Trial Outcomes & Findings for The Sensorimotor Locus of Balance Control in Elderly Gait (NCT NCT03341728)

NCT ID: NCT03341728

Last Updated: 2019-07-05

Results Overview

Magnitude of side-to-side postural sway

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

Baseline, 10 minutes

Results posted on

2019-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention, Then Control Older adults will first walk during exposure to optical flow perturbations Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality. Normal walking	Control, Then Intervention Older adults will first walk normally (without optical flow perturbations) Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality. Normal walking
Session 1 STARTED	7	7
Session 1 COMPLETED	7	7
Session 1 NOT COMPLETED	0	0
Washout (1 Week) STARTED	7	7
Washout (1 Week) COMPLETED	7	7
Washout (1 Week) NOT COMPLETED	0	0
Session 2 STARTED	7	7
Session 2 COMPLETED	7	7
Session 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Sensorimotor Locus of Balance Control in Elderly Gait

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=14 Participants Older adults will walk during exposure to optical flow perturbations Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality. Normal walking
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=39 Participants
Age, Categorical >=65 years	14 Participants n=39 Participants
Sex: Female, Male Female	9 Participants n=39 Participants
Sex: Female, Male Male	5 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	1 Participants n=39 Participants
Race (NIH/OMB) White	13 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Region of Enrollment United States	14 Participants n=39 Participants
History of Falls	4 Participants n=39 Participants

PRIMARY outcome

Timeframe: Baseline, 10 minutes

Magnitude of side-to-side postural sway

Outcome measures

Outcome measures
Measure	Intervention n=14 Participants Older adults will walk during exposure to optical flow perturbations Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality.	Normal Walking (Control) n=14 Participants Older adults will first walk normally (without optical flow perturbations)
Change in Postural Sway After 10 Min of Walking	-2.39 cm Standard Deviation 1.10	-0.01 cm Standard Deviation 0.59

PRIMARY outcome

Timeframe: Baseline, 10 minutes

Magnitude of step-to-step corrections in step width measured in cm

Outcome measures

Outcome measures
Measure	Intervention n=14 Participants Older adults will walk during exposure to optical flow perturbations Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality.	Normal Walking (Control) n=14 Participants Older adults will first walk normally (without optical flow perturbations)
Change in Kinematic Variability After 10 Min of Walking	0.55 cm Standard Deviation 0.35	0.00 cm Standard Deviation 0.01

PRIMARY outcome

Timeframe: Baseline, 10 minutes

Population: Data could not be collected because motion capture markers tracking the location of the targeting device were too often obstructed to be able to reliably estimate foot placement targeting accuracy.

Accuracy of performing foot placement targeting task. i.e., distance between heel marker at initial contact and target line (measured using three-dimensional motion capture during walking).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 10 minutes

Population: Data could not be collected because noise from the treadmill motor interfered with the collection of auditory stroop test responses.

Accuracy performing an auditory stroop test (cognitive dual-task)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 10 minutes

Population: Data could not be collected because noise from the treadmill motor interfered with the collection of auditory stroop test responses.

Response time in performing an auditory stroop test (cognitive dual-task)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 10 minutes

Change in step-to-step fluctuations in margin of stability (the distance between the lateral boundary of the foot and the body's center of mass, measured in cm)

Outcome measures

Outcome measures
Measure	Intervention n=14 Participants Older adults will walk during exposure to optical flow perturbations Optical flow perturbations: Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality.	Normal Walking (Control) n=14 Participants Older adults will first walk normally (without optical flow perturbations)
Change in Margin of Stability Variability After 10 Min of Walking	-1.02 cm Standard Deviation 0.99	0.16 cm Standard Deviation 0.26

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Walking (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jason R Franz, PhD

University of North Caroilina at Chapel Hill

Phone: 919-966-6119

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place