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临床试验/NCT04610346
NCT04610346已完成不适用

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

Albert Einstein Healthcare Network2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2023年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Assessment of Living With Aphasia (ALA, Kagan et al., 2010)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Diagnosis of neurological injury or disease other than CVA

结局指标

主要结局

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

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

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.

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

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

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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sharon Antonucci, PhD

Director, MossRehab Aphasia Center

Albert Einstein Healthcare Network

研究点 (2)

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