Improving finger joint motion with exercise orthoses
Effectiveness of Exercise Relative Motion Orthoses for Improving Limited Proximal Phalangeal Joint Motion: A Single-Center, Single-Blinded Randomized Controlled Trial
NA · Insel Gruppe AG, University Hospital Bern · NCT06985459
This study is testing if two types of exercise braces can help people with stiff finger joints move better after hand injuries.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern, Canton of Bern) |
| Trial ID | NCT06985459 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two types of exercise orthoses, the Relative Motion Flexion (RMF) and Relative Motion Extension (RME), in enhancing motion for patients with proximal interphalangeal joint stiffness. A total of 148 adult patients with acute hand injuries and a significant difference between active and passive joint motion will be enrolled and randomized to receive either the exercise orthosis or a placebo. Participants will wear the orthosis for four weeks while continuing standard hand therapy, with follow-up assessments to measure range of motion and patient satisfaction. The study aims to determine if these innovative orthoses can improve joint mobility during daily activities.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with acute proximal interphalangeal joint motion deficits of at least 10°.
Not a fit: Patients with previous hand injuries or conditions like osteoarthritis that affect joint mobility may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the range of motion and functional ability of patients with finger joint stiffness.
How similar studies have performed: Previous studies have shown positive outcomes with similar exercise-based orthoses, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PIPJ motion deficit with a minimum difference of 10° between passive and active motion * To have an acute injury, i.e. operated on or within maximum 6 weeks of accident * Only one hand is affected * Adult patients over 18 years of age * Understanding German, French or English * Hand therapy treatment in-house at Inselspital in Bern * Ability to give informed consent as documented by signature Exclusion Criteria: * Previous injuries to the hand or PIPJ (e.g., intra-articular fractures, PIPJ ligament damage) that may limit baseline joint mobility and influence responsiveness to the intervention. * Presence of conditions such as osteoarthritis (OA) or rheumatoid arthritis (RA) that may affect PIPJ stiffness, pain, or inflammation. * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia * Boutonniere deformity * Minors (below 18 years of age)
Where this trial is running
Bern, Canton of Bern
- University Hospital Bern — Bern, Canton of Bern, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Bernadette Tobler-Ammann, PhD
- Email: bernadette.tobler@insel.ch
- Phone: +41 31 632 85 58
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Proximal Interphalangeal Joint Stiffness, Proximal Interphalangeal Joint, Limited Range of Motion, Exercise Relative Motion Orthosis, Randomized Controlled Trial