NCT06793865

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 21, 2025

Last Update Submit

January 21, 2025

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (2)

  • Berg balance scale

    6 weeks

  • Risk of falls index

    6 weeks

Study Arms (2)

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.

Other: Russian Current Stimulation for Anterior Tibial GroupOther: 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.

Other: Placebo Russian Current Stimulation for Anterior Tibial GroupOther: Selected physical therapy exercise for both limbs

Interventions

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.

Russian Current Stimulation + selected physical therapy exercise
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.

Placebo Russian Current Stimulation + selected physical therapy exercise
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.

Placebo Russian Current Stimulation + selected physical therapy exerciseRussian Current Stimulation + selected physical therapy exercise

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deraya University

Minya, Egypt

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hoda Mohamed Zakaria, PhD

    Professor, Cairo University

    STUDY CHAIR

Central Study Contacts

Abdelrahman Refaat Mohamed, B.Sc

CONTACT

01069278792abdelrahmanrefaat56@gmail.com

Hoda Mohamed Zakaria, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 27, 2025

Study Start

October 10, 2024

Primary Completion

February 10, 2025

Study Completion

February 10, 2025

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations

EG(1)