Comparison Between Unihemispheric and Bihemispheric TCDS in Subacute Ischemic Stroke Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hemiparesis
- Hemiplegia
- Hemiplegic Gait
- Motor Activity
- Spastic
- Spasticity, Muscle
- Stroke Acute
- Stroke Ischemic
- Stroke, Lacunar
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will participate into the study, each patient will undergo a detailed neurological examination through filling out a medical sheet questionnaire and checking the most common risk factors of stroke and other parameters. ActivaDose tDCS (USA), the only FDA cleared device available for tDCS will be used in the clinical study. Fifty-four patients will be allocated randomly into three group.Masking: Double (Participant, Outcomes Assessor)Masking Description: Double (Participant, Outcomes Assessor) To make sure that no bias should enter the assessment of the results, neither the patient nor the external assessor will be aware whether active tDCS will be applicated to a particular case. The patients don't know if which group they are participated in, bihemispheric, unihemispheric, of sham group, external assessor was recruited to assess patients after the intervention ended.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Despite the central origin of stroke affecting the primary motor cortex M1, majority of the rehabilitative techniques of physical therapy and occupational therapy practice depending peripheral methods for gaining motor functions. There is a great need to develop methods in order to improve the outco...
Despite the central origin of stroke affecting the primary motor cortex M1, majority of the rehabilitative techniques of physical therapy and occupational therapy practice depending peripheral methods for gaining motor functions. There is a great need to develop methods in order to improve the outcome of physical or medical rehabilitation and enhance long-term functional outcome. Many researches' work over the past several years have inspected the use of transcranial direct current stimulation (tDCS) to promote the advantageous effect of neurological rehabilitation. The aim of This study Is to compare between the effect of unihemispheric and bihemispheric tDCS on the motor outcome, and spasticity in sub-acute ischemic stroke patients. Thirty sub-acute ischemic stroke patients participated in the study, randomly assigned to one of three groups-tDCS bihemispheric or unihemispheric or sham group. Those patients had stroke in the last 3 months at maximum with NIH stroke score less than 25. ActivaDose tDCS (USA), the only FDA cleared device available for tDCS used in the clinical study to deliver noninvasive brain stimulation, consisted of 20 minutes of 2 mA in each session for twelve sessions three sessions per week. All participants received physiotherapy and rehabilitation therapy was tailored to meet all patients' deficits, and lasted a total of 45 minutes per day, 3 days per week for four weeks.
Tracking Information
- NCT #
- NCT04770363
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nema Mohamed, PHD Prof Faculty of Science - Alexandria University
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