- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07720622
Comparison of Motor Relearning Program and Electric Muscle Stimulation in Subacute Stroke Patients (MORE-EMS)
Stroke is one of the leading causes of long-term disability worldwide, with upper limb motor impairment being a common consequence that limits independence in activities of daily living. The Motor Relearning Program (MRP) is a task-oriented rehabilitation approach designed to improve motor recovery through repetitive functional practice. Electrical Muscle Stimulation (EMS) may further enhance muscle activation and facilitate motor recovery when combined with conventional rehabilitation.
The purpose of this single-blinded randomized controlled trial is to compare the effectiveness of the Motor Relearning Program combined with Electrical Muscle Stimulation versus the Motor Relearning Program alone in improving upper limb function in individuals with subacute stroke. Thirty-six eligible participants with subacute stroke will be randomly allocated into two groups. Group A will receive MRP together with EMS, while Group B will receive the same MRP without EMS. Both groups will undergo treatment for 1 hour per day, 5 days per week, for 6 weeks.
Upper limb motor recovery and muscle tone will be evaluated at baseline and after the intervention using the Upper Extremity Fugl-Meyer Assessment (UEFMA), Modified Ashworth Scale (MAS), and Motor Evaluation Scale for Upper Extremity in Stroke (MESUPES). The findings of this study may help determine whether adding EMS to a structured Motor Relearning Program provides greater improvements in upper limb function than MRP alone in individuals with subacute stroke.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Stroke frequently results in upper limb motor impairment, reduced functional independence, and diminished quality of life. Despite advances in stroke rehabilitation, recovery of upper extremity function remains challenging. The Motor Relearning Program (MRP) is a task-oriented rehabilitation approach that promotes neuroplasticity through repetitive practice of meaningful functional activities. Electrical Muscle Stimulation (EMS) has been proposed as an adjunctive intervention to facilitate voluntary muscle activation, improve neuromuscular recruitment, and enhance functional recovery.
This study is designed as a single-center, single-blinded, randomized controlled trial conducted at the University of Lahore Teaching Hospital. A total of 36 participants with subacute stroke who meet the eligibility criteria will be recruited and randomly allocated into two equal groups using the sealed envelope randomization technique.
Participants in Group A will receive a structured Motor Relearning Program combined with Electrical Muscle Stimulation. The intervention will include repetitive task-oriented upper limb activities such as opening and closing bottle lids, lifting and drinking from a glass, arranging puzzles, reaching in different directions, transferring small objects, turning door handles, and turning book pages. EMS will be applied to the affected upper limb muscles, including the deltoid, biceps brachii, triceps brachii, wrist flexors and extensors, and finger flexors and extensors, using surface electrodes for 10 minutes during each treatment session.
Participants in Group B will receive the identical Motor Relearning Program without Electrical Muscle Stimulation. Both groups will receive treatment for 1 hour per day, 5 days per week, for 6 consecutive weeks, with progression of task difficulty according to individual performance.
Outcome assessments will be performed at baseline and after completion of the 6-week intervention. The primary outcome measures are the Upper Extremity Fugl-Meyer Assessment (UEFMA) and the Modified Ashworth Scale (MAS). The secondary outcome measure is the Motor Evaluation Scale for Upper Extremity in Stroke (MESUPES). These validated outcome measures will be used to evaluate motor recovery, upper limb function, and muscle tone.
The study aims to determine whether the addition of Electrical Muscle Stimulation to a Motor Relearning Program produces superior improvements in upper limb motor function compared with the Motor Relearning Program alone in individuals with subacute stroke. The results may contribute evidence to support the development of effective rehabilitation strategies for upper limb recovery following stroke.
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: Laraib Gull, MSPTN
- Telefonní číslo: 03123592198
- E-mail: laraibgull9697@gmail.com
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 54000
- Nábor
- Shadman Medical Center, Lahore
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Kontakt:
- Montiha Azeem, MSPTN
- Telefonní číslo: 03479717317
- E-mail: muntahaazeem9@gmail.com
-
Kontakt:
- Laraib Gull, MSPT N
- Telefonní číslo: 03123592198
- E-mail: muntahaazeem9@gmail.com
-
Vrchní vyšetřovatel:
- Laraib Gull, MSPTN
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Age 40-65 years
- Both male and female
- Sub acute stroke patients diagnosed by neurologist
- Motor assessment scale score 2-3
- Subjects able to sit for 30 secs without using upper extremities for support.
- Modified Ashworth scale value < 2
Exclusion Criteria:
- Patients with Mini Mental State Examination <23
- Cognitive disorders and perceptual disorders
- Any musculoskeletal disorders
- Severe cardiac diseases
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 Motor Relearning Program + Electrical Muscle Stimulation
Participants will receive a Motor Relearning Program combined with Electrical Muscle Stimulation (EMS).
The Motor Relearning Program will consist of task-oriented upper limb activities for 1 hour per session, 5 days per week, for 6 weeks.
EMS will be applied to the affected upper limb muscles for 10 minutes during each treatment session.
|
Electrical Muscle Stimulation will be applied to the affected upper limb muscles, including the deltoid, biceps brachii, triceps brachii, wrist flexors and extensors, and finger flexors and extensors, using surface electrodes for 10 minutes during each treatment session.
Stimulation intensity will be adjusted to produce visible, pain-free muscle contractions according to participant tolerance.
EMS will be administered in combination with the Motor Relearning Program, 5 days per week for 6 weeks.
|
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Aktivní komparátor: group B Motor Relearning Program
Participants will receive the same Motor Relearning Program consisting of task-oriented upper limb exercises for 1 hour per session, 5 days per week, for 6 weeks, without Electrical Muscle Stimulation.
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Participants will receive a structured Motor Relearning Program consisting of repetitive task-oriented upper limb activities, including reaching, grasping, object manipulation, lifting, puzzle arrangement, and functional daily living tasks.
Therapy will be provided for 1 hour per session, 5 days per week, for 6 weeks, with progressive increases in task difficulty according to participant performance.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Upper Extremity Fugl-Meyer Assessment (UEFMA)
Časové okno: Baseline and Week 6
|
The UEFMA will be used to assess upper limb motor recovery following the intervention.
Scores obtained at baseline and after the 6-week intervention will be compared between the two study groups to evaluate changes in upper extremity motor function.
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Baseline and Week 6
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Laraib Gull, 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
Klíčová slova
Další identifikační čísla studie
- UOL/IREB/25/15/03/23
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