Gait Analysis in Patients With Hemiplegia Using Insole Splint.

NCT05908149 | Recruiting

• 1 other identifier: 10/12-4-2023 (T.34)
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gait, Hemiplegic; Splints; EMG

Outcome Measures

Primary Outcomes (4)

• Gait speed

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

  up to 6 months

• Gait cadence

  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

  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

  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

Study Arms (1)

HEMIPLEGIC PATIENTS

EXPERIMENTAL

HEMIPLEGIC PATIENTS WITH PES EQUINUS WILL BE EXAMINED BY GAIT ANALYSIS WITH AND WITHOUT THE INSOLE SPLINT, RANDOMLY

Device: Insole Splint

Interventions

Insole Splint DEVICE

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

HEMIPLEGIC PATIENTS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina

Ioannina, 45100, Greece

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Avraam Ploumis

CONTACT

+306932080701; aploumis@uoi.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Physical Medicine and Rehabilitation Clinic

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 18, 2023
• Study Start: April 12, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

GR (1)