Testing the Efficacy of Social Robot-led YogaNCT05476614
Testing the Efficacy of Social Robot-led Yoga
A study testing Yoga (Robot-instructed) and Yoga (Human-instructed) in people with Testing the Efficacy of Social Robot-led Yoga, run by DreamFace Technologies, LLC at 1 site in United States.
Trial summary
Research demonstrates that yoga is beneficial for the older adults with or nearing mild cognitive impairment. Social robots are increasingly being used as companions and caregivers for older adults with or nearing MCI . Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Testing the Efficacy of Social Robot-led Yoga
- What is being tested?
- Yoga (Robot-instructed) and Yoga (Human-instructed)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 30 Nov 2022
- 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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years or older.
- SLUMS score of 20-26 will include persons with moderate cognitive impairment
- SLUMS score of >26 will include persons without moderate cognitive impairment
- Verbal skill to interact
- Available for a period of 12 weeks to participate in yoga
- Ability to stand without supports
Who cannot join
- Age younger than 65 years
- Aggressive behaviors
- Medical diagnosis of dementia or memory loss
- An inability to balance on a single leg without supports
- Acute physical illness that impairs or precludes physical activity
- SLUMS score equal to or below 20, the cutoff for dementia
- A drop in SLUMS score greater than 3 points from the beginning of the study to the midpoint of the study
Trial locations and contacts
1 site in 1 country.
About this study
Research demonstrates that yoga is beneficial for the older adults with or nearing mild cognitive impairment. Social robots are increasingly being used as companions and caregivers for older adults with or nearing MCI . The purpose of this study is to test the efficacy of social robot-led yoga for older adults with or nearing MCI. The study hypothesizes that social robot-led yoga is similar in effectiveness to human-led yoga across a range of measures.
Read the detailed description
Research demonstrates that yoga is beneficial for the older adults with or nearing mild cognitive impairment. Social robots are increasingly being used as companions and caregivers for older adults with or nearing MCI. The purpose of this study is to test the efficacy of social robot-led yoga for older adults with or nearing MCI. The study hypothesizes that social robot-led yoga is similar in effectiveness to human-led yoga across a range of measures.
A group of approximately 40-50 older adults (65+) will follow a yoga routine twice per week for 12 weeks taught by either a social robot or human instructor. Details of the yoga instruction can be found below. Yoga sessions will be conducted at an assisted living facility in Denver, Colorado.
Prior to, at the midway point, and after the yoga intervention, researchers will measure participants for the following:
- Range of motion, overhead flexion: Ryan, the social robot, can scan participants using infrared cameras and create a digital remembrance of their end range of overhead flexion. n = 40 participants will complete the range of motion assessment prior to intervention, midway through the intervention (week 6), post intervention (week 12), and at follow up (week 18).
- Single-leg balance: Ryan, the social robot, can measure the duration of participant single-leg balance. participants will be asked to balance on their nondominant leg for up to 60 seconds. n = 40 participants will complete the single-leg balance assessment prior to intervention, midway through the intervention (week 6), post intervention (week 12), and at follow up (week 18).
- The Saint Louis University Mental Status examination (SLUMS): the SLUMS questionnaire will be administered to measure cognitive performance. n = 40 participants will complete the slums prior to intervention, midway through the intervention (week 6), post intervention (week 12), and at follow up (week 18). If at any point the participant meets the exclusion criteria based on SLUMS score, they will be removed from the study.
- The patient health questionnaire (PHQ-9): researchers will administer the PHQ-9 to measure depression. n = 40 participants will complete the phq-9 prior to intervention, midway through the intervention (week 6), post intervention (week 12), and at follow up (week 18).
- Kentucky inventory of mindfulness skills (KIMS): researchers will administer the KIMS to measure mindful attention capacity. n= 40 participants will complete the KIMS prior to intervention, midway through the intervention (week 6), post intervention (week 12), and at follow up (week 18).
