NCT05518058

Brief Summary

my study aims to apply treatment program for postural instability in stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

June 5, 2025

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

August 24, 2022

Last Update Submit

June 3, 2025

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Postural stability

    biodex balance system

    2 months

Secondary Outcomes (1)

  • dynamic balance

    2 months

Study Arms (2)

Control group

EXPERIMENTAL

strengthening exercises program plus balance exercises program

Other: device and exercises

Study group

EXPERIMENTAL

strengthening exercises program plus balance exercises program conducted with EMG triggered FES

Other: device and exercises

Interventions

device and exercisesOTHER

strengthening exercises plus balance training program conducted with type of functional electrical stimulation for muscles

Also known as: therapeutic exercises program / EMG triggered FES device
Control groupStudy group

Eligibility Criteria

Age45 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • stroke patients
  • normal body mass index
  • mild spasticity

You may not qualify if:

  • musculoskeletal deformities
  • cognitive abnormalities
  • cardiovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hend Elsharkawy

Damietta, Texas, 002, Egypt

Location

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Assistant lecturer

Study Record Dates

First Submitted

August 24, 2022

First Posted

August 26, 2022

Study Start

November 1, 2021

Primary Completion

March 30, 2023

Study Completion

April 30, 2023

Last Updated

June 5, 2025

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
after 12 months from publication

Locations

EG(1)