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Effectiveness of Functional Electric Stimulation With Bicycle Ergometer and Mirror Therapy in Stroke Patients Lower Extremity

G

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status

Completed

Conditions

Stroke

Treatments

Device: Bicycle ergometer with functional electric stimulation
Other: Mirror therapy
Other: Conventional rehabilitation

Study type

Interventional

Funder types

Other

Identifiers

NCT06558721
E1-23-4032

Details and patient eligibility

About

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.

Full description

Aim of study is to compare functional electric stimulation with bicycle ergometer therapy and mirror therapy applied to lower extremity in stroke patients.

Enrollment

45 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18-85 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 3 patient groups

Conventional Rehabilitation
Active Comparator group
Description:
Lower extremity conventional rehabilitation in stroke patients
Treatment:
Other: Conventional rehabilitation
Conventional Rehabilitation + Mirror Therapy
Active Comparator group
Description:
Mirror therapy in addition to conventional rehabilitation of the lower extremity in stroke patients
Treatment:
Other: Conventional rehabilitation
Other: Mirror therapy
Conventional Rehabilitation + Bicycle Ergometer with Functional Electric Stimulation
Active Comparator group
Description:
Bicycle Ergometer with Functional Electric Stimulation Therapy in addition to conventional rehabilitation of the lower extremity in stroke patients
Treatment:
Other: Conventional rehabilitation
Device: Bicycle ergometer with functional electric stimulation

Trial contacts and locations

1

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Central trial contact

Muhammed Sefa Çınar, Asist. Dr.

Data sourced from clinicaltrials.gov

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