NCT04610346

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
2.4 years until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 16, 2025

Completed
Last Updated

October 16, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

October 21, 2020

Results QC Date

August 18, 2025

Last Update Submit

September 30, 2025

Conditions

Keywords

aphasiaanimal-assisted therapy

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Secondary Outcomes (2)

  • The Confidence After Stroke Measure (Horne et al., 2017)

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

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

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

Study Arms (2)

Immediate

OTHER

Participants in this group will begin the training protocol immediately (within 1 week) after baseline pre-training evaluation is completed.

Behavioral: Persons with Aphasia Training Dogs Program

Delayed

OTHER

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

Behavioral: Persons with Aphasia Training Dogs Program

Interventions

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

Also known as: PATD Program
DelayedImmediate

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosis of neurological injury or disease other than CVA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, 19027, United States

Location

Related Publications (7)

  • 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.

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

    BACKGROUND
  • 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.

    PMID: 30967589BACKGROUND
  • 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.

    PMID: 22119074BACKGROUND
  • 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.

    PMID: 16950329BACKGROUND
  • 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.

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

    BACKGROUND

MeSH Terms

Conditions

Aphasia

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Challenges to feasibility, both with respect to initial recruitment and completion (for those in the shelter dog condition) primarily related to access to a dog, not inability to engage in the treatment. However, we do not feel this unduly limits the feasibility of the treatment overall as future iterations are planned to be embedded within direct clinical service delivery with therapy or facility dog- handler teams, rather than relying on participants' own family dogs or shelter dogs.

Results Point of Contact

Title
Sharon Antonucci, Ph.D CCC-SLP, C-AAIS
Organization
Jefferson Moss Rehabilitation Research Institute

Study Officials

  • Sharon M Antonucci, Ph.D.

    AEHN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized to one of two study arms, immediate or delayed treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, MossRehab Aphasia Center

Study Record Dates

First Submitted

October 21, 2020

First Posted

October 30, 2020

Study Start

March 30, 2023

Primary Completion

August 28, 2024

Study Completion

August 28, 2024

Last Updated

October 16, 2025

Results First Posted

October 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations