FES-assisted arm ergometer training for people with subacute stroke
The Effect of Functional Electrical Stimulation-Assisted Upper Extremity Ergometer Training on Aerobic Capacity and Upper Extremity Function in Patients With Subacute Stroke
This trial will test whether adding functional electrical stimulation to arm ergometer (arm cycling) training helps people with subacute stroke improve arm movement and aerobic fitness more than ergometer training alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara, Çankaya) |
| Trial ID | NCT07484854 on ClinicalTrials.gov |
What this trial studies
This is a single-center, randomized trial enrolling 24 adults with subacute unilateral stroke (≤6 months) to compare conventional rehabilitation plus upper-extremity ergometer training versus the same program with functional electrical stimulation (FES) added. Both groups receive standard rehabilitation five days per week, and the ergometer or FES-assisted ergometer sessions are 30 minutes each for a total of 10 sessions over about four weeks. In the FES group, surface electrodes are placed on selected upper-limb muscles (for example wrist extensors) tailored to each participant to assist cycling movements. Primary aims are to measure changes in upper-extremity function and aerobic capacity after the intervention.
Who should consider this trial
Good fit: Adults aged 18–85 with subacute ischemic or hemorrhagic unilateral stroke (≤6 months), Brunnstrom upper-extremity stage 1–5, Modified Ashworth Scale <3, able to follow simple commands, and medically stable for exercise are ideal candidates.
Not a fit: Patients with severe cognitive or communication impairment, uncontrolled cardiac or pulmonary disease, severe musculoskeletal restrictions of the affected arm, or those beyond the subacute window (>6 months) are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could improve arm motor recovery and cardiovascular fitness, helping patients regain more independence in daily activities.
How similar studies have performed: Prior research has shown FES can aid motor recovery and ergometer training can improve aerobic fitness, but combining FES with upper-extremity ergometer training in the subacute stroke population has limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ankara, Çankaya
- Ankara Bilkent City Hospital — Ankara, Çankaya, Turkey (Türkiye) (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.