Rapid Rehabilitation to Treat Lower Extremity Trauma

Lower Limb Trauma Clinical Trial

Official title:

Improved Training Method for Advanced Rehabilitation of Warfighters With Lower Extremity Trauma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05225792
• Other study ID #: 21-010009
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Christine Huyber, CCRP
• Phone: (507) 266-0984
• Email: Huyber.Christine[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Limb Trauma
• Wounds and Injuries

Intervention

Behavioral:
• Promis Physical Function Questionnaire
Patient reported physical function outcomes
• L Test
Performance based measure assessing general physical function and balance ability.
• Narrowing Beam Walking Test
Subjects attempt to walk along 4 progressively narrower beam segments with their arms crossed over their chest.
• PEQ-A
Survey on confidence, stumbles and falls.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prosthesis Evaluation Questionnaire-Addendum (PEQ-A)	Fall incidence change between baseline and 6 months	0, 6 months