Gait Analysis in Patients With Hemiplegia Using Insole Splint.

December 3, 2023 updated by: Avraam Ploumis, University of Ioannina

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Ioannina, Greece, 45100
        • Recruiting
        • Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HEMIPLEGIC PATIENTS
HEMIPLEGIC PATIENTS WITH PES EQUINUS WILL BE EXAMINED BY GAIT ANALYSIS WITH AND WITHOUT THE INSOLE SPLINT, RANDOMLY
Device: Insole Splint
Insole splint used in 'Pes equinus' in patients with hemiplegia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait speed
Time Frame: up to 6 months
Patients are going to walk 15 metres with speed (meter/second) decided from the patient himself.
up to 6 months
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)
up to 6 months
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.
up to 6 months
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)
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ioannina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 3, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/12-4-2023 (T.34)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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