Back to resultsGait Analysis in Patients With Hemiplegia Using Insole Splint.
Primary Purpose
Gait, Hemiplegic, Splints, EMG
Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Insole Splint
Sponsored by
About this trial
This is an interventional supportive care trial for Gait, Hemiplegic
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.
Sites / Locations
- Department of Physical Medicine and Rehabilitation, University Hospital of IoanninaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HEMIPLEGIC PATIENTS
Arm Description
HEMIPLEGIC PATIENTS WITH PES EQUINUS WILL BE EXAMINED BY GAIT ANALYSIS WITH AND WITHOUT THE INSOLE SPLINT, RANDOMLY
Outcomes
Primary Outcome Measures
Gait speed
Patients are going to walk 15 metres with speed (meter/second) decided from the patient himself.
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)
Gait angles
Patients are going to walk 15 meters with speed decided from the patient himself. More specific, we are going to count Ankle angles, Knee angles, Hip angles (in degrees) during gait
Stride length
Patients are going to walk 15 meters with speed decided from the patient himself. More specific, we are going to count Stride length (a full walking cycle of both feet making 1 step each)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05908149
Brief Title
Gait Analysis in Patients With Hemiplegia Using Insole Splint.
Official Title
Gait Analysis in Patients With Hemiplegia Using Insole Splint.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ioannina
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Hemiplegic, Splints, EMG
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HEMIPLEGIC PATIENTS
Arm Type
Experimental
Arm Description
HEMIPLEGIC PATIENTS WITH PES EQUINUS WILL BE EXAMINED BY GAIT ANALYSIS WITH AND WITHOUT THE INSOLE SPLINT, RANDOMLY
Intervention Type
Device
Intervention Name(s)
Insole Splint
Intervention Description
Insole splint used in 'Pes equinus' in patients with hemiplegia
Primary Outcome Measure Information:
Title
Gait speed
Description
Patients are going to walk 15 metres with speed (meter/second) decided from the patient himself.
Time Frame
up to 6 months
Title
Gait cadence
Description
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
Title
Gait angles
Description
Patients are going to walk 15 meters with speed decided from the patient himself. More specific, we are going to count Ankle angles, Knee angles, Hip angles (in degrees) during gait
Time Frame
up to 6 months
Title
Stride length
Description
Patients are going to walk 15 meters with speed decided from the patient himself. More specific, we are going to count Stride length (a full walking cycle of both feet making 1 step each)
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avraam Ploumis
Phone
+306932080701
Email
aploumis@uoi.gr
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
City
Ioannina
ZIP/Postal Code
45100
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avraam Ploumis
Phone
6932080701
Email
aploumis@uoi.gr
12. IPD Sharing Statement
Learn more about this trial
Gait Analysis in Patients With Hemiplegia Using Insole Splint.
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