- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05191524
Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation on Lower Limb Motor Function
Comparison of Constraint Induced Movement Therapy and Proprioceptive Neuromuscular Facilitation on Lower Limb Motor Function in Stroke Patients
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
There have been many rehabilitation techniques to treat post-stroke impairments. These include aerobic exercises, the Bobath approach, proprioceptive neuromuscular facilitation (PNF) constraint-induced movement therapy (CIMT), and mobilization and stimulation of neuromuscular tissue. The selection of techniques at the defined level of recovery varies among clinicians.
Constraint-induced movement therapy (CIMT) is a neurological rehabilitation technique that has been used in various neurological disorders including stroke both in acute and chronic stages, traumatic brain injury, cerebral palsy, multiple sclerosis, and spinal cord injury to improve motor function and strengthen weak muscles which are characterized by the restraint of the less affected extremity accompanied by the shaping and repetitive task-oriented training of more affected extremity.
Proprioceptive facilitation (PNF) is one of the major therapeutic techniques aimed at enhancing the essential characteristics required for the functional ambulation of patients with hemiplegia, such as muscular control, strength, and flexibility. Changes in the excitation of the cortical motor area mediate this and the corresponding.
Motor neurons. Previous researches are on the separate effect of CIMT and they have conducted PNF approaches, but there is no study available on the comparison of the effect of both techniques on lower limb function in stroke patients. Most of the studies administered PNF in combination with other approaches and the duration of intervention in these studies was in favor of CIMT groups compared to PNF. Therefore, this study is aimed at determining the comparative effect of CIMT and PNF on lower limb recovery.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Mansehra, Pakistan
- Helping Hand Institute Of rehabilitation sciences
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Both male and female
- Patients who will be diagnosed with hemiplegia due to stroke
- Patient who has an asymmetrical stance, ability to walk and stand with minimal assistance
- Patient must have 15 degrees of knee flexion in the affected limb
- Mini mental state examination Mini Mental State Examination >23
Exclusion Criteria:
- Patients who cannot perform the active movement of a limb due to pre stroke musculoskeletal problems
- Cardiopulmonary diseases which could hinder their ability to take part in rehabilitation
- Patient with impaired cognition
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Constrained induced movement therapy
In this group of patients, they will use the CIMT technique for treatment. Patient will perform following tasks, while unaffected limb in constrains for 3 hours/day
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Practice in two sessions per day (supervised) for 3 days per week, for six consecutive weeks.
The unaffected limb will be constraint using a knee immobilizer only during practice sessions.
We will perform the interventions under the supervision of a trained physiotherapist.
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Aktywny komparator: Proprioceptive Neuromuscular facilitation therapy
Different PNF components (such as commands, stretching, timing, and manual resistance) will be used for optimizing patients' output. We will do ten repetitions of each pattern before Proceeding to the next pattern. The PNF patterns in the set used in the study will be : Lower extremity: < Flexion-abduction-external rotation (knee flexed and knee extended) < Extension-adduction-internal rotation (knee flexed and knee extended) < Flexion-adduction-internal rotation (knee flexed and knee extended) < Extension-abduction-external rotation (knee flexed and knee extended |
Group B will receive PNF intervention given for 30 minutes to the lower limb 3 times a week for 6 weeks
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Fugl-Meyer Assessment (FMA)
Ramy czasowe: week 6
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The FMA scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke.
They divided it into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain.
Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
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week 6
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Timed up and go test
Ramy czasowe: week 6
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The Timed Up and Go (TUG) is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old). They can use the TUG with but is not limited to, persons with stroke. 10s Completely independent With or without walking aid for ambulation and transfers < 20s Independent for main transfers With or without walking aid, independent for basic tub or shower transfers and able to climb most stairs and go outside alone > 30s Requires assistance dependent in most activities |
week 6
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Berg Balance Scale
Ramy czasowe: week 6
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The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
It is a 14 item list with each item comprising a five-point ordinal scale ranging from 0 to 4, with 0 showing the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
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week 6
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- GBD 2015 Neurological Disorders Collaborator Group. Global, regional, and national burden of neurological disorders during 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 2017 Nov;16(11):877-897. doi: 10.1016/S1474-4422(17)30299-5. Epub 2017 Sep 17.
- Lakhan SE, Kirchgessner A, Hofer M. Inflammatory mechanisms in ischemic stroke: therapeutic approaches. J Transl Med. 2009 Nov 17;7:97. doi: 10.1186/1479-5876-7-97.
- Çoban O. İnmeli hastalarda mekanik hippoterapi cihazı ile yapılan egzersizin postural kontrol ve denge üzerine etkisi. 2019
- Abba M, Muhammad A, Badaru U, Abdullahi A. Comparative effect of constraint-induced movement therapy and proprioceptive neuromuscular facilitation on upper limb function of chronic stroke survivors. Physiotherapy Quarterly. 2020;28(1):1-5
- He L, Wang J, Wang F, Zhang L, Zhang L, Zhao W. Increased neutrophil-to-lymphocyte ratio predicts the development of post-stroke infections in patients with acute ischemic stroke. BMC Neurol. 2020 Sep 1;20(1):328. doi: 10.1186/s12883-020-01914-x.
- Randolph SA. Ischemic Stroke. Workplace Health Saf. 2016 Sep;64(9):444. doi: 10.1177/2165079916665400.
- Yu L, Tao J, Zhao Q, Xu C, Zhang Q. Confirmation of potential neuroprotective effects of natural bioactive compounds from traditional medicinal herbs in cerebral ischemia treatment. J Integr Neurosci. 2020 Jun 30;19(2):373-384. doi: 10.31083/j.jin.2020.02.63.
- Ojaghihaghighi S, Vahdati SS, Mikaeilpour A, Ramouz A. Comparison of neurological clinical manifestation in patients with hemorrhagic and ischemic stroke. World J Emerg Med. 2017;8(1):34-38. doi: 10.5847/wjem.j.1920-8642.2017.01.006.
- Chen S, Zeng L, Hu Z. Progressing haemorrhagic stroke: categories, causes, mechanisms and managements. J Neurol. 2014 Nov;261(11):2061-78. doi: 10.1007/s00415-014-7291-1. Epub 2014 Mar 5.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- REC/00818 Aqdas
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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