Short-term Spinal Stimulation Effects in Cerebral Palsy
Acute Effects of Transcutaneous Spinal Stimulation on Spasticity and Gait in Cerebral Palsy
연구 개요
상세 설명
Children with cerebral palsy (CP) have altered neuromuscular control that impacts gait and participation in daily activities. This research will characterize the acute effects of transcutaneous spinal stimulation (tSCS) on spasticity and gait for individuals with CP using a combined approach of quantitative biomechanical assessment and clinician assessment. Previous research has shown decreases in spasticity after walking with tSCS, but it is unclear whether these changes are due to physical activity or neuromodulation. This research will provide a foundation to characterize changes in spasticity after an acute session of tSCS for individuals with CP.
This research will use the SpineX Spinal Cord Innovation in Pediatrics (SCiP) system. The SCIP system allows for tSCS intensity (mA) at two electrodes to be independently adjusted in 1 mA increments. Other stimulation parameters such as pulse frequency (30 Hz), overlap frequency (10 kHz), pulse width (1 ms), and waveform (biphasic) are constant on the SCiP device. To target sensorimotor function of lower-extremity muscle groups within the spinal cord, the two electrodes are positioned over the spinous process at T11 and L1 with grounding electrodes placed on the pelvis. The tSCS intensity will be set to each individual's maximum tolerable stimulation intensity.
This study will recruit 20 individuals with CP to attend two in-lab visits. One visit will include treadmill walking with tSCS and the other will include treadmill walking without tSCS. The visit order will be pseudo-randomized and balanced across participants. Participants will be consented at the initial visit and will also conduct 3 trials of the 10-Meter Walk Test to evaluate self-selected walking speed. The average speed from these trials will be used to set treadmill speed. At the beginning of each visit, participants will complete a physical exam to characterize range of motion and spasticity via the Modified Tardieu Scale. Participants will complete a 5-minute treadmill familiarization at their self-selected speed to ensure it is comfortable. The tSCS intensity will gradually increase during treadmill familiarization until participants report discomfort. The tSCS intensity will be set at 1 mA below the level of discomfort if the visit calls for tSCS. During the treadmill walking, participants will walk at their self-selected walking speed for 10 - 20 minutes with either (1) no stimulation or (2) tSCS at their maximum tolerable stimulation intensity.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Katherine Steele, PhD
- 전화번호: 206-685-2390
- 이메일: kmsteele@uw.edu
연구 연락처 백업
- 이름: Katie Landwehr, MS
- 전화번호: 206-543-0116
- 이메일: klandweh@uw.edu
연구 장소
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Washington
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Seattle, Washington, 미국, 98195
- 모병
- University of Washington
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연락하다:
- Katie Landwehr, MS
- 전화번호: 206-543-0116
- 이메일: klandweh@uw.edu
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-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Individuals who:
- have a diagnosis of spastic cerebral palsy or high likelihood of CP diagnosis
- are 4-65 years of age
- have spasticity in lower-extremity muscles
- are at a functional Gross Motor Function Classification System (GMFCS) Level I-III
- can walk for at least 10 minutes with/without support
- can understand and follow simple directions
- have a stable medical condition, as reported by the caregiver/parent
Exclusion Criteria:
Individuals who:
- who have had lower-extremity surgery or injury in the prior 12 months
- have had botulinum toxin injections in the prior 3 months
- have had selective dorsal rhizotomy (SDR) in the past
- have uncontrolled seizures
- have significant cardiovascular or musculoskeletal disease that would prevent full participation
- are dependent on ventilation support
- have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump)
- have established osteoporosis and taking medication for osteoporosis treatment.
- have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- have active cancer
- have received stem cell injections into the spinal cord
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Spinal Stimulation First (AB Arm)
Participants randomized into this arm will complete two visits.
The first visit will use spinal stimulation while walking on a treadmill, and the second visit will be treadmill walking without stimulation.
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A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).
다른 이름들:
Participant will walk on a treadmill.
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실험적: No Spinal Stimulation First (BA Arm)
Participants randomized into this arm will complete two visits.
The first visit will involve walking on a treadmill without stimulation, while the second visit will be treadmill walking with stimulation.
|
A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).
다른 이름들:
Participant will walk on a treadmill.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Modified Tardieu Scale of Spasticity
기간: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
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Change in quality of muscle reaction of the gastrocnemius assessed by the score on the Tardieu assessment.
Lower score indicates less spasticity.
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End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Step Length
기간: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
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From quantitative gait analysis step length is quantified as the average during the final minute of walking using gait analysis and markers on the foot.
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End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
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Gait Deviation Index (GDI)
기간: Last 5 minutes of treadmill walking during visit relative to baseline at start of walking.
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A multivariate metric derived from quantitative gait analysis that quantifies how much a gait cycle deviates from normative data.
Average GDI calculated at the last 5 minutes of walking.
Higher GDI indicates more normative walking.
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Last 5 minutes of treadmill walking during visit relative to baseline at start of walking.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Katherine Steele, PHD, University of Washington
- 수석 연구원: Heather Feldner, PhD, University of Washington
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
기타 연구 ID 번호
- STUDY00014877-A
- R21HD121135 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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