- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07615569
Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke (ROCHAS)
This randomized controlled trial aims to compare the effectiveness of robotic-assisted physiotherapy and conventional physiotherapy in improving hand function among patients with sub-acute stroke. Stroke often results in weakness, reduced hand strength, impaired dexterity, and difficulty performing daily activities due to upper-limb motor dysfunction. Early rehabilitation targeting hand recovery is essential to improve independence and quality of life.
A total of 30 participants with sub-acute post-stroke spastic hemiplegia will be recruited from the University of Lahore Hospital and randomly assigned into two groups. The intervention group will receive robotic-assisted physiotherapy focused on repetitive, task-specific wrist and finger extension training using a robotic hand/wrist device, while the control group will receive conventional therapist-led upper-limb rehabilitation exercises. Both groups will undergo treatment sessions lasting 30-45 minutes, five days per week for four weeks.
Outcome measures will include hand muscle strength assessed using a hand-held dynamometer, hand dexterity evaluated through the Action Research Arm Test (ARAT), and functional improvement measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Additional measures such as spasticity, activities of daily living, and quality of life will also be recorded. Assessments will be conducted at baseline, during treatment, and after completion of the intervention period by a blinded assessor.
The study is expected to determine whether robotic-assisted physiotherapy provides greater improvements in hand strength, dexterity, and upper-limb functional recovery compared to conventional physiotherapy in individuals recovering from stroke. Findings from this research may contribute to evidence-based rehabilitation strategies for improving upper-limb outcomes after stroke.
Přehled studie
Postavení
Detailní popis
Stroke is one of the leading causes of long-term disability worldwide and frequently results in upper-limb impairments that significantly affect independence and quality of life. Hand dysfunction, including reduced grip strength, poor dexterity, impaired coordination, and difficulty performing functional tasks, is common during the sub-acute phase following stroke. Recovery of hand and upper-limb function is considered a major goal of neurorehabilitation because deficits in grasping, object manipulation, and coordinated movement restrict performance of activities of daily living and social participation.
Conventional physiotherapy remains a widely used rehabilitation approach for upper-limb recovery after stroke. It typically involves therapist-guided range-of-motion exercises, strengthening, task-oriented training, neuromuscular facilitation, and functional retraining techniques. Although beneficial, conventional therapy may be limited by therapist fatigue, reduced intensity of repetitions, and variability in treatment delivery. Emerging rehabilitation technologies such as robotic-assisted physiotherapy have been introduced to overcome these limitations by providing high-intensity, repetitive, task-specific, and feedback-driven training that may enhance neuroplasticity and motor relearning.
Robotic-assisted physiotherapy allows patients to perform repeated wrist and finger movements with adjustable assistance or resistance while receiving visual or sensory feedback. These systems can increase the number of movement repetitions, promote active participation, and objectively monitor patient performance. Previous studies have suggested that robotic rehabilitation may improve motor control, muscle strength, and functional outcomes in stroke survivors; however, evidence comparing robotic-assisted therapy with conventional physiotherapy specifically for hand recovery in sub-acute stroke patients remains limited.
This randomized controlled trial will compare robotic-assisted physiotherapy with conventional physiotherapy for improving hand function in individuals with sub-acute stroke. Thirty participants meeting the eligibility criteria will be recruited from the University of Lahore Hospital and randomly allocated into two equal groups using the sealed-envelope randomization method. Group A will receive robotic-assisted physiotherapy targeting wrist and finger extension through repetitive, task-specific robotic training combined with visual feedback and progressive assistance or resistance. Group B will receive conventional physiotherapy consisting of active-assisted and resistive exercises, task-oriented training, neuromuscular facilitation, mirror therapy, and activities of daily living training. Both groups will receive treatment five days per week for four weeks, with each session lasting approximately 30-45 minutes.
Primary outcomes will include hand muscle strength measured by a hand-held dynamometer, hand dexterity assessed using the Action Research Arm Test (ARAT), and upper-limb functional recovery measured through the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). Secondary outcomes will include spasticity using the Modified Ashworth Scale, activities of daily living using the Modified Barthel Index, and quality of life using the EQ-5D questionnaire. Outcome assessments will be performed at baseline, midpoint, and post-intervention by a blinded assessor using standardized protocols.
The findings of this study may help determine whether robotic-assisted physiotherapy offers superior benefits over conventional physiotherapy for hand rehabilitation in sub-acute stroke patients. The results may contribute to the development of evidence-based rehabilitation protocols and support the integration of advanced robotic technologies into stroke rehabilitation programs to optimize upper-limb recovery and functional independence.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Montiha Azeem, MSPTN
- Telefonní číslo: 03479717317
- E-mail: muntahaazeem9@gmail.com
Studijní záloha kontaktů
- Jméno: Muhammad Uzair, MSPTN
- Telefonní číslo: 03001850678
- E-mail: druzairmuhammad@gmail.com
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 54000
- Nábor
- University of Lahore Teaching Hospital, Lahore
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Kontakt:
- Montiha Azeem, MSPTN
- Telefonní číslo: 03479717317
- E-mail: muntahaazeem9@gmail.com
-
Kontakt:
- Muhammad Uzair, MSPT N
- Telefonní číslo: 03001850678
- E-mail: druzairmuhammad@gmail.com
-
Vrchní vyšetřovatel:
- Muhammad Uzair, MSPTN
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Both male and female adults aged 30-50 years diagnosed with post-stroke spastic hemiplegia confirmed by a neurologist.
Stroke duration 2 weeks to 6 months (sub acute stage) with medically stable condition.
Presence of mild to moderate upper-limb spasticity using screening test(Modified Ashworth Scale score 1-3).
Ability to comprehend and follow simple verbal instructions using screening test (MMSE ≥ 24).
Exclusion Criteria:
No history of upper-limb orthopedic surgery or botulinum toxin injections in the last 6 months.
History of recurrent or uncontrolled seizure disorders, progressive neurological diseases, or unstable cardiovascular conditions.
Participation in any intensive upper-limb rehabilitation program (CIMT, bimanual training, task-specific training, robotic therapy, FES therapy) within the past 6 months.
Comorbid conditions affecting upper-limb function (fractures, severe arthritis, peripheral nerve injuries).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: group A Robotic-Assisted Physiotherapy Group
Participants in this group will receive robotic-assisted physiotherapy focused on wrist and finger extension training using a robotic hand/wrist rehabilitation device.
Treatment will include repetitive task-specific movements, active-assist and active-resist exercises, visual feedback tasks, and functional grasp-release training.
Sessions will be conducted for 30-45 minutes per session, 5 days per week for 4 weeks under therapist supervision.
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Participants will receive robotic-assisted hand rehabilitation using a robotic hand/wrist training device designed to improve wrist and finger extension, hand coordination, and functional upper-limb recovery after stroke.
The intervention will include repetitive task-specific movements, active-assist and active-resist training, grasp-release exercises, visual feedback activities, and functional motor practice supervised by a physiotherapist.
Treatment intensity and robotic assistance will be progressively adjusted according to patient performance and recovery level.
Sessions will last 30-45 minutes, 5 days per week for 4 weeks.
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Aktivní komparátor: group B Conventional Physiotherapy Group
Participants in this group will receive conventional therapist-led upper-limb rehabilitation consisting of active-assisted and active range-of-motion exercises, strengthening exercises for wrist and finger extensors, task-oriented functional training, neuromuscular facilitation, mirror therapy, and activities of daily living training.
Sessions will be conducted for 30-45 minutes per session, 5 days per week for 4 weeks.
|
Participants will receive conventional physiotherapy focused on upper-limb rehabilitation after stroke.
The treatment program will include active-assisted and active range-of-motion exercises, strengthening exercises for wrist and finger extensors, task-specific functional training, neuromuscular facilitation techniques, mirror therapy, and activities of daily living practice.
Exercise intensity and task difficulty will be progressively increased according to patient ability and motor recovery.
Sessions will last 30-45 minutes, 5 days per week for 4 weeks under physiotherapist supervision.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Upper Limb Motor Function Using Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Časové okno: Baseline and after 4 weeks of intervention
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The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) will be used to evaluate motor recovery and functional improvement of the affected upper limb in participants with sub-acute stroke.
The assessment includes evaluation of reflexes, movement synergy, wrist control, hand function, and coordination.
Higher scores indicate better upper-limb motor performance and recovery.
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Baseline and after 4 weeks of intervention
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Muhammad Uzair, MSPTN, The University of Lahore, Lahore
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UOL/IREB/25/15/03/50
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