Transcranial Direct Current Stimulation vs Pilates Core Training in Stroke

NCT06312306 | Recruiting

• 1 other identifier: TDCS vs pilates in stroke
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebrovascular Accident

Keywords

stroke; tDCS; core training; pilates; gait; balance

Outcome Measures

Primary Outcomes (2)

• Gait kinematics

  Gait video will be recorded by a high-definition digital camera, and analysis will be done by Kinovea 2D motion analysis software

  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.

  6 weeks

Secondary Outcomes (1)

• Stroke Impact Scale (SIS)

  6 weeks

Study Arms (3)

Transcranial direct current stimulation (tDCS) group

EXPERIMENTAL

Anodal tDCS applied using a DC stimulator

Device: transcranial direct current stimulation; Other: conventional physiotherapy program

pilates based core training group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

Will receive conventional physiotherapy program

Other: conventional physiotherapy program

Interventions

transcranial direct current stimulation 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)

Transcranial direct current stimulation (tDCS) group

Pilates based core training 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.

pilates based core training group

conventional physiotherapy program 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

Transcranial direct current stimulation (tDCS) group; control group; pilates based core training group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therpay cairo university

Dokki, Giza Governorate, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Aisha Saleh

  Cairo University

  PRINCIPAL INVESTIGATOR

• Hussein Shaker, Professor

  cairo univeristy

  STUDY DIRECTOR

• Ebtesam Fahmy, Professor

  Cairo University

  STUDY DIRECTOR

• Mohamed Helayel, lecturer

  cairo univeristy

  STUDY CHAIR

Central Study Contacts

Aisha Saleh

CONTACT

+201020234593; ayshasaleh608@hotmail.com

Hussein Shaker, Professor

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc. in Physical Therapy

Study Record Dates

• First Submitted: February 24, 2024
• First Posted: March 15, 2024
• Study Start: February 25, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Locations

EG (1)