Clinical trial NCT06312306: Transcranial Direct Current Stimulation vs Pilates Core Training in Stroke
Official title: Effect of Transcranial Direct Current Stimulation Versus Pilates Based Core Stability Training on Balance and Gait in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Cerebrovascular Accident
Keywords: stroke
tDCS
core training
pilates
gait
balance
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effects of transcranial direct current stimulation and pilates based core stability training on gait and balance in stroke patients. The main question\[s\] it aims to answer are:

* is there an effect of transcranial direct current stimulation and pilates based core training on gait and balance
* Is there a significant effect of tDCS over Pilates-based core training

Participants will be assigned to three groups:

* Group 1: will receive 18 sessions(3 sessions/week 20 minutes each) of anodal tDCS in addition to conventional physical therapy exercises
* Group 2: Will receive 18 Pilates exercise sessions over a period of 6 weeks (3 sessions / week) in addition to conventional physical therapy exercises.
* Group 3: Will receive conventional physiotherapy program

Researchers will compare the transcranial direct current stimulation group with the pilates exercise group to see if one of them is superior to the other on balance and gait.

Detailed description: The ultimate goal for rehabilitation is to enhance functional performance in various essential real life activities. There is a need for a more effective, cost-efficient treatments for balance and gait in stroke patients. Many studies have reported that Pilates exercise has positive effects in development of muscular strength, endurance, flexibility, and in prevention of falls in elderly population and in orthopedic rehabilitation. However, there are only a few studies available with Pilates as intervention in neurological conditions such as multiple sclerosis, Parkinson's disease and stroke. This study aims to evaluate the efficacy of Pilates exercise on balance, in post stroke survivors and thereby provide an evidence for further studies in neurological conditions. Transcranial direct current stimulation(tDCS) is a promising noninvasive neuromodulatory intervention that aims to maximize recovery of function after stroke. There are numerous arguments to suggest that tDCS may become interesting tools to promote gait and balance improvement in stroke patients. The ability of these techniques to modulate cortical excitability was demonstrated. However, very few study has examined the effect of stimulating the SMA with tDCS on balance and gait performance. Motor learning is crucial in human daily life, both throughout the lifespan as well as for the recovery from a variety of neurological diseases. The ability of both exercise such as pilates and non invasive neuromodulation such as tDCS to modulate cortical excitability and therefore enhance motor learning has been demonstrated. Therefore, the aim of this study is to compare the effect of a Pilates-based core training program and tDCS over the supplementary motor area on balance and gait in stroke patients

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with either hemorrhagic or ischemic stroke for the first time, with an onset of more than eight weeks
* Their age should be 50-60 years old.
* Patients of a minor (1-4) to moderate (5-15) national institutes of health stroke scale (NIHSS) score.
* Sufficient cognitive ability to participate, as indicated by Mini-mental state examination score of 21 or higher.
* ambulatory before stroke
* ability to stand or walk with or without assistance
* mild to moderate spasticity (MAS scale less than grade 3)
* hemodynamically stable

Exclusion Criteria:

* History of seizures.
* Patients with Any medical metal devices incompatible with transcranial direct current stimulation (e.g. pacemaker).
* Bi-hemispheric or multifocal stroke.
* any other neurological pathology affecting balance (cerebellar or brain stem lesions, impaired vision, visual field defect or hemineglect)
* Premorbid neurological impairment prior to onset of stroke.
* Co-morbidities impairing the motor function such as fracture or deformity.
* Medically unstable.
* Mental and cognitive impairment.

Primary outcomes:
measure: Gait kinematics
timeFrame: 6 weeks
measure: The Biodex Balance System
timeFrame: 6 weeks
Secondary outcomes:
measure: Stroke Impact Scale (SIS)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Faculty of physical therpay cairo university
state: Giza
Study officials:
affiliation: Cairo University
name: Aisha Saleh
role: PRINCIPAL_INVESTIGATOR
affiliation: cairo univeristy
name: Hussein Shaker, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Ebtesam Fahmy, Professor
role: STUDY_DIRECTOR
affiliation: cairo univeristy
name: Mohamed Helayel, lecturer
role: STUDY_CHAIR
References: