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

NCT07570199 | Completed

• 1 other identifier: TABED 1-24-352
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Complex Regional Pain Syndrome I of Upper Limb; Pain

Keywords

Stroke, Complex Regional Pain Syndrome, Functional Electrical Stimulation, Rehabilitation, Pain

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Group 1

Exercise + TENS + whirlpool therapy + contrast bath + FES-assisted cycling ergometer

Device: Functional Electrical Stimulation

Group 2

Exercise + TENS + whirlpool therapy + contrast bath

Interventions

Functional Electrical Stimulation DEVICE

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 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zeynep Nur Köseoğlu: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 35214311 BACKGROUND

• 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.

  PMID: 25642030 BACKGROUND

MeSH Terms

Conditions

Pain; Stroke; Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Autonomic Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Güldal Funda Yüzer Nakıpoğlu, Prof. Dr.

  Ankara City Hospital Bilkent

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: July 15, 2024
• Primary Completion: January 15, 2026
• Study Completion: February 15, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)