Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05908149

Gait Analysis in Patients With Hemiplegia Using Insole Splint.

The goal of this clinical trial is to compare the gait of patients with hemiplegia, with or without the use of insole splint. The main questions it aims to answer are:

Does the insole splint improve the gait of these patients? Does any difference exist in the use of muscles?

Participants will have to walk in the gait analysis' aisle with and without the insole splint, using wireless EMG device.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Gait, Hemiplegic EMG Gait Disorders, Neurologic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Splints

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina

Ioannina, 45100, Greece

Location status: Recruiting

Location contact

Avraam Ploumis

CONTACT

[email protected]

6932080701

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insole Splint

Device

Insole splint used in 'Pes equinus' in patients with hemiplegia

Primary outcomes

  1. Gait speed

    Time frame: up to 6 months

    Patients are going to walk 15 metres with speed (meter/second) decided from the patient himself.

  2. Gait cadence

    Time frame: up to 6 months

    Patients are going to walk 15 meters with speed decided from the patient himself and will measure cadence (number of full steps per minute)

  3. Gait angles

    Time frame: up to 6 months

    Patients are going to walk 15 meters with speed decided from the patient himself. More specific, the investigators are going to count Ankle angles, Knee angles, Hip angles (in degrees) during gait.

  4. Stride length

    Time frame: up to 6 months

    Patients are going to walk 15 meters with speed decided from the patient himself. More specific, the investigators are going to count Stride length (a full walking cycle of both feet making 1 step each)

Study contacts

Contact information is provided by the study sponsor or research team.

Avraam Ploumis

CONTACT

[email protected]

+306932080701

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2023
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.