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

4. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

  • 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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

150

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Gerät: 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.
Schein-Komparator: Sham Transcranial direct current stimulation + Task-Oriented Training
Participants receive sham (inactive) transcranial direct current stimulation combined with task-oriented training.
Gerät: 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.
Experimental: Active Anodal Transcranial direct current stimulation + Virtual Reality Therapy
Participants receive active anodal transcranial direct current stimulation (tDCS) combined with virtual reality based rehabilitation.
Gerät: 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)
Schein-Komparator: Sham Transcranial direct current stimulation + Virtual Reality Therapy
Participants receive sham (inactive) transcranial direct current stimulation combined with virtual reality based rehabilitation.
Gerät: 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
Aktiver Komparator: Conventional Physiotherapy
Participants receive conventional physiotherapy based on standard clinical practice for spastic cerebral palsy.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Cortical Activity
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Riphah International University

Ermittler

  • Studienstuhl: Waqar Ahmed Awan, PhD, Riphah International University
  • Hauptermittler: Riafat Mehmood, PhD*, Riphah International University
  • Studienstuhl: Qamar Mehmood, PhD, Riphah international univesty

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

18. November 2027

Studienabschluss (Geschätzt)

14. Januar 2028

Studienanmeldedaten

Zuerst eingereicht

17. Februar 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Mai 2026

Zuerst gepostet (Tatsächlich)

8. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PhD/011109

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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