Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury
2022년 1월 6일 업데이트: Dorothy Barthélemy, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sensorimotor Integration Underlying Balance Control in Individuals With Incomplete Spinal Cord Injury: Assessing Neural Changes After the Injury and Promoting Recovery Through Specific Training
The objectives of the study are to evaluate a 4-week mixed training paradigm consisting of explosive strength training and balance perturbation training efficacy on balance control during standing and locomotion, and to understand the mechanisms of neuroplasticity that would improve sensorimotor integration at supraspinal and spinal levels.
연구 개요
상세 설명
After obtaining their consent, participants will undertake evaluations at different times:
- Assessment 1 week prior to training
- Training over 4 weeks (nature of the training depends on the group)
- Assessment 1 week after training
- Assessment 1 month after training (follow-up)
Each assessment will be divided in 2 sessions and data will be collected over 2 days, at one session per day. Days can be consecutive or non-consecutive but will be within a given week. The assessment consists of:
- Session 1 (S1; duration: 3h) will include presentation of the Study and obtainment of consent, clinical tests, galvanic vestibular stimulation testing, postural reactions and gait assessment.
- Session 2 (S2; duration: 3h) will include muscle strength, short-afference inhibition, paired pulse and trans cranial magnetic stimulation conditioning of H reflex.
After the initial assessment, iSCI participants will be separated in 2 groups and will receive combination of explosive strength and balance training or no intervention. The training will span over 12 sessions (3 times per week for 4 weeks) and each training session will last approximately 1h (including effective training and installation periods).
연구 유형
중재적
등록 (예상)
36
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Dorothy Barthélemy, PhD, PT
- 전화번호: 514-343-7712
- 이메일: dorothy.barthelemy@umontreal.ca
연구 장소
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Quebec
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Montréal, Quebec, 캐나다
- 모병
- Neuromobility lab
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연락하다:
- Dorothy Barthélemy, PhD, PT
- 전화번호: 514-343-7712
- 이메일: dorothy.barthelemy@umontreal.ca
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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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
FOR PARTICIPANTS WITH SPINAL CORD INJURY
Inclusion Criteria:
- Have an incomplete lesion of spinal cord
- Level of spinal cord lesion between C5 and T12
- At least, 6 months post-injury
- Be considered as AIS C or D
- Be able to stand without support for 15 seconds
- Be able to provide informed consent in English or in French
Exclusion Criteria:
- To have cognitive deficits
- To have personal or family history of epilepsy
- To have suffered moderate or severe traumatic brain injury
- To have cochlear implant
FOR CONTROL PARTICIPANTS
Exclusion Criteria:
- To have orthopedics problems
- To have cognitive deficits
- To have neurological problems
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: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Combined explosive strength and specific balance training group
This group will be formed with participants with incomplete spinal cord injury.
This group will perform 4 weeks of combined explosive strength and specific balance training.
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Training will consist to perform one hour of combined ankle explosive strength training and specific balance training using randomized perturbations. Explosive strength training: Participants will perform only 2 sets of 3 min (12 contractions for each set) for both lower limbs and both ankle plantar- and dorsiflexion movements. Balance specific training: Participants will be standing, secured by an adjusted harness, which do not support the weight but is strictly there to prevent a fall. They will have online visual feedback of their CoP via an avatar on the screen in front of them. Each training session will consist of 10 sequences of 3 min, including the 5 different conditions:
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간섭 없음: Spinal cord injury control group
This group will be formed with participants with incomplete spinal cord injury.
They will perform all the evaluation before and after a 4-week period of rest (no training).
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간섭 없음: Healthy control group
Healthy participants will be recruited based on the age and sex of the participants with incomplete spinal cord injury to realize clinical and neurophysiological cortical evaluations.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in muscles EMG responses following balance perturbation
기간: Pre-intervention, immediately after and one-month after intervention
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Evaluation of the latency on Soleus and Tibialis anterior muscles EMG following backward and forward perturbations will be done.
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Pre-intervention, immediately after and one-month after intervention
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Change in center of pressure displacement following balance perturbation using a force platform
기간: Pre-intervention, immediately after and one-month after intervention
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Excursion of centre of pressure will be analyzed following forward and backward perturbation.
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Pre-intervention, immediately after and one-month after intervention
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Change in ankle muscle strength using force transducer
기간: Pre-intervention, immediately after and one-month after intervention
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Evaluation of isometric dorsi- and planti-flexors muscle strength in Newton will be done using a force transducer attached to the participant's feet.
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Pre-intervention, immediately after and one-month after intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in intracortical mechanisms using transcranial magnetic stimulation (TMS)
기간: Pre-intervention, immediately after and one-month after intervention
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A paired-pulses paradigm (two trans cranial magnetic stimulations at motor cortex level) will be used to evaluate the intracortical mechanisms
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Pre-intervention, immediately after and one-month after intervention
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Change in the influence of peripheral afferents on cortical output using short-afference inhibition
기간: Pre-intervention, immediately after and one-month after intervention
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A stimulation (using TMS) at motor cortex level will be triggered just after a peripheral electrical stimulation of tibial nerve to evaluate the peripheral afferents on cortical output.
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Pre-intervention, immediately after and one-month after intervention
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Change in the modulation of the H reflex by the corticospinal tract
기간: Pre-intervention, immediately after and one-month after intervention
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A stimulation (using TMS) at motor cortex level will be triggered just before a tibial nerve stimulation to evaluate the modulation of the H reflex by the corticospinal tract.
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Pre-intervention, immediately after and one-month after intervention
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Change in EMG responses following vestibular stimulations during quiet standing
기간: Pre-intervention, immediately after and one-month after intervention
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Galvanic vestibular stimulation will be triggered during quiet standing.
EMG responses of Soleus and Tibialis Anterior muscles will be analyzed.
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Pre-intervention, immediately after and one-month after intervention
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Change in the excursion of the center of pressure following vestibular stimulations
기간: Pre-intervention, immediately after and one-month after intervention
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Galvanic vestibular stimulation will be triggered during quiet standing.
The displacement of the center of pressure will be analyzed using a force platform.
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Pre-intervention, immediately after and one-month after intervention
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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MOntreal Cognitive Assessment (MoCA) score
기간: Before enrollment
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The maximal score is 30 and minimal score 0.
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Before enrollment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (실제)
2018년 7월 9일
기본 완료 (예상)
2022년 12월 1일
연구 완료 (예상)
2022년 12월 1일
연구 등록 날짜
최초 제출
2021년 9월 1일
QC 기준을 충족하는 최초 제출
2022년 1월 6일
처음 게시됨 (실제)
2022년 1월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 1월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 1월 6일
마지막으로 확인됨
2022년 1월 1일
추가 정보
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척수 손상에 대한 임상 시험
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Rennes University Hospital완전한