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

Not Applicable

Recruiting

• Conditions: Proximal Interphalangeal Joint Stiffness

• Registration Number: NCT06646029
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-17
• Study Start: 2024-12-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-11
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score	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 Outcome Measures

Name	Time	Method
Change in Active Range of Motion (AROM)	Baseline, End-of-treatment (~Month 3)	Active Range of Motion (AROM) measurement will be evaluated using a universal goniometer. The goniometer is placed at the joint, and the joint is moved through its range of motion. The goniometer measures the angle in degrees, ranging from 0 to 180. An increase from baseline indicates improved range of motion.

Trial Locations

Locations (1)

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