Effectiveness of Exercise Relative Motion Orthoses for Limited Finger Joint Motion

NCT06985459 | Recruiting

• 1 other identifier: RM Orthosis Study 2025-00427
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial investigates the effectiveness of two exercise orthosis designs-the Relative Motion Flexion (RMF) and Relative Motion Extension (RME) orthoses-for improving motion in patients with proximal interphalangeal joint (PIPJ) flexion or extension deficits. A total of 148 adult patients with acute hand injuries and a minimum 10° difference between active and passive PIP joint motion will be enrolled. Participants are stratified by their primary motion deficit and randomized to either the exercise orthosis or placebo orthosis group. The orthosis is worn for 4 weeks, with follow-up assessments at weeks 6 and 8 to evaluate range of motion and patient satisfaction. All participants will continue standard hand therapy throughout the study.

Conditions

Proximal Interphalangeal Joint Stiffness

Keywords

Proximal Interphalangeal Joint; Limited Range of Motion; Exercise Relative Motion Orthosis; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Finger range of motion

  PIPJ active and passive motion will be measured using a hand-held goniometer. The goniometer is placed dorsal to the joint in all cases with the arms of the goniometer aligned on the finger bones. The DIP, the PIP and MCP joints will be measured in both extension and flexion range of motion. The degrees of measurement will be noted using the neutral-zero method.

  Change from baseline to 2, 4 and 6 weeks

Secondary Outcomes (3)

• Patient satisfaction

  Change from baseline to 2, 4 and 8 weeks

• Patient Specific Functional Scale (PSFS)

  Change from baseline to 4 and 8 weeks

• Orthosis diary

  continuous

Study Arms (4)

PIP extension deficit treated with an exercise RMF orthosis

EXPERIMENTAL

The orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed.

Device: PIP extension deficit treated with an exercise RMF orthosis

PIP extension deficit treated with a placebo RMF orthosis

PLACEBO COMPARATOR

The orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed.

Device: PIP extension deficit treated with a placebo RMF orthosis

PIP flexion deficits treated with an exercise RME orthosis

ACTIVE COMPARATOR

The orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed.

Device: PIP flexion deficits treated with an exercise RME orthosis

PIP flexion deficits treated with a placebo RMF orthosis

PLACEBO COMPARATOR

The orthosis is worn for 4 weeks. At week 6 and 8, follow-up visits are planned to measure PIPJ range of motion and patient satisfaction. For all arms, standard hand therapy treatment continues as needed

Device: PIP flexion deficits treated with a placebo RMF orthosis

Interventions

PIP extension deficit treated with an exercise RMF orthosis DEVICE

The RM orthoses will be worn between 6-12 hours per day during functional use.

PIP extension deficit treated with an exercise RMF orthosis

PIP extension deficit treated with a placebo RMF orthosis DEVICE

The placebo orthosis has the same design as the exercise RM orthoses, but without a difference in the extension or flexion angle, respectively, to the adjacent finger - therefore neutralizing the "quadriga phenomena", which is the effect that makes RM orthoses work.

PIP extension deficit treated with a placebo RMF orthosis

PIP flexion deficits treated with a placebo RMF orthosis DEVICE

The placebo orthosis have the same design as the exercise RM orthoses, but without a difference in the extension or flexion angle, respectively, to the adjacent finger - therefore neutralizing the "quadriga phenomena", which is the effect that makes RM orthoses work.

PIP flexion deficits treated with a placebo RMF orthosis

PIP flexion deficits treated with an exercise RME orthosis DEVICE

The dedicated orthosis wearing time is 6-12 hours per day during functional use.

PIP flexion deficits treated with an exercise RME orthosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Bern

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Related Publications (13)

• Glasgow C, Fleming J, Tooth LR, Peters S. Randomized controlled trial of daily total end range time (TERT) for Capener splinting of the stiff proximal interphalangeal joint. Am J Occup Ther. 2012 Mar-Apr;66(2):243-8. doi: 10.5014/ajot.2012.002816.

  PMID: 22394534 BACKGROUND

• Horn KK, Jennings S, Richardson G, Vliet DV, Hefford C, Abbott JH. The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure. J Orthop Sports Phys Ther. 2012 Jan;42(1):30-42. doi: 10.2519/jospt.2012.3727. Epub 2011 Oct 25.

  PMID: 22031594 BACKGROUND

• Hefford C, Abbott JH, Arnold R, Baxter GD. The patient-specific functional scale: validity, reliability, and responsiveness in patients with upper extremity musculoskeletal problems. J Orthop Sports Phys Ther. 2012 Feb;42(2):56-65. doi: 10.2519/jospt.2012.3953. Epub 2012 Feb 1.

  PMID: 22333510 BACKGROUND

• Schreuders TA. The quadriga phenomenon: a review and clinical relevance. J Hand Surg Eur Vol. 2012 Jul;37(6):513-22. doi: 10.1177/1753193411430810. Epub 2011 Dec 14.

  PMID: 22170246 BACKGROUND

• Shaw AV, Verma Y, Tucker S, Jain A, Furniss D. Relative motion orthoses for early active motion after finger extensor and flexor tendon repairs: A systematic review. J Hand Ther. 2023 Apr-Jun;36(2):332-346. doi: 10.1016/j.jht.2023.02.011. Epub 2023 Apr 8.

  PMID: 37037728 BACKGROUND

• Arslan OB, Sigirtmac IC, Ayvali C, Bas CE, Ayhan E, Bilgin SS, Oksuz C. The Use of Relative Motion Flexion Orthoses for Chronic Boutonniere Deformity. J Hand Surg Am. 2024 May;49(5):488.e1-488.e8. doi: 10.1016/j.jhsa.2022.08.007. Epub 2022 Oct 4.

  PMID: 36202676 BACKGROUND

• Yates SE, Glinsky JV, Hirth MJ, Fuller JT. The use of exercise relative motion orthoses to improve proximal interphalangeal joint motion: A survey of Australian hand therapy practice. J Hand Ther. 2023 Apr-Jun;36(2):414-424. doi: 10.1016/j.jht.2022.12.002. Epub 2023 Apr 6.

  PMID: 37031058 BACKGROUND

• Arslan OB, Sahin Y, Sigirtmac IC, Yildiz B, Ayhan E, Oksuz C. Use of relative motion orthoses from the perspective of hand-injured patients: A qualitative study. J Hand Ther. 2023 Apr-Jun;36(2):425-432. doi: 10.1016/j.jht.2023.02.003. Epub 2023 Apr 8.

  PMID: 37037730 BACKGROUND

• Howell JW, Ewald SG, Schwartz DA. Exercise relative motion orthoses: Use of the pencil test and variations of its use for assessing and managing different finger conditions. J Hand Ther. 2023 Apr-Jun;36(2):473-478. doi: 10.1016/j.jht.2022.10.004. Epub 2023 Mar 11. No abstract available.

  PMID: 36914489 BACKGROUND

• Wajon S, Howell JW. Prescription of exercise relative motion orthoses to improve limited proximal interphalangeal joint movement: A prospective, multi-center, consecutive case series. J Hand Ther. 2023 Apr-Jun;36(2):378-388. doi: 10.1016/j.jht.2021.09.006. Epub 2022 Jan 14.

  PMID: 35039211 BACKGROUND

• Michlovitz SL, Harris BA, Watkins MP. Therapy interventions for improving joint range of motion: A systematic review. J Hand Ther. 2004 Apr-Jun;17(2):118-31. doi: 10.1197/j.jht.2004.02.002.

  PMID: 15162100 BACKGROUND

• Yates SE, Glinsky JV, Hirth MJ, Fuller JT. Orthotic interventions for restoring proximal interphalangeal joint motion for patients with hand injuries or conditions: A systematic review and meta-analysis. J Hand Ther. 2024 Oct-Dec;37(4):495-506. doi: 10.1016/j.jht.2023.12.018. Epub 2024 Jan 26.

  PMID: 38278697 BACKGROUND

• Kamnerdnakta S, Huetteman HE, Chung KC. Complications of Proximal Interphalangeal Joint Injuries: Prevention and Treatment. Hand Clin. 2018 May;34(2):267-288. doi: 10.1016/j.hcl.2017.12.014.

  PMID: 29625645 BACKGROUND

Central Study Contacts

Bernadette Tobler-Ammann, PhD

CONTACT

+41 31 632 85 58; bernadette.tobler@insel.ch

Esther Vögelin, Prof, MD

CONTACT

+41 31 63 2 37 18; esther.voegelin@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of hand therapy research unit

Model Details: The investigators plan to stratify participants into two groups based on their greater PIPJ movement deficit (in flexion or in extension). Within each group, they are randomized to one of the orthosis interventions. This trial has four intervention arms: * Arm 1: PIP extension deficit treated with an exercise RMF orthosis. * Arm 2: PIP extension deficit treated with a placebo RMF orthosis. * Arm 3: PIP flexion deficits treated with an exercise RME orthosis. * Arm 4: PIP flexion deficits treated with a placebo RMF orthosis.

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 22, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)