Gait, HemiplegicNCT05908149
Gait Analysis in Patients With Hemiplegia Using Insole Splint.
A study testing Insole Splint in people with Gait, Hemiplegic and Splints, run by University of Ioannina at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gait, Hemiplegic, Splints, EMG
- What is being tested?
- Insole Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGreece
- Study dates
- 12 Apr 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
Ioannina, 45100
Avraam Ploumis, 6932080701, aploumis@uoi.gr
About this study
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.
- Conditions
- Gait, Hemiplegic, Splints, EMG
- Being tested
- Insole Splint
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insole SplintDevice
Insole splint used in 'Pes equinus' in patients with hemiplegia
| Study group | Role | What they receive |
|---|---|---|
| HEMIPLEGIC PATIENTS | Experimental | HEMIPLEGIC PATIENTS WITH PES EQUINUS WILL BE EXAMINED BY GAIT ANALYSIS WITH AND WITHOUT THE INSOLE SPLINT, RANDOMLY Receives: Device: Insole Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Patients are going to walk 15 metres with speed (meter/second) decided from the patient himself.
Measured: up to 6 months
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)
Measured: up to 6 months
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.
Measured: up to 6 months
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)
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start12 Apr 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, HemiplegicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avraam Ploumis, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908149
- Sponsor's protocol ID
- 10/12-4-2023 (T.34)
- Status last verified
- Dec 2024
- First submitted
- 30 May 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analysis in Patients With Hemiplegia Using Insole Splint.
- ClinicalTrials.gov ID
- NCT05908149
- Acronym / sponsor ID
- 10/12-4-2023 (T.34)
- Conditions
- Gait, Hemiplegic, Splints, EMG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEMIPLEGIC PATIENTS | Experimental | Device: Insole SplintHEMIPLEGIC PATIENTS WITH PES EQUINUS WILL BE EXAMINED BY GAIT ANALYSIS WITH AND WITHOUT THE INSOLE SPLINT, RANDOMLY |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insole SplintInsole splint used in 'Pes equinus' in patients with hemiplegia | Device | HEMIPLEGIC PATIENTS |
Primary outcome
Gait speed
Time frame: up to 6 months
Patients are going to walk 15 metres with speed (meter/second) decided from the patient himself.
Gait cadence
Time frame: up to 6 months
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
Time frame: up to 6 months
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.
Stride length
Time frame: up to 6 months
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insole Splint in people with Gait, Hemiplegic and Splints, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avraam Ploumis (+306932080701, aploumis@uoi.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.