With Aphasia: The Persons With Aphasia Training Dogs Program

A study testing Persons with Aphasia Training Dogs Program in people with Aphasia, run by Albert Einstein Healthcare Network at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The lives of more than 2 million Americans are affected by aphasia, an acquired language impairment most commonly resulting from stroke that affects the ability to remember and express words. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Aphasia
What is being tested?
Persons with Aphasia Training Dogs Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
30 Mar 2023to 28 Aug 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of aphasia acquired as the result of cerebro-vascular accident (CVA)
  • English as a native or primary language
  • Evidence of linguistic and cognitive capacity to understand the research requirements
  • Willingness and stamina to participate in the protocol
  • Lives within 1 hour driving distance to MRRI (50 Township Line Rd, Elkins Park, PA 19027 and (as appropriate) PSPCA HQ (350 E. Erie Ave., Philadelphia, PA 19134

Who cannot join

  • Diagnosis of neurological injury or disease other than CVA

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Moss Rehabilitation Research Institute

    Elkins Park, Pennsylvania, 19027

Other trials in United States

About this study

The lives of more than 2 million Americans are affected by aphasia, an acquired language impairment most commonly resulting from stroke that affects the ability to remember and express words. The well-being of these individuals is affected not just by the loss of words that is aphasia, but also the loss of friendships and opportunities for community engagement in which the loss of words can result. This study evaluates an animal-assisted treatment, The Persons with Aphasia Training Dogs (PATD) Program, designed to target the psychosocial consequences of aphasia by training participants in positive reinforcement dog training techniques that harness new skill learning and the advantages of interaction with family- or shelter-dwelling dogs to increase confidence and social engagement to support participants in living well with aphasia.

Read the detailed description

Our long-term goals are to evaluate the effectiveness of canine- assisted therapy for persons with aphasia (PWA) and to operationalize aphasia treatments targeting psychosocial consequences of aphasia such that they may be implemented with fidelity across clinical settings. The overall objective of this application is to determine the feasibility and impact of a canine-assisted therapy program, the Persons with Aphasia Training Dogs (PATD) Program. This feasibility study, a crucial first step toward our long-term goals, will evaluate participants' ability to learn positive reinforcement dog training techniques, and provide data regarding the impact of treatment with respect to feasibility metrics associated with recruitment, retention, compliance, and importantly, program satisfaction/acceptability. The hypotheses are that PWA are able to learn positive reinforcement techniques to apply to dog training and that retention, compliance, and program satisfaction rates for this canine-assisted treatment will be high, with program satisfaction linked to psychosocial benefits such as increased self-confidence and social engagement for PWA. These hypotheses have been formulated on the basis of the PI's funded work designing and implementing the PATD program for the MossRehab Aphasia Center, as well as work in aphasia rehabilitation and canine-assisted interventions, including those with persons with aphasia. Accomplishment of the overall objective of this application will be achieved through this small-scale feasibility study aimed to garner preliminary support for our hypotheses and provide data to inform design of a future, large-scale clinical trial.

Specific Aim 1: Determine whether PWA, through participation in the PATD program, can learn and implement positive reinforcement techniques to train dogs in basic obedience skills. Hypothesis 1: On program completion, PWA will be competent in using positive reinforcement techniques, to independently cue a dog to complete a minimum of 4 (of 5) trained obedience skills. To test this hypothesis, participants will be assessed using a PI-adapted version of the Pet Partners© Animal-Handler Evaluation.

Specific Aim 2: Define participant characteristics associated with recruitment, retention, compliance and program acceptability/satisfaction relevant for determining PATD candidacy. Hypothesis 2: PWA will demonstrate high (above 80%) retention and compliance rates, and high program satisfaction, including increases in self-reported ratings of psychosocial well-being. To test this hypothesis, our primary outcome measure will be the Assessment of Living with Aphasia, complemented by self-report of participants' PATD experience gathered through an ALA-modeled qualitative spoken interview and a written, aphasia-friendly, satisfaction survey.

Accomplishment of the overall objective of this application will be achieved through this small-scale, feasibility study aimed to garner preliminary support for our hypotheses and to provide the foundation for a future, large-scale clinical trial.

Specific Aim 1: Determine whether PWA, through participation in the PATD program, can learn and implement positive reinforcement techniques to train dogs in basic obedience skills. Hypothesis 1: On program completion, PWA will be competent in using positive reinforcement techniques, to independently cue a dog to complete a minimum of 4 (of 5) trained obedience skills. To test this hypothesis, program participants will be assessed using a PI-adapted version of the Pet Partners© Animal-Handler Evaluation.

Skills Training: In consultation with a certified professional dog trainer, the PATD program was developed by the PI, a trained speech language-pathologist with eighteen years of experience working with people with aphasia, who has spent more than ten years working with shelter animals using positive reinforcement techniques. Participants enrolled in the PATD program will engage in five once-weekly individual training sessions with the PI, either with a family dog (PATD) or by volunteering at a local shelter, the Pennsylvania SPCA (PATD-PSPCA). PATD-PSPCA participants will work only with dogs that have been evaluated by PSPCA staff as appropriate for interaction with new volunteers. Each session will be dedicated to one of five pre-determined, sequentially-presented, obedience skills (i.e., LOOK, TOUCH, SIT, STAY, COME). Training sessions will last approximately 75 minutes, with an additional half hour allotted to the beginning of the first training session to review principles of positive-reinforcement training. Subsequent sessions will begin with a brief probe of the participant's skill in cueing the dog to perform the behavior trained the previous week. Following the probe, sessions will continue with a review of that week's lesson plan, after which the PI will model the first training step three times. After the model has been provided, the participant will attempt the procedure, receiving instructive feedback or reinforcement from the trainer. Instruction will proceed to the subsequent step when the participant and dog have attained 5 successful trials at the current step. The same demonstration procedure will be used at each subsequent step. Commands will be trained using one hand gesture for each behavior. To mark behaviors, participants will use a clicker attached to a wrist band, which can be hand-held or allowed to dangle for ease of use for those with hemiplegia. Participants will have the option of introducing the verbal command, but will not be required to do so. All participants will be asked to provide their dog with a walk before training sessions to support the dog in being ready to participate.

Skills Practice: Participants will not be required to complete all steps for an obedience skill in a single session, and will be encouraged to practice the skill with the dog for at least 3 practice sessions over the course of the week. Practice will be used as a measure of participant compliance. Each participant will be provided with a copy of the lesson plan and, if interested, a video demonstrating the PI performing the target skill with her own dog. Participants will also be provided with a training log to complete after each time they practice over the course of the week. Using a nine-point visual analog scale adapted from the Assessment of Living with Aphasia (ALA), participants will rate their own and the dog's performance during each practice session. To facilitate responses on the log, participants will be provided with a pictographic list of questions to consider in determining their ratings (e.g., "How many times did I have to cue the dog", "Did I 'click' as soon as the dog did what I asked?".

Specific Aim 2: Define participant characteristics associated with recruitment, retention, compliance and program acceptability/satisfaction relevant for determining PATD candidacy. Hypothesis 2: PWA will demonstrate high (above 80%) retention and compliance rates, and high program satisfaction, including increases in self-reported ratings of psychosocial well-being. To test this hypothesis, the primary outcome measure will be the Assessment of Living with Aphasia, complemented by self-report of participants' PATD experience gathered through an ALA-modeled qualitative spoken interview and a written, aphasia-friendly, satisfaction survey.

Feasibility Metrics: Recruitment rates will be tracked appropriate to the creation of a CONSORT flow diagram including: # contacted, # screened, # eligible (vs. ineligible), # consented/enrolled (vs. declined). To evaluate further the size of the population that may benefit from the treatment, participant screening will include surveying of interest in interaction with dogs and in dog-related activities. Similarly, participant retention rates will be tracked including: # completing baseline assessment, # completing immediate post-treatment assessment, and # completing follow-up assessment. Participant withdrawals will be tracked for whether initiated by researcher or participant. Participant compliance rates will be tracked including # assessment and training sessions (relative to total possible) completed, and # self-reported home practice sessions.

Outcome Measurement: The primary quantitative outcome measure of acceptability, the ALA, is a pictographic self-report measure of quality of life developed to assess the impact of aphasia on daily life. Questions address participants' perceptions of aphasia, their environment, their relationships, their community engagement, experiences of self-confidence and respect, and their progress toward "living well with aphasia". Participants respond by pointing to a visual analog scale, providing for quantification of responses, and rendering the tool accessible to those with language impairment. Overall score and subdomain scores have demonstrated acceptable-to-high test-retest reliability and internal consistency. To augment standardized evaluation, the PI has developed a complementary interview, consistent with the format of the ALA, to more specifically probe PATD participants' perceptions of the impact of the training program. Participant narratives produced during the administration will be supported using interviewing strategies appropriate for persons with aphasia. A written, visual analog scale satisfaction survey designed to adhere to guidelines of 'aphasia-friendly' written materials will also be administered. It is anticipated that the assessment battery will take two hours to complete.

Outcome Measurement/Participation Timeline: Participants will be randomized into immediate and waitlist treatment groups using permuted block randomization with stratification. Analysis between these two arms will be exploratory only in nature, and will inform us regarding the feasibility of the waitlist control design for use in a larger clinical trial. All participants will be evaluated before training begins, immediately following training, and at a 3-month follow-up. Participants in the delayed arm will participate in two pre-training evaluations, one immediately upon enrollment and one at the end of the delay period immediately before beginning training.

Conditions
Aphasia
Being tested
Persons with Aphasia Training Dogs Program
Keywords
aphasia, animal-assisted therapy
Medical subject headings
Aphasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Persons with Aphasia Training Dogs ProgramBehavioural

    Also called PATD Program

    Participants will learn and apply positive reinforcement training techniques for working with dogs to train them in basic obedience behaviors (e.g., SIT, STAY).

Study groups in NCT04610346
Study groupRoleWhat they receive
ImmediateOtherParticipants in this group will begin the training protocol immediately (within 1 week) after baseline pre-training evaluation is completed.
Receives: Behavioral: Persons with Aphasia Training Dogs Program
DelayedOtherParticipants in the delayed arm will participate in two pre-training evaluations, one immediately upon enrollment and one at the end of the delay period immediately before beginning training
Receives: Behavioral: Persons with Aphasia Training Dogs Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of Living With Aphasia (ALA, Kagan et al., 2010)

    The Assessment of Living with Aphasia is a pictographic self-reported measure of quality of life living with aphasia across four domains (aphasia, participation, environment, and personal) and an overall evaluation of how well the participant judges that they are overcoming the 'wall' (obstacle) of aphasia. Participants respond using a visual-analog scale with nine points (0 (minimum), .5, 1, 1.5, 2, 2.5, 3, 3.5, 4 (maximum) with higher values being associated with a better outcome. The total scaled score (0- minimum - 4- maximum) is the sum of the raw scores in each of the four domains divided by the number of questions pertaining to each domain, plus the response to the 'wall' question.

    Measured: Once within approximately 1 week of the end of training, then once approximately 3 months after end of training

  2. PI-adapted Version of Pet Partners Animal-handler Evaluation.

    Participants were score on a PI-adapted version of the Pet Partners Animal-Handler Evaluation. Each participant was scored on a 3-point scale ( 0= not ready (minimum), 1= ok, 2= best (maximum)) by a certified professional dog trainer on their cueing of each of five basic obedience behaviors (LOOK, TOUCH TARGET, SIT, STAY, COME), hence the maximum score on each summative evaluation is 10 (rating of 2 x each of the 5 obedience behaviors). On this scale, a higher number indicates a better outcome. An a-priori criterion was set at 5 (out of 10) or higher for achieving competence.