- Task engagement: researchers will administer a task engagement questionnaire to measure engagement in the yoga experience. This modified scale will provide a reliable measure of user engagement with both instructors. n = 40 participants will complete the user engagement questionnaire after each yoga session (week 1-12).
At the end of each yoga session, participants will fill out a brief qualitative questionnaire. the questionnaire will ask the following: 1) Please described your experience. 2) What did your instructor do well, where did they struggle? To increase questionnaire brevity, the task engagement questionnaire and qualitative questionnaire are displayed on the same single page of paper.
After six weeks have passed from the date of the last yoga session, participants will be measured one final time as a form of post-participation follow up. Measures will include range of motion, single-leg balance, SLUMS examination, PHQ-9, and KIMS.
Yoga Instruction: Social robot-led yoga will be instructed by Ryan, the social robot. Ryan will be programmed to instruct 10-14 yoga postures in addition to an opening and closing meditation. Each yoga posture will be selected for appropriateness to the developmental age of participants. Several postures will be seated. Others will be standing. Participants will be given the option to stand if they wish and encouraged to move at their own pace. Each posture focuses on creating requisite strength for older adults and correlates to the study's physical measures of single-leg balance and overhead flexion, range of motion. All postures re-enforce each other. Postures will be randomized to ensure variety and updated periodically throughout the study to ensure proper level of challenge and engagement. Updates may include new postures, new verbal or video-based instruction in conjunction with physical instruction changes. Human-led yoga will follow the same format as the social robot-led yoga sessions. Instruction will be 45-minutes of yoga designed with an integrative focus. Human-led yoga will mirror social robot-led yoga in intent, duration, and posture selection.
- Being tested
- Yoga (Robot-instructed), Yoga (Human-instructed)
- Keywords
- yoga, mindfulness, robot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga (Robot-instructed)Other
Yoga that is instructed by a social robot
Yoga (Human-instructed)Other
Yoga that is instructed by a human
| Study group | Role | What they receive |
|---|---|---|
| Social robot-instructed yoga group | Experimental | A socially assistive robot will be programmed to instruct 10-14 yoga postures for a group of 20-25 older adults. The yoga session will also include meditation and centering exercises. Receives: Other: Yoga (Robot-instructed) |
| Human-instructed yoga group | Active comparator | A human yoga instructor will lead 10-14 yoga postures for a group of 20-25 older adults. The yoga session will also include meditation and centering exercises. Receives: Other: Yoga (Human-instructed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overhead flexion range of motion
Participant range of motion while standing, arms raise to maximal overhead flexion position. Increased overhead flexion range of motion indicates improved shoulder mobility.
Measured: At Week 0
Overhead flexion range of motion
Participant range of motion while standing, arms raise to maximal overhead flexion position. Increased overhead flexion range of motion indicates improved shoulder mobility.
Measured: At Week 6
Overhead flexion range of motion
Participant range of motion while standing, arms raise to maximal overhead flexion position. Increased overhead flexion range of motion indicates improved shoulder mobility.
Measured: At Week 12
Overhead flexion range of motion
Participant range of motion while standing, arms raise to maximal overhead flexion position. Increased overhead flexion range of motion indicates improved shoulder mobility.
Measured: At Week 18
Single-leg balance hold duration
Participants will hold a balance position unsupported by their arms for a maximum of 60 seconds. Increased single-leg balance hold duration indicates improved fall resilience.
Measured: At Week 0
Single-leg balance hold duration
Participants will hold a balance position unsupported by their arms for a maximum of 60 seconds. Increased single-leg balance hold duration indicates improved fall resilience.
Measured: At Week 6
Single-leg balance hold duration
Participants will hold a balance position unsupported by their arms for a maximum of 60 seconds. Increased single-leg balance hold duration indicates improved fall resilience.
Measured: At Week 12
Single-leg balance hold duration
Participants will hold a balance position unsupported by their arms for a maximum of 60 seconds. Increased single-leg balance hold duration indicates improved fall resilience.
Measured: At Week 18
Secondary outcomes (12)
Kentucky Inventory of Mindfulness Skills (KIMS)
A questionnaire used to assess a participant's ability interact with their environment mindfully. Scoring takes into consideration four facets of mindfulness (Observation, Description, Acting with Awareness, and Judgement). Observation score range (12-60); Description score range (8-40); Act with Awareness score range (10-50); Judgement (9-45). A higher score within the mindfulness attributes of observation, description and awareness indicates increased mindfulness skills. A lower score within the mindfulness attribute of judgement indicates an improvement.
Measured: At Week 0
Kentucky Inventory of Mindfulness Skills (KIMS)
A questionnaire used to assess a participant's ability interact with their environment mindfully. Scoring takes into consideration four facets of mindfulness (Observation, Description, Acting with Awareness, and Judgement). Observation score range (12-60); Description score range (8-40); Act with Awareness score range (10-50); Judgement (9-45). A higher score within the mindfulness attributes of observation, description and awareness indicates increased mindfulness skills. A lower score within the mindfulness attribute of judgement indicates an improvement.
Measured: At Week 6
Kentucky Inventory of Mindfulness Skills (KIMS)
A questionnaire used to assess a participant's ability interact with their environment mindfully. Scoring takes into consideration four facets of mindfulness (Observation, Description, Acting with Awareness, and Judgement). Observation score range (12-60); Description score range (8-40); Act with Awareness score range (10-50); Judgement (9-45). A higher score within the mindfulness attributes of observation, description and awareness indicates increased mindfulness skills. A lower score within the mindfulness attribute of judgement indicates an improvement.
Measured: At Week 12
Kentucky Inventory of Mindfulness Skills (KIMS)
A questionnaire used to assess a participant's ability interact with their environment mindfully. Scoring takes into consideration four facets of mindfulness (Observation, Description, Acting with Awareness, and Judgement). Observation score range (12-60); Description score range (8-40); Act with Awareness score range (10-50); Judgement (9-45). A higher score within the mindfulness attributes of observation, description and awareness indicates increased mindfulness skills. A lower score within the mindfulness attribute of judgement indicates an improvement.
Measured: At Week 18
The Patient Health Questionnaire (PHQ-9)
Depression Questionnaire. Scale minimum value: 0. Scale maximum value: 27). A lower score indicates minimal depression or decreasing depression severity.
Measured: At Week 0
The Patient Health Questionnaire (PHQ-9)
Depression Questionnaire. Scale minimum value: 0. Scale maximum value: 27). A lower score indicates minimal depression or decreasing depression severity.
Measured: At Week 6
The Patient Health Questionnaire (PHQ-9)
Depression Questionnaire. Scale minimum value: 0. Scale maximum value: 27). A lower score indicates minimal depression or decreasing depression severity.
Measured: At Week 12
The Patient Health Questionnaire (PHQ-9)
Depression Questionnaire. Scale minimum value: 0. Scale maximum value: 27). A lower score indicates minimal depression or decreasing depression severity.
Measured: At Week 18
The Saint Louis University Mental Status Examination
A measure of cognitive impairment. Scale minimum value: 0. Scale maximum value: 30. For those with a high school education or greater a score of 27-30 indicates normal function; 21-26 indicates a mild neurocognitive disorder; 0-20 indicates dementia. For those with less than a high school education a score of 25-30 indicates normal function; 20-24 indicates a mild neurocognitive disorder; 0-19 indicates dementia.
Measured: At Week 0
The Saint Louis University Mental Status Examination
A measure of cognitive impairment. Scale minimum value: 0. Scale maximum value: 30. For those with a high school education or greater a score of 27-30 indicates normal function; 21-26 indicates a mild neurocognitive disorder; 0-20 indicates dementia. For those with less than a high school education a score of 25-30 indicates normal function; 20-24 indicates a mild neurocognitive disorder; 0-19 indicates dementia.q
Measured: At Week 6
The Saint Louis University Mental Status Examination
A measure of cognitive impairment. Scale minimum value: 0. Scale maximum value: 30. For those with a high school education or greater a score of 27-30 indicates normal function; 21-26 indicates a mild neurocognitive disorder; 0-20 indicates dementia. For those with less than a high school education a score of 25-30 indicates normal function; 20-24 indicates a mild neurocognitive disorder; 0-19 indicates dementia.
