Gait Training for Improving Walking in Older Adults

Overseen By Gelsy Torres-Oviedo, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Neurological disorders, Heart disease, Respiratory disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

44 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have any of the listed health conditions or are taking medications for them, you may not be eligible to participate.

What data supports the effectiveness of the treatment Multiple transitions between split-belt and tied-belt walking for improving walking in older adults?

Research shows that split-belt treadmill walking helps people adapt their walking patterns by adjusting step length and muscle activity, which can improve walking symmetry. This adaptability is seen in both young and middle-aged adults, suggesting it could be beneficial for older adults as well. ^{1 2 3 4 5}

Is split-belt treadmill walking safe for humans?

The research does not specifically address safety concerns, but split-belt treadmill walking has been used in studies with young and middle-aged adults without reported safety issues, suggesting it is generally safe for humans. ^{1 4 6 7 8}

How does split-belt walking therapy differ from other treatments for improving walking in older adults?

Split-belt walking therapy is unique because it uses a treadmill with two belts that can move at different speeds, helping to improve walking by training the brain and body to adapt to new walking patterns. This approach focuses on both immediate and long-term changes in gait, making it different from traditional therapies that may not address these adaptive processes. ^{1 3 4 6 9}

Research Team

Gelsy Torres-Oviedo, Ph.D.

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for individuals aged 65 or older with a BMI of 35 or less, who can walk unaided and continuously for at least 5 minutes. It's not suitable for those with neurological disorders, severe heart/respiratory conditions, significant visual impairments, dementia, recent hospitalization for serious illness/surgery, orthopedic pain issues in the lower body, uncontrolled high blood pressure or certain movement disorders.

Inclusion Criteria

I can walk for 5 minutes at my own pace.

I am 65 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

Exclusion Criteria

I had leg surgery within the last year.

I have a hip, knee, or ankle joint that cannot move.

I have a history of neurological, heart, respiratory conditions, or brain injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Pre-Intervention Assessment

Assessment of baseline cognitive and motor functions using various neuropsychological tests and fNIRS measurements

2 weeks

1 visit (in-person)

Intervention

Participants undergo split-belt walking protocol with multiple adaptation and de-adaptation blocks to improve locomotor adaptability

1 week

Multiple visits (in-person)

Post-Intervention Assessment

Re-assessment of cognitive and motor functions to evaluate changes post-intervention

1 week

1 visit (in-person)

Follow-up

Participants are monitored for sustained improvements in locomotor adaptability and cognitive function

4 weeks

Treatment Details

Interventions

• Multiple transitions between split-belt and tied-belt walking
• Split-belt walking

Trial Overview The study tests how well older adults can adapt their walking patterns using split-belt treadmills (where each leg moves at different speeds) and transition between this and normal walking. Researchers will measure brain activity during these tasks to see if they improve gait automaticity and balance as assessed by the Functional Gait Assessment.

Participant Groups

Group I: Intervention: Split-belt walking; Multiple transitions between split-belt and tied-belt walking Experimental Treatment 2 Interventions

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).

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

U.S. National Science Foundation

Collaborator

Trials

35

Recruited

9,000+

University of Pittsburgh Momentum Fund

Collaborator

Trials

1

Recruited

40+

Central Research Development Fund

Collaborator

Trials

1

Recruited

40+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Findings from Research

In a study examining human walking on split-belt treadmills with speed ratios from 1:1.2 to 1:2, researchers found that reactive feedback control was consistently involved in gait adjustments across all tested ratios, indicating its importance in immediate adaptations.

Predictive feedforward control was only necessary for greater speed ratios, suggesting that different adaptation strategies are engaged depending on the split-belt conditions, which could inform rehabilitation strategies for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of the gait adaptation process due to split-belt treadmill walking under a wide range of right-left speed ratios in humans. Yokoyama, H., Sato, K., Ogawa, T., et al.[2018]

The study involving 22 healthy subjects revealed that during split-belt treadmill walking, the braking force adapted significantly, with muscle activity in the tibialis anterior playing a key role in this adjustment.

The findings suggest that both predictive and passive feedback controls are essential for adapting gait patterns, which could inform the development of targeted rehabilitation strategies for individuals with locomotor impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive control of ankle stiffness at heel contact is a key element of locomotor adaptation during split-belt treadmill walking in humans. Ogawa, T., Kawashima, N., Ogata, T., et al.[2014]

In a study involving 8 individuals with Parkinson's disease, using a split belt treadmill (SBTM) significantly improved gait symmetry, particularly when the speed of the best side (BS) was decreased compared to increasing the speed of the worst side (WS).

