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

NCT05625451 | Completed

• 1 other identifier: 002
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Interphalangeal Finger Joint Contractures

Outcome Measures

Primary Outcomes (4)

• Change in the proximal interphalangeal joint extension

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

  7 days

• Change in the proximal interphalangeal joint extension

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

  21 days

• - 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

  fifteen minutes

• - Contraction Test

  Finger reaction at release of the orthosis

  21 days

Study Arms (2)

20-22 hours of daily total end range time intervention

EXPERIMENTAL

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

Device: Elastic Tension Digital Neoprene Orthosis

11-13 hours daily total end range time intervention

ACTIVE COMPARATOR

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

Device: Elastic Tension Digital Neoprene Orthosis

Interventions

Elastic Tension Digital Neoprene Orthosis DEVICE

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.

11-13 hours daily total end range time intervention; 20-22 hours of daily total end range time intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vicenç Punsola Izard: lead

Study Sites (1)

Hand Therapy Barcelona

Barcelona, 08010, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical Therapist, Certified Hand Therapist in Hand Therapy Barcelona, MSc Gimbernat Universiy , Assistant lecturer at Gimbernat University, PhD Candidate at University of Barcelona

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

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 23, 2022
• Study Start: November 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: January 1, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)