Trip Recovery Training Without a Specialized Treadmill

Trip Recovery Training Without a Specialized Treadmill: A Pilot Randomized Controlled Trial

The goal of this study is to investigate the effects of a novel form of balance training called trip training. Trip training typically involves repeatedly exposing an individual to trip-like losses of balance on a specialized treadmill. This repeated exposure can lead to improvements in responses to trips while walking in the future, thereby reducing the risk of falling after a trip. Trip training typically is commonly conducted using a costly specialized treadmill. This study will evaluate the efficacy of a trip training protocol that does not require a treadmill. Adults age 65-80 will be assigned to either 1) non-treadmill trip training, 2) treadmill trip training, or 3) no intervention. The investigators hypothesized that responses to laboratory-induced trips would be better after non-treadmill trip training compared to no intervention, and that there would be no statistical difference between responses to laboratory-induced trips after non-treadmill trip training and treadmill trip training. The results from this work will advance the use of trip training, and may enable its wider use by establishing a protocol that does not require a costly treadmill.

Study Overview

• Status: Completed
• Conditions: Accidental Fall
• Intervention / Treatment: Behavioral: non-treadmill trip training; Behavioral: treadmill trip training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael L. Madigan, PhD; Phone Number: 540-231-3543; Email: mlm@vt.edu

Study Locations

• United States
  • Virginia
    • Blacksburg, Virginia, United States, 24061
      • Virginia Tech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 65-80 years old
• willing to use wearable sensors for 2-3 weeks (for a separate study)
• no lower limb amputation
• not weigh over 250 pounds
• pass a telephone interview related to cognitive status

Exclusion Criteria:

• participants must pass a health screening involving a questionnaire that will be reviewed by a health care specialist.
• participants must not have clinical osteoporosis as indicated by a bone mineral density of the lumbar vertebra and proximal femur of t<-2.0 as obtained from dual energy x-ray absorptiometry (DEXA), or a DEXA scan completed within the last year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: non-treadmill trip training; Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated volitional and reactive stepping movements that mimic the movements necessary to recover balance after tripping while walking.	Behavioral: non-treadmill trip training; Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.
Experimental: treadmill trip training; Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated exposure to simulated trips on a treadmill. To simulate a trip, participants first stand on the stationary treadmill belt. A sudden and unexpected increase in backward treadmill belt speed induces a forward loss of balance similar to when tripping. Participants are then required to take steps to recover balance and establish a stable gait pattern before the trial ends. Trials are repeated using pseudo-random speeds that provide variability and are individualized to each participant's capabilities.	Behavioral: treadmill trip training; Sudden treadmill changes in speed (from standing) induce trip-like losses of balance, after which participants take steps to recover balance and establish a stable gait pattern. This is repeated over a range of speeds to both provide training variability and to individualize training to each participant's capability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trunk angle at touchdown of the first recovery step	After a laboratory-induced trip: Angle from vertical of a line connecting midpoint of greater trochanter markers and midpoint of the acromion markers	during the week after the 3-weeks of intervention
Trip outcome	This is a binary variable that has a value of either "fall" or "recovery." After a laboratory-induced trip, trip outcome will be assign to one of the following two values: "fall" if a participant is fully and continuously supported by the harness as observed from video, or if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is greater than 40% of body weight * seconds. The harness force will be measured by a uniaxial load cell. "recovery" if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is less than 40% of body weight * seconds. The harness force will be measured by a uniaxial load cell.	during the week after the 3-weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trunk angular velocity at touchdown of the first recovery step	After a laboratory-induced trip: time derivative of trunk angle, and its value at the instant of touchdown of the first recovery step.	during the week after the 3-weeks of intervention
Recovery step length	After a laboratory-induced trip, the distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping foot at touchdown	during the week after the 3-weeks of intervention
Minimum hip height after trip onset	After a laboratory-induced trip, the minimum distance between the walkway and the greater trochanter marker on the non-tripping limb during trip recovery.	during the week after the 3-weeks of intervention
Gait speed	The average forward speed of the participant prior to the laboratory-induced trip.	during the week after the 3-weeks of intervention
Average step speed	After a laboratory-induced trip, the distance between a lateral malleolus marker of the stance limb and a lateral malleolus marker of the stepping foot at touchdown divided by the time from impact with the trip obstacle and touchdown of the initial recovery step.	during the week after the 3-weeks of intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trip recovery strategy	This is a binary variable that has a value of either "elevating" or "lowering." Elevating or lowering, depending upon how the participant uses the foot that trips on the obstacle after the laboratory-induced trip. If the foot is elevated over the obstacle, then this will be elevating. If the foot is lowered to the ground and the opposite foot first steps over the obstacle, then this will be lowering. The measurement tool to determine this outcome is a video recording of the trip, and this outcome has no units.	during the week after the 3-weeks of intervention

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Investigators: Principal Investigator: Michael L. Madigan, PhD, Virginia Polytechnic Institute and State University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Luteolytic Agents; Triptorelin Pamoate
• Other Study ID Numbers: 21-1072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No