Transcranial Direct Current Stimulation vs Pilates Core Training in Stroke

NCT ID: NCT06312306

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-25
• Study Completion Date: 2024-09-30

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

Conditions

Stroke; Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Transcranial direct current stimulation (tDCS) group

Anodal tDCS applied using a DC stimulator

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

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)

conventional physiotherapy program

Intervention Type: OTHER

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

pilates based core training group

The Pilates training program will last 30 min per session. The selected exercises will be given to all patients and progressed week-wise

Group Type: EXPERIMENTAL

Pilates based core training

Intervention Type: OTHER

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

Intervention Type: OTHER

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

control group

Will receive conventional physiotherapy program

Group Type: ACTIVE_COMPARATOR

conventional physiotherapy program

Intervention Type: OTHER

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

Interventions

transcranial direct current stimulation

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)

Intervention Type: DEVICE

Pilates based core training

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.

Intervention Type: OTHER

conventional physiotherapy program

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aisha Mohamed Khaled Ahmed Saleh

M.Sc. in Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aisha Saleh

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Hussein Shaker, Professor

Role: STUDY_DIRECTOR

cairo univeristy

Ebtesam Fahmy, Professor

Role: STUDY_DIRECTOR

Cairo University

Mohamed Helayel, lecturer

Role: STUDY_CHAIR

cairo univeristy

Locations

Faculty of physical therpay cairo university

Dokki, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Aisha Saleh

Role: CONTACT

ayshasaleh608@hotmail.com

+201020234593

Hussein Shaker, Professor

Role: CONTACT

Hussein.abdel-rahman@pt.cu.edu.eg

Facility Contacts

Amal Abdel-Baky, Professor

Role: primary

p.grad@pt.cu.edu.eg

+202 37617691

Other Identifiers

TDCS vs pilates in stroke

Identifier Type: -

Identifier Source: org_study_id