Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Soleus H-Reflex size
研究概览
简要总结
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 baseline trials and 225 down conditioning trials to decrease the magnitude of the H-Reflex.
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 with stroke and spinal cord. Its many known benefits include easy administration, non-invasive technique, no side effects, and long-term retention. In the study, the investigators will attempt to decrease the increased muscle tone of individuals with CP. If successful, it will not only provide evidence for future clinical application but also broaden the scope for alternate or supplementary non-invasive treatment approaches to decrease spasticity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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)
研究组 & 干预措施
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 their reflex in their calf.
干预措施: Spinal reflex conditioning (Behavioral)
结局指标
主要结局
Soleus H-Reflex size
时间窗: Within one week before first intervention session to within one week after the end of intervention
Size of h-reflex as measured by EMG
Attendance
时间窗: At the end of the intervention, we will count the number of sessions each participant completed
Measure of feasibility of protocol, whether or not people can attend all sessions
次要结局
- Fugl-Meyer(Within one week before the first intervention session to within one week after the end of intervention)
- Fatigue Severity Scale(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(Within one week before the first intervention session to within one week after the end of intervention)
- 10 meter walk test(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(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(Within one week before the first intervention session to within one week after the end of intervention)
- Patient Reported Outcome Measures (PROMIS) Physical Function(Within one week before the first intervention session to within one week after the end of intervention)
- 6 minute walk test(Within one week before the first intervention session to within one week after the end of intervention)
- Modified Ashworth Scale(Within one week before the first intervention session to within one week after the end of intervention)
- Range of motion(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(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(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(Within one week before the first intervention session to within one week after the end of intervention)
- Jebsen-Taylor Test of Hand Function(Within one week before the first intervention session to within one week after the end of intervention)
- Berg Balance Scale(Within one week before the first intervention session to within one week after the end of intervention)
- Timed up and Go(Within one week before the first intervention session to within one week after the end of intervention)
- Sit to Stand Test(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(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(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(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(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(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(Within one week before the first intervention session to within one week after the end of intervention)
- Manual Ability Classification System(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(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(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(Within one week before the first intervention session to within one week after the end of intervention)