Gait Analysis in Patients With Hemiplegia Using Insole Splint.

Not Applicable

Recruiting

• Conditions: Gait, Hemiplegic; Splints; EMG
• Interventions: Device: Insole Splint

• Registration Number: NCT05908149
• Lead Sponsor: University of Ioannina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-12
• Study First Submitted: 2023-05-30
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HEMIPLEGIC PATIENTS	Insole Splint	HEMIPLEGIC PATIENTS WITH PES EQUINUS WILL BE EXAMINED BY GAIT ANALYSIS WITH AND WITHOUT THE INSOLE SPLINT, RANDOMLY

Primary Outcome Measures

Name	Time	Method
Stride length	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)
Gait speed	up to 6 months	Patients are going to walk 15 metres with speed (meter/second) decided from the patient himself.
Gait angles	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.
Gait cadence	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)

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina; 🇬🇷 Ioannina, Greece