Gait Analysis in Patients With Hemiplegia Using Insole Splint.

University of Ioannina

Status: Enrolling

Conditions: EMG; Splints; Gait, Hemiplegic

Treatments: Device: Insole Splint

Study type: Interventional

Funder types: Other

Identifiers

NCT05908149

10/12-4-2023 (T.34)

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

HEMIPLEGIC PATIENTS

Experimental group

Description:

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

Treatment:

Device: Insole Splint