Measured: At Week 12
The Saint Louis University Mental Status Examination
A measure of cognitive impairment. Scale minimum value: 0. Scale maximum value: 30. For those with a high school education or greater a score of 27-30 indicates normal function; 21-26 indicates a mild neurocognitive disorder; 0-20 indicates dementia. For those with less than a high school education a score of 25-30 indicates normal function; 20-24 indicates a mild neurocognitive disorder; 0-19 indicates dementia.
Measured: At Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Aug 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Testing the Efficacy of Social Robot-led YogaStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be grouped at random into social robot-instructed yoga or human-instructed yoga.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- DreamFace Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sean Mapoles, MS, Principal investigator, University of Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476614
- Sponsor's protocol ID
- 2022-001
- Status last verified
- Feb 2024
- First submitted
- 15 May 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brenes GA, Sohl S, Wells RE, Befus D, Campos CL, Danhauer SC. The Effects of Yoga on Patients with Mild Cognitive Impairment and Dementia: A Scoping Review. Am J Geriatr Psychiatry. 2019 Feb;27(2):188-197. doi: 10.1016/j.jagp.2018.10.013. Epub 2018 Oct 25.
PubMed 30413292Kachouie, R., Sedighadeli, S., Khosla, R., & Chu, M. T. (2014). Socially assistive robots in elderly care: a mixed-method systematic literature review. International Journal of Human-Computer Interaction, 30(5), 369-393.
Fan JT, Chen KM. Using silver yoga exercises to promote physical and mental health of elders with dementia in long-term care facilities. Int Psychogeriatr. 2011 Oct;23(8):1222-30. doi: 10.1017/S1041610211000287. Epub 2011 Mar 9.
PubMed 21385519
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of Social Robot-led Yoga
- ClinicalTrials.gov ID
- NCT05476614
- Acronym / sponsor ID
- 2022-001
- Keywords
- yoga, mindfulness, robot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- DreamFace Technologies, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 27 Jul 2022 (actual)
- 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.
Research demonstrates that yoga is beneficial for the older adults with or nearing mild cognitive impairment. Social robots are increasingly being used as companions and caregivers for older adults with or nearing MCI . The purpose of this study is to test the efficacy of social robot-led yoga for older adults with or nearing MCI. The study hypothesizes that social robot-led yoga is similar in effectiveness to human-led yoga across a range of measures.
Detailed description
Research demonstrates that yoga is beneficial for the older adults with or nearing mild cognitive impairment. Social robots are increasingly being used as companions and caregivers for older adults with or nearing MCI. The purpose of this study is to test the efficacy of social robot-led yoga for older adults with or nearing MCI. The study hypothesizes that social robot-led yoga is similar in effectiveness to human-led yoga across a range of measures.
A group of approximately 40-50 older adults (65+) will follow a yoga routine twice per week for 12 weeks taught by either a social robot or human instructor. Details of the yoga instruction can be found below. Yoga sessions will be conducted at an assisted living facility in Denver, Colorado.
Prior to, at the midway point, and after the yoga intervention, researchers will measure participants for the following:
- Range of motion, overhead flexion: Ryan, the social robot, can scan participants using infrared cameras and create a digital remembrance of their end range of overhead flexion. n = 40 participants will complete the range of motion assessment prior to intervention, midway through the intervention (week 6), post intervention (week 12), and at follow up (week 18).
- Single-leg balance: Ryan, the social robot, can measure the duration of participant single-leg balance. participants will be asked to balance on their nondominant leg for up to 60 seconds. n = 40 participants will complete the single-leg balance assessment prior to intervention, midway through the intervention (week 6), post intervention (week 12), and at follow up (week 18).
