Gait Analysis in Patients With Hemiplegia Using Insole Splint.

• Sponsor: University of Ioannina (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05908149
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 8.6
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gait, Hemiplegic; Splints; EMG	Device: Insole Splint	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Gait Analysis in Patients With Hemiplegia Using Insole Splint.
• Actual Study Start Date: Apr 12, 2023
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HEMIPLEGIC PATIENTS HEMIPLEGIC PATIENTS WITH PES EQUINUS WILL BE EXAMINED BY GAIT ANALYSIS WITH AND WITHOUT THE INSOLE SPLINT, RANDOMLY	Device: Insole Splint; Insole splint used in 'Pes equinus' in patients with hemiplegia

Outcome Measures

Primary Outcome Measures

1. Gait speed [up to 6 months]

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

2. Gait cadence [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)

3. Gait angles [up to 6 months]

   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

4. Stride length [up to 6 months]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina	Ioannina		Greece	45100

Sponsors and Collaborators

• University of Ioannina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Avraam Ploumis, Director of Physical Medicine and Rehabilitation Clinic, University of Ioannina
• ClinicalTrials.gov Identifier: NCT05908149
• Other Study ID Numbers: 10/12-4-2023 (T.34)
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: Jun 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemiplegia; Gait Disorders, Neurologic

Study Results

No Results Posted as of Jun 18, 2023