StrokeNCT02606006
Inpatient Physical Activity Function Through Enhanced Participation Levels in Animal-Assisted Therapy Programs
A study testing Canine Animal-Assisted Therapy in people with Stroke and Parkinson's Disease, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Thousands of canines are used for therapy in health care centers throughout the United States as part of a volunteer therapy team, yet little is known about the outcomes provided by these teams. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Parkinson's Disease, Muscle Weakness
- What is being tested?
- Canine Animal-Assisted Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are being rehabilitated as an inpatient for Parkinson's, stroke, or generalized weakness deconditioning (muscle weakness);
- Are able to give informed consent or communicate either verbally or in writing;
- Are able to follow instructions;
- Are at least 18 years old; and
- Choose to participate.
Who cannot join
- Have a fear/dislike of dogs;
- Show noticeable cues of resistance/discomfort to dogs;
- Are allergic to dogs;
- Are immunocompromised;
- Are not being rehabilitated for Parkinson's, stroke, or generalized weakness deconditioning (muscle weakness);
- Are not able to give informed consent or communicate either verbally or in writing;
Show all 10Show fewer
- Are not able to follow instructions;
- Do not speak English;
- Are not at least 18 years old; and
- Do not choose to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
About this study
Thousands of canines are used for therapy in health care centers throughout the United States as part of a volunteer therapy team, yet little is known about the outcomes provided by these teams. Although many studies have been published, few used randomized, controlled formats to identify whether canine therapy has an impact and any mechanisms by which any impact may occur. The purpose of this study is use a randomized, controlled setup for canine animal-assisted therapy (AAT) in patients undergoing inpatient physical therapy for stroke, Parkinson's disease, or generalized weakness deconditioning to determine whether use of AAT produces desirable outcomes, such as increased motivation, in patients.
Read the detailed description
Many medical care facilities in the United States employ therapy dogs in Animal Assisted Interventions (AAI), which can be categorized as either Animal Assisted Activities (AAA) or Animal Assisted Therapy (AAT). AAA programs are more casual and are typically not goal-oriented, instead tending to focus on human-animal engagement. AAT programs are formal interventions targeting specific therapeutic goals using defined therapy sessions with a physical, psychological, occupational, or speech therapist. AAT programs with Physical Therapists focus on patients with motor deficits, such as those hospitalized due to stroke (14.5-16.1% lifetime incidence), Parkinson's (1.3-2% lifetime incidence), or other neurological injuries/disorders.
In the last decade, the popularity of AAT programs in hospitals has significantly increased, and there has been tremendous growth in the number of studies assessing whether the use of canine AAA or AAT have positive medical impacts on patients. Currently, the majority of studies focus on AAA programs, possibly because AAT programs require formally trained therapists and animals, program consistency, and strict program structure. Unfortunately, while most studies suggest that use of AAT can improve patient outcomes, many are poorly designed, poorly described, and few include randomized, controlled trials (RCT). The few existing RCT AAT studies focus on depression, schizophrenia, or other psychiatric disorders and suggest improvements in depression, anxiety, self-esteem, social outcomes, and enjoyment/pleasure. No RCT studies have looked at AAT in a physical therapy setting. However, non-controlled, non-randomized studies suggest that AAT as part of physical therapy may improve patient physical outcomes (such as walking speed, number of steps, gait, etc.), possibly by impacting patient motivation and participation in physical therapy activities.
The Aurora Sinai Medical Center (ASMC) currently utilizes both AAA and AAT programs. Most patients involved in the AAT program at ASMC are undergoing intensive inpatient physical therapy due to stroke, Parkinson's disease, or other diseases causing generalized weakness deconditioning, and these inpatients receive daily physical therapy with the occasional opportunity to include AAT in their therapy sessions. Previous studies suggest that patient interactions with therapy dogs are intrinsically rewarding, suggesting that use of an AAT program may increase patient motivation to participate and thus improve physical indices. However, this has yet to be objectively analyzed.
Hypothesis: Canine AAT in inpatient physical therapy improves physical activity function through enhanced levels of participation in physical therapy sessions.
Specific Aim 1: To evaluate whether patient participation increases during physical therapy using canine AAT. Physical activity function is impacted by a patient's level of participation, which is influenced by multiple sub-factors. Participation can be measured in multiple ways, including subjectively by the patient, subjectively by an observer (the physical therapist), or objectively through activity outputs. The level of participation may or may not correlate with the patient's self-perceived motivation.
Specific Aim 2. To determine whether use of canine AAT increases patient enjoyment and motivation in physical therapy. Many people perceive interactions with animals as intrinsically motivating and enjoyable. Consistent with this, canine AAT can improve patient motivation to participate in physical therapy. However, neither enjoyment nor motivation have been studied in physical therapy rehabilitation inpatients, nor have they been tested in RCT settings.
Specific Aim 3: To assess whether patient perceptions of care improve with use of canine AAT in physical therapy. Because the presence of a therapy canine may improve mood, motivation, and/or patient/caregiver communications, we hypothesize that use of canine AAT in inpatient physical therapy will improve patient perceptions of their caregivers, their care, and the hospital.
Innovation and Impact While AAT programs are currently used throughout the United States in inpatient rehabilitation programs, it is unknown whether and how these programs impact patient physical activity functions. This study will elucidate whether these programs provide benefits to patients or medical institutions, thereby providing medical providers with the data necessary to choose the most effective and impactful care for their patients.
- Conditions
- Stroke, Parkinson's Disease, Muscle Weakness
- Being tested
- Canine Animal-Assisted Therapy, Standard of Care Physical Therapy
- Keywords
- Physical Therapy Modalities, Motivation, Patient Participation, Animal Assisted Therapy
- Medical subject headings
- Stroke, Parkinson Disease, Muscle Weakness, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canine Animal-Assisted TherapyBehavioural
Canine Animal-Assisted Therapy is the inclusion of a certified therapy canine in the standard of care physical therapy session, such as for walking, fetching balls, standing/petting, etc.
Standard of Care Physical TherapyBehavioural
This intervention is the standard of care physical therapy currently offered. No canine is present.
| Study group | Role | What they receive |
|---|---|---|
| Non-AAT Group | Active comparator | Inpatients in this group will receive 3-5 brief afternoon physical therapy sessions over 3-5 successive days. None of the sessions will include use of a canine for AAT. This group will include the intervention of Standard of Care Physical Therapy Receives: Behavioral: Standard of Care Physical Therapy |
| AAT Group | Experimental | Inpatients in this group will receive 3-5 brief afternoon physical therapy sessions over 3-5 successive days. The session on the middle day will include use of a canine for AAT. This group will receive a behavioral intervention of Canine Animal-Assisted Therapy. Receives: Behavioral: Canine Animal-Assisted Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Ball Throwing Distance
The change in the distance a tennis ball is thrown (averaged over three throws) between daily trials.
Measured: The change in ball throwing distance will be measured every day over 3-5 days.
Change in Standing Time
The change in the amount of time the patient spends standing per session over time.
Measured: During every therapy session over 3-5 days.
Change in Patient Engagement/Motivation Levels
The change in patient engagement will be measured by the therapist's perceptions of engagement, as well as the patient's self-perceived engagement/motivation levels between daily trials through questionnaires.
Measured: Between every therapy session over 3-5 days.
Change in Walking Capacity
The change in distance or amount of time patients spend walking between daily trials.
Measured: Between every therapy session over 3-5 days.
Change in Sitting Count
The change in the number of times the patient sits (stops standing) between daily trials.
Measured: Between every therapy session over 3-5 days.
Change in Patient Visual Cues of Emotion
The change in the number of times the patient demonstrates visual cues for different emotions between daily trials.
Measured: Between every therapy session over 3-5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionMar 2018 (estimated)
Why it stopped: Removing from ClinicalTrials.gov as this is not really a clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mindy Waite, PhD, Principal investigator, Aurora Health Care - Aurora Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606006
- Sponsor's protocol ID
- 15-95
- Status last verified
- Dec 2016
- First submitted
- 12 Nov 2015
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Therapy Dogs International: In W. M (ed), 2015.
Handbook on Animal-Assisted Therapy (2 Ed.): Academic Press, 2006.
Carandang R, Seshadri S, Beiser A, Kelly-Hayes M, Kase CS, Kannel WB, Wolf PA. Trends in incidence, lifetime risk, severity, and 30-day mortality of stroke over the past 50 years. JAMA. 2006 Dec 27;296(24):2939-46. doi: 10.1001/jama.296.24.2939.
PubMed 17190894Delta Society: What are Animal-Assisted Activities/Therapy? Retrieved June 19, 2015, from http://www.petpartners.org/document.doc?id=1102
Elbaz A, Bower JH, Maraganore DM, McDonnell SK, Peterson BJ, Ahlskog JE, Schaid DJ, Rocca WA. Risk tables for parkinsonism and Parkinson's disease. J Clin Epidemiol. 2002 Jan;55(1):25-31. doi: 10.1016/s0895-4356(01)00425-5.
PubMed 11781119Kamioka H, Okada S, Tsutani K, Park H, Okuizumi H, Handa S, Oshio T, Park SJ, Kitayuguchi J, Abe T, Honda T, Mutoh Y. Effectiveness of animal-assisted therapy: A systematic review of randomized controlled trials. Complement Ther Med. 2014 Apr;22(2):371-90. doi: 10.1016/j.ctim.2013.12.016. Epub 2014 Jan 6.
PubMed 24731910Maujean A, Pepping CA, Kendall E: A Systematic Review of Randomized Controlled Trials of Animal-Assisted Therapy on Psychosocial Outcomes. Anthrozoos: A Multidisciplinary Journal of The Interactions of People & Animals. 2015, 28:23-36.
Nimer J, Lundahl B: Animal-Assisted Therapy: A Meta-Analysis. Anthrozoos: A Multidisciplinary Journal of The Interactions of People & Animals. 2007, 20:225-238.
Chur-Hansen A, McArthur M, Winefield H, Hanieh E, Hazel S: Animal-Assisted Interventions in Children's Hospitals: A Critical Review of the Literature. European Journal of Marketing. 2014, 27:5-18.
Marino L: Construct Validity of AnimalAssisted Therapy and Activities: How Important Is the Animal in AAT? Anthrozoos: A Multidisciplinary Journal of The Interactions of People & Animals. 2012, 25:139-151.
Berry A, Borgi M, Francia N, Alleva E, Cirulli F. Use of assistance and therapy dogs for children with autism spectrum disorders: a critical review of the current evidence. J Altern Complement Med. 2013 Feb;19(2):73-80. doi: 10.1089/acm.2011.0835. Epub 2012 Sep 14.
PubMed 22978246Antonioli C, Reveley MA. Randomised controlled trial of animal facilitated therapy with dolphins in the treatment of depression. BMJ. 2005 Nov 26;331(7527):1231. doi: 10.1136/bmj.331.7527.1231.
PubMed 16308382Pedersen I, Nordaunet T, Martinsen EW, Berget B, Braastad BO. Farm animal-assisted intervention: relationship between work and contact with farm animals and change in depression, anxiety, and self-efficacy among persons with clinical depression. Issues Ment Health Nurs. 2011;32(8):493-500. doi: 10.3109/01612840.2011.566982.
PubMed 21767251Chu CI, Liu CY, Sun CT, Lin J. The effect of animal-assisted activity on inpatients with schizophrenia. J Psychosoc Nurs Ment Health Serv. 2009 Dec;47(12):42-8. doi: 10.3928/02793695-20091103-96.
PubMed 20000282Barak Y, Savorai O, Mavashev S, Beni A. Animal-assisted therapy for elderly schizophrenic patients: a one-year controlled trial. Am J Geriatr Psychiatry. 2001 Fall;9(4):439-42.
PubMed 11739071
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Physical Activity Function Through Enhanced Participation Levels in Animal-Assisted Therapy Programs
- ClinicalTrials.gov ID
- NCT02606006
- Acronym / sponsor ID
- 15-95
- Conditions
- Stroke, Parkinson's Disease, Muscle Weakness
- Keywords
- Physical Therapy Modalities, Motivation, Patient Participation, Animal Assisted Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Removing from ClinicalTrials.gov as this is not really a clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thousands of canines are used for therapy in health care centers throughout the United States as part of a volunteer therapy team, yet little is known about the outcomes provided by these teams. Although many studies have been published, few used randomized, controlled formats to identify whether canine therapy has an impact and any mechanisms by which any impact may occur. The purpose of this study is use a randomized, controlled setup for canine animal-assisted therapy (AAT) in patients undergoing inpatient physical therapy for stroke, Parkinson's disease, or generalized weakness deconditioning to determine whether use of AAT produces desirable outcomes, such as increased motivation, in patients.
Detailed description
Many medical care facilities in the United States employ therapy dogs in Animal Assisted Interventions (AAI), which can be categorized as either Animal Assisted Activities (AAA) or Animal Assisted Therapy (AAT). AAA programs are more casual and are typically not goal-oriented, instead tending to focus on human-animal engagement. AAT programs are formal interventions targeting specific therapeutic goals using defined therapy sessions with a physical, psychological, occupational, or speech therapist. AAT programs with Physical Therapists focus on patients with motor deficits, such as those hospitalized due to stroke (14.5-16.1% lifetime incidence), Parkinson's (1.3-2% lifetime incidence), or other neurological injuries/disorders.
In the last decade, the popularity of AAT programs in hospitals has significantly increased, and there has been tremendous growth in the number of studies assessing whether the use of canine AAA or AAT have positive medical impacts on patients. Currently, the majority of studies focus on AAA programs, possibly because AAT programs require formally trained therapists and animals, program consistency, and strict program structure. Unfortunately, while most studies suggest that use of AAT can improve patient outcomes, many are poorly designed, poorly described, and few include randomized, controlled trials (RCT). The few existing RCT AAT studies focus on depression, schizophrenia, or other psychiatric disorders and suggest improvements in depression, anxiety, self-esteem, social outcomes, and enjoyment/pleasure. No RCT studies have looked at AAT in a physical therapy setting. However, non-controlled, non-randomized studies suggest that AAT as part of physical therapy may improve patient physical outcomes (such as walking speed, number of steps, gait, etc.), possibly by impacting patient motivation and participation in physical therapy activities.
The Aurora Sinai Medical Center (ASMC) currently utilizes both AAA and AAT programs. Most patients involved in the AAT program at ASMC are undergoing intensive inpatient physical therapy due to stroke, Parkinson's disease, or other diseases causing generalized weakness deconditioning, and these inpatients receive daily physical therapy with the occasional opportunity to include AAT in their therapy sessions. Previous studies suggest that patient interactions with therapy dogs are intrinsically rewarding, suggesting that use of an AAT program may increase patient motivation to participate and thus improve physical indices. However, this has yet to be objectively analyzed.
Hypothesis: Canine AAT in inpatient physical therapy improves physical activity function through enhanced levels of participation in physical therapy sessions.
Specific Aim 1: To evaluate whether patient participation increases during physical therapy using canine AAT. Physical activity function is impacted by a patient's level of participation, which is influenced by multiple sub-factors. Participation can be measured in multiple ways, including subjectively by the patient, subjectively by an observer (the physical therapist), or objectively through activity outputs. The level of participation may or may not correlate with the patient's self-perceived motivation.
Specific Aim 2. To determine whether use of canine AAT increases patient enjoyment and motivation in physical therapy. Many people perceive interactions with animals as intrinsically motivating and enjoyable. Consistent with this, canine AAT can improve patient motivation to participate in physical therapy. However, neither enjoyment nor motivation have been studied in physical therapy rehabilitation inpatients, nor have they been tested in RCT settings.
Specific Aim 3: To assess whether patient perceptions of care improve with use of canine AAT in physical therapy. Because the presence of a therapy canine may improve mood, motivation, and/or patient/caregiver communications, we hypothesize that use of canine AAT in inpatient physical therapy will improve patient perceptions of their caregivers, their care, and the hospital.
Innovation and Impact While AAT programs are currently used throughout the United States in inpatient rehabilitation programs, it is unknown whether and how these programs impact patient physical activity functions. This study will elucidate whether these programs provide benefits to patients or medical institutions, thereby providing medical providers with the data necessary to choose the most effective and impactful care for their patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-AAT Group | Active comparator | Behavioral: Standard of Care Physical TherapyInpatients in this group will receive 3-5 brief afternoon physical therapy sessions over 3-5 successive days. None of the sessions will include use of a canine for AAT. This group will include the intervention of Standard of Care Physical Therapy |
| AAT Group | Experimental | Behavioral: Canine Animal-Assisted TherapyInpatients in this group will receive 3-5 brief afternoon physical therapy sessions over 3-5 successive days. The session on the middle day will include use of a canine for AAT. This group will receive a behavioral intervention of Canine Animal-Assisted Therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are being rehabilitated as an inpatient for Parkinson's, stroke, or generalized weakness deconditioning (muscle weakness);
- Are able to give informed consent or communicate either verbally or in writing;
- Are able to follow instructions;
- Are at least 18 years old; and
- Choose to participate.
Key exclusion criteria (10 listed)
- Have a fear/dislike of dogs;
- Show noticeable cues of resistance/discomfort to dogs;
- Are allergic to dogs;
- Are immunocompromised;
- Are not being rehabilitated for Parkinson's, stroke, or generalized weakness deconditioning (muscle weakness);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Canine Animal-Assisted TherapyCanine Animal-Assisted Therapy is the inclusion of a certified therapy canine in the standard of care physical therapy session, such as for walking, fetching balls, standing/petting, etc. | Behavioural | AAT Group |
| Standard of Care Physical TherapyThis intervention is the standard of care physical therapy currently offered. No canine is present. | Behavioural | Non-AAT Group |
Primary outcome
Change Ball Throwing Distance
Time frame: The change in ball throwing distance will be measured every day over 3-5 days.
