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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemiplegia; Stroke, Acute; Sensory Disorders
• Intervention / Treatment: Other: Sensory training; Other: Electrical stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Eksen Sağlık

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment Of Joint Position Sense	Joint position sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. The patient's eyes will be closed. One of the foot on the hemiplegic side of the patient will be brought to a certain position and the patient will be asked to bring the other extremity to a similar position. In the case of the 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. Higher scores mean better outcomes with 0 being minimum and 10 being maximum.	Baseline and Week 3
Assesment of Joint Passive Motion Sense	Joint passive motion sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. The patient's eyes will be closed. One of the patient's big toe in hemiplegic their side will be held on either side and moved up or down. During this time, the patient will be asked to indicate the direction of the movement. In the case of the 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. Higher scores mean better outcomes with 0 being minimum and 10 being maximum.	Baseline and Week 3
Assessment of Vibration Sense	Vibration sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. It is evaluated with a vibrating diapason. While the eyes are closed, the diapason will be placed on the tip of the big toe of the hemiplegic foot, the patient will be asked if the vibration is felt or not. If it is felt, this time the patient will be asked to indicate the moment when the vibration ends. Thus, the time it detects the vibration is determined. This period is about 20 seconds in normal youth. As the age progresses, it should be remembered that vibration time is shortened in lower extremities.	Baseline and Week 3
Assesment of Deep Pain Sense	Deep pain sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. If the Achilles tendon is squeezed or the muscles are severely suppressed, it is investigated whether or not the pain is felt. If pain is felt, the result will be counted as positive. The positive result is an unwanted result.	Baseline and Week 3
Assessment of Two-point Discrimination	Two-point discrimination sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. The points of the blunt wig will be held against the hemiplegic sole of the foot at different distances from each other. Instruct the client to respond to each touch, by saying one point or two points. Eyes should be closed during the examination. When the patient feels two, it will be noted how far away in cm away from the wig.	Baseline and Week 3
Assessment of Graphesthesia	Graphesthesia assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. The patient will be asked to estimate a letter or number written the sole of the hemiplegic foot with a blunt object while the eyes are closed. In the case of the 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. Higher scores mean better outcomes with 0 being minimum and 10 being maximum.	Baseline and Week 3
Assessment of Tactile Localization Sense	Tactile localization sense assessment will be applied to all subjects (30 patients) at the beginning and end of treatments. Patients will be stimulated on 10 different locations of the hemiplegic sole of the foot. They will be asked to localize the touch. The response will be recorded. In the case of the 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. Higher scores mean better outcomes with 0 being minimum and 10 being maximum.	Baseline and Week 3
Assessment of Tactile Inattention	Tactile inattention assessment will be applied to all subjects (30 patients) at the beginning and end of treatments.The patient will close his eyes. The right and the left half of the body will be needled at the same time. The patient with tactile inattention perceives only one of them which is counted as positive. The positive result is an unwanted result.	Baseline and Week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment Of Cognitive Level	Mini-mental test will be applied to all subjects (30 patients) at the beginning of treatments. A mini-mental test will be performed to evaluate the patient's cognitive level. This test will be used because it evaluates orientation, recording memory, attention, and computation, remembering and language, orientation, praxis skills. In the test consisting of 30 questions and 30 points, a total of ≥25 points were considered normal, 21-24 points Light, 10-20 points medium, and ≤9 serious cognitive disorders. Higher scores mean better outcome with 0 being minimum and 30 being maximum.	Baseline

Collaborators and Investigators

• Sponsor: Yeditepe University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Actual): April 22, 2020
• Study Completion (Actual): August 25, 2020

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: September 29, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Stroke; Electrical stimulation; Proprioception; Sensory education; Sensory evaluation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia; Sensation Disorders
• Other Study ID Numbers: i79zrwdy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No