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

2026년 5월 4일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

  • 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.

연구 유형

중재적

등록 (추정된)

150

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

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.
가짜 비교기: Sham Transcranial direct current stimulation + Task-Oriented Training
Participants receive sham (inactive) transcranial direct current stimulation combined with 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.
실험적: Active Anodal Transcranial direct current stimulation + Virtual Reality Therapy
Participants receive active anodal transcranial direct current stimulation (tDCS) combined with virtual reality based rehabilitation.

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)
가짜 비교기: Sham Transcranial direct current stimulation + Virtual Reality Therapy
Participants receive sham (inactive) transcranial direct current stimulation combined with virtual reality based rehabilitation.
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
활성 비교기: Conventional Physiotherapy
Participants receive conventional physiotherapy based on standard clinical practice for spastic cerebral palsy.
  • 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Cortical Activity
기간: 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
기간: 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.
기간: 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.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 연구 의자: Waqar Ahmed Awan, PhD, Riphah International University
  • 수석 연구원: Riafat Mehmood, PhD*, Riphah International University
  • 연구 의자: Qamar Mehmood, PhD, Riphah international univesty

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2027년 11월 18일

연구 완료 (추정된)

2028년 1월 14일

연구 등록 날짜

최초 제출

2026년 2월 17일

QC 기준을 충족하는 최초 제출

2026년 5월 4일

처음 게시됨 (실제)

2026년 5월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 4일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • PhD/011109

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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