An interventional study of transcranial direct current stimulation and Pilates based core training in Stroke and Cerebrovascular Accident, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 50 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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:
Participants will be assigned to three groups:
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.
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
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
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Exclusion Criteria:
Anodal tDCS applied using a DC stimulator
Device: transcranial direct current stimulation · Other: conventional physiotherapy program
The Pilates training program will last 30 min per session. The selected exercises will be given to all patients and progressed week-wise
Other: Pilates based core training · Other: conventional physiotherapy program
Will receive conventional physiotherapy program
Other: conventional physiotherapy program
Anodal tDCS applied using a direct current stimulator and two saline-soaked electrodes. The anode electrodes will be positioned approximately 2 cm anterior to Cz according to the International 10/20 EEG System. The cathode will be positioned over the inion. Stimulation intensity will be at 2.0 milliampere (as suggested to achieve excitation in the lower limb motor cortex areas)
The Pilates training program will last 30 min per session, Each action in the training will be repeated eight times these actions are at beginner level, considering the characteristics of stroke patients. The selected exercises will be given to all patients and progressed week-wise.
Conventional physiotherapy program: * Stretching Slow sustained stretching of spastic muscles (generally hip flexors and adductors, knee extensors or flexors and ankle plantar flexors) * Strengthening Abdominals, lumbar spine extensors, hip flexors, extensors and abductors, knee extensors and flexors and ankle dorsi flexors * Gait training In level surface and in stairs
Gait kinematics
Gait video will be recorded by a high-definition digital camera, and analysis will be done by Kinovea 2D motion analysis software
Time frame: 6 weeks
The Biodex Balance System
The Biodex Balance System (BBS; Biodex Inc.) will be used to assess postural stability. The BBS measures, in degrees, the tilt about each axis during dynamic conditions and calculates a medial-lateral stability index, anterior-posterior stability index, and an overall stability index.
Time frame: 6 weeks
Stroke Impact Scale (SIS)
Quality of life was measured using the SIS Version 3.0 which is a 59 item self report scale designed to measure a person's perspective of the effect of stroke on quality of life. The SIS assesses eight domains: strength, hand function, activity of daily living, mobility, communication, emotion, memory and thinking, and participation. Each item was rated on a five point ordinal scale where five was "not difficult at all" to one which was "extremely difficult". Summative scores are generated for each domain and can range from 0 to 100
Time frame: 6 weeks
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Cairo University