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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04252092

Enrollment

Registered

2020-02-05

Start date

2020-02-17

Completion date

2020-08-25

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia, Stroke, Acute, Sensory Disorders

Keywords

Electrical stimulation, Sensory education, Sensory evaluation, Stroke, Proprioception

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.

Interventions

OTHERSensory training

15 session,20 minutes sensory training program

OTHERElectrical stimulation

15 session,20 minutes electrical stimulation program

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.
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.
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.

Secondary

Measure	Time frame	Description
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.

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

Arm	Count
Sensory Group 15 patients who will be applied 15 sessions of sensory training Sensory training: 15 session,20 minutes sensory training program	15
Electrical Stimulation Group 15 patients who will be applied 15 sessions of electrical stimulation Electrical stimulation: 15 session,20 minutes electrical stimulation program	15
Total	30

Baseline characteristics

Characteristic	Electrical Stimulation Group	Total	Sensory Group
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	13 Participants	25 Participants	12 Participants
Age, Categorical Between 18 and 65 years	2 Participants	5 Participants	3 Participants
Age, Continuous	69.4 years STANDARD_DEVIATION 8.3	67.6 years STANDARD_DEVIATION 7.75	65.8 years STANDARD_DEVIATION 7.2
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment Turkey	15 participants	30 participants	15 participants
Sex: Female, Male Female	6 Participants	12 Participants	6 Participants
Sex: Female, Male Male	9 Participants	18 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 0	0 / 0
other Total, other adverse events	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0

Outcome results

Primary

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.