MedPath

Does Weightbearing Crutch Technology Impact Patient Compliance?

Not Applicable
Recruiting
Conditions
Fracture Healing
Registration Number
NCT05825079
Lead Sponsor
NYU Langone Health
Brief Summary

The goal of this study is to determine if weight-bearing crutch technology that delivers active feedback to patients during their treatment will impact patient compliance with physician instructions.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
30
Inclusion Criteria
  • Willing and able to participate in study and complete consent
  • Will undergo treatment of an isolated tibial plateau, pilon, or ankle fracture and placed in a non-weightbearing status with the use of crutches at NYU.
  • Have access and use of a mobile phone (exclusively iOS and/or Android devices)
Exclusion Criteria
  • Patients with concomitant TBI
  • Polytrauma patients
  • Pathologic fractures
  • Prisoners

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Percent (%) Change in Average Weight On Crutch from Week 2 to Week 12Week 2, Week 12

Average weight put on crutch measured using the Smart Crutch Tip.

Secondary Outcome Measures
NameTimeMethod
Change in Visual Analogue Scale (VAS) - Pain Score from Baseline to Week 12Baseline, Week 12

Participants rate pain using a VAS ranging from 0 (no hurt) to 10 (unbearable pain). A decrease in scores indicates pain decreased during the observational period.

Time to RecoveryUp to Week 12

Measured as the duration of time from treatment (operative or non-operative) to recovery.

Percent (%) of Participants with Injury ComplicationsUp to Week 12
Percent (%) of Participants who Experience Nonunion/Malunion of Lower Extremity InjuryUp to Week 12

Nonunion/malunion assessed using radiographic imaging.

Trial Locations

Locations (1)

NYU Langone Health

🇺🇸

New York, New York, United States

NYU Langone Health
🇺🇸New York, New York, United States

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