StrokeNCT06793865
Effect of Russian Current Stimulation for Anterior Tibial Group on Postural Stability and Risk of Falling in Patients With Stroke
A study testing Russian Current Stimulation for Anterior Tibial Group and Selected physical therapy exercise for both limbs in people with Stroke, run by Cairo University at 1 site in Egypt.
Trial summary
This study aimed to examine the effect of Russian current stimulation on Anterior tibial group on postural stability and risk of falling in patients with stroke. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Stroke
- What is being tested?
- Russian Current Stimulation for Anterior Tibial Group and Selected physical therapy exercise for both limbs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2024to 10 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Forty patient with stroke manifest with weakness of anterior tibial group.
- Patients with moderate spasticity,
- Patient's ages ranged from 40-55 years.
- Patients BMI not exceed 30 kg/m².
- Medically and clinically stable patients.
Who cannot join
- Patients suffering from psychological, cognitive, or emotional disturbance.
- Patients with severe spasticity (3 or more by the modified Ashworth scale).
- Patients with atrial fibrillation.
- Patients with infectious processes.
- Patients with impaired pain sensitivity.
- Patients with epilepsy.
- Patients with lower limb joint endoprosthetics.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hoda Mohamed Zakaria, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Deraya University
Minya
Abdelrahman Refaat Mohamed, B.Sc, 01069278792, abdelrahmanrefaat56@gmail.com
About this study
This study aimed to examine the effect of Russian current stimulation on Anterior tibial group on postural stability and risk of falling in patients with stroke.
Read the detailed description
Stroke is the second leading cause of death globally and the main cause of disability, with ischemic strokes accounting for about 87% of cases. In 2010, over 11 million ischemic strokes occurred, predominantly in low and middle-income countries, leading to approximately three million deaths. Hemorrhagic strokes account for 13% of cases.
Egypt, with an estimated population of 85.5 million, has a high stroke prevalence of 963 per 100,000 inhabitants. Postural imbalance is a common limitation, affecting 83% of acute stroke patients, and falls are frequent across all stages of recovery, with rates as high as 73% within six months post-discharge. Even in chronic stroke patients, the fall risk remains elevated compared to age-matched controls. Postural imbalance impacts quality of life, and rehabilitation is vital for regaining independence in daily activities.
Up to 30% of stroke survivors experience significant permanent disabilities, and 20% require rehabilitation. Motor impairments, particularly in the lower limbs, limit daily activities, community participation, and quality of life. Poor lower-limb muscle performance affects balance, gait, and functionality, but interventions like Russian current have shown effectiveness in improving walking performance and motor recovery in chronic stroke survivors.
- Conditions
- Stroke
- Being tested
- Russian Current Stimulation for Anterior Tibial Group, Placebo Russian Current Stimulation for Anterior Tibial Group, Selected physical therapy exercise for both limbs
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Russian Current Stimulation for Anterior Tibial GroupOther
Parameters were adjusted as the following frequency of 2.5 kHz and 50 bursts per second with 50 pulses per burst. The stimulus was applied for a 10 seconds "on" period followed by a 10 seconds "off" period for total treatment time 20 minutes.
Placebo Russian Current Stimulation for Anterior Tibial GroupOther
Placebo Russian current stimulation was applied to the anterior tibial group without active current for 20 minutes.
Selected physical therapy exercise for both limbsOther
The selected physical therapy exercise for both limbs was applied for 40 minutes, including passive, active assisted and active range of motion exercises, stretching of spastic muscles, strengthening of weak muscles (anterior tibial group), and finally functional mobility exercises.
| Study group | Role | What they receive |
|---|---|---|
| Russian Current Stimulation + selected physical therapy exercise | Experimental | Patients received Russian current stimulation for 20 minutes and physical therapy for 40 minutes, 3 times/week for 6 weeks. Receives: Other: Russian Current Stimulation for Anterior Tibial Group; Other: Selected physical therapy exercise for both limbs |
| Placebo Russian Current Stimulation + selected physical therapy exercise | Placebo comparator | All patients in this group received Russian current for 20 minutes as placebo in addition to the same selected physical therapy exercise for both limbs for 40 minutes. Receives: Other: Placebo Russian Current Stimulation for Anterior Tibial Group; Other: Selected physical therapy exercise for both limbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static postural stability overall stability index (OST)
It was assessed for both groups through Biodex balance system. A training test was given to each patient followed by three consecutive tests in static mode. Each one lasted for 20 seconds with 10 seconds rest between each, changes were recorded in relation to the center of the platform, and the mean of three tests showing the postural fluctuations of women was automatically calculated by the device, and displayed on the screen of device.
Measured: 6 weeks
Secondary outcomes (2)
Berg balance scale
It was used to assess the balance for all patients in both groups. The scale consists of 14 items, scored from 0 to 4, which are added to make a total score between 0 and 56. A higher score indicates better balance. The items vary in difficulty, from sitting in a chair to standing on one leg.
Measured: 6 weeks
Risk of falls index
Risk of falls index of all patients in both groups was assessed through Biodex balance system. All patients in both groups were asked to bilaterally stand on the locked platform; then were asked to look in front to the screen that will adjusted according to their height, the hands were placed comfortably beside the body and they were advised to use the handles of the device in case of loss of balance and repeat the test from the beginning.
