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Clinical Trials/NCT05625451
NCT05625451CompletedNot Applicable

A Comparison Between Two Intervals of Daily Total End Range Time for Treatment of Proximal Interphalangeal Joint Flexion Contracture Using an Elastic Tension Digital Neoprene Orthosis

Vicenç Punsola Izard2 sites in 1 country91 target enrollmentStarted: November 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
91
Locations
2
Primary Endpoint
Change in the proximal interphalangeal joint extension

Study Overview

Brief Summary

Elastic Tension Digital Neoprene Orthosis is a new device that can increase the dose of treatment of the proximal interphalangeal flexion contractures. This treatment improved the results in extension and also reducing the time to obtain it.

Detailed Description

Question: In fingers with proximal interphalangeal joint flexion contractures, do significant differences exist between the passive range of motion improvement achieved in joints that receive higher doses of daily total end range time compared to those that receive lower doses of daily total end range time?

Design: Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat

Participants: Fifty-seven fingers in fifty patients suffering a proximal interphalangeal joint flexion contracture

Intervention: The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate extension. Researchers applied two different daily total end range time doses. Group A patients used the orthosis with a dose of twenty to twenty-two hours of daily total end range time while group B patients used the elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours. The exercise program was the same for both groups.

Outcome measures: The researchers performed the goniometric measurements manually twice at the beginning of every session during the three-week period. The first measurement was at the patient arrival after a preconditioning and the second was after twenty minutes. This measurement at the first session was included as a Modified weeks test while at the second, third and forth session was recorded as a contraction test. Patient report of orthosis wear time and

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient Inclusion Criteria:
  • Patients with flexion contractures of the proximal interphalangeal joint after trauma or post-surgical complications.
  • Patients with long standing flexion contractures
  • Patients with contractures greater than 45º.

Exclusion Criteria

  • Patients with acute tendon injuries or fractures
  • Patients with inflammatory conditions,
  • Patients with proximal interphalangeal joint replacements,
  • Patients with Dupuytren conservative treatments
  • Patients lacking active proximal interphalangeal joint extension

Outcomes

Primary Outcomes

Change in the proximal interphalangeal joint extension

Time Frame: 21 days

difference in passive finger extension between the first day and the twenty first day

- Contraction Test

Time Frame: 21 days

Finger reaction at release of the orthosis

- Modified Weeks Test

Time Frame: fifteen minutes

Difference in finger extension at the beginning of te session and after a 15 min passive assisted extension exercise with a force of 500g

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Vicenç Punsola Izard
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Vicenç Punsola Izard

Physical Therapist, Certified Hand Therapist in Hand Therapy Barcelona, MSc Gimbernat Universiy , Assistant lecturer at Gimbernat University, PhD Candidate at University of Barcelona

Hand Therapy Barcelona

Study Sites (2)

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