The findings suggest that adjusting the speed of the treadmill belts can enhance gait adaptation, indicating that future clinical studies should consider these specific conditions to optimize therapeutic outcomes for patients with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential gait adaptation patterns in Parkinson's disease - a split belt treadmill pilot study. Plotnik, M., Arad, E., Grinberg, A., et al.[2023]

Both young (average age 23) and middle-aged adults (average age 55) showed similar abilities to adapt their gait and muscle activation patterns when walking on a split-belt treadmill, indicating that these adaptations are preserved at middle age.

The study suggests that changes in muscle activation patterns are linked to improvements in gait symmetry during split-belt walking, and significant age-related differences in gait adaptability may not emerge until later in life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do gait and muscle activation patterns change at middle-age during split-belt adaptation? Vervoort, D., den Otter, AR., Buurke, TJW., et al.[2020]

Split-belt treadmill (SBT) walking resulted in significantly greater step length asymmetry aftereffects in overground gait compared to both slow and fast unilateral stepping, indicating it may be a more effective rehabilitation strategy for addressing step length asymmetry.

During unilateral stepping, the largest aftereffects were observed when participants maintained hip, knee, and ankle flexion in the stationary limb, suggesting that active engagement of the stationary limb can enhance the effectiveness of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing aftereffects after split-belt treadmill walking and unilateral stepping. Huynh, KV., Sarmento, CH., Roemmich, RT., et al.[2021]

The split-belt treadmill is an effective tool for studying locomotor learning, allowing researchers to investigate both immediate and long-term gait adaptations in a controlled environment, which is crucial for optimizing motor rehabilitation strategies.

This paper outlines a specific protocol for using the split-belt treadmill, emphasizing the importance of controlling variables such as belt speeds and participant experience to ensure reliable results in understanding locomotor learning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Split-belt Treadmill to Evaluate Generalization of Human Locomotor Adaptation. Vasudevan, EVL., Hamzey, RJ., Kirk, EM.[2019]

A new method for detecting gait cycle timing using the loading response peak (LRP) on split-belt treadmills has been developed, which shows high reliability with less than 5.1% error compared to the traditional initial contact (IC) method.

This LRP detection method provides strong correlations with established gait parameters, making it a valuable tool for accurately measuring temporal gait characteristics, especially in cases where participants may cross their legs during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the loading response peak for defining gait cycle timing: A novel solution for the double-belt problem. Ben-Gal, O., Benady, A., Zadik, S., et al.[2021]

The Gait Enhancing Mobile Shoe (GEMS) can replicate the beneficial effects of a split-belt treadmill for gait rehabilitation while allowing users to walk in various environments, making it more practical for long-term use.

Preliminary tests with healthy subjects showed that wearing the GEMS for just twenty minutes can effectively alter walking patterns and produce lasting after-effects similar to those observed with split-belt treadmill training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Gait Enhancing Mobile Shoe to Alter Over-Ground Walking Coordination. Handzic, I., Vasudevan, E., Reed, KB.[2021]

Locomotor therapy using treadmill stimulation with partial body weight support has emerged as a promising rehabilitation method for patients with neurological conditions, allowing them to practice complex gait cycles repeatedly.

This therapy has shown potential benefits for various conditions, including stroke, spinal cord injury, Parkinson's disease, and cerebral palsy, and the use of electromechanical gait trainers can enhance the effectiveness of rehabilitation by reducing the physical strain on therapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locomotor therapy in neurorehabilitation. Hesse, S.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Characteristics of the gait adaptation process due to split-belt treadmill walking under a wide range of right-left speed ratios in humans. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Predictive control of ankle stiffness at heel contact is a key element of locomotor adaptation during split-belt treadmill walking in humans. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Differential gait adaptation patterns in Parkinson's disease - a split belt treadmill pilot study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Do gait and muscle activation patterns change at middle-age during split-belt adaptation? [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Comparing aftereffects after split-belt treadmill walking and unilateral stepping. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Using a Split-belt Treadmill to Evaluate Generalization of Human Locomotor Adaptation. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Using the loading response peak for defining gait cycle timing: A novel solution for the double-belt problem. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Developing a Gait Enhancing Mobile Shoe to Alter Over-Ground Walking Coordination. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Locomotor therapy in neurorehabilitation. [2016]