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The aim of the study is to test the effect of tDCS stimulation on upper and lower limb function in neurological patients and to reduce pain in gynaecological patients. And the impact of tDCS stimulation on patients' quality of life. Standardised questionnaires will be used for pre- and post-stimulation evaluation.
Neurological patients:
Main objective: The aim of the study is to see whether the use of tDCS stimulation incorporated into a rehabilitation programme in post-stroke patients and patients with spinal cord and nerve root dysfunction following neurosurgery and non-surgery will improve upper and lower limb function.
Specific aim: To test whether the application of 1, 5 or 10 tDCS stimulations is sufficient to achieve improvements in upper and lower limb function, taking into account the dominant limb.
Description of the study group
The study will include women and men after stroke and spinal cord and nerve root dysfunction admitted for rehabilitation after surgery and not qualified for surgery, as well as healthy subjects. Study participants will be aged between 20-90 years. Post-stroke subjects with spinal cord and nerve root dysfunction will undergo individual rehabilitation using the PNF (Proprioceptive Neuromuscular Facilitation, Polish for proprioceptive neuromuscular facilitation) neurophysiological method performing upper and lower limb patterns. Rehabilitation will last between one and three months. Inclusion criterion: impairments of upper and lower limb function. Exclusion criterion: no written consent to participate in the study. Due to the assessment to be carried out, participants will be divided into groups:
Methods used in the research:
For the purpose of the study to be conducted, the subjects will have an assessment of:
Completion of questionnaires, the questionnaires used are:
Planned procedures:
Gynaecology patients:
Exclusion criterion: use of treatment other than tDCS stimulation, no written consent to participate in the study.
Patients who do not consent to tDCS stimulation will be placed in the control group.
Gynaecological patients will be asked to complete anonymously standardised questionnaires before and after stimulation, i.e. after 3 or 5 or 10.
Age of female respondents 18-70
For the purpose of the study to be conducted, the subjects will have an assessment of:
body weight, body height, body composition using the Tanita BC-418 MA device before the start of the study, the subject stands barefoot on the electrodes in the shape of the foot, in his/her hand he/she also grasps the electrodes while being only in underwear and a measurement is taken, body composition indicators like BMI (Body Mass Index), muscle mass, fat mass, lean body mass and water content will be assessed, measured before the start of the study biomechanical and viscoelastic properties of the skin using the MyotonPRO: during the measurement the subject will be in a standing position, the limbs of the subject will be exposed, the skin of both upper limbs (arm and forearm) and lower limbs (thigh and shank) will be assessed, on the anterior, posterior, lateral and medial sides, measurement before and after the test,
Standardised questionnaires:
Planned procedures:
Planned use of research results It is planned to present the obtained results in the form of publications in punctuated scientific journals and at Polish and foreign scientific conferences/congresses/symposia. Upon completion of the research experiment, the research participants will receive the results of the research along with their interpretation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS stimulation | Experimental | The study group will have tDCS stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDSC stimulation | Other | tDCA stimulation not exceeding 2 mA |
|
| Measure | Description | Time Frame |
|---|---|---|
| body height using Tanita BC-418 MA device | height will be measured in centimeters | through study completion, an average of 1 year |
| biomechanical and viscoelastic properties of the skin using MyotonPRO | The tissue voltage will be measured in Hertz (Hz) | through study completion, an average of 1 year |
| postural stability using the stabilometric platform Koordynacja | the lower the frequency of anterior-posterior and medial-lateral swings, the better the stability | through study completion, an average of 1 year |
| upper limb reaction time using the Witty SEM Microgate device | the shorter the time in seconds measured with a stopwatch, the better the result, | through study completion, an average of 1 year |
| assessment of right and left limb compression strength (hand dynamometer) | test participants will be asked to grasp the dynamometer and clench their hands at maximum force for 5 seconds, the higher the value measured in kilograms, the greater the hand strength | through study completion, an average of 1 year |
| lower limb reaction time using the Balance Toutor MedTouch platform | the shorter the time expressed in seconds, the better the function of the upper limb | through study completion, an average of 1 year |
| tDCS stimulation |
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Neurological patients
Inclusion Criteria:
Exclusion Criteria:
Gynaecological patients
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Małgorzata Wójcik, PhD PT | Contact | +48(95) 72 79 100 | m.wojcik@awf-gorzow.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1Department of Physiotherapy, Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow Wlkp., 61-871 Poznan | Recruiting | Poznan | 61-871 | Poland |
When contacted by e-mail, when submitting a publication to a journal, editors often wish to send the raw data.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D013118 | Spinal Cord Diseases |
| D011843 | Radiculopathy |
| D004715 | Endometriosis |
| D004414 | Dyspareunia |
| D004412 | Dysmenorrhea |
| D011085 | Polycystic Ovary Syndrome |
| D010146 | Pain |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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the subject will be subjected to neuromodulation of the motor cortex, the treatment will be carried out in sitting position, the subject will have a cap on his head with electrodes attached, the treatment time will be 20-30 minutes, the maximum value of direct current will be 2 mA, the number of treatments will be 1, 3, 5 or 10 ( 5 or 10 treatments performed daily from Monday to Friday) in the afternoon
| through study completion, an average of 1 year |
| tapping test, reflex Flop test, Nine-Hole-Peg Test | before and after the neuromodulation, the shorter the time expressed in seconds, the better the hand performance | through study completion, an average of 1 year |
| questionnaire Rolland-Morris | maximum number of points 24, the higher the point value the higher the disability | through study completion, an average of 1 year |
| Barthel scale | maximum score 100, the higher the score the more independent the person is | through study completion, an average of 1 year |
| ASIS scale | maximum score 5, the higher the score the better the function | through study completion, an average of 1 year |
| Oswestry questionnaire | maximum score 50, the higher the score the greater the disability due to lumbosacral pain | through study completion, an average of 1 year |
| Neck Disability Index questionnaire | maximum score 50, the higher the score the greater the disability due to cervical pain | through study completion, an average of 1 year |
| Sexual Satisfaction Scale for Women questionnaire | Maximum score 55, the lower the score the lower the sexual satisfaction | through study completion, an average of 1 year |
| Female Sexual Function Index questionnaire | Maximum score 36, the lower the score the lower the sexual satisfaction | through study completion, an average of 1 year |
| IEF-5 male sex life assessment questionnaire | A score of 21 or less may indicate symptoms of penile erectile dysfunction | through study completion, an average of 1 year |
| Katz scale (ADL - Activities of Daily Living) | maximum score of 6 indicates preserved activities of daily living, lower scores indicate loss of function | through study completion, an average of 1 year |
| Lawton scale - IADL (basic activities of daily living) | The maximum number of points is 27, the lower the score indicates a reduction in everyday functions | through study completion, an average of 1 year |
| WHOQOL-BREF questionnaire | 130 points (this is the maximum number of points that can be obtained) if it is satisfactory quality of life, 26 points (this is the minimum number of points that can be obtained) if there is no satisfactory quality of life | through study completion, an average of 1 year |
| Insomnia Severity Index | maximum score of 28 indicating severity of insomnia symptoms, the lower the score the lower the insomnia symptoms | through study completion, an average of 1 year |
| body weight using Tanita BC-418 MA device | body weight will be measured in kilograms | through study completion, an average of 1 year |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |