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High Doses of Total End Range Time Offer Better Results Than Low Doses Treating Proximal Interphalangeal Joint Stiffness

Primary Purpose

Proximal Interphalangeal Finger Joint Contractures

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Elastic Tension Digital Neoprene Orthosis
Sponsored by
Vicenç Punsola Izard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proximal Interphalangeal Finger Joint Contractures

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hand Therapy Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

20-22 hours of daily total end range time intervention

11-13 hours daily total end range time intervention

Arm Description

used the elastic tension digital neoprene orthosis from twenty to twenty-two hours

used the elastic tension digital neoprene orthosis from eleven to thirteen hours

Outcomes

Primary Outcome Measures

Change in the proximal interphalangeal joint extension
difference in passive finger extension between the first day and the seventh day
Change in the proximal interphalangeal joint extension
difference in passive finger extension between the first day and the twenty first day
- Modified Weeks Test
Difference in finger extension at the beginning of te session and after a 15 min passive assisted extension exercise with a force of 500g
- Contraction Test
Finger reaction at release of the orthosis

Secondary Outcome Measures

Full Information

First Posted
November 7, 2022
Last Updated
November 27, 2022
Sponsor
Vicenç Punsola Izard
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1. Study Identification

Unique Protocol Identification Number
NCT05625451
Brief Title
High Doses of Total End Range Time Offer Better Results Than Low Doses Treating Proximal Interphalangeal Joint Stiffness
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vicenç Punsola Izard

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Interphalangeal Finger Joint Contractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized parallel-group trial with concealed allocation, assessor blinding and intention-to-treat
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20-22 hours of daily total end range time intervention
Arm Type
Experimental
Arm Description
used the elastic tension digital neoprene orthosis from twenty to twenty-two hours
Arm Title
11-13 hours daily total end range time intervention
Arm Type
Active Comparator
Arm Description
used the elastic tension digital neoprene orthosis from eleven to thirteen hours
Intervention Type
Device
Intervention Name(s)
Elastic Tension Digital Neoprene Orthosis
Intervention Description
The treatment consisted of an exercise program in conjunction with the use of an extension elastic tension digital neoprene orthosis to generate two different daily total end range time doses. Group A patients used a dose of twenty to twenty-two hours of daily total end range time while group B patients used the extension elastic tension digital neoprene orthosis to achieve a daily total end range time between eleven and thirteen hours for a mean of twenty hours a day. The exercise program was the same for both groups.
Primary Outcome Measure Information:
Title
Change in the proximal interphalangeal joint extension
Description
difference in passive finger extension between the first day and the seventh day
Time Frame
7 days
Title
Change in the proximal interphalangeal joint extension
Description
difference in passive finger extension between the first day and the twenty first day
Time Frame
21 days
Title
- Modified Weeks Test
Description
Difference in finger extension at the beginning of te session and after a 15 min passive assisted extension exercise with a force of 500g
Time Frame
fifteen minutes
Title
- Contraction Test
Description
Finger reaction at release of the orthosis
Time Frame
21 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hand Therapy Barcelona
City
Barcelona
ZIP/Postal Code
08010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

High Doses of Total End Range Time Offer Better Results Than Low Doses Treating Proximal Interphalangeal Joint Stiffness

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