Trial Outcomes & Findings for Effects Of Sensory Training and Electrical Stimulation on Sole of The Foot Sensations in Patients With Acute Hemiplegia (NCT NCT04252092)
NCT ID: NCT04252092
Last Updated: 2020-10-22
Results Overview
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.
COMPLETED
NA
30 participants
Baseline and Week 3
2020-10-22
Participant Flow
Participant milestones
| Measure |
Sensory Group
15 patients who will be applied 15 sessions of sensory training
Sensory training: 15 session,20 minutes sensory training program
|
Electrical Stimulation Group
15 patients who will be applied 15 sessions of electrical stimulation
Electrical stimulation: 15 session,20 minutes electrical stimulation program
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sensory Group
n=15 Participants
15 patients who will be applied 15 sessions of sensory training
Sensory training: 15 session,20 minutes sensory training program
|
Electrical Stimulation Group
n=15 Participants
15 patients who will be applied 15 sessions of electrical stimulation
Electrical stimulation: 15 session,20 minutes electrical stimulation program
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=15 Participants
|
2 Participants
n=15 Participants
|
5 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=15 Participants
|
13 Participants
n=15 Participants
|
25 Participants
n=30 Participants
|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 7.2 • n=15 Participants
|
69.4 years
STANDARD_DEVIATION 8.3 • n=15 Participants
|
67.6 years
STANDARD_DEVIATION 7.75 • n=30 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=15 Participants
|
6 Participants
n=15 Participants
|
12 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=15 Participants
|
9 Participants
n=15 Participants
|
18 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 3Joint 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.
Outcome measures
| Measure |
Sensory Group
n=15 Participants
15 patients who will be applied 15 sessions of sensory training
Sensory training: 15 session,20 minutes sensory training program
|
Electrical Stimulation Group
n=15 Participants
15 patients who will be applied 15 sessions of electrical stimulation
Electrical stimulation: 15 session,20 minutes electrical stimulation program
|
|---|---|---|
|
Assessment Of Joint Position Sense
Baseline
|
5.0 correct responses
Standard Deviation 2.8
|
6.4 correct responses
Standard Deviation 3.0
|
|
Assessment Of Joint Position Sense
Week 3
|
8.1 correct responses
Standard Deviation 2.3
|
8.6 correct responses
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Baseline and Week 3Joint 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.
Outcome measures
| Measure |
Sensory Group
n=15 Participants
15 patients who will be applied 15 sessions of sensory training
Sensory training: 15 session,20 minutes sensory training program
|
Electrical Stimulation Group
n=15 Participants
15 patients who will be applied 15 sessions of electrical stimulation
Electrical stimulation: 15 session,20 minutes electrical stimulation program
|
|---|---|---|
|
Assesment of Joint Passive Motion Sense
Baseline
|
5.3 correct responses
Standard Deviation 2.3
|
6.8 correct responses
Standard Deviation 1.8
|
|
Assesment of Joint Passive Motion Sense
Week 3
|
8.4 correct responses
Standard Deviation 1.4
|
8.5 correct responses
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Baseline and Week 3Vibration 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.
Outcome measures
| Measure |
Sensory Group
n=15 Participants
15 patients who will be applied 15 sessions of sensory training
Sensory training: 15 session,20 minutes sensory training program
|
Electrical Stimulation Group
n=15 Participants
15 patients who will be applied 15 sessions of electrical stimulation
Electrical stimulation: 15 session,20 minutes electrical stimulation program
|
|---|---|---|
|
Assessment of Vibration Sense
Week 3
|
6.6 seconds
Standard Deviation 3.3
|
6.4 seconds
Standard Deviation 4.5
|
|
Assessment of Vibration Sense
Baseline
|
2.5 seconds
Standard Deviation 2.2
|
4.2 seconds
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: Baseline and Week 3Deep 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.
Outcome measures
| Measure |
Sensory Group
n=15 Participants
15 patients who will be applied 15 sessions of sensory training
Sensory training: 15 session,20 minutes sensory training program
|
Electrical Stimulation Group
n=15 Participants
15 patients who will be applied 15 sessions of electrical stimulation
Electrical stimulation: 15 session,20 minutes electrical stimulation program
|
|---|---|---|
|
Assesment of Deep Pain Sense
Baseline
|
66.7 percentage of positive results
Standard Deviation 4.5
|
53.3 percentage of positive results
Standard Deviation 4.5
|
|
Assesment of Deep Pain Sense
Week 3
|
13.3 percentage of positive results
Standard Deviation 3.2
|
6.7 percentage of positive results
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Baseline and Week 3Two-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.
Outcome measures
| Measure |
Sensory Group
n=15 Participants
15 patients who will be applied 15 sessions of sensory training
Sensory training: 15 session,20 minutes sensory training program
|
Electrical Stimulation Group
n=15 Participants
15 patients who will be applied 15 sessions of electrical stimulation
Electrical stimulation: 15 session,20 minutes electrical stimulation program
|
|---|---|---|
|
Assessment of Two-point Discrimination
Baseline
|
7.5 cm
Standard Deviation 2.6
|
6.9 cm
Standard Deviation 2.8
|
|
Assessment of Two-point Discrimination
Week 3
|
3.1 cm
Standard Deviation 1.2
|
3.6 cm
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Baseline and Week 3Graphesthesia 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.
Outcome measures
| Measure |
Sensory Group
n=15 Participants
15 patients who will be applied 15 sessions of sensory training
Sensory training: 15 session,20 minutes sensory training program
|
Electrical Stimulation Group
n=15 Participants
15 patients who will be applied 15 sessions of electrical stimulation
Electrical stimulation: 15 session,20 minutes electrical stimulation program
|
|---|---|---|
|
Assessment of Graphesthesia
Week 3
|
6.8 correct responses
Standard Deviation 1.8
|
5.7 correct responses
Standard Deviation 2.6
|
|
Assessment of Graphesthesia
Baseline
|
3.9 correct responses
Standard Deviation 1.9
|
3.1 correct responses
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: Baseline and Week 3Tactile 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.
Outcome measures
| Measure |
Sensory Group
n=15 Participants
15 patients who will be applied 15 sessions of sensory training
Sensory training: 15 session,20 minutes sensory training program
|
Electrical Stimulation Group
n=15 Participants
15 patients who will be applied 15 sessions of electrical stimulation
Electrical stimulation: 15 session,20 minutes electrical stimulation program
|
|---|---|---|
|
Assessment of Tactile Localization Sense
Baseline
|
6.3 correct responses
Standard Deviation 2.3
|
7.1 correct responses
Standard Deviation 1.9
|
|
Assessment of Tactile Localization Sense
Week 3
|
8.7 correct responses
Standard Deviation 1.5
|
8.8 correct responses
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: Baseline and Week 3Tactile 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.
Outcome measures
| Measure |
Sensory Group
n=15 Participants
15 patients who will be applied 15 sessions of sensory training
Sensory training: 15 session,20 minutes sensory training program
|
Electrical Stimulation Group
n=15 Participants
15 patients who will be applied 15 sessions of electrical stimulation
Electrical stimulation: 15 session,20 minutes electrical stimulation program
|
|---|---|---|
|
Assessment of Tactile Inattention
Baseline
|
60 percentage of positive results
Standard Deviation 6.5
|
26.7 percentage of positive results
Standard Deviation 6.5
|
|
Assessment of Tactile Inattention
Week 3
|
20 percentage of positive results
Standard Deviation 2.1
|
13.3 percentage of positive results
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: BaselineMini-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.
Outcome measures
| Measure |
Sensory Group
n=15 Participants
15 patients who will be applied 15 sessions of sensory training
Sensory training: 15 session,20 minutes sensory training program
|
Electrical Stimulation Group
n=15 Participants
15 patients who will be applied 15 sessions of electrical stimulation
Electrical stimulation: 15 session,20 minutes electrical stimulation program
|
|---|---|---|
|
Assessment Of Cognitive Level
|
23 score on a scale
Standard Deviation 2.9
|
22.9 score on a scale
Standard Deviation 4.1
|
Adverse Events
Sensory Group
Electrical Stimulation Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place