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NCT Number: NCT06646029

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.

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Key information

Conditions

Proximal Interphalangeal Joint Stiffness

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard of care

Other

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

Primary outcomes

  1. Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score

    Time frame: 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 outcomes

  1. Change in Active Range of Motion (AROM)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Natalia Ruiz, DPT

CONTACT

[email protected]

646-501-4782

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 17, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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