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Search / Trial NCT05908149

Gait Analysis in Patients With Hemiplegia Using Insole Splint.

Launched by UNIVERSITY OF IOANNINA · Jun 7, 2023

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how the use of an insole splint can affect walking in patients who have hemiplegia, which is a condition that causes weakness on one side of the body, often after a stroke. The researchers want to find out if wearing this splint helps improve walking and if it changes how the muscles are used while walking. Participants will walk in a special area both with and without the splint while wearing a device that monitors muscle activity.

To be eligible for this trial, participants should be between 18 and 70 years old, have had their first stroke at least two months ago, and should be able to walk with or without the splint. They also need to have been using the insole splint during their therapy sessions for at least a week before joining the study. Participants will be expected to follow instructions from the researchers and actively engage in the trial. This study is currently looking for both men and women and aims to include a balanced number of each.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients that can walk with or without the splint, having their first stroke episode at least two months ago and their hospitalisation period does not overcome six months, having also a diagnosis from a neurologist coming with a Brain CT-scan.
  • Patients must have use the insole splint during physiotherapy sessions for at least 1 week before their inclusion in the trial.
  • Patients must be able to communicate and fully understand the instructions given by the researchers.
  • Researchers are going to try to have a sex ratio 50/50.
  • Patients' age is going to be between 18-70 years.
  • Functional Ambulation Category: FAC \> 2
  • Modified Ashworth Scale of the affected lower Limb (MAS): MAS ≤2
  • Normal Gait before the stroke.
  • Exclusion Criteria:
  • Peripheral Neurological Damage.
  • Past or ongoing orthopedic or reumatologic disease that bothers patient's gait.
  • Past damage of the Central Nervous System.
  • Dermatologic problems or human factors that limitate the use of insole splint.
  • Patients must not have used intramuscular botox injection recently.
  • Patients with low motivation and low perception are also excluded.

About University Of Ioannina

The University of Ioannina, located in Greece, is a leading academic institution renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, the university leverages its extensive resources and expertise to facilitate innovative studies aimed at improving healthcare outcomes. With a focus on collaborative research, the University of Ioannina engages in multidisciplinary partnerships and adheres to rigorous ethical standards, ensuring the integrity and reliability of its clinical trials. Through its dedication to scientific excellence, the university aims to contribute significantly to the body of medical knowledge and the development of effective therapeutic interventions.

Locations

Ioannina, , Greece

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported