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

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve walking and balance in older adults by testing a special treadmill exercise called split-belt walking, where each leg moves at a different speed. Researchers aim to determine if this method helps people adapt their walking and improve their balance. Participants must be able to walk without a cane or walker for at least five minutes at their own pace and should not have conditions such as neurological disorders or heart disease. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mobility and balance for many older adults.

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 prior data suggests that this gait training protocol is safe for older adults?

Previous studies have shown that split-belt walking is safe for older adults. Research indicates that both younger and older adults, including a group of 10 older participants, completed split-belt walking trials without significant issues. This method involves walking on a treadmill where each leg moves at a different speed, which can help improve walking patterns.

Promising data show that older adults improved their ability to adapt their walking during multiple transitions between split-belt and tied-belt walking. This method has been tested in similar settings and found to be well-tolerated by participants.

No major safety concerns have been reported for either method. These exercises are designed to be safe and help improve walking ability in older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about split-belt walking because it offers a new way to improve walking in older adults by targeting motor adaptation and switching. Unlike current treatments that mainly focus on strength and balance exercises, this technique involves walking on a treadmill where each leg moves at different speeds, challenging the brain to adapt and improve coordination. By incorporating multiple transitions between split-belt and tied-belt walking, this approach aims to enhance the brain's ability to adjust and improve walking efficiency, potentially leading to better mobility and reduced fall risk for older adults.

What evidence suggests that this trial's treatments could be effective for improving walking in older adults?

Research has shown that split-belt walking, one of the interventions in this trial, can improve the gait of older adults. In one study, both young and older adults adjusted to split-belt walking by achieving better balance and more even steps. This trial will also investigate the effects of multiple transitions between split-belt and tied-belt walking. Promising data suggest these transitions help older participants adapt better to new walking conditions. Additionally, training on a split-belt treadmill has improved how evenly and quickly people walk, aiding balance and movement. These improvements are crucial for reducing fall risk and enhancing overall walking ability in older adults. ^{1 3 4 5 6}

Who Is on the Research Team?

Gelsy Torres-Oviedo, Ph.D.

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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 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]

Citations

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withpower.com

withpower.com/trial/phase-9-2021-2a208

Gait Training for Improving Walking in Older Adults

This N/A medical study run by University of Pittsburgh is evaluating whether Multiple transitions between split-belt and tied-belt walking and Split-belt ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04934956?cond=Automaticity&viewType=Table&rank=1

Increasing Gait Automaticity in Older Adults by Exploiting ...

Promising data from our labs (n=8) indicate that older participants improve locomotor adaptation after experiencing multiple transitions between the split ...

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Split-Belt Treadmill Adaptation Transfers to Overground ...

Abstract. Background and Objective. Following stroke, subjects retain the ability to adapt interlimb symmetry on the split-belt treadmill.

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biorxiv.org/content/10.1101/2021.08.06.455403.full

Older adults generalize their movements across walking ...

We compared the generalization of split-belt adaptation to overground walking in older (75.9±4.8 years old) and young adults (24.7±5.9 years old) when adapted ...

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researchgate.net

researchgate.net/publication/330701438_Effects_of_Aging_and_Task_Prioritization_on_Split-Belt_Gait_Adaptation

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Results: Both age groups adapted to split-belt walking by re-establishing symmetry in step length and double support time. However, young and ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10526769/

The Influence of Age and Physical Activity on Locomotor ...

Indeed, older adults have been demonstrated to be poorer at switching from split-belt to overground walking [44]. While several studies have ...