Increasing Gait Automaticity in Older Adults by Exploiting Locomotor Adaptation

NCT04934956 | Recruiting

• 7 other identifiers: STUDY19060017K01NS092785-01A1NSF 1535036NSF 1847891P30AG024827CRDF 4.302043455
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will test the following: 1) the extent of locomotor adaptation improvement in individuals aged 65 years and older; 2) the association between initial walking automaticity (i.e. less PFC activity while walking with a cognitive load) and prefrontal-subcortical function (measured via neuropsychological testing); and 3) whether improvements in locomotor adaptability result in improvements in the Functional Gait Assessment (FGA), a clinically relevant indicator of dynamic balance and mobility in older adults. To answer these questions, the investigators will combine innovative techniques from multiple laboratories at the University of Pittsburgh. Automatic motor control (Dr. Rosso's expertise) will be assessed by wireless functional near-infrared spectroscopy (fNIRS) of the PFC during challenged walking conditions (walking on an uneven surface and walking while reciting every other letter of the alphabet). fNIRS allows for real-time assessment of cortical activity while a participant is upright and moving by way of light-based measurements of changes in oxygenated and deoxygenated hemoglobin. Locomotor adaptation (Dr. Torres-Oviedo's expertise) will be evaluated with a split-belt walking protocol (i.e., legs moving at different speeds) that the investigators and others have used to robustly quantify motor adaptation capacity in older individuals and have shown to be reliant on cerebellar and basal ganglia function. The investigators will focus on two important aspects of locomotor adaptation that the investigators have quantified before: (Aim 1) rate at which individuals adapt to the new (split) walking environment and (Aim 2) capacity to transition between distinct walking patterns (i.e., the split-belt and the overground walking patterns), defined as motor switching. Adaptation rate and motor switching are quantified using step length asymmetry, which is the difference between a step length taken with one leg vs. the other. The investigators will focus on this gait parameter because it robustly characterizes gait adaptation evoked by split-belt walking protocols. Finally, the investigators will quantify participant's cognitive function (Dr. Weinstein's expertise) through neuropsychological battery sensitive to prefrontal-subcortical function. The investigators will mainly focus on evaluating 1) learning capacity reliant on cerebellar structures and 2) assessing executive function heavily reliant on PFC and, to a lesser extent, the basal ganglia.

Conditions

Community Mobility of Older Adults; Locomotor Adaptability; Gait Automaticity

Outcome Measures

Primary Outcomes (5)

• Change in Adaptation rate

  Adaptation is measured by the mean of the first 32 strides of in adaptation. This metric approximates the rate of learning. Higher adaptation rate means better learning rate. The adaptation rate will be measured during the visits 1 week pre-intervention, during intervention and 1 week post-intervention. The changes through the process, most importantly before and after intervention, will be calculated. Larger the change, better the learning capacity.

  1 week pre-Intervention, during Intervention and 1 week post-Intervention

• Change in Aftereffect

  Aftereffect is the difference in error between the last 40 strides of baseline walking and the first 5 strides of walking over ground after adaptation. Higher aftereffect value represents higher transfer of the learning. The aftereffects will be measured during the visits 1 week pre-intervention, during intervention and 1 week post-intervention. The changes through the process, most importantly before and after intervention, will be calculated. Larger the change, better the cognitive switching ability.

  1 week pre-Intervention, during Intervention and 1 week post-Intervention

• Change in FGA

  Change in Functional gait assessment (FGA) score post-Intervention relative to pre-Intervention. The FGA consists of 10 items: gait on level surface, change in gait speed, gait with horizontal and vertical head turns, gait with 180° pivot turn, stepping over obstacles, gait with narrow base of support, gait with eyes closed, backwards gait and stairs. Scoring of each of these activities is done on a 4-point ordinal scale ranging from 0-3, with 0 indicating severe impairment (cannot perform without assistance, severe gait deviations or imbalance, increased time to perform task), 1 indicating moderate impairment, 2 indicating mild impairment, and 3 indicating normal ambulation (no gait or balance impairment, completion of task in a timely manner). All items are summed to calculate a total score (max. 30).

  2 weeks pre-Intervention and 1 week post-Intervention

• Executive function

  Subtests of Delis-Kaplan Executive Function System (D-KEFS) will be used: (1) Color-Word Interference Task that measures the ability to inhibit a dominant and automatic verbal response (inhibition) and the ability to switch between inhibiting and executing an automatic verbal response (inhibition/switching); (2) Trail Making Test that measures flexibility of thinking and set-shifting ability on a visual-motor sequencing task (Condition 4), and (3) Verbal Fluency (for letters and categories) that measures letter fluency, category fluency, and category switching. The performance of each of test is measured by seconds to completion, except for verbal fluency, which is determined by total number of correct responses and switches between categories. Raw scores are normed using the D-KEFS normative data structure (mean = 10, SD = 3). All tests are co-normed to allow averaging to create a single, composite executive function measure. Higher score means better executive function.

