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Clinical Trials/NCT06646029
NCT06646029
Recruiting
Not Applicable

Pilot Study on The Effectiveness of Relative Motion Orthosis in Finger Motion

NYU Langone Health1 site in 1 country64 target enrollmentDecember 7, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Proximal Interphalangeal Joint Stiffness
Sponsor
NYU Langone Health
Enrollment
64
Locations
1
Primary Endpoint
Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of this feasibility pilot study is to determine the effectiveness of Relative Motion Orthosis (RMO) in regaining finger range of motion compared to standard care in patients diagnosed with Proximal Interphalangeal (PIP) stiffness with an extension lag secondary to finger injury. Participants will be enrolled and randomized into groups receiving either standard conservative interventions or standard interventions in addition to the RMO. The primary endpoint is to evaluate the efficacy of relative motion orthosis in PIP ROM using clinical scoring and physical exam findings.

Registry
clinicaltrials.gov
Start Date
December 7, 2024
End Date
December 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age range 18-80
  • Any gender
  • Any Proximal Interphalangeal (PIP) injury that causes reduced PIP Active Range of Motion (AROM) in extension
  • Right or left hand injury
  • Level of Chronicity (4 weeks - 6 months)
  • Able to follow instructions

Exclusion Criteria

  • PIP with hard end feel (feels they need serial casting) - level of chronicity
  • Any digital nerve injury / skin laceration that can prevent the patient from using the orthosis
  • Severe arthropathy
  • Literacy deficits: patients need to be able to follow verbal and written instructions independently to minimize risks and improve outcomes from care.

Outcomes

Primary Outcomes

Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score

Time Frame: Baseline, End-of-treatment (~Month 3)

The QuickDASH Questionnaire consists of 30 items where each question in the scale is scored between 1 and 5. The total score ranges from from 0 (no difficulty or symptoms) to 100 (no activity or very severe symptoms). A decrease from baseline indicates improvement in symptoms.

Secondary Outcomes

  • Change in Active Range of Motion (AROM)(Baseline, End-of-treatment (~Month 3))

Study Sites (1)

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