StrokeNCT06312306
Transcranial Direct Current Stimulation vs Pilates Core Training in Stroke
A study testing transcranial direct current stimulation, Pilates based core training and conventional physiotherapy program in people with Stroke and Cerebrovascular Accident, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Stroke, Cerebrovascular Accident
- What is being tested?
- transcranial direct current stimulation, Pilates based core training and conventional physiotherapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hussein Shaker, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therpay cairo university
Dokki, Giza Governorate, 12613
Amal Abdel-Baky, Professor, +202 37617691, p.grad@pt.cu.edu.eg
About this study
Official title: 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
Read more
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.
Read the 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
- Being tested
- transcranial direct current stimulation, Pilates based core training, conventional physiotherapy program
- Keywords
- stroke, tDCS, core training, pilates, gait, balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
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)
Pilates based core trainingOther
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 programOther
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
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulation (tDCS) group | Experimental | Anodal tDCS applied using a DC stimulator Receives: 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 Receives: Other: Pilates based core training; Other: conventional physiotherapy program |
| control group | Active comparator | Will receive conventional physiotherapy program Receives: Other: conventional physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait kinematics
Gait video will be recorded by a high-definition digital camera, and analysis will be done by Kinovea 2D motion analysis software
Measured: 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.
Measured: 6 weeks
Secondary outcomes (1)
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start25 Feb 2024
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aisha Mohamed Khaled Ahmed Saleh, Cairo University
- Investigators
- Aisha Saleh, Principal investigator, Cairo UniversityHussein Shaker, Professor, Study director, cairo univeristyEbtesam Fahmy, Professor, Study director, Cairo UniversityMohamed Helayel, lecturer, Study chair, cairo univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312306
- Sponsor's protocol ID
- TDCS vs pilates in stroke
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Direct Current Stimulation Versus Pilates Based Core Stability Training on Balance and Gait in Stroke Patients
- ClinicalTrials.gov ID
- NCT06312306
- Acronym / sponsor ID
- TDCS vs pilates in stroke
- Conditions
- Stroke, Cerebrovascular Accident
- Keywords
- stroke, tDCS, core training, pilates, gait, balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation (tDCS) group | Experimental | Device: transcranial direct current stimulation, Other: conventional physiotherapy programAnodal tDCS applied using a DC stimulator |
| pilates based core training group | Experimental | Other: Pilates based core training, Other: conventional physiotherapy programThe Pilates training program will last 30 min per session. The selected exercises will be given to all patients and progressed week-wise |
| control group | Active comparator | Other: conventional physiotherapy programWill receive conventional physiotherapy program |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationAnodal 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) | Device | Transcranial direct current stimulation (tDCS) group |
| Pilates based core trainingThe 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. | Other | pilates based core training group |
| conventional physiotherapy programConventional 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 | Transcranial direct current stimulation (tDCS) group, control group, pilates based core training group |
Primary outcome
Gait kinematics
Time frame: 6 weeks
Gait video will be recorded by a high-definition digital camera, and analysis will be done by Kinovea 2D motion analysis software
The Biodex Balance System
Time frame: 6 weeks
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.
1 secondary outcome
Stroke Impact Scale (SIS)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hussein Shaker, Professor contact
Aisha Saleh principal investigator
Cairo University
Hussein Shaker, Professor study director
cairo univeristy
Ebtesam Fahmy, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation, Pilates based core training and conventional physiotherapy program in people with Stroke and Cerebrovascular Accident, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aisha Saleh (+201020234593, ayshasaleh608@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait kinematics (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.