Cerebral Palsy
Conditions
Brief summary
The purpose of this research study is to determine if remote limb ischemic conditioning (RLIC) can increase skeletal muscle power, enhance learning of motor (dynamic balance) task, and improve walking performance in children with cerebral palsy (CP).
Detailed description
Ischemic conditioning is a phenomenon in which an organ exposed to a controlled, short-term, local, sublethal ischemia protects from subsequent ischemia. Remote ischemic conditioning is another more practical approach where transient ischemia and reperfusion applied to a remote organ or tissue, protects other organs or tissues from further episodes of lethal ischemia/reperfusion injury. Remote limb ischemic conditioning (RLIC) is a clinically feasible way of performing remote ischemic conditioning where alternating, brief ischemia and reperfusion is delivered with cyclic inflation and deflation of a blood pressure cuff on the arm or leg. The overall goal of this research is to use ischemic conditioning to enhance muscle power, motor leaning, and mobility in children with CP. Our previous work demonstrated that when paired with strength training, RLIC improved muscle strength and activation in healthy, young adults and motor learning in healthy older adults. The current study extends that work to determine if RLIC enhances muscle power, dynamic balance, and walking performance in children with CP. This Phase II study will yield the necessary information to design and execute subsequent randomized controlled trials in children with CP as well as other neurological conditions.
Interventions
BEHAVIORALRLIC
See descriptions under arm/group descriptions. RLIC is delivered for 14 visits. Visits 1-3 occur on consecutive work days and visits 4-14 occur on alternating week days.
BEHAVIORALSham Conditioning
See descriptions under arm/group descriptions. Sham conditioning is delivered for 14 visits. Visits 1-3 occur on consecutive work days and visits 4-14 occur on alternating week days.
BEHAVIORALMuscle Power training
All participants undergo power training of the quadriceps muscles using unilateral and bilateral leg presses (Total Gym GTS, San Diego, CA), 3 times/week for 4 consecutive weeks (12 sessions). Power training will follow standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Power training is provided at visits 3-14.
BEHAVIORALBalance training
All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-14.
BEHAVIORALTreadmill Training
All participants will undergo short burst interval treadmill training using self-selected and fast walking speeds.
Sponsors
East Carolina University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are masked to group assignment (RLIC vs. Sham conditioning) and the assessor will be masked to group assignment of the participants.
Intervention model description
Double blinded, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Children diagnosed with unilateral or diplegia cerebral palsy (CP) 2. Gross Motor Function Classification System (GMFCS) levels I-III
Exclusion criteria
1. Children with other developmental disabilities such as autism, developmental coordination disorders, etc. 2. Children with cognitive deficits or communication problem 3. Children with balance disorders such as vestibular disorders, posterior fossa tumors etc. 4. Children with known cardiorespiratory dysfunctions 5. Children who are receiving other adjunct therapies such as TMS, tDCS, vagal nerve stimulation 6. Presence of lower extremity condition, injury, or surgery which could compromise conditioning and training 7. Children with sickle cell disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak knee extension power | Pre-intervention to 1 month post-intervention follow-up | Power is defined as the ability to exert a maximum force in short amount of time (speed) while performing knee extension. Bilateral quadriceps power will be measured using Humac Norm Isokinetic testing device (Computer Sports Medicine Inc, Stoughton, MA). |
| Change in Balance Score | Pre-intervention to 1 month post-intervention follow-up | The average amount of time in seconds that a participant maintains the stability platform within ±5° of horizontal position during 15 trials of 30 seconds each. The total score will range between 0-30 seconds. Higher balance score indicates better balance performance. |
| Change in Walking Speed | Pre-intervention to 1 month post-intervention follow-up | Self-selected and fast walking speeds will be measured using 10-meter walk test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Electromyography | Pre-intervention to 1 month post-intervention follow-up | While performing the isokinetic power testing, the electromyography (EMG) data will be recorded simultaneously. The EMG data will be used to quantify the electrical amplitude of quadriceps muscle. |
| Gait Analysis | Pre-intervention to 1 month post-intervention follow-up | Lower extremity walking kinematics and kinetics will be measured using 10-camera motion analysis system (Qualisys Inc., Gothenburg, Sweden). Specific kinematic variables are hip, knee, and ankle joint torques. Kinetic variables are peak hip, knee, and ankle sagittal plane joint moments. |
| Lower limb activity | Pre-intervention to 1 month post-intervention follow-up | Lower extremity activity will be measured using accelerometers (Actigraphs) worn on bilateral ankles for 24 hours. Specific accelerometry variable will be number of steps. |
Countries
United States
Outcome results
None listed