Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP (tDCS)
Additional Effects on Transcranial Direct Current Stimulation (tDCS) With Action Observation Therapy on Lower Limb Functions on Children With Diplegic Cerebral Palsy
The goal of this clinical trial is to evaluate the therapeutic effects of combining active transcranial direct current stimulation (tDCS) with Action Observation Therapy (AOT) in pediatric patients diagnosed with spastic Cerebral Palsy. The main questions it aims to answer are:
- Does combining tDCS with AOT yield significantly greater improvements in gross motor function (measured by GMFM-88) compared to AOT alone?
- Does active tDCS paired with AOT lead to greater reductions in spasticity (MAS) and improvements in walking speed (10MWT) at 6 weeks post-intervention?
Researchers will compare participants receiving active tDCS plus AOT against a control group receiving sham tDCS plus AOT to isolate the synergistic effects of active brain stimulation.
Participants will:
- Complete baseline clinical evaluations including gross motor, spasticity, and gait assessments.
- Undergo scheduled intervention sessions consisting of tDCS administration combined with video-based Action Observation Therapy.
- Attend follow-up assessment sessions at the end of the intervention period and 6 weeks post-intervention.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Dr. Ayesha Bashir, MS-NMPT
- 전화번호: +923335256920
- 이메일: ayesha.bashir@riphah.edu.pk/
연구 연락처 백업
- 이름: Ayesha Bashir
연구 장소
-
-
Punjab Province
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Wah, Punjab Province, 파키스탄, 47000
- 모병
- Alam Family Hospital
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participants diagnosed with spastic diplegic cerebral palsy with a Modified Ashworth Scale (MAS) score of 2
- Age between 6 to 12 years old
- Participants classified as Communication Function Classification System (CFCS) Level II
- Participant with CFCS Level II
Exclusion Criteria:
- Presence of uncontrolled epilepsy (any seizure within the past 6 months).
- Implanted metallic or electronic devices (e.g., pacemaker, cochlear implant, deep brain stimulator).
- Severe dystonia, ataxia, or predominant weakness interfering with upper limb or lower limb function.
- Severe visual impairment (not correctable with aids) preventing participation in action observation tasks.
- Botulinum toxin injections in the affected limb(s) within the past 6 months or planned during study period.
- Orthopedic surgery to the affected limb(s) within the past 12 months or planned during study period.
- Skin conditions, lesions, or infections at electrode placement sites.
- Current use of medications significantly affecting cortical excitability (e.g., high-dose benzodiazepines, anticonvulsants), unless cleared by neurologist.
- Participation in another interventional clinical trial within the past 3 months.
- Any medical or psychiatric condition that, in the investigator's judgment, makes participation unsafe or interferes with study outcomes.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: Experimental Group
TDCS+ Action observation Therapy |
Observation of video recorded Active Anodal tDCS (1-1.5 mA) |
|
가짜 비교기: Control Group
Sham TDCs + Action Observation Therapy |
Observation of video recorded Sham TDCs |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Gross Motor Functional Measurement (GMFM-88)
기간: Baseline and 6 months (post - intervention)
|
Assessment of Gross Motor Capacity focusing on standing |
Baseline and 6 months (post - intervention)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
10-Meter Walk Test (10MWT)
기간: Baseline and 6 weeks (post-intervention)
|
Measures walking speed in meters per second over 10 meters |
Baseline and 6 weeks (post-intervention)
|
|
Modified Ashworth Scale (MAS) - Muscle tone
기간: Baseline and 6 weeks (post-intervention)
|
Evaluate muscle spasticity in lower limb joints |
Baseline and 6 weeks (post-intervention)
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Ayesha Bashir, Riphah International University
간행물 및 유용한 링크
일반 간행물
- Jeong YA, Lee BH. Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy. Children (Basel). 2020 Jun 18;7(6):64. doi: 10.3390/children7060064.
- Magdy E, Hanna S, Shoukry KE-S. Effect of Action Observation Training on Gross Motor Functions in Children with Spastic Cerebral Palsy. Egyptian Journal of Hospital Medicine. 2025;97(1):3820-6.
- Zhong M, Zhang Y, Luo J, Chen T, Zhang J, Peng T Sr, Han M, Le W, Peng T Jr, Xu K. Safety and effectiveness of non-invasive brain stimulation on mobility and balance function in children with cerebral palsy: a systematic review and meta-analysis. J Neuroeng Rehabil. 2025 May 18;22(1):111. doi: 10.1186/s12984-025-01619-7.
