StrokeFES-UE-EXNCT07484854
FES-Assisted Upper Extremity Ergometer Training in Subacute Stroke
A study testing Upper Extremity Ergometer Training and FES-Assisted Upper Extremity Ergometer Training in people with Stroke, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Upper Extremity Ergometer Training and FES-Assisted Upper Extremity Ergometer Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2024to 26 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
Banu E Savtok Güler, 905543691220, banuecesavtok@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Upper Extremity Ergometer Training, FES-Assisted Upper Extremity Ergometer Training
- Keywords
- stroke, Functional electrical stimulation, Aerobic capacity, Stroke rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Extremity Ergometer TrainingOther
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.
FES-Assisted Upper Extremity Ergometer TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Upper Extremity Ergometer Training | Active comparator | Participants receive conventional rehabilitation combined with upper extremity ergometer training. Receives: Other: Upper Extremity Ergometer Training |
| FES-Assisted Upper Extremity Ergometer Training | Experimental | Participants receive conventional rehabilitation combined with functional electrical stimulation (FES)-assisted upper extremity ergometer training. Receives: Other: FES-Assisted Upper Extremity Ergometer Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Capacity
Aerobic capacity will be assessed using cardiopulmonary exercise testing by measuring peak oxygen consumption (VO2max).
Measured: aseline and at the end of the 4 week (10 session) intervention period
Upper Extremity Motor Function
Upper extremity motor function will be evaluated using the Brunnstrom Motor Evaluation..
Measured: Baseline and at the end of the 4 week (10 session) intervention period
Upper Extremity Motor Function
Upper extremity motor function will be evaluated using the Fugl-Meyer Motor Assessment.
Measured: Baseline and at the end of the 4 week (10 session) intervention period
Secondary outcomes (4)
Upper Extremity Muscle Strength
Grip strength of the unaffected upper extremity will be measured using a hand dynamometer.
Measured: Baseline and at the end of the 4 week (10 session) intervention period
Upper Extremity Sensory Function
Sensory function will be assessed using the Erasmus MC Nottingham Sensory Assessment.
Measured: Baseline and at the end of the 4 week (10 session) intervention period
Functional Independence
Functional independence in activities of daily living will be assessed using the Modified Barthel Index.
Measured: Baseline and at the end of the 4 week (10 session) intervention period
Health-Related Quality of Life
Health-related quality of life will be assessed using the Nottingham Health Profile.
Measured: Baseline and at the end of the 4 week (10 session) intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start9 Dec 2024
- Primary completion20 Mar 2026 (estimated)
- Study completion26 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are allocated into two parallel groups using the sealed envelope method and receive different upper extremity ergometer-based interventions in addition to conventional rehabilitation.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484854
- Sponsor's protocol ID
- TABED 1-25-876
- Acronym
- FES-UE-EX
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Electrical Stimulation-Assisted Upper Extremity Ergometer Training on Aerobic Capacity and Upper Extremity Function in Patients With Subacute Stroke
- ClinicalTrials.gov ID
- NCT07484854
- Acronym / sponsor ID
- FES-UE-EX / TABED 1-25-876
- Conditions
- Stroke
- Keywords
- stroke, Functional electrical stimulation, Aerobic capacity, Stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 20 Mar 2026 (estimated)
- Study completion
- 26 Mar 2026 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are allocated into two parallel groups using the sealed envelope method and receive different upper extremity ergometer-based interventions in addition to conventional rehabilitation.
| Arm | Type | Receives |
|---|---|---|
| Upper Extremity Ergometer Training | Active comparator | Other: Upper Extremity Ergometer TrainingParticipants receive conventional rehabilitation combined with upper extremity ergometer training. |
| FES-Assisted Upper Extremity Ergometer Training | Experimental | Other: FES-Assisted Upper Extremity Ergometer TrainingParticipants receive conventional rehabilitation combined with functional electrical stimulation (FES)-assisted upper extremity ergometer training. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper Extremity Ergometer TrainingUpper 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. | Other | Upper Extremity Ergometer Training |
| FES-Assisted Upper Extremity Ergometer TrainingFunctional 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. | Other | FES-Assisted Upper Extremity Ergometer Training |
Primary outcome
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).
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..
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.
4 secondary outcomes
Upper Extremity Muscle Strength
Time frame: 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
Functional Independence
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Extremity Ergometer Training and FES-Assisted Upper Extremity Ergometer Training in people with Stroke, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Capacity (time frame: aseline and at the end of the 4 week (10 session) intervention period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.