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- Ensaio Clínico NCT07701577
Robotic-Assisted Training on Hand Function in Stroke
8 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Real)
34
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Cairo Governorate
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Cairo, Cairo Governorate, Egito, 11432
- Cairo University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Hand-held dynamometer for measuring hand strength
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fugl-Meyer Test (Upper limb impairment test)
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: Mushira H Darwish, Professor, Cairo University; Faculty of Physical Therapy
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de maio de 2025
Conclusão Primária (Real)
1 de março de 2026
Conclusão do estudo (Real)
30 de maio de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
8 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de julho de 2026
Primeira postagem (Real)
14 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P.T.REC/012/005776
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
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Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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