Trip Recovery Training Without a Specialized Treadmill

Accidental Fall Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05734443
• Other study ID #: 21-1072
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: September 2023
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Accidental Fall

Intervention

Behavioral:
• non-treadmill trip training
Participants practice volitional and reactive stepping responses that mimic those needed when recovering balance after tripping.
• 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.

Locations

Country	Name	City	State
United States	Virginia Tech	Blacksburg	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Gait speed	The average forward speed of the participant prior to the laboratory-induced trip.	during the week after the 3-weeks of intervention
Secondary	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