Transcranial Direct Current Stimulation vs Pilates Core Training in Stroke

Effect of Transcranial Direct Current Stimulation Versus Pilates Based Core Stability Training on Balance and Gait in Stroke Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Cerebrovascular Accident
• Intervention / Treatment: Device: transcranial direct current stimulation; Other: conventional physiotherapy program; Other: Pilates based core training

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aisha Saleh; Phone Number: +201020234593; Email: ayshasaleh608@hotmail.com
• Study Contact Backup: Name: Hussein Shaker, Professor; Email: Hussein.abdel-rahman@pt.cu.edu.eg

Study Locations

• Egypt
  • Giza
    • Dokki, Giza, Egypt, 12613
      • Recruiting
      • Faculty of physical therpay cairo university
      • Contact: Amal Abdel-Baky, Professor; Phone Number: +202 37617691; Email: p.grad@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial direct current stimulation (tDCS) group; Anodal tDCS applied using a DC stimulator	Device: 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); 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
Experimental: 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	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; Other: 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.
Active Comparator: control group; Will receive conventional physiotherapy program	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Aisha Saleh, Cairo University; Study Director: Hussein Shaker, Professor, Cairo Univeristy; Study Director: Ebtesam Fahmy, Professor, Cairo University; Study Chair: Mohamed Helayel, lecturer, Cairo Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: February 24, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: tDCS; stroke; gait; balance; pilates; core training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: TDCS vs pilates in stroke

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No