Dual Task Perturbation Training for OAwMCI
NCT04938349, Not applicable, Recruiting, University of Illinois Chicago
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Dual Task Perturbation Training for OAwMCI | ClinicalTrials.gov |
| NCT number | NCT04938349 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 142 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Illinois Chicago | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment, Old Age; Debility | ClinicalTrials.gov |
| Interventions | Dual task perturbation training | ClinicalTrials.gov |
| First posted | 2021-06-24 | ClinicalTrials.gov |
| Last updated | 2026-07-08 | ClinicalTrials.gov |
Registered outcomes 25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Stability gain or loss | Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Primary | Change in Limb support gain or loss | Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Primary | Change in laboratory-induced falls | Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Primary | Change in postural stability during reactive balance control (single and dual-task) on treadmill slips | Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Primary | Change in postural stability during reactive balance control (single and dual-task) on overground slips | Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Primary | Change in walking step length | Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Primary | Change in walking cadence | Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Primary | Change in walking stride length | Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Primary | Change of accuracy in letter number sequencing | Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Primary | Change in accuracy of Visual clock test | Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Primary | Change in dual-task cost | Baseline (week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Primary | Change in visuomotor task | Baseline (week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Primary | Fractional anisotropy | Baseline (week 1) | White matter integrity tested using magnetic resonance imaging | ClinicalTrials.gov |
| Primary | Gray matter volume | Baseline (week 1) | Gray matter volume tested using magnetic resonance imaging | ClinicalTrials.gov |
| Primary | Functional connectivity Z score | Baseline (week 1) | Resting state functional connectivity using magnetic resonance imaging | ClinicalTrials.gov |
| Secondary | Perceived task load | Baseline (1st novel slip, trip week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training | NASA TLX visual analog scale will be used to determine the perceived task load after every trial is completed. Higher scores indicates poor performance. | ClinicalTrials.gov |
| Secondary | Balance evaluation Systems test | Baseline (week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Secondary | Berg Balance scale | Baseline (week 1) and 4 weeks of training | 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. | ClinicalTrials.gov |
| Secondary | Cognitive Timed up and Go test | Baseline (week 1) and 4 weeks of training | Time taken to walk 3 meters as quickly as possible while concurrently performing a counting backward task. Higher scores indicate poor performance. | ClinicalTrials.gov |
| Secondary | Muscle Strength | Baseline (week 1) and 4 weeks of training | The isokinetic dynamometer for determining lower extremity (hip, knee, and ankle) muscle strength bilaterally. Muscle strength will be measured via Newton, i.e., force applied to perform the movement pre training compared to post training. Higher values indicate higher muscle strength. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01AG073152 | Neuromechanisms of falls in older adults with MCI: Targeting assessment and training of reactive balance control | BHATT, TANVI | UNIVERSITY OF ILLINOIS AT CHICAGO | NATIONAL INSTITUTE ON AGING | 2021 to 2024 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Letter-Number Sequencing Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)