Dual Task Perturbation Training for OAwMCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Dual task perturbation training
BehavioralParticipants 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.
Treatment groups
142 Participants
are divided into 3 treatment groupsGroup A: Single session dual task perturbation training-OAwMCIExperimental treatment 1 intervention
Group B: Multiple session dual task perturbation training-OAwMCIExperimental treatment 1 intervention
Group C: Single session dual task perturbation training-CIOAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training2
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.
Time frame
Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training3
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.
Time frame
Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training4
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.
Time frame
Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of trainingSecondary outcomes
1
Perceived task load
NASA TLX visual analog scale will be used to determine the perceived task load after every trial is completed. Higher scores indicates poor performance.
Time frame
Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training2
Balance evaluation Systems test
consists of 36 different performances which will be used to determine different balance control domains such as self-initiated performances and reactive balance control, and gait functions. Each item in the scale ranges from 0 to 3 indicating severe impairment to no impairment amounting to a total score of 108 converted to percentage. Higher scores indicate better performance.
Time frame
Baseline (week 1) and 4 weeks of training3
Berg Balance scale
Assess static and dynamic balance. This scale consists of the participant transferring from one chair to another, reaching forward, stepping up and down from a stepping stool, standing with eyes closed and open, one leg standing. It is a 14-item scale with each item score ranging from 0-4. Performance on the scale will be calculated on a total of 56. Less than 45 will indicate greater risk of falling.
Time frame
Baseline (week 1) and 4 weeks of training4
Cognitive Timed up and Go test
Time taken to walk 3 meters as quickly as possible while concurrently performing a counting backward task. Higher scores indicate poor performance.
Time frame
Baseline (week 1) and 4 weeks of trainingSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Roybal Predoctoral pilot grant
Collaborator
Source ClinicalTrials.gov