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

Primary Purpose

Hemiplegia, Stroke, Acute, Sensory Disorders

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sensory training
Electrical stimulation
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring Electrical stimulation, Sensory education, Sensory evaluation, Stroke, Proprioception

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eksen Sağlık

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sensory Group

Electrical Stimulation Group

Arm Description

15 patients who will be applied 15 sessions of sensory training

15 patients who will be applied 15 sessions of electrical stimulation

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 17, 2019
Last Updated
September 29, 2020
Sponsor
Yeditepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04252092
Brief Title
Effects Of Sensory Training and Electrical Stimulation on Sole of The Foot Sensations in Patients With Acute Hemiplegia
Official Title
Effects Of Sensory Training and Electrical Stimulation in Sole of The Foot on Proprioceptive and Cortical Sensations in Patients With Acute Hemiplegia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 17, 2020 (Actual)
Primary Completion Date
April 22, 2020 (Actual)
Study Completion Date
August 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yeditepe University

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Stroke, Acute, Sensory Disorders
Keywords
Electrical stimulation, Sensory education, Sensory evaluation, Stroke, Proprioception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sensory Group
Arm Type
Experimental
Arm Description
15 patients who will be applied 15 sessions of sensory training
Arm Title
Electrical Stimulation Group
Arm Type
Experimental
Arm Description
15 patients who will be applied 15 sessions of electrical stimulation
Intervention Type
Other
Intervention Name(s)
Sensory training
Intervention Description
15 session,20 minutes sensory training program
Intervention Type
Other
Intervention Name(s)
Electrical stimulation
Intervention Description
15 session,20 minutes electrical stimulation program
Primary Outcome Measure Information:
Title
Assessment Of Joint Position Sense
Description
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.
Time Frame
Baseline and Week 3
Title
Assesment of Joint Passive Motion Sense
Description
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.
Time Frame
Baseline and Week 3
Title
Assessment of Vibration Sense
Description
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.
Time Frame
Baseline and Week 3
Title
Assesment of Deep Pain Sense
Description
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.
Time Frame
Baseline and Week 3
Title
Assessment of Two-point Discrimination
Description
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.
Time Frame
Baseline and Week 3
Title
Assessment of Graphesthesia
Description
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.
Time Frame
Baseline and Week 3
Title
Assessment of Tactile Localization Sense
Description
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.
Time Frame
Baseline and Week 3
Title
Assessment of Tactile Inattention
Description
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.
Time Frame
Baseline and Week 3
Secondary Outcome Measure Information:
Title
Assessment Of Cognitive Level
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Eksen Sağlık
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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

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