- Lench DH, Christopher P, Gavioli M, Nytes G, Ikonomidou C, Villegas MA, Gillick BT. Long-term outcome safety assessment after teleneuromodulation in children with cerebral palsy. Brain Stimul. 2024 May-Jun;17(3):633-635. doi: 10.1016/j.brs.2024.04.017. Epub 2024 May 11. No abstract available.
- Stein A, Riddle J, Caulfield KA, Dux PE, Friehs MA, Schroeder PA, Craven MP, Groom MJ, Iyer KK, Barlow KM. Safety, Feasibility, and Tolerability of Ten Days of At-Home, Remotely Supervised tDCS During Gamified Attention Training in Children with Acquired Brain Injury: An Open-Label, Dose-Controlled Pilot Trial. Brain Sci. 2025 May 24;15(6):561. doi: 10.3390/brainsci15060561.
- Farzamfar P, Heirani A, Amiri E, Sedighi M, da Silva Machado DG. The Effect of Transcranial Direct Current Stimulation on M1 with and without Mirror Visual Feedback on Range of Motion and Hand Grip Strength of the Affected Upper Limb in Children with Spastic Hemiplegic Cerebral Palsy. Iran J Child Neurol. 2024 Fall;18(4):93-106. doi: 10.22037/IJCN.V18I4.45110. Epub 2024 Sep 29.
- Tang L, Wu Y, Ma J, Lu Y, Wang L, Shan C. Application of tDCS in children with cerebral palsy: A mini review. Front Pediatr. 2022 Sep 20;10:966650. doi: 10.3389/fped.2022.966650. eCollection 2022.
- Christopher P, Sutter EN, Gavioli M, Lench DH, Nytes G, Mak V, Simpson EA, Ikonomidou C, Villegas MA, Saiote C, Gillick BT. Safety, tolerability and feasibility of remotely-instructed home-based transcranial direct current stimulation in children with cerebral palsy. Brain Stimul. 2023 Sep-Oct;16(5):1325-1327. doi: 10.1016/j.brs.2023.08.024. Epub 2023 Aug 29. No abstract available.
- He W, Huang Y, He L, Liu L, Zeng P, Qiu H, Wang X, Zhou H, Chen Z, Xu Y, Zhao J, Wang W, Tang H, Xu K. Safety and effects of transcranial direct current stimulation on hand function in preschool children with hemiplegic cerebral palsy: A pilot study. Front Behav Neurosci. 2022 Sep 9;16:925122. doi: 10.3389/fnbeh.2022.925122. eCollection 2022.
- Beani E, Menici V, Sicola E, Ferrari A, Feys H, Klingels K, Mailleux L, Boyd R, Cioni G, Sgandurra G. Effectiveness of the home-based training program Tele-UPCAT (Tele-monitored UPper Limb Children Action Observation Training) in unilateral cerebral palsy: a randomized controlled trial. Eur J Phys Rehabil Med. 2023 Oct;59(5):554-563. doi: 10.23736/S1973-9087.23.07945-5. Epub 2023 Jul 18.
- Errante A, Beccani L, Verzelloni J, Maggi I, Filippi M, Bressi B, Ziccarelli S, Bozzetti F, Costi S, Ferrari A, Fogassi L. Effectiveness of action observation treatment based on pathological model in hemiplegic children: a randomized-controlled trial. Eur J Phys Rehabil Med. 2024 Aug;60(4):643-655. doi: 10.23736/S1973-9087.24.08413-2. Epub 2024 May 30.
- Simon-Martinez C, Mailleux L, Jaspers E, Ortibus E, Desloovere K, Klingels K, Feys H. Effects of combining constraint-induced movement therapy and action-observation training on upper limb kinematics in children with unilateral cerebral palsy: a randomized controlled trial. Sci Rep. 2020 Jun 26;10(1):10421. doi: 10.1038/s41598-020-67427-2.
- Beani E, Matteucci E, Sicola E, Martini G, Di Lieto MC, Bombonato C, Menici V, Cotardo A, Rizzo M, Filogna S, Camuncoli F, Biagi L, Cioni G, Fedeli F, Gelmini C, Neviani R, Vecchi O, Perazza S, Faccioli S, Errante A, Piras A, Sicuri E, Bozzetti F, Boyd RN, Ferrari A, Fogassi L, Sgandurra G. ACT-ON-DIP: Study Protocol of a Randomized Controlled Trial of a Home-Based ACTion Observation Tele-RehabilitatioN for Upper Limb in Children with DIPlegic Cerebral Palsy. Children (Basel). 2025 Sep 14;12(9):1229. doi: 10.3390/children12091229.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- RCRAHS-ISB/REC/MS-PT/02470
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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