Pilot Study on The Effectiveness of Relative Motion Orthosis in Finger Motion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RMO flexion orthosis (splint), Standard of care.
- Who it may be relevant to
- Registry conditions: Proximal Interphalangeal Joint Stiffness. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in QuickDASH (Disability of the Arm, Shoulder, and Hand) score [Time frame: Baseline, End-of-treatment (~Month 3)]
Secondary outcome measures (1)
- Change in Active Range of Motion (AROM) [Time frame: Baseline, End-of-treatment (~Month 3)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT06646029 · 23-00609