Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects Of Sensory Training and Electrical Stimulation on Sole of The Foot Sensations in Patients With Acute Hemiplegia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252092
Recruitment Status : Enrolling by invitation
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Yeditepe University

Brief Summary:
The aim of this study is to investigate the effects of the sole of foot sensory education and electrical stimulation on proprioceptive and cortical senses in patients with acute hemiplegia.

Condition or disease Intervention/treatment Phase
Hemiplegia Stroke, Acute Sensory Disorders Other: Sensory training Other: Electrical stimulation Not Applicable

Detailed Description:

Hemiplegia is a syndrome characterized by disorders of motor and sensory functions, speech and mental abilities. Hemiplegia is a common neurological problem in the world and is the third most common cause of death.

In addition to motor loss in patients after stroke, sensory problems are accompanied and close to 60% of stroke patients experience sensory problems. In a limited number of studies in the literature, it is stated that sensory impairment in the lower extremity negatively affects standing, walking speed, balance during ambulation and symmetrical gait. At the same time, it has been proven that the sole of the foot sense plays an important role in the balance of sitting, standing up and performing independent daily living activities. After a stroke, sensory training increases functionality, patients with sensory training recover faster, mobility, balance and daily life activities become better, and daily life improvement is expressed. The purpose of sensory training is to maximize the patient's learning through the connection between environment and repetitive activities.

The aim of this study is to compare the effects of neurodevelopmental physiotherapy program combined with sensory training or electrical stimulation on the sole of the foot proprioceptive and cortical senses in individuals diagnosed with hemiplegia.

There is no study on how proprioceptive and cortical sensations will be affected in acute hemiplegic patients if sensory training and electrical stimulation are added to the classical treatment program. By finding and comparing the effects of active (sensory training) and passive treatment (electric stimulation) with this study, it was planned to propose an effective treatment protocol for developing the sole of the foot senses to the experts working in this field.

As a result, purpose of the study is to prevent inadequate sensory input in hemiplegic patients from adversely affecting quality of life.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects Of Sensory Training and Electrical Stimulation in Sole of The Foot on Proprioceptive and Cortical Sensations in Patients With Acute Hemiplegia
Estimated Study Start Date : February 17, 2020
Estimated Primary Completion Date : February 17, 2020
Estimated Study Completion Date : December 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Sensory Group
15 patients who will be applied 15 sessions of sensory training
Other: Sensory training
15 session,20 minutes sensory training program

Experimental: Electrical Stimulation Group
15 patients who will be applied 15 sessions of electrical stimulation
Other: Electrical stimulation
15 session,20 minutes electrical stimulation program




Primary Outcome Measures :
  1. Assessment Of Sensation [ Time Frame: 3 weeks ]

    Proprioceptive and cortical sense assessment will be applied all subjects (30 patients) at the beginning and end of treatments.

    In the case of correct response to 8 and above from ten attempts, the sense of sensation is considered normal; correct response between 3-7, the sense of sensation is considered decreased; correct response 3 and below, the sense of sensation is considered lost.



Secondary Outcome Measures :
  1. Assessment Of Cognitive Level [ Time Frame: 1 day ]
    Mini mental test will be used all subjects (30 patient)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participating to the study in a voluntary basis
  • Patients with 50-80 years old
  • A stroke diagnosis by a neurologist
  • A stroke attack within 6 months
  • Minimum 18 points from Mini Mental Test
  • Medically stable

Exclusion Criteria:

  • Unstable condition
  • Other neurological or orthopaedic problems that will affect function other than stroke
  • Uncontrolled hypertension
  • Diabetic foot ulcers
  • Part/total foot amputation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252092


Locations
Layout table for location information
Turkey
Eksen Sağlık
Istanbul, Turkey
Sponsors and Collaborators
Yeditepe University
Layout table for additonal information
Responsible Party: Yeditepe University
ClinicalTrials.gov Identifier: NCT04252092    
Other Study ID Numbers: i79zrwdy
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yeditepe University:
Electrical stimulation
Sensory education
Sensory evaluation
Stroke
Proprioception
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Hemiplegia
Sensation Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms