Comparison of the Effects of Cycling FES and Conservative Rehabilitation Therapy on Stroke Patients

NCT05667025 | Completed

• 1 other identifier: AIBU-FTR-SK-05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of the effects of cycling functional electrical stimulation and conservative rehabilitation therapy on the functional status and muscle characteristics of stroke patients

Conditions

Hemiplegia

Outcome Measures

Primary Outcomes (6)

• Berg Balance Scale

  The BBS is used to objectively determine a patient's ability to balance safely during a predetermined set of tasks. The scale comprises 14 items. Each item receives a score ranging from 0 to 4, which is a five-point rank scale with 0 indicating the lowest level of functioning and 4 indicating the highest level of functioning

  Before Treatment

• Berg Balance Scale

  The BBS is used to objectively determine a patient's ability to balance safely during a predetermined set of tasks. The scale comprises 14 items. Each item receives a score ranging from 0 to 4, which is a five-point rank scale with 0 indicating the lowest level of functioning and 4 indicating the highest level of functioning

  6 Week After Treatment

• Functional Ambulation Scale

  Functional Ambulation Scale is a 6-point functional walking test that evaluates ambulation ability and determines the amount of human support required by patients while walking, regardless of whether they use a personal assistive device. A score of 0 indicates that the patient has a dysfunctional ambulation A score of 5 denotes independent ambulation on any surface.

  Before Treatment

• Functional Ambulation Scale

  Functional Ambulation Scale is a 6-point functional walking test that evaluates ambulation ability and determines the amount of human support required by patients while walking, regardless of whether they use a personal assistive device. A score of 0 indicates that the patient has a dysfunctional ambulation A score of 5 denotes independent ambulation on any surface.

  6 Week After Treatment

• Brunnstrom Stages

  Brunnstrom stages is a scale used to assess motor recovery after a stroke, which is expressed using values between 1 and 6. The higher the value on this scale, the higher would be the recovery.

  Before Treatment

• Brunnstrom Stages

  Brunnstrom stages is a scale used to assess motor recovery after a stroke, which is expressed using values between 1 and 6. The higher the value on this scale, the higher would be the recovery.

  6 Week After Treatment

Secondary Outcomes (16)

• Barthel Index

  Before Treatment

• Barthel Index

  6 Week After Treatment

• Modified Ashworth Scale

  Before Treatment

• Modified Ashworth Scale

  6 Week After Treatment

• 6 min walking test

  Before Treatment

Study Arms (2)

Conservative Rehabilitation

ACTIVE COMPARATOR

Conservative Rehabilitation

Other: Conservative rehabilitation

Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

ACTIVE COMPARATOR

Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

Other: Conservative rehabilitation; Other: Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

Interventions

Conservative rehabilitation OTHER

Joint range of motion, strengthening, balance-coordination and stretching exercises included in the conservative physiotherapy program 5 days a week for a total of 6 weeks

Conservative Rehabilitation; Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation OTHER

In addition to conservative treatment, cycling FES to the affected lower extremity for 20 minutes, 3 days a week for 4 weeks. During the treatment, the patient will be seated on a chair and her feet will be fixed to the pedal with velcro tape, and the comfort during the treatment will be provided with calf supports.

Cycling Functional Electrical Stimulation in addition to Conservative Rehabilitation

Eligibility Criteria

• Age: 25 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be between the ages of 21-85.
• The time elapsed after stroke must be between 3-60 months.
• Patients must have had cerebrovascular disease for the first time.
• Patients' Functional Ambulation Scale grade ≤ 4
• Patients must be able to sit unsupported for 30 minutes and walk 6 meters with support or device.
• Patients' mini mental test score ≥ 24

You may not qualify if:

• Patients with peripheral nerve injury in the lower extremity
• Patients with a pacemaker or a pacemaker.
• Patients with severe spasticity of the lower extremities
• Patients with a history of more than one cerebrovascular disease
• Patients with a history of lower extremity fractures in the last 6 months
• Patients diagnosed with Parkinson, Multiple Sclerosis
• Patients with unstable cardiac pathology
• Patients' mini mental test score ≤ 24

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Serdar Kılınç

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 28, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: January 30, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

TU (1)