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

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.

Study Overview

• Status: Recruiting
• Conditions: Proximal Interphalangeal Joint Stiffness
• Intervention / Treatment: Device: RMO flexion orthosis (splint); Other: Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalia Ruiz, DPT; Phone Number: 646-501-4782; Email: Natalia.ruiz@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orthosis + standard hand therapy care; Patients will receive a custom splint/orthosis will be made by the hand therapist for patients to wear through the day for the length of the treatment as much as possible in additional to standard of care hand therapy. Patients will be encouraged use the orthosis during the day (at least 6-8 hours) for 6 weeks.	Device: RMO flexion orthosis (splint); RMO flexion is an orthosis fabricated by hand therapists made of thermoplastic material design to position the involved finger in relative flexion at the metacarpal joint compared to adjacent fingers to facilitate PIP extension during daily activity use.; Other: Standard of care; Treatment includes finger stretches, active range of motion (AROM), passive range of motion (PROM), thermal modalities, LMB finger extension orthosis.
Active Comparator: Standard of care; Standard of care (control group) will only complete the routine treatment. This consists of physical therapy exercises, stretches, manual therapy and use of therapeutic modalities.	Other: Standard of care; Treatment includes finger stretches, active range of motion (AROM), passive range of motion (PROM), thermal modalities, LMB finger extension orthosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score	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.	Baseline, End-of-treatment (~Month 3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Active Range of Motion (AROM)	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.	Baseline, End-of-treatment (~Month 3)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Natalia Ruiz, DPT, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Standard of Care; Splints
• Other Study ID Numbers: 23-00609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared to achieve aims in the approved proposal beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Natalia.Ruiz@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes