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SCED-SA: Efficacity of a Rigid Ankle Foot Orthosis for Persons With Ankle Osteoarthritis

Sponsor
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est (Other)
Overall Status
Completed
CT.gov ID
NCT04312373
Collaborator
(none)
3
Enrollment
1
Location
10.9
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Ankle osteoarthritis (AOA) is a typical long-term complication of an ankle injury. Pain during walking is the main symptom that limits walking distance. Non-surgical treatments could be used to decrease pain. The gold standard treatment for end-stage OA is definitive surgical ankle arthrodesis.

The purpose of this study was to assess the effectiveness of a rigid ankle-foot orthosis (R-AFO) for walking pain in a population suffering from AOA.

Condition or Disease Intervention/Treatment Phase
  • Other: Ankle Foot Orthosis

Detailed Description

This study used the SCED introduction/withdrawal methodology to assess the efficacy of R-AFO on pain and walking distance in the 2-minute walk test (2MWT). Each patient is his or her own comparator. During phase A, considered as the baseline, the patient performs the 2MWT without R-AFO. During phases B, considered as the introduction phases, the patient performs the tests with R-AFO. These tests are performed repeatedly and at regular intervals. The time of transition between phases has been randomized to have a minimum of 3 trials per phase.

At the end of each test, an visual analogue scale for the pain and the walking distance travelled during the 2MWT were recorded.

Study Design

Study Type:
Observational
Actual Enrollment :
3 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Efficacity of a Rigid Ankle Foot Orthosis for Persons With Ankle Osteoarthritis
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Dec 30, 2017

Outcome Measures

Primary Outcome Measures

  1. Evolution of the distance travelled during the 2MWT between each phase [1 day, starting from the baseline]

    In m.

  2. Evolution of the Visual Analogue Scale (VAS) for walking ankle pain between each phase [The VAS was performed after each 2MWT. All 2MWT were completed in one day.]

    Scale from 0 to 10, the higher the score the higher the pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • primary or post-traumatic one-sided Ankle osteoarthritis (AOA)

  • Able to walk at least two minutes

Exclusion Criteria:

  • cardiovascular diseases

  • respiratory diseases that prevent subjects from performing the walking tests

  • neurologic or orthopaedic diseases which could affect their gait (excluding AOA)

  • inability to understand study instructions

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Régional de Médecine Physique et de Réadaptation Nancy France 54000

Sponsors and Collaborators

  • Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est

Investigators

  • Study Chair: Jean Paysant, PhD-MD, Institut Régional de Médecine Physique et de Réadaptation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
ClinicalTrials.gov Identifier:
NCT04312373
Other Study ID Numbers:
  • IRR-2018-SCED
First Posted:
Mar 18, 2020
Last Update Posted:
Mar 18, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est
Ankle Osteoarthritis
Ankle Foot Orthosis
Ankle Arthrodesis
Single Case Experimental Design
Additional relevant MeSH terms:
Osteoarthritis

Study Results

No Results Posted as of Mar 18, 2020