StrokeNCT04611360
Anodal Transcranial Direct Current Stimulation on Mobility and Balance in Post Stroke Patients.
A study testing Anodal Transcranial Direct Current Stimulation Group and Conventional Training Exercises Group in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of anodal transcranial direct current stimulation on mobility and balance in post stroke patients. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Anodal Transcranial Direct Current Stimulation Group and Conventional Training Exercises Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2019to 30 Jul 2019
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with both ischemic and hemorrhagic stroke
- Subacute and chronic stroke patients(onset of stroke from 3 months to 1 year)
- Ambulatory stroke survivors were included who met the criteria of Modified Rankin Scale between 1 and 3
Who cannot join
- Patients with Modified Rankin Scale of 0 and 4-6.
- Brain tumors
- Cognitive impaired
- Known case of seizures
- Metal implant, head injury etc and other disorders which contraindicate the application of anodal transcranial direct current stimulations.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Railway General Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: Effects of Anodal Transcranial Direct Current Stimulation on Mobility and Balance in Post Stroke Patients.
To determine the effects of anodal transcranial direct current stimulation on mobility and balance in post stroke patients.
Read the detailed description
Stroke is characterised as sudden onset of neurological dysfunction of central anxious framework that contain cerebral infarction, intra cranial haemorrhage \& subarachnoid haemorrhage. Around the globe stroke is the chief cause of incapacity and passing.
The trans-cranial direct current stimulations (tDCS) could be a non-invasive,low cost and capable brain stimulator utilised within the treatment of brain disorders.Two modes of tDCS is utilised is stroke patients,anodal stimulation (increased in excitability) of the lesional half of the globe and cathodal stimulation (decreased in excitability) of the contralesional hemisphere. The transcranial direct current stimulation induced polarity-dependent changes in membrane excitability, with Anodal-tDCS causing depolarisation and cathodal-tDCS causing hyper polarization of membrane potential in neurons of the stimulated area.
The role of Trans-cranial Direct Current Stimulation as a catalyst of recovery in stroke population and found that it's a safe,portable,non invasive brain stimulation technique. T-DCS is able to modulate the excitability of specified brain areas by varying the neuronal membrane potentials that based on the polarity of the current transmitted through the scalp via sponge electrodes. Trans-cranial direct current stimulation is clinically potential for use in stroke recovery because of its ease of use, non invasive-ness and safety.
- Conditions
- Stroke
- Being tested
- Anodal Transcranial Direct Current Stimulation Group, Conventional Training Exercises Group
- Keywords
- Balance, Stroke, Anodal Transcranial Direct Current Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal Transcranial Direct Current Stimulation GroupOther
Experimental group were received anodal transcranial direct current stimulation and conventional training exercises for 3 days a weeks for 6 consecutive weeks on alternate days.
Anodal tDCS were given through:
- Anodal electrode:It has been placed over primary motor cortex(ipsilesional) ii. Cathodal electrode: It has been above contralateral eye. iii. Intensity: 2mA iv Density: 0.07C/cm2 iv. Duration:20 min vi Rectangular electrodes(25cm2 ) inserted in saline soaked sponge used
Conventional Training Exercises GroupOther
Conventional physical exercises were given for 3 days a week on alternate days upto 6 weeks. It includes: progressive Conventional Training Exercises : From Bridging,Sitting: weight-bearing, Standing: weight-bearing, Sit to stand, Squat exercises and Tandem walk.