  2 weeks pre-Intervention

• Subcortical/basal ganglia function

  he Action verbal fluency test will be used to measure subcortical/basal ganglia cognitive function. This task requires the participant to rapidly generate as many verbs (i.e., "things that people do") as possible within 1 min. The score is the number of correct words within 1 minute, excluding rule-breaks and intrusions (i.e., non-verbs), from 0 to the max number of correct words participant can generate. Higher score means better basal ganglia cognitive function.

  2 weeks pre-Intervention

Secondary Outcomes (4)

• Change in prefrontal cortex activity

  2 weeks pre-Intervention and 1 week post-Intervention

• Attention, language, immediate memory, delayed memory, and visuospatial function measures

  2 weeks pre-Intervention

• Premorbid estimated verbal ability

  2 weeks pre-Intervention

• Switching Ability

  2 weeks pre-Intervention

Study Arms (1)

Intervention: Split-belt walking; Multiple transitions between split-belt and tied-belt walking

EXPERIMENTAL

Split-belt walking will be used in all experiments and consists of a time period during which the legs move at different speeds (0.5 m/s vs. 1 m/s). The investigators select those speeds since the investigators have observed in our preliminary data and published study (Sombric et al. 2017) that older individuals adapted at these speeds exhibit large deficits at motor switching when transitioning to overground walking. This large reference signal will facilitate the detection of a change in motor switching (Aim 2) following the Intervention. This second intervention consists of multiple short adaptation blocks (i.e., 6 blocks of 200 strides each) interleaved with short de-adaptation blocks (i.e., 5 blocks of 200 strides of tied-belt walking each). It was designed based on several studies showing improvements in adaptation rate in young adults with a similar protocol (Malone et al. 2011; Day et al. 2018; Leech et al. 2018).

Other: Split-belt walking; Other: Multiple transitions between split-belt and tied-belt walking

Interventions

Split-belt walking OTHER

These will be used in all experiments and consists of a time period during which the legs move at different speeds (0.5 m/s vs. 1 m/s). The investigators select those speeds since the investigators have observed in our preliminary data and published study (Sombric et al. 2017) that older individuals adapted at these speeds exhibit large deficits at motor switching when transitioning to overground walking. This large reference signal will facilitate the detection of a change in motor switching (Aim 2) following the Intervention.

Intervention: Split-belt walking; Multiple transitions between split-belt and tied-belt walking

Multiple transitions between split-belt and tied-belt walking OTHER

This intervention consists of multiple short adaptation blocks (i.e., 6 blocks of 200 strides each) interleaved with short de-adaptation blocks (i.e., 5 blocks of 200 strides of tied-belt walking each). It was designed based on several studies showing improvements in adaptation rate in young adults with a similar protocol (Malone et al. 2011; Day et al. 2018; Leech et al. 2018).

Intervention: Split-belt walking; Multiple transitions between split-belt and tied-belt walking

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older.
• Body Mass Index of 35 or less. Muscle activities will be recorded for distinct muscles in the legs and fatty tissue could interfere with these measurements.
• Able to walk without a hand held device
• Able to walk for 5 minutes at their self-paced speed

You may not qualify if:

• Any past or present history of neurological disorders, heart or respiratory disease, brain injury, seizures, spinal cord surgery, or strokes.
• Pregnancy.
• Unable to follow two part commands;
• Uncorrected vision or severe visual impairment with visual acuity \< 20/70 with best correction;
• Cognitive impairments defined as modified mini-mental score \<84;
• orthopedic or pain conditions (lower extremity pain, back pain, calf pain);
• refuse to walk on a treadmill;
• hospitalized 6 months prior to the study for acute illness or surgery, other than minor surgical procedures;
• lower extremity orthopedic surgery within 1 year;
• uncontrolled hypertension (\> 190/110 mmHg);
• diagnosed dementia;
• dyspnea at rest or during daily leaving activities;
• use supplemental oxygen, resting heart rate\> 100 or \<40 beats per minute;
• fixed or fused hip, knee, or ankle joints;
• progressive movement disorder such as Multiple Sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS), or Parkinson's disease

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• National Institute on Aging (NIA): collaborator
• U.S. National Science Foundation: collaborator
• Central Research Development Fund: collaborator
• University of Pittsburgh Momentum Fund: collaborator

Study Sites (1)

Sensorimotor Learning Laboratory, Schenley Place Suite 110

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (26)

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Study Officials

• Gelsy Torres-Oviedo, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gelsy Torres-Oviedo, Ph.D.

CONTACT

412-624-2660; gelsyto@pitt.edu

Study Design

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

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: June 22, 2021
• Study Start: November 8, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

US (1)