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NCT Number: NCT06793865

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deraya University

Minya, Egypt

Location status: Recruiting

Location contact

Abdelrahman Refaat Mohamed, B.Sc

CONTACT

[email protected]

01069278792

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Russian Current Stimulation for Anterior Tibial Group

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.

Placebo Russian Current Stimulation for Anterior Tibial Group

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Berg balance scale

    Time frame: 6 weeks

    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.

  2. Risk of falls index

    Time frame: 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Refaat Mohamed, B.Sc

CONTACT

[email protected]

01069278792

Hoda Mohamed Zakaria, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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