Gait analysis in hemiplegic patients using an insole splint

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of an insole splint in improving the gait of patients with hemiplegia. Participants will walk in a designated gait analysis area both with and without the insole splint while their muscle activity is monitored using a wireless EMG device. The study seeks to determine if the insole splint leads to measurable improvements in gait and muscle usage. Eligible patients must have experienced their first stroke at least two months prior and be able to walk with or without assistance.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
  Ioannina, Greece Recruiting

Study contacts

• Study coordinator: Avraam Ploumis
• Email: aploumis@uoi.gr
• Phone: +306932080701

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.