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Recruiting NCT05908149

Gait Analysis in Patients With Hemiplegia Using Insole Splint.

No phase Interventional Gait, Hemiplegic Splints EMG

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Insole Splint.
Who it may be relevant to
Registry conditions: Gait, Hemiplegic, Splints, EMG. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Device Insole Splint
    Insole splint used in 'Pes equinus' in patients with hemiplegia

Primary outcome measures

  • Gait speed [Time frame: up to 6 months]
  • Gait cadence [Time frame: up to 6 months]
  • Gait angles [Time frame: up to 6 months]
  • Stride length [Time frame: up to 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Greece · 1 center
  • Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina — Ioannina

Identifiers

NCT: NCT05908149 · 10/12-4-2023 (T.34)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