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

NCT06646029 | Recruiting FDA Device

• 1 other identifier: 23-00609
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Interphalangeal Joint Stiffness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Active Range of Motion (AROM)

  Baseline, End-of-treatment (~Month 3)

Study Arms (2)

Orthosis + standard hand therapy care

EXPERIMENTAL

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); Other: Standard of care

Standard of care

ACTIVE COMPARATOR

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

Interventions

RMO flexion orthosis (splint) DEVICE

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.

Orthosis + standard hand therapy care

Standard of care OTHER

Treatment includes finger stretches, active range of motion (AROM), passive range of motion (PROM), thermal modalities, LMB finger extension orthosis.

Orthosis + standard hand therapy care; Standard of care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Interventions

Splints; Standard of Care

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Natalia Ruiz, DPT

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalia Ruiz, DPT

CONTACT

646-501-4782; Natalia.ruiz@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 17, 2024
• Study Start: December 7, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)