    Measured: Once within approximately 1 week of the end of training, then once approximately 3 months after end of training

Secondary outcomes (2)
  1. The Confidence After Stroke Measure (Horne et al., 2017)

    The Confidence after Stroke Measures is a self-report measure that assesses three aspects of confidence after stroke, self-confidence, positive attitude, and social confidence. Per Horne et al., (2017) Participants self-rate on scales, with total values 0-81:

    Scale One -Self - Confidence = 0-27 Scale Two -Positive Attitude =0-24 Scale Three -Social Confidence =0-30

    Higher scores are associated with higher levels of confidence. A change on total score of 4 or more is reported as being considered clinically significant. A score of 36 (-1 SD) indicates a possible concern, a score of 28(-2 SD) indicates a probable problem.

    Measured: Once within approximately 1 week of the end of training, then once approximately 3 months after end of training

  2. Behavioural Assessment of Dysexecutive Syndrome (BADS) (Wilson et al., 1996)

    The Behavioral Assessment of Dysexecutive Syndrome is a standardized assessment of executive function that evaluates skills including planning, organization, and problem-solving. Total profile scores range between 0 (min) - 24 (max), higher scores are associated with a better outcome, i.e., more accurate performance. Total profile scores comprise sub-scores from six subtests:

    Temporal judgement - ability to estimate how long to complete various activities of daily life events.

    Rule shift cards - ability to change an established pattern of responding Action program - practical problem solving. Key search - strategy formation. Zoo map - planning. Modified six elements - planning, task scheduling and performance monitoring. Complete details are available in the BADS manual. This measure was used for exploratory purposes. It has not been validated for use with individuals with aphasia and performance may be confounded by language difficulties associated with aphasia.

    Measured: Once within approximately 1 week of the end of training, then once approximately 3 months after end of training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2020
  2. Study start30 Mar 2023
  3. Primary completion28 Aug 2024
  4. Study completion28 Aug 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to one of two study arms, immediate or delayed treatment.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04610346
Sponsor's protocol ID
IRB-2020-450
Other IDs
R03HD101146
Acronym
PATD
Status last verified
Sep 2025
First submitted
21 Oct 2020
Last updated
16 Oct 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Adams, D. L. (1997). Animal-assisted enhancement of speech therapy: A case study. Anthrozoös: A multidisciplinary journal of the interactions of people and animals, 10(1), 53-56.

  • Beetz, A. M. (2017). Theories and possible processes of action in animal-assisted interventions. Applied Developmental Science, 21(2), 139-149.

  • Hediger K, Thommen S, Wagner C, Gaab J, Hund-Georgiadis M. Effects of animal-assisted therapy on social behaviour in patients with acquired brain injury: a randomised controlled trial. Sci Rep. 2019 Apr 9;9(1):5831. doi: 10.1038/s41598-019-42280-0.

    PubMed 30967589
  • Hilari K, Needle JJ, Harrison KL. What are the important factors in health-related quality of life for people with aphasia? A systematic review. Arch Phys Med Rehabil. 2012 Jan;93(1 Suppl):S86-95. doi: 10.1016/j.apmr.2011.05.028. Epub 2011 Nov 25.

    PubMed 22119074
  • LaFrance C, Garcia LJ, Labreche J. The effect of a therapy dog on the communication skills of an adult with aphasia. J Commun Disord. 2007 May-Jun;40(3):215-24. doi: 10.1016/j.jcomdis.2006.06.010. Epub 2006 Sep 6.

    PubMed 16950329
  • Macauley BL. Animal-assisted therapy for persons with aphasia: A pilot study. J Rehabil Res Dev. 2006 May-Jun;43(3):357-66. doi: 10.1682/jrrd.2005.01.0027.

    PubMed 17041821
  • Shadden, B. (2005). Aphasia as identity theft: Theory and practice. Aphasiology, 19(3-5), 211-223

Questions about this trial

What is this clinical trial studying?

A study testing Persons with Aphasia Training Dogs Program in people with Aphasia, run by Albert Einstein Healthcare Network at 1 site in United States.

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 5 inclusion and 1 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 16 Oct 2025. 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 States. 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?

Yes. Results are posted in the registry (first posted 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Assessment of Living With Aphasia (ALA, Kagan et al., 2010) (time frame: Once within approximately 1 week of the end of training, then once approximately 3 months after end of training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04610346, which also lists 7 linked publications.

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 16 Oct 2025.

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