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Effects of Multimodal Neuro Rehabilitation on Cortical Activity and Muscle Syenergy in Spastic Cerebral Palsy

4. května 2026 aktualizováno: Riphah International University
  • To determine the effects of tDCS in conjunction with task-oriented training (TOT) and virtual reality (VR) as compared with sham stimulation and conventional physiotherapy on cortical activity and muscle synergy.
  • To determine the retention effects of tDCS in conjunction with task-oriented training (TOT) and virtual reality (VR) as compared with sham stimulation and conventional physiotherapy on cortical activity and muscle synergy, one-month follow-up across the five groups.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

  • To determine the effects of tDCS in conjunction with task-oriented training (TOT) and virtual reality (VR) as compared with sham stimulation and conventional physiotherapy on
  • gross motor function, gait, balance, mobility, dexterity, and spasticity.
  • executive functions
  • self-esteem.

Typ studie

Intervenční

Zápis (Odhadovaný)

150

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Children aged 6-18 years.
  • Neurologist-confirmed spastic cerebral palsy.
  • GMFCS Levels I-III (mild to moderate motor impairment).
  • Ability to understand and follow simple instructions.
  • Medically stable (no planned major surgery; no recent adjustment of medications affecting cortical excitability).
  • Parental/guardian written informed consent and child assent.

Exclusion Criteria:

  • Active uncontrolled epilepsy or history of seizure in the last year.
  • Metal implants in the head or implanted medical/electrical devices (e.g., cochlear implants, ventriculoperitoneal shunts, pacemakers).
  • Significant visual or auditory impairments that would interfere with task performance.
  • Severe behavioral or cognitive difficulties that would prevent safe application of tDCS or training tasks.
  • Currently taking medications known to significantly alter cortical excitability (e.g., benzodiazepines, antiepileptics) if dosage is unstable.
  • Participation in other experimental neurorehabilitation or brain stimulation interventions within the last 6 months.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Group A: Active Anodal Transcranial direct current stimulation + Task-Oriented Training
Participants receive active anodal transcranial direct current stimulation (tDCS) applied concurrently with task-oriented training.
Přístroj: Active Anodal Transcranial Direct Current Stimulation (tDCS) + Task-Oriented Training

Active anodal transcranial direct current stimulation is delivered using a certified tDCS device at a low, safe intensity according to pediatric guidelines. Stimulation is applied to the scalp for approximately 20 minutes per session and is delivered concurrently with task-oriented training. Task-oriented activities individualized to motor deficits, emphasizing:

  • Functional reaching
  • Grasp-release tasks
  • Bilateral coordination
  • Balance and postural activities
  • Each session includes 10-15 task circuits, progressing from simple to complex tasks based on child performance.
Falešný srovnávač: Sham Transcranial direct current stimulation + Task-Oriented Training
Participants receive sham (inactive) transcranial direct current stimulation combined with task-oriented training.
Přístroj: Sham Active Anodal Transcranial Direct Current Stimulation + Task-Oriented Training
Sham stimulation will mimic active tDCS for the first 30 seconds (ramp up/down) and then deliver no current for the remainder of the session, ensuring blinding. TOT protocol is identical to Group 1.
Experimentální: Active Anodal Transcranial direct current stimulation + Virtual Reality Therapy
Participants receive active anodal transcranial direct current stimulation (tDCS) combined with virtual reality based rehabilitation.
Přístroj: Active Anodal Transcranial Direct Current Stimulation + Virtual Reality

Active anodal transcranial direct current stimulation is delivered using a certified tDCS device at a low, safe intensity according to pediatric guidelines. Stimulation is applied to the scalp for approximately 20 minutes per session and is delivered concurrently with Virtual Reality. System: Pediatric upper-limb and balance VR rehabilitation system Activities: Interactive tasks including

  • reaching,
  • stepping,
  • virtual object manipulation,
  • coordination games.
  • Session duration: 30 to 40 minutes Difficulty automatically progresses based on performance metrics (speed, accuracy, movement amplitude)
Falešný srovnávač: Sham Transcranial direct current stimulation + Virtual Reality Therapy
Participants receive sham (inactive) transcranial direct current stimulation combined with virtual reality based rehabilitation.
Přístroj: Sham Active Anodal Transcranial Direct Current Stimulation + Virtual Reality
Sham stimulation will mimic active tDCS for the first 30 seconds (ramp up/down) and then deliver no current for the remainder of the session, ensuring blinding. VR protocol identical to Group 3
Aktivní komparátor: Conventional Physiotherapy
Participants receive conventional physiotherapy based on standard clinical practice for spastic cerebral palsy.
Jiný: Conventional Physiotherapy
  • Stretching of spastic muscle groups
  • Strengthening exercises for weak muscle groups
  • Balance and gait training
  • Functional mobility practice
  • Session duration: 45 minutes. Delivered by a trained pediatric physiotherapist following standard clinical guidelines.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Cortical Activity
Časové okno: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Quantitative electroencephalography (EEG) parameters to assess changes in brain activity specifically cortical activity. EEG data will be recorded using a 14-channel system with electrodes placed according to the international 10-20 system, ensuring adequate spatial coverage of relevant cortical regions. Resting-state EEG will be obtained under eyes-open and eyes-closed conditions (5 minutes each) to evaluate baseline neural activity. At the event-related potentials (ERPs) cortical activity will be recorded during cognitive tasks such as oddball or Go/No-Go paradigms. Primary outcomes will include changes in power spectral density across standard frequency bands and alterations in ERP components (P3, N2, P2) in terms of amplitude and latency.
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Change in Muscle Synergy Patterns
Časové okno: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
The outcome measures for this clinical trial will include quantitative electromyography (EMG) parameters and muscle synergy analysis to evaluate neuromuscular function. Surface EMG signals will be recorded from key upper and lower limb muscles, including tibialis anterior, gastrocnemius medialis, soleus, rectus femoris, vastus lateralis, biceps femoris, semitendinosus, gluteus medius, flexor carpi radialis, extensor carpi radialis, biceps brachii, triceps brachii, deltoid, and first dorsal interosseous, at a sampling rate of ≥1000-2000 Hz following SENIAM guidelines for electrode placement. Primary outcomes will include normalized EMG amplitude and temporal activation patterns during functional tasks, processed band-pass filtering (20-450 Hz), rectification, and envelope smoothing. Muscle activity will be normalized using the maximum voluntary contraction (MVC) or peak-amplitude methods. Secondary outcomes will include muscle synergy characteristics derived using a non-negative matrix
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Measure Gross Motor Function children.
Časové okno: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
GMFM-66 focusing on functional movements such as lying, sitting, standing, and walking.
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Measures balance in children.
Časové okno: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Balance will be evaluated using the Pediatric Balance Scale (PBS; Children's Modified Berg, 14 items scored 0-4).
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Assesses walking speed in children
Časové okno: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Walking ability will be assessed using the 10-Meter Walk Test (10MWT) to calculate gait speed (m/s)
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Assesses mobility and balance in children
Časové okno: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Timed Up and Go (TUG): Assesses mobility and balance. (get out of a chair, walk three meters, turn, come back, and sit); time in seconds, average of two trials.
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Measures balance and reach ability in children
Časové okno: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Functional Reach Test (FRT): Measures balance and reach ability. Two to three attempts are recorded in centimeters for the standard forward reach distance.
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Assesses manual dexterity in children
Časové okno: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Box & Block Test (BBT): Assesses manual dexterity. The number of 1-inch cubes moved over the partition in 60 seconds, tested independently for each hand, and one practice trial was used to measure the standard BBT.
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Measures spasticity and muscle tone in children
Časové okno: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Modified Tardieu Scale (MTS): Measures spasticity and muscle tone. Joint specific passive stretches are carried out at predetermined speeds (V1, V2, V3)
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Measures functional performance and disability in children.
Časové okno: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Pediatric Evaluation of Disability Inventory (PEDI / PEDI-CAT): Measures functional performance and disability. record functional skills, caregiver support, and changes in self-care, mobility, and social function
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Assesses the child's self-esteem
Časové okno: Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up
Rosenberg Self-Esteem Scale (Child Version): Assesses the child's self-esteem. 10-item, 4-point Likert scale; total score represents overall self-esteem
Baseline (pre-intervention), immediately post-intervention (6 weeks), and 1-month follow-up

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Riphah International University

Vyšetřovatelé

  • Studijní židle: Waqar Ahmed Awan, PhD, Riphah International University
  • Vrchní vyšetřovatel: Riafat Mehmood, PhD*, Riphah International University
  • Studijní židle: Qamar Mehmood, PhD, Riphah international univesty

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

18. listopadu 2027

Dokončení studie (Odhadovaný)

14. ledna 2028

Termíny zápisu do studia

První předloženo

17. února 2026

První předloženo, které splnilo kritéria kontroly kvality

4. května 2026

První zveřejněno (Aktuální)

8. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PhD/011109

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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