Recruiting

Relative Motion Orthosis

Sponsor:

NYU Langone Health

Code:

NCT06646029

Conditions

Proximal Interphalangeal Joint Stiffness

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

RMO flexion orthosis (splint)

Standard of care

Study Details

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 ID

NCT06646029

Start date

Dec 7, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Standard of care

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

Primary outcome measure

  • Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score [ Time Frame: Baseline, End-of-treatment (~Month 3) ]

Central Contacts and Locations

Central contacts

Natalia Ruiz, DPT

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

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-02-27.