Igniting Mobility in Adolescents and Young Adults With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Time for "Timed Up and Go"
研究概览
简要总结
The study design will consist of a cohort of adolescents and young adults with cerebral palsy (CP) that will undergo a gait training protocol. All participants will complete MEG or EEG baseline brain imaging measures of their sensorimotor cortical activity, MRI brain/spinal cord imaging (previous MRI or template brain may be substituted), neurophysiological tests of the spinal cord H-reflex, and a series of mobility clinical tests and cognitive tests. Participants with metal in their body that would interfere with the MEG (e.g., braces on teeth, permanent retainer) will not undergo the MEG tests but will undergo the EEG assessments. Those who complete the MEG assessments will not undergo the EEG assessments.
After completing the baseline tests, the participants with CP will undergo the therapeutic gait training. After completing all of the therapeutic gait training sessions, the participants with CP will repeat the same assessments that were completed at baseline.
Separately, a cohort of neurotypical adolescents and young adults will also complete the baseline assessments. The neurotypical participants will not undergo the therapeutic gait training, but will be used as a normative group for interpreting if the changes seen in the participants with CP after therapy are in fact moving the system toward a normative state.
详细描述
Cerebral palsy (CP) results from a perinatal brain injury and is one of the most prevalent and costly pediatric neurologic conditions in the United States that often results in mobility deficits. The investigator's extensive experimental work has been focused on developing a therapeutic gait training protocol that will improve the long-term mobility of adolescents and young adults with CP. Despite the major breakthroughs, it is apparent across the investigations that some patients have vast improvements in their mobility after treatment, while others are clearly non-responders. This response variability represents one of the major Gordian knots in the treatment outcomes seen in adolescents and young adults with CP. The investigator will address this knowledge gap with a multimodal approach that blends the investigator's expertise in MEG/EEG brain imaging, MRI spinal cord imaging, and assessments of the spinal cord interneuronal circuitry to probe the neurophysiological differences in participants that are classified as responders and non-responders after therapeutic gait training. The Specific Aims of this study will: (1) identify if responders and non-responders have differences in the strength of the sensorimotor cortical oscillations involved in the planning and execution of a leg motor action, (2) determine if responders and non-responders have differences in the neural synchrony within the somatosensory cortices, following stimulation of the foot mechanoreceptors, and (3) decipher if responders and non-responders have differences in the spinal cord microstructure and circuitry dynamics. (4) Secondary aim: assess cognitive related changes induced via physical therapy. Briefly, the study design consists of a cohort of adolescents and young adults with CP that will initially undergo MEG/EEG brain imaging, MRI spinal cord imaging, neurophysiological tests of the spinal cord interneuronal circuitry, cognitive testing, and clinical mobility assessments. After completing the baseline tests, the participants will undergo the therapeutic gait training protocol. Upon completion of the treatment program, the participants will repeat the same assessments that were completed at baseline. Separation of the participants into responders and non-responders to treatment will be based on the criteria for a clinically relevant change in the 10-meter walking speed test. The new data derived from this project will provide unparalleled insight on the potential neurophysiological origins of the diverse mobility outcomes seen in adolescents and young adults with CP after treatment. Finally, an additional cohort of neurotypical adolescents and young adults of similar age and sex will also complete the mobility, MEG/EEG, spinal cord imaging, and Hoffmann reflex protocols for comparative purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For Cerebral Palsy participants:
- •Cerebral Palsy diagnosis
- •For Non-Cerebral Palsy Controls:
- •No known atypical neurodevelopment (e.g autism, Down Syndrome, ADHD, etc.)
排除标准
- •No orthopedic surgery in the last 6 months or metal in their body that would preclude the use of an MRI.
研究组 & 干预措施
Neurotypical Youth/Young Adults
No intervention administered. The controls will only undergo initial baseline assessments.
Cerebral Palsy Youth/Young Adults
Baseline and 8 week assessments; 8 week gait therapy
干预措施: Gait Therapy (Behavioral)
结局指标
主要结局
Change in Time for "Timed Up and Go"
时间窗: Baseline (CP and Neurotypical) and 8 weeks (CP)
The participant will start the test by sitting on a bench. The time (in seconds) it takes the participant to stand-up, walk to a line on the floor that is 3-meters away and return back to sitting on the bench will be the outcome measure.
Change in Selective Control Assessment of the Lower Extremity
时间窗: Baseline (CP and Neurotypical) and 8 weeks (CP)
This is a clinical assessment where the participant is asked to isolate and move the lower extremity joints. The examiner grades the amount of movement and the ability of the participant to isolate the control. A grade of 0 indicates the participant cannot move the joint, 1 indicates the participant can move the joint but it is impaired, and 2 indicates normal movement of the joint.
Change in Isolation of Movement
时间窗: Baseline (CP and Neurotypical) and 8 weeks (CP)
This is a clinical assessment where the participant is asked to isolate and move the lower extremity joints. The examiner grades the amount of movement and the ability of the participant to isolate the control. A grade of 0 indicates the participant cannot move the joint, 1 indicates the participant can move the joint but it is impaired, and 2 indicates normal movement of the joint.
Change in Mobility Test Time
时间窗: Baseline (CP and Neurotypical) and 8 weeks (CP)
The participant will be asked to perform a series of timed (in seconds) 10-meter walking tasks.
Change in Time for Community Ambulation
时间窗: Baseline (CP and Neurotypical) and 8 weeks (CP)
The participants will walk along a 400 meter course laid out on the Boys Town campus that incorporates uphill/downhill grades, stairs, curbs, grass and uneven surfaces. The time (in seconds) to complete the course will be used as an outcome variable.
Change in Level of Spasticity
时间窗: Baseline (CP and Neurotypical) and 8 weeks (CP)
Modified Ashworth: This is a clinical assessment where the therapist passively moves the participant's joints and rates the level of spasticity. Scores range from 0-5, where 0 indicates no tone, 5 indicates rigidity.
Change in Brain Activity in Sensory Cortices
时间窗: Baseline (CP and Neurotypical) and 8 weeks (CP)
Magnetoencephalogram (MEG) or electroencephalogram (EEG) scan: The frequency bands of interest include theta (4-8 Hz), alpha (8-12 Hz), beta(15-30 Hz) and gamma (\>30 Hz).
Change in Hoffmann Reflex
时间窗: Baseline (CP and Neurotypical) and 8 weeks (CP)
Percutaneous electrical stimulations of the femoral nerve applied via an anode that is positioned on the patella and a cathode that is positioned on the popliteal fossa will be applied to the right leg. A wireless surface EMG sensor positioned on the soleus will measure the Hoffmann reflex. The spinal reflexes (H-wave) will be assessed while resting and walking.
Change in Motor Response
时间窗: Baseline (CP and Neurotypical) and 8 weeks (CP)
Percutaneous electrical stimulations of the femoral nerve applied via an anode that is positioned on the patella and a cathode that is positioned on the popliteal fossa will be applied to the right leg. A wireless surface EMG sensor positioned on the soleus will measure the motor response. The muscular (M-wave) will be assessed while resting and walking.
次要结局
- Cognitive related changes induced via physical therapy - D2 - Test of Attention(Baseline (CP and Neurotypical) and 8 weeks (CP))
- Cognitive related changes induced via physical therapy - WAIS-IV Digit Span - Youth + Adult(Baseline (CP and Neurotypical) and 8 weeks (CP))
- Cognitive related changes induced via physical therapy - Trail Making A+B(Baseline (CP and Neurotypical) and 8 weeks (CP))
- Cognitive related changes induced via physical therapy - Pittsburgh Sleep Quality Index (PSQI)(Baseline (CP and Neurotypical) and 8 weeks (CP))
- Cognitive related changes induced via physical therapy -Wide Range Assessment of Memory and Learning (WRAML)(Baseline (CP and Neurotypical) and 8 weeks (CP))
- Cognitive related changes induced via physical therapy - Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) Questionnaire(Baseline (CP) and 8 weeks (CP))
- Cognitive related changes induced via physical therapy - Child and Adolescent Sleep Checklist (CASC)(Baseline (CP and Neurotypical) and 8 weeks (CP))
- Cognitive related changes induced via physical therapy - MacArthur Scale of Subjective Social Status Youth + Adult(Baseline (CP and Neurotypical) and 8 weeks (CP))
- Cognitive related changes induced via physical therapy - Stroop Test - Youth + Adult(Baseline (CP and Neurotypical) and 8 weeks (CP))
- Cognitive related changes induced via physical therapy - PEDS QL Fatigue Questionnaire (Acute)(Baseline (CP and Neurotypical) and 8 weeks (CP))
- Cognitive related changes induced via physical therapy - Silver Linings Questionnaire - Adapted for CP(Baseline (CP) and 8 weeks (CP))
研究者
Max Kurz
Director of PoWER Lab
Father Flanagan's Boys' Home