- The Saint Louis University Mental Status examination (SLUMS): the SLUMS questionnaire will be administered to measure cognitive performance. n = 40 participants will complete the slums prior to intervention, midway through the intervention (week 6), post intervention (week 12), and at follow up (week 18). If at any point the participant meets the exclusion criteria based on SLUMS score, they will be removed from the study.
- The patient health questionnaire (PHQ-9): researchers will administer the PHQ-9 to measure depression. n = 40 participants will complete the phq-9 prior to intervention, midway through the intervention (week 6), post intervention (week 12), and at follow up (week 18).
- Kentucky inventory of mindfulness skills (KIMS): researchers will administer the KIMS to measure mindful attention capacity. n= 40 participants will complete the KIMS prior to intervention, midway through the intervention (week 6), post intervention (week 12), and at follow up (week 18).
- Task engagement: researchers will administer a task engagement questionnaire to measure engagement in the yoga experience. This modified scale will provide a reliable measure of user engagement with both instructors. n = 40 participants will complete the user engagement questionnaire after each yoga session (week 1-12).
At the end of each yoga session, participants will fill out a brief qualitative questionnaire. the questionnaire will ask the following: 1) Please described your experience. 2) What did your instructor do well, where did they struggle? To increase questionnaire brevity, the task engagement questionnaire and qualitative questionnaire are displayed on the same single page of paper.
After six weeks have passed from the date of the last yoga session, participants will be measured one final time as a form of post-participation follow up. Measures will include range of motion, single-leg balance, SLUMS examination, PHQ-9, and KIMS.
Yoga Instruction: Social robot-led yoga will be instructed by Ryan, the social robot. Ryan will be programmed to instruct 10-14 yoga postures in addition to an opening and closing meditation. Each yoga posture will be selected for appropriateness to the developmental age of participants. Several postures will be seated. Others will be standing. Participants will be given the option to stand if they wish and encouraged to move at their own pace. Each posture focuses on creating requisite strength for older adults and correlates to the study's physical measures of single-leg balance and overhead flexion, range of motion. All postures re-enforce each other. Postures will be randomized to ensure variety and updated periodically throughout the study to ensure proper level of challenge and engagement. Updates may include new postures, new verbal or video-based instruction in conjunction with physical instruction changes. Human-led yoga will follow the same format as the social robot-led yoga sessions. Instruction will be 45-minutes of yoga designed with an integrative focus. Human-led yoga will mirror social robot-led yoga in intent, duration, and posture selection.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be grouped at random into social robot-instructed yoga or human-instructed yoga.
| Arm | Type | Receives |
|---|---|---|
| Social robot-instructed yoga group | Experimental | Other: Yoga (Robot-instructed)A socially assistive robot will be programmed to instruct 10-14 yoga postures for a group of 20-25 older adults. The yoga session will also include meditation and centering exercises. |
| Human-instructed yoga group | Active comparator | Other: Yoga (Human-instructed)A human yoga instructor will lead 10-14 yoga postures for a group of 20-25 older adults. The yoga session will also include meditation and centering exercises. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age 65 years or older.
- SLUMS score of 20-26 will include persons with moderate cognitive impairment
- SLUMS score of >26 will include persons without moderate cognitive impairment
- Verbal skill to interact
- Available for a period of 12 weeks to participate in yoga
Key exclusion criteria (7 listed)
- Age younger than 65 years
- Aggressive behaviors
- Medical diagnosis of dementia or memory loss
- An inability to balance on a single leg without supports
- Acute physical illness that impairs or precludes physical activity
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 |
|---|---|---|
| Yoga (Robot-instructed)Yoga that is instructed by a social robot | Other | Social robot-instructed yoga group |
| Yoga (Human-instructed)Yoga that is instructed by a human | Other | Human-instructed yoga group |
Primary outcome
Overhead flexion range of motion
Time frame: At Week 0
Participant range of motion while standing, arms raise to maximal overhead flexion position. Increased overhead flexion range of motion indicates improved shoulder mobility.
