Effect of Russian Current Stimulation for Anterior Tibial Group on Postural Stability and Risk of Falling in Patients With Stroke

NCT ID: NCT06793865

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2025-02-10

Brief Summary

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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

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Russian Current Stimulation + selected physical therapy exercise

Patients received Russian current stimulation for 20 minutes and physical therapy for 40 minutes, 3 times/week for 6 weeks.

Group Type EXPERIMENTAL

Russian Current Stimulation for Anterior Tibial Group

Intervention Type OTHER

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.

Selected physical therapy exercise for both limbs

Intervention Type OTHER

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.

Placebo Russian Current Stimulation + selected physical therapy exercise

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.

Group Type PLACEBO_COMPARATOR

Placebo Russian Current Stimulation for Anterior Tibial Group

Intervention Type OTHER

Placebo Russian current stimulation was applied to the anterior tibial group without active current for 20 minutes.

Selected physical therapy exercise for both limbs

Intervention Type OTHER

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.

Interventions

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Russian Current Stimulation for Anterior Tibial Group

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.

Intervention Type OTHER

Placebo Russian Current Stimulation for Anterior Tibial Group

Placebo Russian current stimulation was applied to the anterior tibial group without active current for 20 minutes.

Intervention Type OTHER

Selected physical therapy exercise for both limbs

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Abdelrahman Refaat Mohamed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hoda Mohamed Zakaria, PhD

Role: STUDY_CHAIR

Professor, Cairo University

Locations

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Deraya University

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Abdelrahman Refaat Mohamed, B.Sc

Role: CONTACT

01069278792

Hoda Mohamed Zakaria, PhD

Role: CONTACT

Facility Contacts

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Abdelrahman Refaat Mohamed, B.Sc

Role: primary

01069278792

Other Identifiers

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P.T.REC/012/005504

Identifier Type: -

Identifier Source: org_study_id

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