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临床试验 NCT05571033 (SRC-CP) 针对脑瘫，痉挛性脑瘫目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy (SRC-CP) 12
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临床试验NCT05571033 (SRC-CP)是一项针对脑瘫，痉挛性脑瘫的干预性研究试验，目前试验状态为招募中。试验始于2022年9月30日，计划招募12名患者。该研究由Burke Medical Research Institute主导，预计于2026年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2023年9月26日。
简要概括
12 adults with spastic CP will complete 6 baseline sessions and 24 down conditioning sessions held 3 times/week. All clinical and physiological assessments collected at baseline will be reassessed after study completion, and follow ups after 2 weeks, 1 month and 3 months. The soleus H reflex (electric analogue of the stretch reflex) will be elicited in all sessions. In each session, participants will complete 20 base...显示更多
详细描述
Individuals with CP face significant challenges due to spasticity that causes activity and participation restrictions with increase in secondary conditions. This is caused by injury to the upper motor neurons causing disruption to the neural circuitry responsible for maintaining motor tone. A novel intervention, OC of the H reflex has shown promising effects to reduce spasticity and improve motor function in people w...显示更多
官方标题
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
疾病
脑瘫痉挛性脑瘫出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- SRC-CP
NCT编号
实际开始日期
2022-09-30
最近更新发布
2023-09-26
预计完成日期
2026-12-31
计划入组人数
12
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Hoffman Reflex
Spinal Reflex Conditioning
Spinal Reflex Conditioning
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Spinal reflex conditioning The OC intervention includes 6 baseline sessions and 24 conditioning/ no conditioning sessions held 3 times/week.
To elicit an H-reflex, participants will be asked to stand in a comfortable position. Small pulses of energy will be applied to a nerve in the leg called the tibial nerve. We will record when the participant maintains leg muscle activity. During the intervention, participants will be trained to decrease ...显示更多 | Spinal Reflex Conditioning Each participant will serve as their own control. The intervention is 30 sessions. The first 6 sessions are baseline measures of reflexes. The remaining sessions will engage participants in learning how to decrease their reflex activity in their calf muscle on the more-affected leg. Each intervention visit will involve 20 trials in which participants do not get visual feedback about their performance, then 225 trials...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Soleus H-Reflex size | Size of h-reflex as measured by EMG | Within one week before first intervention session to within one week after the end of intervention |
Attendance | Measure of feasibility of protocol, whether or not people can attend all sessions | At the end of the intervention, we will count the number of sessions each participant completed |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
10 meter walk test | Measure of how long it takes the participant to walk 10 meters | Within one week before the first intervention session to within one week after the end of intervention |
6 minute walk test | Measure the distance a participant can walk in 6 min | Within one week before the first intervention session to within one week after the end of intervention |
Fugl-Meyer | Standardized test of motor skill, range of motion, and spasticity | Within one week before the first intervention session to within one week after the end of intervention |
Modified Ashworth Scale | Measure of muscle spasticity in leg muscles | Within one week before the first intervention session to within one week after the end of intervention |
Range of motion | Measure of flexibility of leg joints | Within one week before the first intervention session to within one week after the end of intervention |
Fatigue Severity Scale | A survey of fatigue symptoms | Within one week before the first intervention session to within one week after the end of intervention |
Berg Balance Scale | Measure of participant's ability to balance | Within one week before the first intervention session to within one week after the end of intervention |
Timed up and Go | Measure of how quickly a participant can stand from a chair, walk, return to chair, and sit | Within one week before the first intervention session to within one week after the end of intervention |
Sit to Stand Test | Time it takes for a participant can stand up five times in a row | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) Anxiety question bank | computer-based survey for participants to answer questions about anxiety | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) Fatigue question bank | computer-based survey for participants to answer questions about fatigue | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) Depression question bank | computer-based survey for participants to answer questions about depression | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) General Life Satisfaction question bank | computer-based survey for participants to answer questions about General Life Satisfaction | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) General Self Efficacy question bank | computer-based survey for participants to answer questions about General Self Efficacy | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) Meaning and Purpose question bank | computer-based survey for participants to answer questions about Meaning and Purpose | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) Self-Efficacy for Managing Chronic Conditions question bank | computer-based survey for participants to answer questions about Self-Efficacy for Managing Chronic Conditions | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) Sleep Disturbances question bank | computer-based survey for participants to answer questions about sleep | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) Pain Interference question bank | computer-based survey for participants to answer questions about pain | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) Ability to Participate in Social Roles and Activities question bank | computer-based survey for participants to answer questions about Ability to Participate in Social Roles and Activities | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) Physical Function | computer-based survey for participants to answer questions about physical functioning | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) Satisfaction with Social Roles and Activities | computer-based survey for participants to answer questions about Satisfaction with Social Roles and Activities | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) Mobility question bank | computer-based survey for participants to answer questions about mobility | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) Social Isolation question bank | computer-based survey for participants to answer questions about isolation | Within one week before the first intervention session to within one week after the end of intervention |
Patient Reported Outcome Measures (PROMIS) Upper Extremity question bank | computer-based survey for participants to answer questions about hand and arm function | Within one week before the first intervention session to within one week after the end of intervention |
Change in size of motor evoked potential in the brain | Using single pulse transcranial magnetic stimulation, we will measure the amount of energy required to evoke a leg muscle movement from a stimulus delivered to the head | Within one week before the first intervention session to within one week after the end of intervention |
Manual Ability Classification System | A categorical measure of how well a participant can move their hands | Within one week before the first intervention session to within one week after the end of intervention |
Jebsen-Taylor Test of Hand Function | A timed test that measures how quickly the participant can move checkers, cans, and small objects | Within one week before the first intervention session to within one week after the end of intervention |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
- Age 18 and above
- Diagnosis of spastic Cerebral Palsy
- Gross Motor Function Classification System level I-III
- Stable medical background
- Current medication will remain unchanged for 3 months
- Provides informed consent
- can walk at least 10 meters with or without assistive device
- meets minimum study procedure requirements (elicitation of H-reflex).
- Pregnancy
- uncontrolled diabetes
- weak dorsiflexion
- History of cardiac conditions
- cognitive deficits that interfere with study procedure and steps for completion
- Botox within 2 months of the study
- H/O ankle surgeries in affected leg (Dorsal root rhizotomy etc.)
- regular use of electrical stimulation to lower extremity muscles
- Cochlear or metal implantations on body
- No history of seizure after age 2 years
- Current use of antiseizure medicines
- Any metal or magnetic components in the head (surgical clips, metal work etc.)
- Implanted device or cardiac pacemakers (applicable for DS8R too)
- Skin disorders
- Damaged skin (wounds, broken skin, or recent scar tissue)
- Allergy to latex (tape)
Burke Medical Research Institute研究中心联系人
联系人: Devina Kumar, PhD, 914-368-3160, [email protected]
1 位于 1 个国家/地区的研究中心
New York
Burke Neurological Institute, White Plains, New York, 10605, United States
Kathleen Friel, PhD, 联系人, 914-368-3116, [email protected]
Kathleen Friel, PhD, 主要研究者
招募中