NCT05908149 Gait Analysis in Patients With Hemiplegia Using Insole Splint.
| NCT ID | NCT05908149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ioannina |
| Condition | Gait, Hemiplegic |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-04-12 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2023-04-12 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05908149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Gait, Hemiplegic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05908149 currently recruiting?
Yes, NCT05908149 is actively recruiting participants. Contact the research team at aploumis@uoi.gr for enrollment information.
Where is the NCT05908149 trial being conducted?
This trial is being conducted at Ioannina, Greece.
Who is sponsoring the NCT05908149 clinical trial?
NCT05908149 is sponsored by University of Ioannina. The trial plans to enroll 12 participants.