Effectiveness of Alternative Therapy for Improving Cognition, Balance, and Physical Activity

NCT04160299 | Completed DMC

• 2 other identifiers: 2018-1074P30AG022849
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The composite effect of reduced balance, cognition, gait abnormalities/gait disturbances, and physical activity in older adults with mild cognitive impairments (MCI) leads to fear of falling and reduced participation in daily activities, which results in reduced cardiovascular fitness and deconditioning. Although many conventional balance and strength training programs have been implemented for older adults with MCI; these adults do not receive adequate practice dosage to make significant improvements, most likely due to lack of adherence to therapy and/or inadequate incorporation of all domains of the ICF model (body functions and structures, activities and participation) and lack of targeting cognitive-motor interference (deterioration of motor and/or cognitive function when both tasks are performed together). The use of alternative therapies such as dance and virtual reality (VR) has been found to be relatively enjoyable for older adults due to increased motivation, which led to the added improvement of physical and cognitive functioning. The overall aims of this pilot is to test the feasibility of VR-based dance therapy paradigm for older adults with MCI as well as its effect on enhancing balance, gait, and cognition, and physical fitness. Investigators also hope that the net effect of improvement in these domains of health outcomes will result in pre and post reduction of fall risk and improved quality of life of older adults with MCI. The study investigates the effectiveness of a VR (Kinect)-based dance therapy in older adults with MCI by demonstrating its feasibility and compliance rate and also determine the efficacy of the VR-based dance therapy in improving health outcomes such as motor and cognitive functions, thereby reducing cognitive-motor interference. The study will also aim to determine the effectiveness of the VR-based dance paradigm in improving cardiovascular fitness and physical activity (PA) in older adults with MCI

Conditions

Mild Cognitive Impairment; Older Adults; Neurological Injury

Outcome Measures

Primary Outcomes (12)

• Feasibility of a 10-week Virtual reality-based dance training: questionnaire

  Feasibility of this pilot study will be determined by a feasibility questionnaire based on the ITC-Sense of Presence Inventory questionnaire. The ITC-Sense of Presence Inventory Questionnaire consists of questions and statements about the feasibility of the study and will be scored from 1(strongly disagree) to 5 (strongly agree). The questionnaire comprises of inputs regarding the participants' experiences in the virtual environment including perception and sense of presence in the virtual environment and about their experiences in the VR-based dance training environment, the presence of potential side effects and their input on the design and effects of the intervention.

  Week 10

• Compliance rate of participants to a 10-week virtual reality-based dance training

  Percentage of the number of sessions completed out of a total of 30 by each participant.

  End of all dance training sessions at Week 10

• Change in cognitive functions during single and dual tasks

  Accuracy of performance to cognitive task which assesses attention, executive function and reaction time by the use of computerized Neuropsychological Battery test. Accuracy and reaction time will also be tested by serial subtraction, letter number sequence, Trial Making Test and category naming task. Performance and cost will be evaluated during dual tasking with Serial subtraction, letter number sequence and category fluency cognitive task while walking on gait rite, performing slip and trip test and also during volitional Limits of Stability, LOS and Sensory Organization Test, SOT with NeuroCoM Balance Master. Accuracy (number of correct responses out of the total responses). Higher accuracy indicates better performance.

  Baseline at Week 0, Mid-intervention at week 5, post-intervention week 11 and Follow-up at week 14

• Change in incidence of falls

  Change in the number of falls over 14 weeks will be assessed by the Fall Incidence Questionnaire. This fall questionnaire ascertains the number of falls experienced by participants over 14 weeks of the study. Reduction in the number of falls is a good indication of effectiveness of the intervention.

  Baseline at week 0 and Follow-up at week 14

• Change in end point excursion

  It is the magnitude of a self-initiated movement (i.e., how far he/she wills to reach a target) without taking a step or losing balance measured in percentage under single and dual-task conditions. Higher values indicate better performance.

  Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14

• Change in Movement velocity

  It is the average speed of center of gravity movement during intentional movement measured in degrees per second under single and dual-task conditions. Higher values indicate better performance.

  Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14

• Change in maximum excursion

  It is the actual magnitude of a self-initiated movement (i.e., how far did he/she actually reach a target) without taking a step or losing balance measured in percentage under single and dual-task conditions. Higher values indicate better performance.

  Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14

• Change in directional control

  It is the quality of a self-initiated movement (i.e., amount of movement actually exhibited towards the target to the amount of extraneous movement away from the target) measured in percentage under single and dual-task conditions. Higher values indicate better performance.

  Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14

• Change in postural stability during reactive balance control (single and dual-task)

  Reactive stability balance, in terms of center of mass position and velocity during slips and trips will be assessed with ActiveStep Treadmill equipment and inertial sensors. Postural stability can be defined as simultaneous control of center of mass (COM) position and velocity during slip-like or trip like perturbation relative to the rear edge of base of support (rear heel). The position is normalized with the individual's foot length, and velocity by square root of gravitational acceleration and individual's body height. Larger values indicate greater stability.

  Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14

• Change in step length

  Step length (meters), which is a determinant of fall will be assessed with Gaitrite and inertial sensors.

  Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14

• Change in gait speed

  Gait speed (meters per second), which is determinant of fall will be assessed with Gaitrite and inertial sensors.

  Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14

• Change in cadence

  Cadence (steps per minute), which is determinant of fall will be assessed with Gaitrite and inertial sensors.

  Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14

Secondary Outcomes (7)

• Change in Blood pressure (mmHg)

  Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14

• Change in heart rate (beats per minute, bpm)

  Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14

• Change in physical activity level (step count)

  Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14

• Change in distance covered in Six-minute walk test (6MWT)

  Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14

• Change in time taken to complete Timed-Up and Go (TUG)

  Baseline at week 0, mid-intervention at week 5, post-intervention at week 11 and follow-up test at week 14

Study Arms (1)

Dance-based exergaming

EXPERIMENTAL

This will be an intervention-based study with single-group design, where participants will receive VR-based dance training for ten weeks. An anticipated 20 participants with a diagnosis of mild cognitive deficits will be recruited for initial screening

Behavioral: Dance-based exergaming

Interventions

Dance-based exergaming BEHAVIORAL

Dance sessions

Also known as: Dance therapy, Dance-based virtual reality

Dance-based exergaming

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age group: ≥65 years
• Montreal cognitive Assessment (MOCA) score \<26/30
• Bone density with a t-score ≥ -2
• Absence of any acute or chronic neurological, cardiopulmonary, musculoskeletal, or systemic diagnosis.
• No recent major surgery (\< 6 months)
• No recent hospitalization (\< 3 months)
• Not on any sedative drugs
• Can understand and communicate in English

You may not qualify if:

• HR \> 85% of age-predicted maximal heart rate (HRmax = 220 - age)
• Systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting
• Oxygen saturation (measured by pulse oximeter) during resting \< 95%
• Inability to stand for at least 5 minutes without an assistive device (length of dance game)
• History of bone fracture or significant other systemic disease or surgery in the last six months

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Trauma, Nervous System

Interventions

Dance Therapy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Exercise Movement Techniques; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tanvi Bhatt, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

• Ernest K Ofori, MS

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Older adults with Mild Cognitive Impairments, MCI.

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: November 13, 2019
• Study Start: November 7, 2018
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: November 2018 - December 2020

Locations

US (1)