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

30. dubna 2026 aktualizováno: Zeynep Nur Köseoğlu

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

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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

Typ studie

Pozorovací

Zápis (Aktuální)

40

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Ukázka pravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Group 1
Exercise + TENS + whirlpool therapy + contrast bath + FES-assisted cycling ergometer
Přístroj: 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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
volumetric measurement
Časové okno: 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.

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
Časové okno: 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.
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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Zeynep Nur Köseoğlu

Vyšetřovatelé

  • Ředitel studie: Güldal Funda Yüzer Nakıpoğlu, Prof. Dr., Ankara City Hospital Bilkent

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. července 2024

Primární dokončení (Aktuální)

15. ledna 2026

Dokončení studie (Aktuální)

15. února 2026

Termíny zápisu do studia

První předloženo

30. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

30. dubna 2026

První zveřejněno (Aktuální)

6. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

6. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

30. dubna 2026

Naposledy ověřeno

1. ledna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • TABED 1-24-352

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Data privacy

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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