Sensory Augmentation Methods in Stroke

NCT03988400 | Completed Early Phase 1 Results DMC

• 1 other identifier: A3146-R
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Many chronic stroke survivors have poor walking balance, contributing to an increased risk of falls and fear of falling. One factor contributing to these balance deficits is a reduced ability to place the feet appropriately when walking. This study investigates whether enhancing the sensory information available to chronic stroke survivors while they walk improves their foot placement accuracy and balance.

Conditions

Stroke

Keywords

stroke; gait

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Related or Serious Adverse Events

  The investigators will monitor the safety of the intervention by quantifying the percentage of participants who experience an adverse event potentially related to the intervention (e.g. skin irritation; falls) or any serious adverse event (e.g. hospitalization; death). This information is gathered through participant self-report, or through communication with participant caregiver if necessary.

  Cumulative over the course of the 4-week intervention

• Number of Training Sessions Attended

  The investigators will assess participant adherence as the number of training sessions attended (out of a maximum possible number of 8).

  Cumulative over the course of the 4-week intervention

• Intervention Feasibility (Drop-out)

  The investigators will assess participant drop-out as the number of participants who do not attend the final Assessment Session.

  4-weeks

• Change in Mechanics-dependent Adjustment of Paretic Foot Placement

  The primary effectiveness measure will be the change in participants' gait stabilization strategy over the course of the 4-week intervention. This will be quantified as the partial correlation between paretic mediolateral foot placement and mediolateral pelvis displacement at the start of the step over a 2-minute period of walking. The investigators will calculate the change in this metric from the initial (Week 0) assessment session to the final (Week 4) assessment session.

  4-weeks

Secondary Outcomes (5)

• Intervention Feasibility (Walking Time)

  Cumulative over the course of the 4-week intervention

• Change in Fear of Falling

  4-weeks

• Change in Functional Gait Assessment Score

  4-weeks

• Change in Activity-specific Balance Confidence Score

  4-weeks

• Change in Overground Self-selected Gait Speed

  4-weeks

Study Arms (2)

Sensory augmentation

EXPERIMENTAL

Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.

Behavioral: Sensory Augmentation

Random vibration

ACTIVE COMPARATOR

Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.

Behavioral: Random Vibration

Interventions

Sensory Augmentation BEHAVIORAL

Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.

Sensory augmentation

Random Vibration BEHAVIORAL

Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.

Random vibration

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Experience of a stroke 6 months prior to participation
• Gait speed of at least 0.2 m/s
• Ability to walk on a treadmill without a cane or walker
• Provision of informed consent

You may not qualify if:

• Evidence of cerebellar damage
• Resting blood pressure higher than 220/110 mm Hg
• History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
• Preexisting neurological disorders or dementia
• Legal blindness or severe visual impairment
• History of DVT or pulmonary embolism within 6 months
• Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
• Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Jesse Dean
• Organization: Ralph H. Johnson VA

deaje@musc.edu

8437929566

Study Officials

• Jesse C. Dean, PhD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to either an Experimental (n=22) or Control (n=22) group. These groups will differ only in terms of how vibration is delivered to the hip musculature during training sessions. In the Experimental group, vibration magnitude will be controlled by the real-time mechanical state of the user's body. In the Control group, vibration magnitude will be randomly varied.

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 17, 2019
• Study Start: April 4, 2022
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared 1-month following publication of summary data, and will be shared in perpetuity.
• Access Criteria: No criteria are anticipated to restrict who de-identified data will be shared with.

Locations

US (1)