NCT07484854 FES-Assisted Upper Extremity Ergometer Training in Subacute Stroke
| NCT ID | NCT07484854 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ankara City Hospital Bilkent |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-12-09 |
| Primary Completion | 2026-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2024-12-09 with a primary completion date of 2026-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07484854 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07484854 currently recruiting?
Yes, NCT07484854 is actively recruiting participants. Visit ClinicalTrials.gov or contact Ankara City Hospital Bilkent to inquire about joining.
Where is the NCT07484854 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07484854 clinical trial?
NCT07484854 is sponsored by Ankara City Hospital Bilkent. The trial plans to enroll 24 participants.
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