An interventional study of Sensory training and Electrical stimulation in Hemiplegia, Stroke, Acute and Sensory Disorders, sponsored by Yeditepe University. Completed at 1 site in Turkey. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Yeditepe University · Not applicable, Interventional, and Treatment
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.
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.
374 studies on the registry are indexed under Hemiplegia; 83 are open to participants now.
This study's enrollment of 30 is below the median of 34 across 310 interventional studies indexed under Hemiplegia.
Browse Hemiplegia studies →Yeditepe University is the lead sponsor of 127 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
15 patients who will be applied 15 sessions of sensory training
Other: Sensory training
15 patients who will be applied 15 sessions of electrical stimulation
Other: Electrical stimulation
15 session,20 minutes sensory training program
15 session,20 minutes electrical stimulation program
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and Week 3
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.
Time frame: Baseline
| Milestone | Sensory Group | Electrical Stimulation Group |
|---|---|---|
| Started | 15 | 15 |
| Completed | 15 | 15 |
| Not completed | 0 | 0 |
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.
| correct responses | Sensory Group | Electrical Stimulation Group |
|---|---|---|
| Baseline | 5.0 ± 2.8 | 6.4 ± 3.0 |
| Week 3 | 8.1 ± 2.3 | 8.6 ± 2.1 |
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.
| correct responses | Sensory Group | Electrical Stimulation Group |
|---|---|---|
| Baseline | 5.3 ± 2.3 | 6.8 ± 1.8 |
| Week 3 | 8.4 ± 1.4 | 8.5 ± 1.3 |
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.
| seconds | Sensory Group | Electrical Stimulation Group |
|---|---|---|
| Baseline | 2.5 ± 2.2 | 4.2 ± 4.3 |
| Week 3 | 6.6 ± 3.3 | 6.4 ± 4.5 |
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.
| percentage of positive results | Sensory Group | Electrical Stimulation Group |
|---|---|---|
| Baseline | 66.7 ± 4.5 | 53.3 ± 4.5 |
| Week 3 | 13.3 ± 3.2 | 6.7 ± 2.1 |
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.
| cm | Sensory Group | Electrical Stimulation Group |
|---|---|---|
| Baseline | 7.5 ± 2.6 | 6.9 ± 2.8 |
| Week 3 | 3.1 ± 1.2 | 3.6 ± 1.6 |
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.
| correct responses | Sensory Group | Electrical Stimulation Group |
|---|---|---|
| Baseline | 3.9 ± 1.9 | 3.1 ± 1.4 |
| Week 3 | 6.8 ± 1.8 | 5.7 ± 2.6 |
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.
| correct responses | Sensory Group | Electrical Stimulation Group |
|---|---|---|
| Baseline | 6.3 ± 2.3 | 7.1 ± 1.9 |
| Week 3 | 8.7 ± 1.5 | 8.8 ± 1.0 |
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.
| percentage of positive results | Sensory Group | Electrical Stimulation Group |
|---|---|---|
| Baseline | 60 ± 6.5 | 26.7 ± 6.5 |
| Week 3 | 20 ± 2.1 | 13.3 ± 3.4 |
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.
| score on a scale | Sensory Group | Electrical Stimulation Group |
|---|---|---|
| Assessment Of Cognitive Level | 23 ± 2.9 | 22.9 ± 4.1 |
Collected over 4 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sensory Group | — | — | — |
| Electrical Stimulation Group | — | — | — |
| Age, Categorical(Participants) | Sensory Group | Electrical Stimulation Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 2 | 5 |
| >=65 years | 12 | 13 | 25 |
| Age, Continuous(years) | Sensory Group | Electrical Stimulation Group | Total |
|---|---|---|---|
| Mean | 65.8 ± 7.2 | 69.4 ± 8.3 | 67.6 ± 7.75 |
| Sex: Female, Male(Participants) | Sensory Group | Electrical Stimulation Group | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 9 | 9 | 18 |
| Race and Ethnicity Not Collected(Participants) | Sensory Group | Electrical Stimulation Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Sensory Group | Electrical Stimulation Group | Total |
|---|---|---|---|
| Turkey | 15 | 15 | 30 |
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Yeditepe University