THE EFFECTS OF FUNCTIONAL ELECTRICAL STIMULATION-ASSISTED BICYCLE ERGOMETRY IN PATIENTS DIAGNOSED WITH COMPLEX REGIONAL PAIN SYNDROME.(CRPS) (CRPS)

THE EFFECTS OF FUNCTIONAL ELECTRICAL STIMULATION-ASSISTED BICYCLE ERGOMETER TRAINING ON PAIN, FUNCTIONAL OUTCOMES, AND QUALITY OF LIFE IN PATIENTS WITH POST-STROKE UPPER EXTREMITY COMPLEX REGIONAL PAIN SYNDROME.

The goal of this clinical study is to evaluate the effectiveness of functional electrical stimulation (FES)-assisted cycling in patients with post-stroke Complex Regional Pain Syndrome (CRPS) Type 1. It also aims to assess its effects on pain, edema, functional status, and quality of life. The main questions it aims to answer are:

Does FES-assisted cycling reduce pain levels in patients with CRPS Type 1 after stroke? Does FES-assisted cycling improve functional independence and motor recovery? Does FES-assisted cycling contribute to reductions in edema and improvements in quality of life?

Researchers will compare FES-assisted cycling in addition to conventional rehabilitation with conventional rehabilitation alone to determine whether FES provides additional therapeutic benefits.

Participants will:

Receive conventional rehabilitation treatment consisting of exercises, TENS, contrast bath, and whirlpool therapy Receive FES-assisted cycling (intervention group) or only conventional rehabilitation (control group) for a total of 20 sessions Be evaluated at baseline, at the end of treatment (4th week), and at the 12th week using clinical scales and outcome measures

Study Overview

• Status: Completed
• Conditions: Pain; Complex Regional Pain Syndrome I of Upper Limb
• Intervention / Treatment: Device: Functional Electrical Stimulation

Detailed Description

A total of 44 patients who developed Complex Regional Pain Syndrome (CRPS) Type 1 in the upper extremity following a cerebrovascular event, diagnosed according to the Modified Budapest Criteria, and who were admitted to an inpatient physical therapy and rehabilitation program were included in the study. All participants met the inclusion criteria and provided written informed consent after being fully informed about the study procedures and treatment protocol. The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines.

Demographic data including age, sex, height, weight, educational level, occupation, marital status, and comorbid systemic diseases were recorded for all participants. Patients with a Mini-Mental State Examination score of 23 or higher were included in the study. All participants were evaluated at baseline (pre-treatment), at the end of treatment (4th week), and at the 12th week.

Clinical assessments included evaluation of pain, edema, spasticity, range of motion, motor function, activities of daily living, and quality of life of the upper extremity. The following outcome measures were used:

Visual Analog Scale (VAS) Self-report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) Volumetric Measurement Modified Ashworth Scale (MAS) Range of Motion (ROM) Measurement Brunnstrom Motor Staging CRPS Severity Score (CSS) Functional Independence Measure (FIM) Stroke Impact Scale (SIS)

Eligible patients were randomized into two groups using the sealed envelope method. Both groups received a conventional neurorehabilitation program consisting of whirlpool therapy, transcutaneous electrical nerve stimulation (TENS), contrast bath, and therapeutic exercises.

In addition to conventional therapy, patients in the intervention group received upper extremity functional electrical stimulation (FES)-assisted cycling using a cycle ergometer. This intervention was applied for 30 minutes per day, 5 days per week, for a total of 4 weeks.

The groups were defined as follows:

Group 1: Exercise + TENS + whirlpool therapy + contrast bath + FES-assisted cycling ergometer Group 2: Exercise + TENS + whirlpool therapy + contrast bath

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Çankaya
    • Ankara, Çankaya, Turkey (Türkiye), 06800
      • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

A total of 44 patients who developed Complex Regional Pain Syndrome (CRPS) Type 1 in the upper extremity following a cerebrovascular event, diagnosed according to the Modified Budapest Criteria, and who were admitted to an inpatient physical therapy and rehabilitation program at Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital were included in the study. All participants met the inclusion criteria and provided consent to participate.

