NCT06558721

Brief Summary

There are different methods in stroke rehabilitation. In addition to conventional techniques, functional electric stimulation with bicycle ergometer therapy and mirror therapy can be used. In this study, we will compare functional electric stimulation with bicycle ergometer therapy and mirror therapy in stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2023

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

Study Start

First participant enrolled

October 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
Last Updated

November 19, 2025

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

August 14, 2024

Last Update Submit

November 17, 2025

Conditions

Stroke

Keywords

StrokeLower ExtremityMirror TherapyFunctional Electric StimulationBicycle Ergometer

Outcome Measures

Primary Outcomes (1)

  • Fugl Meyer Lower Extremity Motor Subscale

    Before treatment (0. week), finishing time of treatment (6.week)

Secondary Outcomes (5)

  • Brunnstrom Staging

    Before treatment (0. week), finishing time of treatment (6.week)

  • Berg Balance Scale

    Before treatment (0. week), finishing time of treatment (6.week)

  • Functional Independence Measure - Motor Score

    Before treatment (0. week), finishing time of treatment (6.week)

  • Stroke Specific Quality of Life Scale

    Before treatment (0. week), finishing time of treatment (6.week)

  • Functional Ambulation Scale

    Before treatment (0. week), finishing time of treatment (6.week)

Study Arms (3)

Conventional Rehabilitation

ACTIVE COMPARATOR

Lower extremity conventional rehabilitation in stroke patients

Other: Conventional rehabilitation

Conventional Rehabilitation + Mirror Therapy

ACTIVE COMPARATOR

Mirror therapy in addition to conventional rehabilitation of the lower extremity in stroke patients

Other: Conventional rehabilitationOther: Mirror therapy

Conventional Rehabilitation + Bicycle Ergometer with Functional Electric Stimulation

ACTIVE COMPARATOR

Bicycle Ergometer with Functional Electric Stimulation Therapy in addition to conventional rehabilitation of the lower extremity in stroke patients

Other: Conventional rehabilitationDevice: Bicycle ergometer with functional electric stimulation

Interventions

Conventional rehabilitationOTHER

Lower extremity conventional rehabilitation in stroke patients

Conventional RehabilitationConventional Rehabilitation + Bicycle Ergometer with Functional Electric StimulationConventional Rehabilitation + Mirror Therapy
Mirror therapyOTHER

Mirror therapy of the lower extremity in stroke patients

Conventional Rehabilitation + Mirror Therapy
Bicycle ergometer with functional electric stimulationDEVICE

Bicycle ergometer with functional electric stimulation therapy of the lower extremity in stroke patients

Conventional Rehabilitation + Bicycle Ergometer with Functional Electric Stimulation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age
  • Unilateral stroke
  • First time stroke
  • Time after stroke less than 6 months
  • Lower extremity Brunnstrom stage: 2-4
  • Lower extremity spasticity Modified Ashworth Scale: less than 3
  • Patient with sitting balance
  • Mini Mental Test Score higher than 23
  • Patients signed approval form

You may not qualify if:

  • Bilateral stroke
  • Neurological disease other than stroke
  • Psychiatric disease
  • Lower extremity orthopedic problem
  • Visual or audience problem
  • Neglect
  • Severe aphasia
  • Contraindications of electrical stimulation (cardiac implantation etc.)
  • Severe comorbidity (cardiac failure etc.)
  • Seizure
  • Acute deep vein thromboembolism
  • Local infection
  • Botulinum toxin injection of lower extremity less than 3 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Training and Research Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Engin Koyuncu, Prof. Dr.

    Gaziler Physical Therapy and Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist. Dr.

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 19, 2024

Study Start

October 1, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

November 19, 2025

Record last verified: 2024-08

Locations

TU(1)