Gait analysis in hemiplegic patients using an insole splint
Gait Analysis in Patients With Hemiplegia Using Insole Splint.
NA · University of Ioannina · NCT05908149
This study is testing if an insole splint can help improve walking for people with hemiplegia after a stroke.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Ioannina (other) |
| Locations | 1 site (Ioannina) |
| Trial ID | NCT05908149 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 who have had their first stroke at least two months ago and can walk with or without a splint.
Not a fit: Patients with peripheral neurological damage or significant orthopedic issues affecting their gait may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for hemiplegic patients, enhancing their mobility and quality of life.
How similar studies have performed: While similar studies have explored gait improvement in hemiplegic patients, the specific use of insole splints in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ioannina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gait, Hemiplegic, Splints, EMG