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Gait Analysis in Patients With Hemiplegia Using Insole Splint.

Gait Analysis in Patients With Hemiplegia Using Insole Splint.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05908149
Enrollment
12
Registered
2023-06-18
Start date
2023-04-12
Completion date
2025-12-31
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EMG, Gait, Hemiplegic, Splints

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.

Interventions

DEVICEInsole Splint

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

Sponsors

University of Ioannina
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gait speedup to 6 monthsPatients are going to walk 15 metres with speed (meter/second) decided from the patient himself.
Gait cadenceup to 6 monthsPatients are going to walk 15 meters with speed decided from the patient himself and will measure cadence (number of full steps per minute)
Gait anglesup to 6 monthsPatients 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.
Stride lengthup to 6 monthsPatients 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)

Countries

Greece

Contacts

Primary ContactAvraam Ploumis
aploumis@uoi.gr+306932080701

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026