Back to resultsRapid Rehabilitation to Treat Lower Extremity Trauma
Primary Purpose
Lower Limb Trauma
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Promis Physical Function Questionnaire
L Test
Narrowing Beam Walking Test
PEQ-A
Sponsored by
About this trial
This is an interventional supportive care trial for Lower Limb Trauma
Eligibility Criteria
Inclusion Criteria:
- Research participants will be eligible active duty service members and retired veterans.
- Having lower limb trauma (transtibial and transfemoral amputations, bilateral amputations, and limb salvage).
- Are enrolled in conventional rehabilitation at the participating military treatment centers.
- Subjects with dysvascular disease will be excluded because compromised lower limb somatosensation and circulation are independently linked with poor postural stability and a history of frequent falls.
- For subjects with amputations, the individual must be a community ambulator (i.e., K-Level 3 or 4).
- For subjects with limb salvage, they will need to have an IDEO and be entered into the Return-to-Run training program.
Exclusion Criteria:
- Subjects must not have excessive pain or other neuromuscular problems that preclude them from performing the test protocol.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Injured Service Members
Arm Description
Outcomes
Primary Outcome Measures
Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)
Fall incidence change between baseline and 6 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05225792
Brief Title
Rapid Rehabilitation to Treat Lower Extremity Trauma
Official Title
Improved Training Method for Advanced Rehabilitation of Warfighters With Lower Extremity Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to find out if an advance balance perturbation training program can enhance the rehabilitation process by increasing weight-bearing strategies on the prosthetic or injured limb, and, help reduce stumbles and falls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb Trauma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Injured Service Members
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Promis Physical Function Questionnaire
Intervention Description
Patient reported physical function outcomes
Intervention Type
Behavioral
Intervention Name(s)
L Test
Intervention Description
Performance based measure assessing general physical function and balance ability.
Intervention Type
Behavioral
Intervention Name(s)
Narrowing Beam Walking Test
Intervention Description
Subjects attempt to walk along 4 progressively narrower beam segments with their arms crossed over their chest.
Intervention Type
Behavioral
Intervention Name(s)
PEQ-A
Other Intervention Name(s)
Prosthesis Evaluation Questionnaire - Addendum
Intervention Description
Survey on confidence, stumbles and falls.
Primary Outcome Measure Information:
Title
Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)
Description
Fall incidence change between baseline and 6 months
Time Frame
0, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Research participants will be eligible active duty service members and retired veterans.
Having lower limb trauma (transtibial and transfemoral amputations, bilateral amputations, and limb salvage).
Are enrolled in conventional rehabilitation at the participating military treatment centers.
Subjects with dysvascular disease will be excluded because compromised lower limb somatosensation and circulation are independently linked with poor postural stability and a history of frequent falls.
For subjects with amputations, the individual must be a community ambulator (i.e., K-Level 3 or 4).
For subjects with limb salvage, they will need to have an IDEO and be entered into the Return-to-Run training program.
Exclusion Criteria:
- Subjects must not have excessive pain or other neuromuscular problems that preclude them from performing the test protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Huyber, CCRP
Phone
(507) 266-0984
Email
Huyber.Christine@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenton Kaufman, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Rapid Rehabilitation to Treat Lower Extremity Trauma
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