Variable Visual Stimulus as a Novel Approach for Gait Rehabilitation

NCT03737331 | Terminated DMC

• 1 other identifier: 0395-18-FB
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Deterioration in walking performance as a result of disease or simply as a result of aging is a serious threat to independence in older adults. In this project, the investigators propose an innovative visual stimulus, based on advanced mathematical and biological theories, with which older adults can walk in time to improve their walking. The investigators' goal is to apply this simple, cost-effective, and novel gait rehabilitation therapy across all populations who have difficulties walking, e.g. stroke patients, fallers or those who undergo joint replacement.

Conditions

Gait Disorders, Neurologic

Keywords

Visual; Variability; Gait; Fractals; Rehabilitation; Brain

Outcome Measures

Primary Outcomes (4)

• Stride length

  Meters

  Through study completion, an average of 1 year

• Stride time

  Seconds

  Through study completion, an average of 1 year

• Stride speed

  Meters/seconds

  Through study completion, an average of 1 year

• Cortical hemodynamics

  Micromoles

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Joint angles

  Through study completion, an average of 1 year

• Peak torque of knee extensor muscles at 60º/s

  Through study completion, an average of 1 year

Study Arms (4)

Fractal visual cueing

EXPERIMENTAL

This stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be fractal (i.e., pink noise). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom.

Behavioral: Fractal visual cueing

Periodic visual cueing

ACTIVE COMPARATOR

This stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be periodic (i.e., invariant). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom.

Behavioral: Periodic visual cueing

Random visual cueing

SHAM COMPARATOR

This stimulus will consist of a visual moving bar displayed on a small monitor attached to a pair of glasses. The temporal structure of the movement will be random (i.e., white noise). Participants will be asked to match their hell strikes of right foot with the top of the moving bar's path and their heel strikes of left foot to the bottom.

Behavioral: Random visual cueing

Control

NO INTERVENTION

Natural walking.

Interventions

Fractal visual cueing BEHAVIORAL

Walking to an external visual fractal (i.e., pink noise) stimulus.

Fractal visual cueing

Periodic visual cueing BEHAVIORAL

Walking to an external visual periodic (i.e., invariant) stimulus.

Periodic visual cueing

Random visual cueing BEHAVIORAL

Walking to an external visual random (i.e., white noise) stimulus.

Random visual cueing

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Be able to provide informed consent.
• Be able to walk independently without an assistive device.
• Not suffer from neurological disease.
• Not suffer from any lower limb disabilities, injuries or disease.

You may not qualify if:

• If diagnosed with a pathology that directly affects the musculoskeletal system such as rheumatoid arthritis, neuropathy or myopathy, vertigo, joint replacement, diabetes, stroke or other vascular problems, scoliosis, uncorrected vision problems,major surgery in the last 6 months, or acute illness.
• Any neurologic conditions or lower limb disabilities or disease.
• History of seizures, migraines or headaches, or are visually impaired.
• Subjects unable to walk unassisted or unable to perform 10 minutes of continuous walking.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska at Omaha

Omaha, Nebraska, 68182, United States

Location

Related Publications (4)

• Stergiou N, Decker LM. Human movement variability, nonlinear dynamics, and pathology: is there a connection? Hum Mov Sci. 2011 Oct;30(5):869-88. doi: 10.1016/j.humov.2011.06.002. Epub 2011 Jul 29.

  PMID: 21802756 BACKGROUND

• Brach JS, Wert D, VanSwearingen JM, Newman AB, Studenski SA. Use of stance time variability for predicting mobility disability in community-dwelling older persons: a prospective study. J Geriatr Phys Ther. 2012 Jul-Sep;35(3):112-7. doi: 10.1519/JPT.0b013e318243e5f9.

  PMID: 22314273 BACKGROUND

• Brach JS, Studenski S, Perera S, VanSwearingen JM, Newman AB. Stance time and step width variability have unique contributing impairments in older persons. Gait Posture. 2008 Apr;27(3):431-9. doi: 10.1016/j.gaitpost.2007.05.016. Epub 2007 Jul 13.

  PMID: 17632004 BACKGROUND

• Brach JS, Lowry K, Perera S, Hornyak V, Wert D, Studenski SA, VanSwearingen JM. Improving motor control in walking: a randomized clinical trial in older adults with subclinical walking difficulty. Arch Phys Med Rehabil. 2015 Mar;96(3):388-94. doi: 10.1016/j.apmr.2014.10.018. Epub 2014 Nov 10.

  PMID: 25448244 BACKGROUND

Related Links

• Kaipust JP, McGrath D, Mukherjee M, Stergiou N. Gait variability is altered in older adults when listening to auditory stimuli with differing temporal structures. Ann Biomed Eng. 2013;41(8):1595-1603. doi:10.1007/s10439-012-0654-9.

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis M Silva, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly assigned with a block randomization design for one of the four groups: no stimulus (i.e. control), invariant, random and variable stimuli. Subjects will be assigned to unique ID code such as 'S00NC', where S means subject, 00N refers to participant number (i.e., 001 or 100), and C the group condition (N - No stimulus; P - Periodic stimulus; V - Variant stimulus; R - Random stimulus).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Older adults at risk of a fall will participate in an 8-week training program. There will be four groups: no stimulus (i.e., control), invariant, random and variable stimuli. The training program will consist in an 8-week program, 3 sessions per week. For each training session, participants will come to the Biomechanics Research Building for a 30-minute training session (2 x 10-minute walking trials with a 10-minute resting period in between), 3 times per week. During the training session, the subjects will be instructed to walk while viewing and synchronizing the steps with the visual stimulus. In the first session of weeks 3, 5 and 7, the subjects will undergo a reassessment of the preferred stride time, wearing the footswitches. This reassessment will be needed to recalculate the preferred stride time and incorporate it in the stimulus in use, in case it has been changed as an effect of the training.

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 9, 2018
• Study Start: November 9, 2018
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)