Overhead flexion range of motion
Time frame: At Week 6
Participant range of motion while standing, arms raise to maximal overhead flexion position. Increased overhead flexion range of motion indicates improved shoulder mobility.
Overhead flexion range of motion
Time frame: At Week 12
Participant range of motion while standing, arms raise to maximal overhead flexion position. Increased overhead flexion range of motion indicates improved shoulder mobility.
Overhead flexion range of motion
Time frame: At Week 18
Participant range of motion while standing, arms raise to maximal overhead flexion position. Increased overhead flexion range of motion indicates improved shoulder mobility.
Single-leg balance hold duration
Time frame: At Week 0
Participants will hold a balance position unsupported by their arms for a maximum of 60 seconds. Increased single-leg balance hold duration indicates improved fall resilience.
Single-leg balance hold duration
Time frame: At Week 6
Participants will hold a balance position unsupported by their arms for a maximum of 60 seconds. Increased single-leg balance hold duration indicates improved fall resilience.
Single-leg balance hold duration
Time frame: At Week 12
Participants will hold a balance position unsupported by their arms for a maximum of 60 seconds. Increased single-leg balance hold duration indicates improved fall resilience.
Single-leg balance hold duration
Time frame: At Week 18
Participants will hold a balance position unsupported by their arms for a maximum of 60 seconds. Increased single-leg balance hold duration indicates improved fall resilience.
12 secondary outcomes
Kentucky Inventory of Mindfulness Skills (KIMS)
Time frame: At Week 0
Kentucky Inventory of Mindfulness Skills (KIMS)
Time frame: At Week 6
Kentucky Inventory of Mindfulness Skills (KIMS)
Time frame: At Week 12
Kentucky Inventory of Mindfulness Skills (KIMS)
Time frame: At Week 18
The Patient Health Questionnaire (PHQ-9)
Time frame: At Week 0
The Patient Health Questionnaire (PHQ-9)
Time frame: At Week 6
The Patient Health Questionnaire (PHQ-9)
Time frame: At Week 12
The Patient Health Questionnaire (PHQ-9)
Time frame: At Week 18
The Saint Louis University Mental Status Examination
Time frame: At Week 0
The Saint Louis University Mental Status Examination
Time frame: At Week 6
The Saint Louis University Mental Status Examination
Time frame: At Week 12
The Saint Louis University Mental Status Examination
Time frame: At Week 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 30413292Brenes GA, Sohl S, Wells RE, Befus D, Campos CL, Danhauer SC. The Effects of Yoga on Patients with Mild Cognitive Impairment and Dementia: A Scoping Review. Am J Geriatr Psychiatry. 2019 Feb;27(2):188-197. doi: 10.1016/j.jagp.2018.10.013. Epub 2018 Oct 25.
- BackgroundKachouie, R., Sedighadeli, S., Khosla, R., & Chu, M. T. (2014). Socially assistive robots in elderly care: a mixed-method systematic literature review. International Journal of Human-Computer Interaction, 30(5), 369-393.
- Background: PubMed 21385519Fan JT, Chen KM. Using silver yoga exercises to promote physical and mental health of elders with dementia in long-term care facilities. Int Psychogeriatr. 2011 Oct;23(8):1222-30. doi: 10.1017/S1041610211000287. Epub 2011 Mar 9.
- Individual participant dataSharing planned: Undecided
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.
Sean Mapoles, MS principal investigator
University of Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga (Robot-instructed) and Yoga (Human-instructed) in people with Testing the Efficacy of Social Robot-led Yoga, run by DreamFace Technologies, LLC 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 6 inclusion and 7 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 29 Feb 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overhead flexion range of motion (time frame: At Week 0). The study lists 8 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 NCT05476614, which also lists 3 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 29 Feb 2024.