FES-Assisted Upper Extremity Ergometer Training in Subacute Stroke (FES-UE-EX)

March 16, 2026 updated by: Ankara City Hospital Bilkent

The Effect of Functional Electrical Stimulation-Assisted Upper Extremity Ergometer Training on Aerobic Capacity and Upper Extremity Function in Patients With Subacute Stroke

Stroke is a leading cause of long-term disability and often results in impaired upper extremity function and reduced aerobic capacity. Improving both cardiovascular and function is an important goal in stroke rehabilitation.

This study aims to compare the effects of conventional rehabilitation combined with upper extremity ergometer training versus conventional rehabilitation combined with functional electrical stimulation (FES)-assisted upper extremity ergometer training in patients with subacute stroke.

A total of 24 patients with subacute stroke will be randomly assigned to one of two groups using the sealed envelope method. Both groups will receive conventional rehabilitation. In addition, one group will perform upper extremity ergometer training, while the other group will perform FES-assisted upper extremity ergometer training. The interventions will be applied for 30 minutes per session, for a total of 10 sessions completed over approximately four weeks.

Participants will be evaluated before and after the intervention period. Primary outcomes include aerobic capacity assessed by cardiopulmonary exercise testing and upper extremity motor function. Secondary outcomes include upper extremity strength, sensory function, functional status, and activities of daily living.

The results of this study may help determine whether adding FES-assisted upper extremity ergometer training to conventional rehabilitation provides additional benefits in improving aerobic capacity and upper extremity function in patients with subacute stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke frequently leads to persistent upper extremity motor impairment and reduced aerobic capacity, which negatively affect functional independence and quality of life. In the subacute phase after stroke, rehabilitation interventions that simultaneously target motor recovery and cardiovascular fitness may improve overall functional outcomes.

This study is designed as a prospective, randomized trial conducted at a single center. A total of 24 patients aged 18-85 years with subacute stroke (≤6 months after stroke onset) and unilateral hemiplegia will be included. Eligible participants must be able to follow simple commands, have a Brunnstrom upper extremity stage between 1 and 5, and have a Modified Ashworth Scale score below 3.

Participants will be allocated into two groups using the sealed envelope method. Both groups will receive conventional rehabilitation consisting of range of motion exercises, strengthening exercises, stretching, neurophysiological exercises, balance and coordination training, and functional training, applied for 45 minutes per day, five days per week, for four weeks.

In addition to conventional rehabilitation, the first group will receive upper extremity ergometer training. The second group will receive functional electrical stimulation (FES)-assisted upper extremity ergometer training. In the FES-assisted group, surface electrodes will be placed on selected upper extremity muscles according to individual needs, including wrist extensors with triceps brachii or wrist flexors with biceps brachii. Electrical stimulation will be synchronized with the ergometer cycling movement.

Upper extremity ergometer and FES-assisted ergometer training will be applied for 30 minutes per session, three days per week, for approximately four weeks, resulting in a total of 10 sessions. All interventions will be supervised by trained health care professionals.

Participants will be evaluated at baseline (before the intervention) and at the end of the 10 session intervention period. Primary outcome measures include aerobic capacity assessed by cardiopulmonary exercise testing and upper extremity motor function. Secondary outcome measures include upper extremity strength, sensory function, functional ambulation, functional independence, and activities of daily living.

The findings of this study are expected to provide evidence regarding the effectiveness of adding FES-assisted upper extremity ergometer training to conventional rehabilitation in improving aerobic capacity and upper extremity function in patients with subacute stroke.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inclusion Criteria:
  • Age between 18 and 85 years
  • Diagnosis of subacute stroke (≤6 months after stroke onset)
  • Ischemic or hemorrhagic stroke confirmed by imaging
  • Unilateral hemiplegia affecting the upper extremity
  • Brunnstrom upper extremity motor recovery stage between 1 and 5
  • Modified Ashworth Scale score <3 in the affected upper extremity
  • Ability to follow simple verbal commands and cooperate with assessments
  • Medically stable and able to participate in an exercise-based rehabilitation program
  • Voluntary agreement to participate in the study and provision of written informed consent

Exclusion Criteria:

  • Severe cognitive impairment or communication disorder preventing cooperation
  • Severe cardiopulmonary disease or other medical conditions contraindicating exercise testing or training
  • Uncontrolled hypertension or cardiac arrhythmia
  • Severe musculoskeletal disorders of the upper extremity limiting participation in ergometer training
  • Presence of implanted electronic devices (e.g., pacemaker) contraindicating functional electrical stimulation
  • History of epilepsy or uncontrolled seizures
  • Severe spasticity (Modified Ashworth Scale ≥3)
  • Participation in another interventional study during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Upper Extremity Ergometer Training
Participants receive conventional rehabilitation combined with upper extremity ergometer training.
Other: Upper Extremity Ergometer Training
Upper extremity ergometer training is applied for 30 minutes per session, for a total of 10 sessions over approximately four weeks, in addition to conventional rehabilitation. The training is performed using an upper extremity ergometer in a seated position under supervision.
Experimental: FES-Assisted Upper Extremity Ergometer Training
Participants receive conventional rehabilitation combined with functional electrical stimulation (FES)-assisted upper extremity ergometer training.
Other: FES-Assisted Upper Extremity Ergometer Training
Functional electrical stimulation (FES)-assisted upper extremity ergometer training is applied for 30 minutes per session, for a total of 10 sessions completed over approximately four weeks, in addition to conventional rehabilitation. Surface electrical stimulation is synchronized with the ergometer movement and applied to selected upper extremity muscles according to individual needs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aerobic Capacity
Time Frame: aseline and at the end of the 4 week (10 session) intervention period
Aerobic capacity will be assessed using cardiopulmonary exercise testing by measuring peak oxygen consumption (VO2max).
aseline and at the end of the 4 week (10 session) intervention period
Upper Extremity Motor Function
Time Frame: Baseline and at the end of the 4 week (10 session) intervention period
Upper extremity motor function will be evaluated using the Brunnstrom Motor Evaluation..
Baseline and at the end of the 4 week (10 session) intervention period
Upper Extremity Motor Function
Time Frame: Baseline and at the end of the 4 week (10 session) intervention period
Upper extremity motor function will be evaluated using the Fugl-Meyer Motor Assessment.
Baseline and at the end of the 4 week (10 session) intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper Extremity Muscle Strength
Time Frame: Baseline and at the end of the 4 week (10 session) intervention period
Grip strength of the unaffected upper extremity will be measured using a hand dynamometer.
Baseline and at the end of the 4 week (10 session) intervention period
Upper Extremity Sensory Function
Time Frame: Baseline and at the end of the 4 week (10 session) intervention period
Sensory function will be assessed using the Erasmus MC Nottingham Sensory Assessment.
Baseline and at the end of the 4 week (10 session) intervention period
Functional Independence
Time Frame: Baseline and at the end of the 4 week (10 session) intervention period
Functional independence in activities of daily living will be assessed using the Modified Barthel Index.
Baseline and at the end of the 4 week (10 session) intervention period
Health-Related Quality of Life
Time Frame: Baseline and at the end of the 4 week (10 session) intervention period
Health-related quality of life will be assessed using the Nottingham Health Profile.
Baseline and at the end of the 4 week (10 session) intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2024

Primary Completion (Estimated)

March 20, 2026

Study Completion (Estimated)

March 26, 2026

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TABED 1-25-876

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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