Robotic Exoskeleton Gait Training in Adolescents With Cerebral Palsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- Father Flanagan's Boys' Home
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Change in Motor Response
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
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 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.
After completing the baseline tests, the participants with CP will undergo the therapeutic gait training using either traditional physical therapy or utilizing a robotic exoskeleton. After completing all of the therapeutic gait training sessions, the participants will repeat the same assessments that were completed at baseline. The two groups will be compared based on the assessments for therapeutic outcomes.
Detailed Description
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. Robotic exoskeletons have gained recent attention in the therapeutic community as a high-tech option for assisting with over-ground mobility of various patient populations. The goal of this investigation is to take a fresh new approach on how robotic exoskeletons can be used in a therapeutic setting. As opposed to using them as a compensation tool, we are proposing to use them to perturb the legs to drive beneficial neuroplasticity in the key brain areas that govern the leg motor actions. Essentially, we predict that the neuroplastic changes promoted by the exoskeleton gait training protocol will lead to more robust clinical outcomes than what is seen by gait training alone. The aims of this study will: (1) determine if individuals with CP that undergo a robotic exoskeleton gait training protocol have larger mobility improvements compared to those that undergo gait training alone, (2) determine if individuals that undergo a robotic exoskeleton gait training protocol have larger improvements in key brain areas involved in motor planning and execution of the leg motor actions compared to those that undergo gait training alone, and (3) determine if individuals with CP that undergo a robotic exoskeleton gait training protocol have larger mobility improvements compared to those that undergo gait training alone. It is hypothesized after exoskeleton gait training participants will demonstrate substantially greater improvements in their 10-meter walk speed, one-minute walk test, and Functional Gait Assessment scores. Additionally, following exoskeleton training, the sensorimotor cortical activity will be significantly different from what is seen in those receiving gait training alone. Furthermore, the degree of brain activity changes will be related to the extent of the mobility improvements seen after completing the exoskeleton gait training protocol. Briefly, the study design consists of a cohort of adolescents and young adults with CP that will initially undergo MEG brain imaging, MRI spinal cord imaging, neurophysiological tests of the spinal cord interneuronal circuitry, and clinical mobility assessments. After completing the baseline tests, the participants will undergo either traditional therapeutic gait training or utilize the robotic exoskeleton gait therapy. Upon completion of the treatment program, participants will undergo the same baseline assessments. The results from the post therapy outcomes will be compared between the two groups: traditional gait therapy and robotic exoskeleton.
Investigators
Max Kurz
Director of PoWER Lab
Father Flanagan's Boys' Home
Eligibility Criteria
Inclusion Criteria
- •For Cerebral Palsy participants:
- •Cerebral Palsy diagnosis
- •For Non-Cerebral Palsy Controls:
- •No known atypical neurodevelopment (e.g autism, Down Syndrome, ADHD, etc.)
Exclusion Criteria
- •No orthopedic surgery in the last 6 months or metal in their body that would preclude the use of an MRI.
Outcomes
Primary Outcomes
Change in Motor Response
Time Frame: 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.
Change in Mobility Test Time
Time Frame: 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
Time Frame: 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 Time for "Timed Up and Go"
Time Frame: 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
Time Frame: 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 Level of Spasticity
Time Frame: 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 Isolation of Movement
Time Frame: 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 Hoffmann Reflex
Time Frame: 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 Brain Activity in Sensory Cortices
Time Frame: 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).
Secondary Outcomes
- 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 - WAIS-IV Digit Span - 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 - Silver Linings Questionnaire - Adapted for CP(Baseline (CP and Neurotypical) 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 -Wide Range Assessment of Memory and Learning (WRAML)(Baseline (CP and Neurotypical) and 8 weeks (CP))
- 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 - Caregiver Priorities & Child Health Index of Life with Disabilities (CPCHILD) Questionnaire(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 - MacArthur Scale of Subjective Social Status 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))