FES-Assisted Upper Extremity Ergometer Training in Subacute Stroke

NCT07484854 | Recruiting

• 1 other identifier: TABED 1-25-876
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; Functional electrical stimulation; Aerobic capacity; Stroke rehabilitation

Outcome Measures

Primary Outcomes (3)

• Aerobic Capacity

  Aerobic capacity will be assessed using cardiopulmonary exercise testing by measuring peak oxygen consumption (VO2max).

  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..

  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.

  Baseline and at the end of the 4 week (10 session) intervention period

Secondary Outcomes (4)

• Upper Extremity Muscle Strength

  Baseline and at the end of the 4 week (10 session) intervention period

• Upper Extremity Sensory Function

  Baseline and at the end of the 4 week (10 session) intervention period

• Functional Independence

  Baseline and at the end of the 4 week (10 session) intervention period

• Health-Related Quality of Life

  Baseline and at the end of the 4 week (10 session) intervention period

Study Arms (2)

Upper Extremity Ergometer Training

ACTIVE COMPARATOR

Participants receive conventional rehabilitation combined with upper extremity ergometer training.

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.

Other: FES-Assisted Upper Extremity Ergometer Training

Interventions

Upper Extremity Ergometer Training OTHER

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.

Upper Extremity Ergometer Training

FES-Assisted Upper Extremity Ergometer Training OTHER

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.

FES-Assisted Upper Extremity Ergometer Training

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: March 20, 2026
• Study Start: December 9, 2024
• Primary Completion: March 20, 2026
• Study Completion: March 26, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)