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

30 kwietnia 2026 zaktualizowane przez: 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

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Rzeczywisty)

40

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Group 1
Exercise + TENS + whirlpool therapy + contrast bath + FES-assisted cycling ergometer
Urządzenie: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
volumetric measurement
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Zeynep Nur Köseoğlu

Śledczy

  • Dyrektor Studium: Güldal Funda Yüzer Nakıpoğlu, Prof. Dr., Ankara City Hospital Bilkent

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 lipca 2024

Zakończenie podstawowe (Rzeczywisty)

15 stycznia 2026

Ukończenie studiów (Rzeczywisty)

15 lutego 2026

Daty rejestracji na studia

Pierwszy przesłany

30 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

6 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 kwietnia 2026

Ostatnia weryfikacja

1 stycznia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • TABED 1-24-352

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Data privacy

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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