Gait Analysis in Patients With Hemiplegia Using Insole Splint.

Gait, Hemiplegic Clinical Trial

Official title:

Gait Analysis in Patients With Hemiplegia Using Insole Splint.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908149
• Other study ID #: 10/12-4-2023 (T.34)
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: University of Ioannina
• Contact: Avraam Ploumis
• Phone: +306932080701
• Email: aploumis[@]uoi.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Hemiplegia
• Splints

Intervention

Device:
• Insole Splint
Insole splint used in 'Pes equinus' in patients with hemiplegia

Locations

Country	Name	City	State
Greece	Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina	Ioannina

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait speed	Patients are going to walk 15 metres with speed (meter/second) decided from the patient himself.	up to 6 months
Primary	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
Primary	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
Primary	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