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

NCT ID: NCT06646029

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-07
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RMO flexion orthosis (splint)

Intervention Type: 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.

Standard of care

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Standard of care

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalia Ruiz, DPT

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Natalia Ruiz, DPT

Role: CONTACT

Natalia.ruiz@nyulangone.org

646-501-4782

Other Identifiers

23-00609

Identifier Type: -

Identifier Source: org_study_id