Description

Inclusion Criteria:

History of ischemic or hemorrhagic stroke Patients who experienced their first stroke within the last 1 year Diagnosis of upper extremity CRPS Type 1 according to the Modified Budapest Criteria No cognitive impairment (Mini-Mental State Examination score ≥ 23) Provision of written informed consent by the patient or their legal guardian

Exclusion Criteria:

Unstable medical condition Presence of visual impairment Presence of shoulder subluxation or contracture in the upper extremity and hand joints History of upper extremity injections within the last 6 months (e.g., suprascapular nerve block, intra-articular shoulder injections, hand/wrist intra-articular or peri-tendinous injections) History of systemic steroid use within the last 6 months Use of neuropathic pain medications within the last 6 months, including tricyclic antidepressants and gabapentinoids such as gabapentin or pregabalin Presence of neglect syndrome Presence of another etiology causing upper extremity pain Presence of another neurological disorder (e.g., progressive central nervous system disease, peripheral neuropathy) Presence of concomitant rheumatologic or orthopedic conditions in the upper extremity or hand (e.g., inflammatory arthritis, cellulitis, osteomyelitis) Presence of active deep vein thrombosis or thrombophlebitis in the upper extremity Conditions characterized by pain, swelling, and edema of the extremity, such as chronic vascular disorders Presence of malignancy History of epilepsy Presence of aphasia Pregnancy or suspicion of pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Exercise + TENS + whirlpool therapy + contrast bath + FES-assisted cycling ergometer	Device: Functional Electrical Stimulation; Although the FES cycling ergometer is a treatment modality used in various patient groups in neurological rehabilitation, no study has been found in the literature evaluating its effectiveness in patients with upper extremity CRPS following stroke. Therefore, the aim of this study was to investigate the effects of FES cycling ergometer, added to a conventional physical therapy and rehabilitation program, on pain, edema, functional status, and quality of life in patients diagnosed with post-stroke upper extremity CRPS Type 1.
Group 2; Exercise + TENS + whirlpool therapy + contrast bath

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
volumetric measurement	The total volume of the hand was measured using a volumetric device based on the water displacement method. The volumeter method has been used since the 1950s and is considered a highly valid and reliable measurement tool with a very low margin of error. It is accepted as the "gold standard" for assessing hand edema, particularly in cases of diffuse swelling. The patient immersed the affected extremity into the volumeter, positioning the hand so that the web space between the third and fourth fingers rested on a plastic rod. The displaced water was collected in a beaker and subsequently measured using a graduated cylinder. Measurements were recorded in milliliters.Considering that water temperature may influence measurement results, it was maintained between 20-35 °C.	All measurements were performed at baseline (pre-treatment), at the end of treatment (4th week), and at the 12th week, by the same investigator, with the patient in a seated position and at the same time of day.
visual analog scala	Pain intensity was assessed subjectively using a 10-cm Visual Analog Scale (VAS) (Appendix 2). Participants were shown a horizontal line with the left end defined as "0 = no pain" and the right end as "10 = unbearable pain," and were asked to mark the point that best represented their current pain level. The distance from the starting point to the marked point was measured in millimeters and recorded, with higher scores indicating greater pain intensity.	Within the scope of the study, measurements were performed at baseline (pre-treatment), at the end of treatment (4th week), and at the 12th week. Pain was evaluated separately under three conditions: at rest, during movement, and at night.

Collaborators and Investigators

• Sponsor: Zeynep Nur Köseoğlu
• Investigators: Study Director: Güldal Funda Yüzer Nakıpoğlu, Prof. Dr., Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• Sousa ASP, Moreira J, Silva C, Mesquita I, Macedo R, Silva A, Santos R. Usability of Functional Electrical Stimulation in Upper Limb Rehabilitation in Post-Stroke Patients: A Narrative Review. Sensors (Basel). 2022 Feb 12;22(4):1409. doi: 10.3390/s22041409.
• Devrimsel G, Turkyilmaz AK, Yildirim M, Beyazal MS. The effects of whirlpool bath and neuromuscular electrical stimulation on complex regional pain syndrome. J Phys Ther Sci. 2015 Jan;27(1):27-30. doi: 10.1589/jpts.27.27. Epub 2015 Jan 9.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): January 15, 2026
• Study Completion (Actual): February 15, 2026

Study Registration Dates

• First Submitted: April 30, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Stroke, Complex Regional Pain Syndrome, Functional Electrical Stimulation, Rehabilitation, Pain
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Stroke; Complex Regional Pain Syndromes
• Other Study ID Numbers: TABED 1-24-352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data privacy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No