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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04308239
Other study ID # 18-486
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2018
Est. completion date July 1, 2019

Study information

Verified date March 2020
Source Virginia Polytechnic Institute and State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study was to evaluate the effects of reactive balance training (RBT) targeting slipping and tripping on laboratory-induced slips and trips. In an effort to build upon prior work, the present study included: 1) a control group receiving an alternative balance training intervention; 2) separate training and assessment sessions; 3) alternative RBT methods that may be more amenable to work outside the lab compared to prior methods, and 4) older adult participants receiving individualized training to reduce drop-out. The investigators hypothesized that slips after RBT would result in improved reactive balance kinematics, and a lower incidence of falls, compared to either initial slips before any intervention or after a control intervention. The investigators also hypothesized that trips after RBT would result in improved reactive balance kinematics, and a lower incidence of falls, compared to either initial trips before any intervention or after a control intervention. Results were intended to contribute to knowledge regarding the efficacy of alternative methods for RBT, and provide additional evidence regarding its efficacy.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

1) pass a medical history and screening administered by a physician that excluded participants with osteoporosis of the lumbar spine or proximal femur as assessed by Dual Energy X-ray Absorptiometry (Lunar iDXA, GE Healthcare, Chicago, IL), or any unstable or progressive medical conditions that could contribute to imbalance or falls

Exclusion Criteria:

1. smoked

2. were in physical therapy

3. had a self-reported fragility fracture within the last 10 years

4. had an acute lower extremity injury within the last 3 months

5. had lower extremity surgery within the last six months

6. had an ankle arthroplasty

7. had a knee or hip arthroplasty within the last 12 months

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Reactive balance training
Participants were exposed to simulated trips and slips under safe, controlled conditions in order to practice their reactive response to these common balance perturbations.
Otago Balance Training
Balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support).

Locations

Country Name City State
United States Virginia Tech - Department of Industrial and Systems Engineering 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
Primary Peak Slip Speed highest instantaneous speed of slipping foot during actual slip during week 1, before the intervention that spanned weeks 2 and 3
Primary Peak Slip Speed highest instantaneous speed of slipping foot during actual slip during week 4, after the intervention that spanned weeks 2 and 3
Primary Trunk Angle at Touchdown After Tripping anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle during week 1, before the intervention that spanned weeks 2 and 3
Primary Trunk Angle at Touchdown After Tripping anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle during week 4, after the intervention that spanned weeks 2 and 3
Secondary Slip Distance distance moved by slipping foot during actual slip during week 1, before the intervention that spanned weeks 2 and 3
Secondary Slip Distance distance moved by slipping foot during actual slip during week 4, after the intervention that spanned weeks 2 and 3
Secondary Fall Incidence After a Laboratory-induced Slip the outcome of each slip was categorized as either a: fall, recovery, or harness-assisted during week 1, before the intervention that spanned weeks 2 and 3
Secondary Fall Incidence After a Laboratory-induced Slip the outcome of each slip was categorized as either a: fall, recovery, or harness-assisted during week 4, after the intervention that spanned weeks 2 and 3
Secondary Recovery Step Length After Tripping anterior-posterior step distance of first step over tripping obstacle during week 1, before the intervention that spanned weeks 2 and 3
Secondary Recovery Step Length After Tripping anterior-posterior step distance of first step over tripping obstacle during week 4, after the intervention that spanned weeks 2 and 3
Secondary Fall Incidence After a Laboratory-induced Trip the outcome of each trip was categorized as a: fall, recovery, or harness-assisted during week 1, before the intervention that spanned weeks 2 and 3
Secondary Fall Incidence After a Laboratory-induced Trip the outcome of each trip was categorized as a: fall, recovery, or harness-assisted during week 4, after the intervention that spanned weeks 2 and 3
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