The change in the distance a tennis ball is thrown (averaged over three throws) between daily trials.
Change in Standing Time
Time frame: During every therapy session over 3-5 days.
The change in the amount of time the patient spends standing per session over time.
Change in Patient Engagement/Motivation Levels
Time frame: Between every therapy session over 3-5 days.
The change in patient engagement will be measured by the therapist's perceptions of engagement, as well as the patient's self-perceived engagement/motivation levels between daily trials through questionnaires.
Change in Walking Capacity
Time frame: Between every therapy session over 3-5 days.
The change in distance or amount of time patients spend walking between daily trials.
Change in Sitting Count
Time frame: Between every therapy session over 3-5 days.
The change in the number of times the patient sits (stops standing) between daily trials.
Change in Patient Visual Cues of Emotion
Time frame: Between every therapy session over 3-5 days.
The change in the number of times the patient demonstrates visual cues for different emotions between daily trials.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- BackgroundTherapy Dogs International: In W. M (ed), 2015.
- BackgroundHandbook on Animal-Assisted Therapy (2 Ed.): Academic Press, 2006.
- Background: PubMed 17190894Carandang R, Seshadri S, Beiser A, Kelly-Hayes M, Kase CS, Kannel WB, Wolf PA. Trends in incidence, lifetime risk, severity, and 30-day mortality of stroke over the past 50 years. JAMA. 2006 Dec 27;296(24):2939-46. doi: 10.1001/jama.296.24.2939.
- BackgroundDelta Society: What are Animal-Assisted Activities/Therapy? Retrieved June 19, 2015, from http://www.petpartners.org/document.doc?id=1102
- Background: PubMed 11781119Elbaz A, Bower JH, Maraganore DM, McDonnell SK, Peterson BJ, Ahlskog JE, Schaid DJ, Rocca WA. Risk tables for parkinsonism and Parkinson's disease. J Clin Epidemiol. 2002 Jan;55(1):25-31. doi: 10.1016/s0895-4356(01)00425-5.
- Background: PubMed 24731910Kamioka H, Okada S, Tsutani K, Park H, Okuizumi H, Handa S, Oshio T, Park SJ, Kitayuguchi J, Abe T, Honda T, Mutoh Y. Effectiveness of animal-assisted therapy: A systematic review of randomized controlled trials. Complement Ther Med. 2014 Apr;22(2):371-90. doi: 10.1016/j.ctim.2013.12.016. Epub 2014 Jan 6.
- BackgroundMaujean A, Pepping CA, Kendall E: A Systematic Review of Randomized Controlled Trials of Animal-Assisted Therapy on Psychosocial Outcomes. Anthrozoos: A Multidisciplinary Journal of The Interactions of People & Animals. 2015, 28:23-36.
- BackgroundNimer J, Lundahl B: Animal-Assisted Therapy: A Meta-Analysis. Anthrozoos: A Multidisciplinary Journal of The Interactions of People & Animals. 2007, 20:225-238.
- BackgroundChur-Hansen A, McArthur M, Winefield H, Hanieh E, Hazel S: Animal-Assisted Interventions in Children's Hospitals: A Critical Review of the Literature. European Journal of Marketing. 2014, 27:5-18.
- BackgroundMarino L: Construct Validity of AnimalAssisted Therapy and Activities: How Important Is the Animal in AAT? Anthrozoos: A Multidisciplinary Journal of The Interactions of People & Animals. 2012, 25:139-151.
- Background: PubMed 22978246Berry A, Borgi M, Francia N, Alleva E, Cirulli F. Use of assistance and therapy dogs for children with autism spectrum disorders: a critical review of the current evidence. J Altern Complement Med. 2013 Feb;19(2):73-80. doi: 10.1089/acm.2011.0835. Epub 2012 Sep 14.
- Background: PubMed 16308382Antonioli C, Reveley MA. Randomised controlled trial of animal facilitated therapy with dolphins in the treatment of depression. BMJ. 2005 Nov 26;331(7527):1231. doi: 10.1136/bmj.331.7527.1231.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mindy Waite, PhD principal investigator
Aurora Health Care - Aurora Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canine Animal-Assisted Therapy in people with Stroke and Parkinson's Disease, run by Wake Forest University Health Sciences 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 10 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: withdrawn, as of the sponsor's last update on 2 Oct 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change Ball Throwing Distance (time frame: The change in ball throwing distance will be measured every day over 3-5 days.). The study lists 6 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 NCT02606006, which also lists 49 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 2 Oct 2024.