NCT07484854

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2024-12-09
• Primary completion: 2026-03-20
• Completion: 2026-03-26
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: Turkey (Türkiye)