Gait Analysis in Patients With Hemiplegia Using Insole Splint.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Ioannina
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Insole Splint
DeviceInsole splint used in 'Pes equinus' in patients with hemiplegia
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: HEMIPLEGIC PATIENTSExperimental treatment 1 intervention
Trial outcomes
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 months2
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 months3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov