Testing the Efficacy of Social Robot-led Yoga

February 27, 2024 updated by: DreamFace Technologies, LLC
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.

Study Overview

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:

  1. 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).
  2. 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).
  3. 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.
  4. 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).
  5. 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).
  6. 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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Colorado
      • Denver, Colorado, United States, 80210
        • University of Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Social robot-instructed yoga group
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.
Yoga that is instructed by a social robot
Active Comparator: Human-instructed yoga group
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.
Yoga that is instructed by a human

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At Week 0
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.
At Week 6
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.
At Week 12
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.
At Week 18
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.
At Week 0
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.
At Week 6
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.
At Week 12
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.
At Week 18

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kentucky Inventory of Mindfulness Skills (KIMS)
Time Frame: At Week 0
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.
At Week 0
Kentucky Inventory of Mindfulness Skills (KIMS)
Time Frame: At Week 6
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.
At Week 6
Kentucky Inventory of Mindfulness Skills (KIMS)
Time Frame: At Week 12
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.
At Week 12
Kentucky Inventory of Mindfulness Skills (KIMS)
Time Frame: At Week 18
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.
At Week 18
The Patient Health Questionnaire (PHQ-9)
Time Frame: At Week 0
Depression Questionnaire. Scale minimum value: 0. Scale maximum value: 27). A lower score indicates minimal depression or decreasing depression severity.
At Week 0
The Patient Health Questionnaire (PHQ-9)
Time Frame: At Week 6
Depression Questionnaire. Scale minimum value: 0. Scale maximum value: 27). A lower score indicates minimal depression or decreasing depression severity.
At Week 6
The Patient Health Questionnaire (PHQ-9)
Time Frame: At Week 12
Depression Questionnaire. Scale minimum value: 0. Scale maximum value: 27). A lower score indicates minimal depression or decreasing depression severity.
At Week 12
The Patient Health Questionnaire (PHQ-9)
Time Frame: At Week 18
Depression Questionnaire. Scale minimum value: 0. Scale maximum value: 27). A lower score indicates minimal depression or decreasing depression severity.
At Week 18
The Saint Louis University Mental Status Examination
Time Frame: At Week 0
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.
At Week 0
The Saint Louis University Mental Status Examination
Time Frame: At Week 6
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
At Week 6
The Saint Louis University Mental Status Examination
Time Frame: At Week 12
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.
At Week 12
The Saint Louis University Mental Status Examination
Time Frame: At Week 18
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.
At Week 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sean Mapoles, MS, University of Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

May 15, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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