Recruiting

Perturbation Training

Sponsor:

University of Illinois at Chicago

Code:

NCT04938349

Conditions

Mild Cognitive Impairment

Old Age; Debility

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

Dual task perturbation training

Study Details

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

Study ID

NCT04938349

Start date

Sep 14, 2021

Status verified date

Jul, 2026

Completion date

Jul 10, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single session dual task perturbation training-OAwMCI

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.

experimental: Multiple session dual task perturbation training-OAwMCI

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.

active comparator: Single session dual task perturbation training-CIOA

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.

Interventions

Dual task perturbation training

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.

Primary outcome measure

  • Change in Stability gain or loss [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline (week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training ]
  • Change in visuomotor task [ Time Frame: Baseline (week 1), immediate post-training (repeated perturbation training session, week 1) and 4 weeks of training ]
  • Fractional anisotropy [ Time Frame: Baseline (week 1) ]
  • Gray matter volume [ Time Frame: Baseline (week 1) ]
  • Functional connectivity Z score [ Time Frame: Baseline (week 1) ]

Central Contacts and Locations

Central contacts

Tanvi S Bhatt

312-355-4443tbhatt6@uic.edu

Lakshmi Kannan

312-413-3175lkanna2@uic.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Tanvi S Bhatt, PhD

3123554443tbhatt6@uic.edu

Lakshmi Kannan, MS

3124133175lkanna2@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-07-08.