Robotic-Assisted Training on Hand Function in Stroke
8 lipca 2026 zaktualizowane przez: Adly A Adam
Robotic-Assisted Training on Hand Function in Stroke Patient
Stroke is a neurological deficit attributed to an acute focal injury of the central nervous system.
A key component of stroke rehabilitation is improving upper limb function to reduce impairments and disabilities.
A task-specific approach retraining for upper extremity control seeks to minimize impairments while maximizing the patient's functional performance.
Technology-supported training is emerging to help therapists, patients, and the health system.
Robotic devices allow to facilitate and control the complexity of a motor task.
The benefits of robotic rehabilitation affect both therapists and patients: robot-assisted therapy can increase treatment compliance by way of introducing games or interactive upper limb tasks and patients can train independently with less supervision from therapists.
Therefore, this study was conducted in line to determine the effect of robotic-assisted training on hand function in patients following a stroke.
Przegląd badań
Status
Zakończony
Szczegółowy opis
Stroke is the leading cause of complex adult disability with arm function impairment affecting approximately 69% of stroke survivors.
Enhancing arm function is a priority for stroke survivors, caregivers, and healthcare professionals, as current rehabilitation approaches often neglect arm recovery.
In Motion robotic gym system represents an effective treatment option for improving upper limb function in patients' post-stroke, owing to its ease of application, cost-effectiveness, and tolerability.
Rehabilitation robotics is an emerging research domain aimed at leveraging cutting-edge robotic technology and virtual reality systems for the rehabilitation of neurological patients.
While clinical trials in post-stroke patients with upper limb impairments have yielded positive results regarding motor recovery, they have shown limited efficacy concerning functional outcomes.
Thus, there remains a pressing need to develop a new generation of rehabilitation robots and clinical protocols that can more effectively assist patients in regaining their abilities in activities of daily living.
Therefore, this study was conducted in line to determine the effect of robotic-assisted training 'course of 12 weeks' on hand function 'assessing strength, via dynamometer, function via Fugle-Meyer test, and overall function via Jobson hand function' in patients following a stroke.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
34
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Cairo Governorate
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Cairo, Cairo Governorate, Egipt, 11432
- Cairo University
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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
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
Inclusion Criteria:
- Age ranged from 40 to 60 years old.
- Clinical diagnosis of ischemic stroke and diagnosis confirmed by CT or MRI with hand impairments.
- Stroke started since six months (at chronic stage)
- Mild to moderate upper limb functional limitation according to (Fugl-Meyer score: 85-99).
- Ability to understand and follow instructions and to provide informed consent.
Exclusion Criteria:
- More than one stroke.
- Other current significant impairment of the upper limb affected by stroke, e.g. fixed contracture, frozen shoulder, severe arthritis, recent fracture.
- Diagnosis likely to interfere with rehabilitation or outcome assessments, e.g. registered blind.
- Previous use of the InMotion robotic gym system or other arm rehabilitation robot.
- Current participation in a rehabilitation trial evaluating upper limb rehabilitation after stroke
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
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Study Group (A)
Received Robot-assisted training of a selected physical therapy program using Multifunctional intelligent instrument system for 45 minutes, three times per week, for 12 week.
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The Hand Wrist Assistive Rehabilitation Device or HWARD: 'exoskeleton with 3 degrees of freedom (flexion-extension of the fingers, thumb and wrist) that assists (through pneumatic actuators) the hand in the" grasp and release "movement.
The patient is seated in front of a monitor, the hand is secured to the robot by three soft Velcro strips, The palm of the hand is left free allowing the grasping of real objects, as well as virtual ones.
Its a 45 minutes session , three times per week, for 12 weeks.
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Aktywny komparator: Control Group (B)
Received Conventional physical therapy program for 1 hour per session, three times per week, for12 weeks.
Passive, active assisted, and active range of motion exercises for affected upper extremity for 30 minutes, Facilitation and inhibition techniques, plus neuromuscular electrical stimulation for wrist extensors for 30 minutes.
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Passive, active-assisted, and active range of motion, and facilitation/inhibition techniques for 30 minutes, also Neuromuscular electrical stimulation for wrist extensors, and task-oriented exercise training for strengthening foe 30 minutes.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Hand-held dynamometer for measuring hand strength
Ramy czasowe: 1. Pre-treatment at base-line of the study. 2. Post-treatment after 12 weeks of intervention.
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Handheld dynamometer (Item model number:EH101, Manufacturer: Handeful), it is equipped with high precision strain gauge sensor that provides an accurate momentary digital reading of gripping power with a maximum capacity 198ibs - 90kgm.
It is easy to read as it includes a large LCD screen that displays all measurements.
It is used for measuring hand strength, while patient was seated comfortably, then was asked to place the arms by sides with his\her elbow in a 90-flexion position in neutral, then instructed to squeeze the digital hand dynamometer as hard as possible for 3 seconds, the test was repeated 2 more times and the mean handgrip strength of the 3 attempts were recorded.
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1. Pre-treatment at base-line of the study. 2. Post-treatment after 12 weeks of intervention.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Fugl-Meyer Test (Upper limb impairment test)
Ramy czasowe: 1. Pre-treatment at base-line 2. Post-treatment after 12 weeks of intervention
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Fugl-Meyer Test is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
It takes approximately 30-35 minutes, Scoring is based on direct observation of performance.
Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully.
The total possible scale score is 226.
Noting 0-35: Very severe, 6-55: Severe, 56-79: Moderate, more than 79 indicates mild in the scoring system.
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1. Pre-treatment at base-line 2. Post-treatment after 12 weeks of intervention
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Jobson Hand function test
Ramy czasowe: 1. Pre-treatment at baseline of the study 2. Post-treatment after 12 weeks of intervention
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It is a health and care, UK, that is a used to evaluate the functional capabilities using a stopwatch.
It includes seven items: picking up small common objects, card turning, simulated feeding (bean spooning), picking up large light objects, stacking checkers, picking up large heavy objects, and writing a short sentence.
The time of performance was recorded for each test.
Total score is the sum of time taken for each sub-test, which are rounded to the nearest second.
Shorter times indicate better performance
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1. Pre-treatment at baseline of the study 2. Post-treatment after 12 weeks of intervention
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Jobson Hand function test
Ramy czasowe: 1. Pre-Treatment at baseline of the study 2. Post-treatment of 12 weeks of intervention
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Using a stop watch for scoring and evaluating the functional capabilities of patients.
This test includes seven items: picking up small common objects, card turning, simulated feeding (bean spooning), picking up large light objects, stacking checkers, picking up large heavy objects, and writing a short sentence.
The time of performance was recorded for each test Total score is the sum of time taken for each sub-test, which are rounded to the nearest second.
Shorter times indicate better performance.
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1. Pre-Treatment at baseline of the study 2. Post-treatment of 12 weeks of intervention
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Krzesło do nauki: Mushira H Darwish, Professor, Cairo University; Faculty of Physical Therapy
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)
1 maja 2025
Zakończenie podstawowe (Rzeczywisty)
1 marca 2026
Ukończenie studiów (Rzeczywisty)
30 maja 2026
Daty rejestracji na studia
Pierwszy przesłany
8 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
8 lipca 2026
Pierwszy wysłany (Rzeczywisty)
14 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
14 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
8 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- P.T.REC/012/005776
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- CSR
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 .
Badania kliniczne na Uderzenie
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IRCCS San Raffaele RomaMinistry of Health, ItalyRekrutacyjnyUderzenie | Sabacute StrokeWłochy
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University of ZurichNieznany