| Study group | Role | What they receive |
|---|---|---|
| Anodal Transcranial Direct Current Stimulation Group | Experimental | Anodal Transcranial Direct Current Stimulation and Conventional training exercises Receives: Other: Anodal Transcranial Direct Current Stimulation Group |
| Conventional Training Exercises Group | Active comparator | Conventional Training Exercises : Bridging,Sitting: weight-bearing, Standing: weight-bearing, Sit to stand, Squat exercises and Tandem walk Receives: Other: Conventional Training Exercises Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale
It is commonly used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological disorders.The scale runs from 0-6,running from perfect no symptoms to death.The inter rater reliability of Modified Rankin Scale (MRS) for stroke is (0.95)
Measured: 6 week
Dynamic Gait Index
Dynamic Gait Index (DGI) was to evaluate functional stability in older people and to evaluate their risk of falling.Its a 4 point ordinal scale,ranging from 0-3, "0" indicates the lowest level of function and "3" indicates the highest level of function.The inter rater reliability of DGI for stroke is (0.96)
Measured: 6 week
10 Meter Walk Test
It is to be used for gait speed assesment.According this,individual walk without assistance 10 meters and the time is measured for the intermediate 6 meters. The reliability of 10 meter walk test is (0.97)
Measured: 6 week
Fugl Meyer function test:
Fugl Meyer Function (FMA) is used to assess voluntary movements,reflex activity,grasping and co-ordination of affected limb in stroke.It contain 33 task with a scale of 0-2 with maximum scoring of 66.The reliability of FMA scale is (0.95-1)
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start10 Jan 2019
- Primary completion10 Jun 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611360
- Sponsor's protocol ID
- Rec/00502 Sundus Akhtar
- Status last verified
- Oct 2020
- First submitted
- 26 Oct 2020
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rossi C, Sallustio F, Di Legge S, Stanzione P, Koch G. Transcranial direct current stimulation of the affected hemisphere does not accelerate recovery of acute stroke patients. Eur J Neurol. 2013 Jan;20(1):202-4. doi: 10.1111/j.1468-1331.2012.03703.x. Epub 2012 Mar 26.
PubMed 22448901Iosa M, Morone G, Fusco A, Bragoni M, Coiro P, Multari M, Venturiero V, De Angelis D, Pratesi L, Paolucci S. Seven capital devices for the future of stroke rehabilitation. Stroke Res Treat. 2012;2012:187965. doi: 10.1155/2012/187965. Epub 2012 Dec 13.
PubMed 23304640Fusco A, Iosa M, Venturiero V, De Angelis D, Morone G, Maglione L, Bragoni M, Coiro P, Pratesi L, Paolucci S. After vs. priming effects of anodal transcranial direct current stimulation on upper extremity motor recovery in patients with subacute stroke. Restor Neurol Neurosci. 2014;32(2):301-12. doi: 10.3233/RNN-130349.
PubMed 24398722
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anodal Transcranial Direct Current Stimulation on Mobility and Balance in Post Stroke Patients.
- ClinicalTrials.gov ID
- NCT04611360
- Acronym / sponsor ID
- Rec/00502 Sundus Akhtar
- Conditions
- Stroke
- Keywords
- Balance, Stroke, Anodal Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 2 Nov 2020 (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.
To determine the effects of anodal transcranial direct current stimulation on mobility and balance in post stroke patients.
Detailed description
Stroke is characterised as sudden onset of neurological dysfunction of central anxious framework that contain cerebral infarction, intra cranial haemorrhage \& subarachnoid haemorrhage. Around the globe stroke is the chief cause of incapacity and passing.
The trans-cranial direct current stimulations (tDCS) could be a non-invasive,low cost and capable brain stimulator utilised within the treatment of brain disorders.Two modes of tDCS is utilised is stroke patients,anodal stimulation (increased in excitability) of the lesional half of the globe and cathodal stimulation (decreased in excitability) of the contralesional hemisphere. The transcranial direct current stimulation induced polarity-dependent changes in membrane excitability, with Anodal-tDCS causing depolarisation and cathodal-tDCS causing hyper polarization of membrane potential in neurons of the stimulated area.
The role of Trans-cranial Direct Current Stimulation as a catalyst of recovery in stroke population and found that it's a safe,portable,non invasive brain stimulation technique. T-DCS is able to modulate the excitability of specified brain areas by varying the neuronal membrane potentials that based on the polarity of the current transmitted through the scalp via sponge electrodes. Trans-cranial direct current stimulation is clinically potential for use in stroke recovery because of its ease of use, non invasive-ness and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal Transcranial Direct Current Stimulation Group | Experimental | Other: Anodal Transcranial Direct Current Stimulation GroupAnodal Transcranial Direct Current Stimulation and Conventional training exercises |
| Conventional Training Exercises Group | Active comparator | Other: Conventional Training Exercises GroupConventional Training Exercises : Bridging,Sitting: weight-bearing, Standing: weight-bearing, Sit to stand, Squat exercises and Tandem walk |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting with both ischemic and hemorrhagic stroke
- Subacute and chronic stroke patients(onset of stroke from 3 months to 1 year)
- Ambulatory stroke survivors were included who met the criteria of Modified Rankin Scale between 1 and 3
Key exclusion criteria (5 listed)
- Patients with Modified Rankin Scale of 0 and 4-6.
