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

NCT04252092 | Completed Results

• 1 other identifier: i79zrwdy
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia; Stroke, Acute; Sensory Disorders

Keywords

Electrical stimulation; Sensory education; Sensory evaluation; Stroke; Proprioception

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Assessment Of Cognitive Level

  Baseline

Study Arms (2)

Sensory Group

EXPERIMENTAL

15 patients who will be applied 15 sessions of sensory training

Other: Sensory training

Electrical Stimulation Group

EXPERIMENTAL

15 patients who will be applied 15 sessions of electrical stimulation

Other: Electrical stimulation

Interventions

Sensory training OTHER

15 session,20 minutes sensory training program

Sensory Group

Electrical stimulation OTHER

15 session,20 minutes electrical stimulation program

Electrical Stimulation Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Eksen Sağlık

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia; Stroke; Sensation Disorders

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Results Point of Contact

• Title: PT,Cansu Hayıroğlu
• Organization: Eksen Sağlık ve Rehabilitasyon

cansu5309@gmail.com

+905378405948

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: February 5, 2020
• Study Start: February 17, 2020
• Primary Completion: April 22, 2020
• Study Completion: August 25, 2020
• Last Updated: October 22, 2020
• Results First Posted: August 19, 2020

Record last verified: 2020-09

Locations

TU (1)