FES-Assisted Upper Extremity Ergometer Training in 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
Ankara City Hospital Bilkent
24 participants
Dec 9, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria8
- 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
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Interventions
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.
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.
Locations(1)
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NCT07484854