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

• Sponsor: Yeditepe University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04252092
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.2
• Patients Per Site Per Month: 4.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiplegia; Stroke, Acute; Sensory Disorders	Other: Sensory training; Other: Electrical stimulation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel 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
• Actual Study Start Date: Feb 17, 2020
• Actual Primary Completion Date: Apr 22, 2020
• Actual Study Completion Date: Aug 25, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Assessment Of Joint Position Sense [Baseline and Week 3]

   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.

2. Assesment of Joint Passive Motion Sense [Baseline and Week 3]

   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.

3. Assessment of Vibration Sense [Baseline and Week 3]

   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.

4. Assesment of Deep Pain Sense [Baseline and Week 3]

   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.

5. Assessment of Two-point Discrimination [Baseline and Week 3]

   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.

6. Assessment of Graphesthesia [Baseline and Week 3]

   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.

7. Assessment of Tactile Localization Sense [Baseline and Week 3]

   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.

8. Assessment of Tactile Inattention [Baseline and Week 3]

   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

1. Assessment Of Cognitive Level [Baseline]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eksen Sağlık	Istanbul		Turkey

Sponsors and Collaborators

• Yeditepe University

Investigators

None specified.

Study Documents (Full-Text)

• Statistical Analysis Plan - Feb 17, 2020
• Informed Consent Form - Feb 17, 2020
• Study Protocol - Feb 17, 2020

More Information

Publications

None provided.

• Responsible Party: Yeditepe University
• ClinicalTrials.gov Identifier: NCT04252092
• Other Study ID Numbers: i79zrwdy
• First Posted: Feb 5, 2020
• Last Update Posted: Oct 22, 2020
• Last Verified: Sep 1, 2020

• 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: Stroke; Hemiplegia; Sensation Disorders

Study Results

Participant Flow

Arm/Group Title	Sensory Group	Electrical Stimulation Group
Arm/Group Description	15 patients who will be applied 15 sessions of sensory training Sensory training: 15 session,20 minutes sensory training program	15 patients who will be applied 15 sessions of electrical stimulation Electrical stimulation: 15 session,20 minutes electrical stimulation program
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Sensory Group	Electrical Stimulation Group	Total
Arm/Group Description	15 patients who will be applied 15 sessions of sensory training Sensory training: 15 session,20 minutes sensory training program	15 patients who will be applied 15 sessions of electrical stimulation Electrical stimulation: 15 session,20 minutes electrical stimulation program	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 20%	2 13.3%	5 16.7%
>=65 years	12 80%	13 86.7%	25 83.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.8 (7.2)	69.4 (8.3)	67.6 (7.75)
Sex: Female, Male (Count of Participants)
Female	6 40%	6 40%	12 40%
Male	9 60%	9 60%	18 60%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Turkey	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sensory Group	Electrical Stimulation Group
Arm/Group Description	15 patients who will be applied 15 sessions of sensory training Sensory training: 15 session,20 minutes sensory training program	15 patients who will be applied 15 sessions of electrical stimulation Electrical stimulation: 15 session,20 minutes electrical stimulation program
Measure Participants	15	15
Baseline	5.0 (2.8)	6.4 (3.0)
Week 3	8.1 (2.3)	8.6 (2.1)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sensory Group	Electrical Stimulation Group
Arm/Group Description	15 patients who will be applied 15 sessions of sensory training Sensory training: 15 session,20 minutes sensory training program	15 patients who will be applied 15 sessions of electrical stimulation Electrical stimulation: 15 session,20 minutes electrical stimulation program
Measure Participants	15	15
Baseline	5.3 (2.3)	6.8 (1.8)
Week 3	8.4 (1.4)	8.5 (1.3)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sensory Group	Electrical Stimulation Group
Arm/Group Description	15 patients who will be applied 15 sessions of sensory training Sensory training: 15 session,20 minutes sensory training program	15 patients who will be applied 15 sessions of electrical stimulation Electrical stimulation: 15 session,20 minutes electrical stimulation program
Measure Participants	15	15
Baseline	2.5 (2.2)	4.2 (4.3)
Week 3	6.6 (3.3)	6.4 (4.5)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sensory Group	Electrical Stimulation Group
Arm/Group Description	15 patients who will be applied 15 sessions of sensory training Sensory training: 15 session,20 minutes sensory training program	15 patients who will be applied 15 sessions of electrical stimulation Electrical stimulation: 15 session,20 minutes electrical stimulation program
Measure Participants	15	15
Baseline	66.7 (4.5)	53.3 (4.5)
Week 3	13.3 (3.2)	6.7 (2.1)

5. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sensory Group	Electrical Stimulation Group
Arm/Group Description	15 patients who will be applied 15 sessions of sensory training Sensory training: 15 session,20 minutes sensory training program	15 patients who will be applied 15 sessions of electrical stimulation Electrical stimulation: 15 session,20 minutes electrical stimulation program
Measure Participants	15	15
Baseline	7.5 (2.6)	6.9 (2.8)
Week 3	3.1 (1.2)	3.6 (1.6)

6. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sensory Group	Electrical Stimulation Group
Arm/Group Description	15 patients who will be applied 15 sessions of sensory training Sensory training: 15 session,20 minutes sensory training program	15 patients who will be applied 15 sessions of electrical stimulation Electrical stimulation: 15 session,20 minutes electrical stimulation program
Measure Participants	15	15
Baseline	3.9 (1.9)	3.1 (1.4)
Week 3	6.8 (1.8)	5.7 (2.6)

7. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sensory Group	Electrical Stimulation Group
Arm/Group Description	15 patients who will be applied 15 sessions of sensory training Sensory training: 15 session,20 minutes sensory training program	15 patients who will be applied 15 sessions of electrical stimulation Electrical stimulation: 15 session,20 minutes electrical stimulation program
Measure Participants	15	15
Baseline	6.3 (2.3)	7.1 (1.9)
Week 3	8.7 (1.5)	8.8 (1.0)

8. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sensory Group	Electrical Stimulation Group
Arm/Group Description	15 patients who will be applied 15 sessions of sensory training Sensory training: 15 session,20 minutes sensory training program	15 patients who will be applied 15 sessions of electrical stimulation Electrical stimulation: 15 session,20 minutes electrical stimulation program
Measure Participants	15	15
Baseline	60 (6.5)	26.7 (6.5)
Week 3	20 (2.1)	13.3 (3.4)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sensory Group	Electrical Stimulation Group
Arm/Group Description	15 patients who will be applied 15 sessions of sensory training Sensory training: 15 session,20 minutes sensory training program	15 patients who will be applied 15 sessions of electrical stimulation Electrical stimulation: 15 session,20 minutes electrical stimulation program
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	23 (2.9)	22.9 (4.1)

Adverse Events

Time Frame	4 Months
Adverse Event Reporting Description	No adverse effects has been found as this study is applied on the parts of the body that is not relevant to their vital signs.
Arm/Group Title	Sensory Group		Electrical Stimulation Group
Arm/Group Description	15 patients who will be applied 15 sessions of sensory training Sensory training: 15 session,20 minutes sensory training program		15 patients who will be applied 15 sessions of electrical stimulation Electrical stimulation: 15 session,20 minutes electrical stimulation program
All Cause Mortality
	Sensory Group		Electrical Stimulation Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Sensory Group		Electrical Stimulation Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Sensory Group		Electrical Stimulation Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.