- Brain tumors
- Cognitive impaired
- Known case of seizures
- Metal implant, head injury etc and other disorders which contraindicate the application of anodal transcranial direct current stimulations.
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 |
|---|---|---|
| Anodal Transcranial Direct Current Stimulation GroupExperimental group were received anodal transcranial direct current stimulation and conventional training exercises for 3 days a weeks for 6 consecutive weeks on alternate days. Anodal tDCS were given through: i. Anodal electrode:It has been placed over primary motor cortex(ipsilesional) ii. Cathodal electrode: It has been above contralateral eye. iii. Intensity: 2mA iv Density: 0.07C/cm2 iv. Duration:20 min vi Rectangular electrodes(25cm2 ) inserted in saline soaked sponge used | Other | Anodal Transcranial Direct Current Stimulation Group |
| Conventional Training Exercises GroupConventional physical exercises were given for 3 days a week on alternate days upto 6 weeks. It includes: progressive Conventional Training Exercises : From Bridging,Sitting: weight-bearing, Standing: weight-bearing, Sit to stand, Squat exercises and Tandem walk. | Other | Conventional Training Exercises Group |
Primary outcome
Modified Rankin Scale
Time frame: 6 week
It is commonly used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other neurological disorders.The scale runs from 0-6,running from perfect no symptoms to death.The inter rater reliability of Modified Rankin Scale (MRS) for stroke is (0.95)
Dynamic Gait Index
Time frame: 6 week
Dynamic Gait Index (DGI) was to evaluate functional stability in older people and to evaluate their risk of falling.Its a 4 point ordinal scale,ranging from 0-3, "0" indicates the lowest level of function and "3" indicates the highest level of function.The inter rater reliability of DGI for stroke is (0.96)
10 Meter Walk Test
Time frame: 6 week
It is to be used for gait speed assesment.According this,individual walk without assistance 10 meters and the time is measured for the intermediate 6 meters. The reliability of 10 meter walk test is (0.97)
Fugl Meyer function test:
Time frame: 6 week
Fugl Meyer Function (FMA) is used to assess voluntary movements,reflex activity,grasping and co-ordination of affected limb in stroke.It contain 33 task with a scale of 0-2 with maximum scoring of 66.The reliability of FMA scale is (0.95-1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Background: PubMed 22448901Rossi C, Sallustio F, Di Legge S, Stanzione P, Koch G. Transcranial direct current stimulation of the affected hemisphere does not accelerate recovery of acute stroke patients. Eur J Neurol. 2013 Jan;20(1):202-4. doi: 10.1111/j.1468-1331.2012.03703.x. Epub 2012 Mar 26.
- Background: PubMed 23304640Iosa M, Morone G, Fusco A, Bragoni M, Coiro P, Multari M, Venturiero V, De Angelis D, Pratesi L, Paolucci S. Seven capital devices for the future of stroke rehabilitation. Stroke Res Treat. 2012;2012:187965. doi: 10.1155/2012/187965. Epub 2012 Dec 13.
- Background: PubMed 24398722Fusco A, Iosa M, Venturiero V, De Angelis D, Morone G, Maglione L, Bragoni M, Coiro P, Pratesi L, Paolucci S. After vs. priming effects of anodal transcranial direct current stimulation on upper extremity motor recovery in patients with subacute stroke. Restor Neurol Neurosci. 2014;32(2):301-12. doi: 10.3233/RNN-130349.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Mirza Obaid Baig, MSPT principal investigator
Riphah International 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 Anodal Transcranial Direct Current Stimulation Group and Conventional Training Exercises Group in people with Stroke, run by Riphah International University at 1 site in Pakistan.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 2 Nov 2020. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (time frame: 6 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04611360, which also lists 3 linked publications.
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 2 Nov 2020.