Dual Task Perturbation Training for OAwMCI

NCT04938349 | Recruiting

• 2 other identifiers: 2021-0478R01AG073152
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief Summary

Studies have determined that compared to cognitively intact older adults (CIOA), older adults with mild cognitive impairment (OAwMCI) exhibit more pronounced balance and gait impairments which lead to an increased risk of falls and mobility decline. Such impairments are evident during dual-tasking (i.e., simultaneous performance of cognitive and motor task) and OAwMCI have demonstrated an increased cognitive-motor interference (deteriorated performance of either or both cognitive/motor task). Furthermore, our preliminary laboratory findings indicate that compared to CIOA, OAwMCI in response to large-magnitude treadmill perturbations exhibits poor reactive responses (first line of defense against balance loss) and are unable to modulate their responses as the magnitude of perturbation increases. Despite that conventional exercise methods offer beneficial effects; they comprise of self-initiated task-specific exercises and may not focus on training reactive responses. Additionally, due to the presence of subtle balance and gait deficits, clinical measures used may not be sensitive enough to determine the risk of fall post-training. Furthermore, these training methods incorporate multiple sessions due to which adherence to exercise training is difficult with only a fraction of the older adults benefiting from it. Therefore, it is essential to incorporate a task-specific strategy that promotes factors associated with falling like balance control, muscular responses, coordination of limbs, and cognition through which OAwMCI may acquire maximum benefits to prevent a balance loss. One feasible method, which harnesses technology that can be used to deliver balance disturbances either while standing or walking in a consistent and controlled manner, is via a custom-based motorized treadmill. The scientific rigor from preliminary studies has reported a successful reduction of falls through a single session exposing CIOA to multiple treadmill-induced perturbations during gait and has shown significant improvement in reactive responses. For that reason, this stage 1 pilot study will examine the feasibility, applicability, and tolerability of a combined cognitive, and perturbation training on biomechanical determinants associated with falls and promote physical activity: kinematic variables, muscular responses, and cognitive function.

Conditions

Mild Cognitive Impairment; Old Age; Debility

Keywords

Dual-task training; Mild cognitive impairment; Perturbation-based training; treadmill training; cognitive-motor training; perturbation

Outcome Measures

Primary Outcomes (15)

• Change in Stability gain or loss

  Stability is defined by both the position of a person's center-of-mass (COM) with respect to his or her base-of-support (BOS) and it's velocity.

  Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training

• Change in Limb support gain or loss

  The inability to provide timely limb support due to insufficient amount of upward impulse generated from the ground reactive force can cause limb collapse, as characterized by the quotient of amount and rate of hip descent (Vhip/Zhip) measured from hip height and lead to an eventual fall.

  Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training

• Change in laboratory-induced falls

  Perturbation is induced successfully and safely to reproduce inadvertent falls in a protective laboratory environment. Falls will be measured by the amount of body weight supported by the full-body harness system and measured by a load cell attached to this system. Instability of the body's COM and poor limb support prior to touchdown of the recovery step account for 90\~100% of subsequent falls (occurring \~500ms later) in both sit-to-stand-slip and in gait-slip, in the laboratory settings. Intervention consists of repeated perturbation training to induce a change in the laboratory induced falls immediately post-training and examine it's retention after the initial training session.

  Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training

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

  Reactive balance control will be examined via the stance perturbation test under single and dual-task conditions (simultaneous performance of Letter number sequencing task or auditory stroop task). 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 (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training

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

  Reactive balance control will be examined via the stance perturbation test under single and dual-task conditions (simultaneous performance of Letter number sequencing task or auditory stroop task). 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 (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training

• Change in walking step length

  Step length will be determined during single and dual-task walking performance via the walking on the treadmill and the GaitRite mat. Higher values for step length indicate better performance.

  Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training

• Change in walking cadence

  Cadence will be determined during single and dual-task walking performance via the walking on the treadmill and the GaitRite mat. Lower cadence indicate better performance.

  Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training

• Change in walking stride length

  Stride length will be determined during single and dual-task walking performance via the walking on the treadmill and the GaitRite mat. Higher values for stride length indicate better performance.

  Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training

• Change of accuracy in letter number sequencing

  This is an oral trail making test which includes listing alternate letter and number from the cue given in sequence. This test will be performed under single and dual-task conditions. Higher scores indicate better performance.

  Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training

• Change in accuracy of Visual clock test

  This test involves responding to the location of the minute and hour hand on a clock. This test will be performed under single and dual-task conditions. Higher scores indicate better performance.

  Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training

• Change in dual-task cost

  Dual-task motor and cognitive cost will be calculated using the formula- \[(Dual-task performance- Single Task performance)/Single task performance\]. This will be calculated for dual-task performance during intentional postural sway, reactive balance control and gait conditions. Lower cost indicates better performance.

  Baseline (week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training

• Change in visuomotor task

  This test involves continuous tracking of a cyclic moving target on the screen using a motion sensor placed on the head. Higher scores indicates poor performance.

  Baseline (week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training

• Fractional anisotropy

  White matter integrity tested using magnetic resonance imaging

  Baseline (week 1)

• Gray matter volume

  Gray matter volume tested using magnetic resonance imaging

  Baseline (week 1)

• Functional connectivity Z score

  Resting state functional connectivity using magnetic resonance imaging

  Baseline (week 1)

Secondary Outcomes (10)

• Perceived task load

  Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training

• Balance evaluation Systems test

  Baseline (week 1) and 4 weeks of training

• Berg Balance scale

  Baseline (week 1) and 4 weeks of training

• Cognitive Timed up and Go test

  Baseline (week 1) and 4 weeks of training

• Muscle Strength

  Baseline (week 1) and 4 weeks of training

Study Arms (3)

Single session dual task perturbation training-OAwMCI

EXPERIMENTAL

Participants will receive single session training of dual task. Six cognitive games that target working memory, executive functioning, visuomotor reactions, and language fluency will be provided in standing to get themselves familiarized. Following the cognitive tasks, participants will receive 12 slips without performing cognitive task (Single task training) at the highest intensity. Subsequently, 12 slips during standing while performing a cognitive task (dual task) will be administered. Similarly, they will then undergo 12 dual task walking trials (at self-selected speed) followed by 12 walking slips.

Behavioral: Dual task perturbation training

Multiple session dual task perturbation training-OAwMCI

EXPERIMENTAL

All participants will undergo stance and walking perturbation training for 4 weeks. Six cognitive games that target working memory, executive functioning, visuomotor reactions, and language fluency will be provided in standing to get themselves familiarized. Following the cognitive tasks, participants will receive 12 slips without performing cognitive task (Single task training) at the highest intensity. Subsequently, 12 slips during standing while performing a cognitive task (dual task) will be administered. Similarly, they will then undergo 12 dual task walking trials (at self-selected speed) followed by 12 walking slips.

Behavioral: Dual task perturbation training

Single session dual task perturbation training-CIOA

ACTIVE COMPARATOR

All participants will receive only one training session of dual task. Six cognitive games that target working memory, executive functioning, visuomotor reactions, and language fluency will be provided in standing to get themselves familiarized. Following the cognitive tasks, participants will receive 12 slips without performing cognitive task (Single task training) at the highest intensity. Subsequently, 12 slips during standing while performing a cognitive task (dual task) will be administered. Similarly, they will then undergo 12 dual task walking trials (at self-selected speed) followed by 12 walking slips.

Behavioral: Dual task perturbation training

Interventions

Dual task perturbation training BEHAVIORAL

Participants will play six cognitive games targeting working memory, executive functioning, visuomotor reactions, and language fluency provided in standing. Following which they will receive 12 slips without performing cognitive task (Single task training) at the highest intensity and 12 slips during standing while performing a cognitive task (dual task). Also, they will then undergo 12 dual task walking trials (at self-selected speed) followed by 12 walking slips.

Multiple session dual task perturbation training-OAwMCI; Single session dual task perturbation training-CIOA; Single session dual task perturbation training-OAwMCI

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age group: Older adults between the age group \> 55 years old with MOCA less than 26 out of 30 will be classified as mild cognitive impairment and those above 26 out of 30 as cognitively intact older adults .
• Absence of any acute or chronic neurological (Stroke, Parkinson's disease, Alzheimer's disease), cardiopulmonary, musculoskeletal, or systemic diagnosis.
• No recent major surgery (\< 6 months) or hospitalization (\< 3 months)
• Not on any sedative drugs
• Can understand and communicate in English
• Ability to walk more than 10 meters without an assistive device

You may not qualify if:

• Participants will not proceed with the study if any of the following occurs at baseline measurement: 1) HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age), 2) systolic blood pressure (SBP) \> 165 mmHg and/or diastolic blood pressure (DBP) \> 110 mmHg during resting), and/or 3) oxygen saturation (measured by pulse oximeter) during resting \< 90%.
• History of bone fracture or significant other systemic disease or surgery in the last six months
• Specific to MRI participants: Self-reported presence of a pacemaker, metal implants other than orthopedic implants, and/or Claustrophobia, cataract surgery (lens not compatible to the MRI confirmed by the MRI technician)
• Weighs \> 220 lbs (Harness weight threshold)

Sponsors & Collaborators

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

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Frailty

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tanvi Bhatt

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanvi S Bhatt

CONTACT

312-355-4443; tbhatt6@uic.edu

Lakshmi Kannan

CONTACT

312-413-3175; lkanna2@uic.edu

Study Design

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

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 24, 2021
• Study Start: September 14, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)