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RecruitingNCT05908149Updated Dec 6, 2024

Gait Analysis in Patients With Hemiplegia Using Insole Splint.

An interventional study of Insole Splint in Gait, Hemiplegic, Splints and EMG, sponsored by University of Ioannina. Recruiting at 1 site in Greece. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by University of Ioannina · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gait, Hemiplegic
  • Splints
  • EMG
03

In context

Hemiplegia

374 studies on the registry are indexed under Hemiplegia; 83 are open to participants now.

This study's planned enrollment of 12 is below the median of 34 across 310 interventional studies indexed under Hemiplegia.

Browse Hemiplegia studies →

Lead sponsor

University of Ioannina is the lead sponsor of 53 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    HEMIPLEGIC PATIENTS

    HEMIPLEGIC PATIENTS WITH PES EQUINUS WILL BE EXAMINED BY GAIT ANALYSIS WITH AND WITHOUT THE INSOLE SPLINT, RANDOMLY

    Device: Insole Splint

Interventions

  • DeviceInsole Splint

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

06

What researchers measure

Primary outcomes

  1. Gait speed

    Patients are going to walk 15 metres with speed (meter/second) decided from the patient himself.

    Time frame: up to 6 months

  2. 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)

    Time frame: up to 6 months

  3. 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.

    Time frame: up to 6 months

  4. 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)

    Time frame: up to 6 months

07

Study locations

1 of 1 sites recruiting
  • Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
    Ioannina, 45100, Greece
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05908149
Lead sponsor
University of Ioannina
Responsible party
Avraam Ploumis (Director of Physical Medicine and Rehabilitation Clinic, University of Ioannina) — Principal investigator
First posted
Jun 18, 2023
Start date
Apr 12, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Dec 6, 2024

Study contacts

Avraam Ploumis
Contact
aploumis@uoi.gr
+306932080701

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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