NCT05251571

Brief Summary

The aim of the study is to compare the video-based balance coordination exercise program and the video-based conventional exercise program in patients with subacute stroke.

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 Aug 2022

Shorter than P25 for not_applicable stroke

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

First Submitted

Initial submission to the registry

January 31, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

January 31, 2022

Last Update Submit

April 1, 2023

Conditions

Keywords

StrokeTelerehabilitationBalanceCoordination

Outcome Measures

Primary Outcomes (3)

  • FES-I

    There are 16 items in FES-I that assess the fear of falling during daily activities. FES-I is scored from 0 to 64. Higher scores indicate higher concerns about falling.

    Change from Baseline FES-I at 6 weeks

  • ABC

    This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in the elderly with various levels of function. Higher scores indicate more confidence. ABC is scored from 0 to 100. Higher scores indicate higher function.

    Change from Baseline ABC at 6 weeks

  • SSEQ

    The 13-item SSEQ is used to measure participants' self-efficacy levels in performing daily functional activities and self-management. SSEQ is scored from 0 to 130. Higher scores indicate higher confidence.

    Change from Baseline SSEQ at 6 weeks

Secondary Outcomes (1)

  • TSQ

    Change from Baseline TSQ at 6 weeks

Study Arms (2)

Conventional Exercise Group with Telerehabilitation

ACTIVE COMPARATOR

Exercises such as muscle strengthening exercises applied to antigravity muscles, agonist antagonist spastic muscles, stretching exercises for spastic muscles, weight transfer will be applied, and a telerehabilitation platform will be used in the home exercise program.

Other: Conventional Exercise Group with Telerehabilitation

Balance Coordination Group with Telerehabilitation

EXPERIMENTAL

Sit and stand exercise from chair, standing posture, weight transfer to right and left extremities, stepping over obstacles, standing on one leg with support from the table, standing on two legs with support from the table, hip abduction with support from the table, extension, flexion, supported tandem walking exercises such as stepping on the stairs, standing functional stretches will be applied. Whatsapp application-based Telerehabilitation platform will be used to deliver the home exercise program.

Other: Balance Coordination Group with Telerehabilitation

Interventions

Exercises such as conventional muscle strengthening and stretching given with telerehabilitation are applied.

Conventional Exercise Group with Telerehabilitation

Functional muscle strengthening, stretching, balance and coordination exercises given with telerehabilitation are applied.

Balance Coordination Group with Telerehabilitation

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients aged 40 - 65 years
  • Having been diagnosed with stroke by a specialist physician and at least 3 months and maximum 6 months have passed since the diagnosis
  • No serious medical complications
  • Being able to understand verbal and visual commands
  • Getting at least 24 points on the mini mental state test
  • Able to walk at least 10 m without assistance using crutches or a walker
  • Having signed the consent form

You may not qualify if:

  • Situations that will prevent assessments or communication with the individual
  • Being on psychotropic medication
  • People with ataxia or any other cerebellar symptoms
  • Other problems that would preclude evaluation and/or treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Hospital Neurology Polyclinic

Izmir, Bornova, 35030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Mehmet Özkeskin, PhD

    Ege University

    PRINCIPAL INVESTIGATOR
  • İsmet Tümtürk, MSc

    Ege University

    PRINCIPAL INVESTIGATOR
  • Bedriye Karaman, MD

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 22, 2022

Study Start

August 1, 2022

Primary Completion

February 1, 2023

Study Completion

April 1, 2023

Last Updated

April 4, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations