- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07619703
Effects of a Neurorehabilitation Program Based on CIMT and Non-invasive Neuromodulation Through C-tDCS on the Recovery of Paretic Upper Limb Function, Quality of Life, and Therapeutic Alliance in Women From the Araucanía Region Who Suffered a Stroke (CIMT + tDCS). ((CIMT - tDCS))
Effects of a Neurorehabilitation Program Based on Constraint-Induced Movement Therapy (CIMT) and Non-invasive Neuromodulation Through Cerebellar Transcranial Direct Current Stimulation (C-tDCS) on the Recovery of Paretic Upper Limb Function, Quality of Life, and Therapeutic Alliance in Women From the Araucanía Region Who Suffered a Stroke.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Arlette Doussoulin, PhD
- 전화번호: +56997445912
- 이메일: arlette.doussoulin@ufrontera.cl
연구 장소
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Araucania
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Temuco, Araucania, 칠레, 4780000
- 모병
- Universidad de La Frontera, Temuco, Chile.
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연락하다:
- Arlette Doussoulin, Phd Human Motricity
- 전화번호: 997445912
- 이메일: arlette.doussoulin@ufrontera.cl
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부수사관:
- Ornella Bahamondes, Msc
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부수사관:
- Mauro Obreque, Msc
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Women aged between 30 and 80 years.
- Who present hemorrhagic or ischemic stroke confirmed by CT with evolution greater than 1 month, corroborated by discharge epicrisis supporting the diagnosis of the patient.
- Who presents trunk control in sitting.
- Score greater than 14 points on the Minimental Examination scale.
- Function of the upper extremity, referring to taking and releasing a small ball with the affected hand and signing or accepting the consent written informed.
Exclusion Criteria:
- Shoulder pain greater than 4 according to the VAS scale and spasticity greater than 2 according to the Modified Ashworth Scale.
- Sensory compromise (visual-auditory).
- Presence of severe aphasia.
- Cochlear implants, aneurysm clips, brain electrodes and cardiac pacemaker.
- Epilepsy or psychiatric disorders (diagnosed in the last 3 months).
- Pregnancy, use of psychotropic medications.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: CIMTm y ctDCS
c-tDCS will be applied during the first 20 minutes of the session simultaneously with the practice of motor tasks of specific movements aimed at the upper extremity, continuing the session with 100 minutes of CIMTm.
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Intervention: The protocol will be carried out in a total of 10 sessions, with a daily frequency over a period of 2 weeks. Experimental group: The c-tDCS will be applied for the first 20 minutes, along with the performance of the first motor tasks associated with CIMTm. To do this, a direct current of between 1.5 to 2 mA will be used in the right cerebellar hemisphere. The CIMTm will be implemented with a duration of 120 minutes and consists of 3 components: repetitive task training, use of a glove on the healthy hand and behavioral transfer package. Control group: The electrodes will be located in the same position of the EG, but simulated stimulation (sham) will be used, which will consist of the application of an initial current that will be maintained for one minute with a 30-second ramp until reaching 1.5 mA and a 30-second descending ramp, after which the device will turn off (program available on the equipment). The CIMTm session is the same as the experimental group.
다른 이름들:
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가짜 비교기: CIMTm y ctDCS sham
c-tDCS (sham) will be used, which will consist of the application of an initial current that will be maintained for one minute with a 30-second ramp until reaching 1.5 mA and a 30-second descending ramp, after which the device will turn off (program available on the device).
|
Intervention: The protocol will be carried out in a total of 10 sessions, with a daily frequency over a period of 2 weeks. Experimental group: The c-tDCS will be applied for the first 20 minutes, along with the performance of the first motor tasks associated with CIMTm. To do this, a direct current of between 1.5 to 2 mA will be used in the right cerebellar hemisphere. The CIMTm will be implemented with a duration of 120 minutes and consists of 3 components: repetitive task training, use of a glove on the healthy hand and behavioral transfer package. Control group: The electrodes will be located in the same position of the EG, but simulated stimulation (sham) will be used, which will consist of the application of an initial current that will be maintained for one minute with a 30-second ramp until reaching 1.5 mA and a 30-second descending ramp, after which the device will turn off (program available on the equipment). The CIMTm session is the same as the experimental group.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Effects of CIMTm combined with c-tDCS on paretic upper extremity function in women with stroke.
기간: From enrollment to the end of treatment at 8 weeks.
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Evaluated through the Action Research Arm Test (pre- and post-treatment): scale that evaluates both arms in order to obtain a total description of the function of the upper extremity, after a cortical injury.
It is made up of 19 items grouped into 4 subtests: grip, grasp, clamp, gross movement.
All items are evaluated on a 4-point scale from 0 (no movement) to 3 (normal movement).
This measure has been widely validated in Spanish-American speaking countries, thereby obtaining its degree of reliability and instrumental validity.
The reliability analysis using Cronbach's alpha obtained in the studies was 0.96, indicating high internal consistency.
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From enrollment to the end of treatment at 8 weeks.
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Effects of CIMTm combined with c-tDCS on paretic upper extremity function in women with stroke.
기간: From enrollment to the end of treatment at 4 weeks.
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Evaluated through the Action Research Arm Test (pre-postreatment), a scale that evaluates both arms in order to obtain a total description of the function of the upper extremity, after a cortical injury.
It is made up of 19 items grouped into 4 subtests: grip, grasp, clamp, gross movement.
All items are evaluated on a 4-point scale from 0 (no movement) to 3 (normal movement).
This measure has been widely validated in Spanish-American speaking countries, thereby obtaining its degree of reliability and instrumental validity.
The reliability analysis using Cronbach's alpha obtained in the studies was 0.96, indicating high internal consistency.
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From enrollment to the end of treatment at 4 weeks.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Universidad de La Frontera
- CIMT + ctDCS (기타 식별자: Universidad de La Frontera)
- CIMTm + ctDCS (기타 식별자: Red Neuroaraucanía Chile)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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