- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07565363
The Effect of Motor Imagery on Upper Extremity Function in Stroke Rehabilitation
The Effect of Motor Imagery on Upper Extremity Function in Stroke Rehabilitation: A Randomized Controlled Trial
Stroke is one of the leading causes of mortality and disability worldwide. A proportion of individuals who experience a stroke fail to achieve the desired level of motor recovery in the affected upper extremity following rehabilitation, resulting in significant limitations in activities of daily living. After stroke, rehabilitation programs are essential to reduce disability and enhance functional outcomes.
This study aims to evaluate whether the addition of Motor Imagery (MI) to a standard rehabilitation program contributes to improvements in upper extremity motor function in individuals with stroke. MI is a mental practice technique in which individuals cognitively rehearse movements without physically performing them. Although the movement is not executed, the brain regions involved in the movement are activated.
Eligible participants will be randomly assigned to three groups. All groups will receive a standard physical therapy and rehabilitation program. The first group will receive only standard physical therapy and rehabilitation. The second group will receive, in addition to conventional therapy, 15 minutes of MI training three days per week, while the third group will receive 15 minutes of MI training five days per week. The total treatment duration for all groups is planned as 30 sessions.
Assessments will be conducted at baseline, at the end of the treatment period, and again at the 12th week. This study is based on the hypothesis that adding MI practice to a conventional upper extremity rehabilitation program after stroke will contribute to improvements in activities of daily living and functional recovery, and that these effects may be associated with the frequency of the intervention.
Přehled studie
Postavení
Podmínky
Detailní popis
Stroke is defined by the World Health Organization as a clinical syndrome characterized by focal or generalized neurological impairment of cerebrovascular origin lasting longer than 24 hours or resulting in death. Stroke is one of the leading causes of mortality and disability worldwide. Approximately 30% to 66% of individuals who experience a stroke fail to achieve satisfactory motor recovery in the affected upper extremity following rehabilitation; this condition constitutes a major source of disability and leads to substantial limitations in activities of daily living.
The majority of functional recovery is achieved within the first three months after onset. In the chronic phase, functional recovery is slower; however, neuroplastic changes continue to occur during this period. Following stroke, rehabilitation programs are essential to reduce disability. Upper extremity rehabilitation after stroke commonly includes range of motion exercises, stretching, strengthening exercises, neuromuscular facilitation techniques, neurophysiological approaches such as Brunnstrom and Bobath, and functional electrical stimulation.
Motor imagery (MI) and mental practice can be defined as continuous processes in which an individual attempts to simulate a movement using cognitive processes without physically performing the motor action. In other words, MI consists of the mental representation of a movement that is not actually executed. Through this process, it is aimed to acquire and optimize motor skills by generating a voluntary neural drive. MI does not require substantial economic investment and can be performed in any setting, as it does not necessitate specialized equipment. It is also considered safe, as it can be repeated multiple times without requiring significant physical effort.
In the existing literature, there is no clear consensus regarding the optimal duration and frequency of treatment. Although some authors suggest that the number of weekly treatment sessions and repetitions may influence motor learning, our review did not identify studies specifically addressing this issue.
Considering these factors, the present study aims to investigate the effects of MI on upper extremity motor function in individuals with stroke during the late subacute and chronic phases, and to determine whether these effects are associated with the frequency of the applied intervention. For this purpose, participants will be divided into three groups.
All groups will receive a routine conventional physical therapy and rehabilitation program in accordance with the clinical practice guidelines of the Turkish Society of Physical Medicine and Rehabilitation. The first group will receive only the routine conventional physical therapy and rehabilitation program. The second group will receive, in addition to conventional therapy, 15 minutes of MI training three days per week, while the third group will receive 15 minutes of MI training five days per week. The treatment program for all groups is planned as 30 sessions, each lasting 60 minutes.
For the MI intervention, a goal-oriented video recording will be prepared, including visually and auditorily guided representations of activities of daily living. These will include elbow flexion and extension, wrist flexion and extension, forearm pronation and supination, hand opening and closing, finger walking, thumb-to-finger opposition (touching the tip of each finger sequentially), reaching for an object, grasping and lifting it, drinking water from a bottle, combing hair, and opening a door handle. This video will be used as a supportive tool during MI training.
The motor imagery intervention will be conducted in a quiet room under the supervision of a physiotherapist and will follow the procedure below: the session will begin with whole-body relaxation. The participant will then watch the video depicting the target movement. Afterwards, the participant will be asked to close their eyes and imagine themselves performing the movement. The session will end with a return to a relaxed bodily state. This cycle will be repeated five times for each movement. During the procedure, participants will be instructed to focus on themselves and to avoid excessive stress and anxiety.
Assessments will be conducted at baseline, at the end of the treatment period, and at the 12th week.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Elvan Gözügül
- Telefonní číslo: +905360263839
- E-mail: elvangzgl@gmail.com
Studijní záloha kontaktů
- Jméno: Pelin Yıldırım
- Telefonní číslo: +905323801078
- E-mail: drpeliny@gmail.com
Studijní místa
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Istanbul, Turecko (Türkiye), 34785
- Nábor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
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Kontakt:
- Elvan Gözügül
- Telefonní číslo: +905360263839
- E-mail: brnelv.98@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Being aged 18 years or older
- Having a diagnosis of ischemic or hemorrhagic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI)
- Being in the late subacute phase (more than 3 months post-stroke) or chronic phase (more than 6 months post-stroke) following stroke onset
- Presence of unilateral extremity hemiparesis
- Upper extremity stage between II and V for both proximal and distal segments according to the Modified Brunnstrom Classification
- A score of 21 or higher on the Mini-Mental State Examination (MMSE)
Exclusion Criteria:
- Severe spasticity in the affected upper extremity, defined as a Modified Ashworth Scale score > 2
- Presence of impaired consciousness, or severe hearing, visual impairment or global aphasia.
- Musculoskeletal disorders affecting upper extremity motor function, such as fracture or arthritis in the affected upper limb
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Conventional Rehabilitation Group
Participants will receive a structured, conventional rehabilitation program consisting of range of motion exercises, stretching, strengthening exercises, neuromuscular facilitation techniques, and neurophysiological approaches such as Brunnstrom and Bobath.
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A physiotherapy program comprising range of motion exercises, stretching, strengthening exercises, neuromuscular facilitation techniques, and neurophysiological approaches such as Brunnstrom and Bobath.
Ostatní jména:
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Experimentální: Motor Imagery + Conventional Rehabilitation Group 1
Participants will receive, in addition to conventional rehabilitation, 15 minutes of motor imagery training three days per week.
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A structured motor imagery program, applied in addition to conventional rehabilitation, consisting of visual and kinesthetic mental rehearsal of functional movements, delivered for 15 minutes per session, three days per week.
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Experimentální: Motor Imagery + Conventional Rehabilitation Group 2
Participants will receive, in addition to conventional rehabilitation, 15 minutes of motor imagery training five days per week.
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A structured motor imagery program, applied in addition to conventional rehabilitation, consisting of visual and kinesthetic mental rehearsal of functional movements, delivered for 15 minutes per session, five days per week.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score from baseline assessment
Časové okno: Baseline, at 6 weeks (end of intervention), and at 12 weeks (follow-up)
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The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index designed to assess motor function of the upper extremity.
The scale evaluates movement, coordination, and reflex activity of the shoulder, elbow, forearm, wrist, and hand.
Scores range from 0 to 66, with higher scores indicating better motor function
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Baseline, at 6 weeks (end of intervention), and at 12 weeks (follow-up)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in the Modified Barthel Index (MBI) score from baseline assessment.
Časové okno: Baseline, at 6 weeks (end of intervention), and at 12 weeks (follow-up)
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The Modified Barthel Index (MBI) is used to assess functional independence in activities of daily living (ADL), including feeding, bathing, grooming, dressing, toileting, transfers, mobility, and stair use.
The total score ranges from 0 to 100, with higher scores indicating greater independence
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Baseline, at 6 weeks (end of intervention), and at 12 weeks (follow-up)
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Change in the Wolf Motor Function Test (WMFT) score from baseline assessment
Časové okno: Baseline, at 6 weeks (end of intervention), and at 12 weeks (follow-up)
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The Wolf Motor Function Test (WMFT) is used to assess upper extremity motor ability through timed and functional tasks.
It includes 15 tasks evaluating movement and object manipulation.
Performance is measured by the time required to complete each task (in seconds) and a functional ability scale ranging from 0 to 5, where higher scores indicate better motor performance.
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Baseline, at 6 weeks (end of intervention), and at 12 weeks (follow-up)
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
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
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MI-STROKE-UE-2026
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Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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