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 posted27 Jan 2025
- Study start10 Oct 2024
- Primary completion10 Feb 2025 (estimated)
- Study completion10 Feb 2025 (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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Refaat Mohamed, Cairo University
- Investigators
- Hoda Mohamed Zakaria, PhD, Study chair, Professor, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793865
- Sponsor's protocol ID
- P.T.REC/012/005504
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Russian Current Stimulation for Anterior Tibial Group on Postural Stability and Risk of Falling in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06793865
- Acronym / sponsor ID
- P.T.REC/012/005504
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 10 Feb 2025 (estimated)
- Study completion
- 10 Feb 2025 (estimated)
- First posted
- 27 Jan 2025 (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.
This study aimed to examine the effect of Russian current stimulation on Anterior tibial group on postural stability and risk of falling in patients with stroke.
Detailed description
Stroke is the second leading cause of death globally and the main cause of disability, with ischemic strokes accounting for about 87% of cases. In 2010, over 11 million ischemic strokes occurred, predominantly in low and middle-income countries, leading to approximately three million deaths. Hemorrhagic strokes account for 13% of cases.
Egypt, with an estimated population of 85.5 million, has a high stroke prevalence of 963 per 100,000 inhabitants. Postural imbalance is a common limitation, affecting 83% of acute stroke patients, and falls are frequent across all stages of recovery, with rates as high as 73% within six months post-discharge. Even in chronic stroke patients, the fall risk remains elevated compared to age-matched controls. Postural imbalance impacts quality of life, and rehabilitation is vital for regaining independence in daily activities.
Up to 30% of stroke survivors experience significant permanent disabilities, and 20% require rehabilitation. Motor impairments, particularly in the lower limbs, limit daily activities, community participation, and quality of life. Poor lower-limb muscle performance affects balance, gait, and functionality, but interventions like Russian current have shown effectiveness in improving walking performance and motor recovery in chronic stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Russian Current Stimulation + selected physical therapy exercise | Experimental | Other: Russian Current Stimulation for Anterior Tibial Group, Other: Selected physical therapy exercise for both limbsPatients received Russian current stimulation for 20 minutes and physical therapy for 40 minutes, 3 times/week for 6 weeks. |
| Placebo Russian Current Stimulation + selected physical therapy exercise | Placebo comparator | Other: Placebo Russian Current Stimulation for Anterior Tibial Group, Other: Selected physical therapy exercise for both limbsAll patients in this group received Russian current for 20 minutes as placebo in addition to the same selected physical therapy exercise for both limbs for 40 minutes. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Forty patient with stroke manifest with weakness of anterior tibial group.
- Patients with moderate spasticity,
- Patient's ages ranged from 40-55 years.
- Patients BMI not exceed 30 kg/m².
- Medically and clinically stable patients.
Key exclusion criteria (7 listed)
- Patients suffering from psychological, cognitive, or emotional disturbance.
- Patients with severe spasticity (3 or more by the modified Ashworth scale).
- Patients with atrial fibrillation.
- Patients with infectious processes.
- Patients with impaired pain sensitivity.
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 |
|---|---|---|
| Russian Current Stimulation for Anterior Tibial GroupParameters were adjusted as the following frequency of 2.5 kHz and 50 bursts per second with 50 pulses per burst. The stimulus was applied for a 10 seconds "on" period followed by a 10 seconds "off" period for total treatment time 20 minutes. | Other | Russian Current Stimulation + selected physical therapy exercise |
| Placebo Russian Current Stimulation for Anterior Tibial GroupPlacebo Russian current stimulation was applied to the anterior tibial group without active current for 20 minutes. | Other | Placebo Russian Current Stimulation + selected physical therapy exercise |
| Selected physical therapy exercise for both limbsThe selected physical therapy exercise for both limbs was applied for 40 minutes, including passive, active assisted and active range of motion exercises, stretching of spastic muscles, strengthening of weak muscles (anterior tibial group), and finally functional mobility exercises. | Other | Placebo Russian Current Stimulation + selected physical therapy exercise, Russian Current Stimulation + selected physical therapy exercise |
Primary outcome
Static postural stability overall stability index (OST)
Time frame: 6 weeks
It was assessed for both groups through Biodex balance system. A training test was given to each patient followed by three consecutive tests in static mode. Each one lasted for 20 seconds with 10 seconds rest between each, changes were recorded in relation to the center of the platform, and the mean of three tests showing the postural fluctuations of women was automatically calculated by the device, and displayed on the screen of device.
2 secondary outcomes
Berg balance scale
Time frame: 6 weeks
Risk of falls index
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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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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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.
Hoda Mohamed Zakaria, PhD contact
Hoda Mohamed Zakaria, PhD study chair
Professor, 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 Russian Current Stimulation for Anterior Tibial Group and Selected physical therapy exercise for both limbs in people with Stroke, 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman Refaat Mohamed, B.Sc (01069278792, abdelrahmanrefaat56@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static postural stability overall stability index (OST) (time frame: 6 weeks). 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 27 Jan 2025.