Short-term Spinal Stimulation Effects in Cerebral Palsy
Acute Effects of Transcutaneous Spinal Stimulation on Spasticity and Gait in Cerebral Palsy
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Children with cerebral palsy (CP) have altered neuromuscular control that impacts gait and participation in daily activities. This research will characterize the acute effects of transcutaneous spinal stimulation (tSCS) on spasticity and gait for individuals with CP using a combined approach of quantitative biomechanical assessment and clinician assessment. Previous research has shown decreases in spasticity after walking with tSCS, but it is unclear whether these changes are due to physical activity or neuromodulation. This research will provide a foundation to characterize changes in spasticity after an acute session of tSCS for individuals with CP.
This research will use the SpineX Spinal Cord Innovation in Pediatrics (SCiP) system. The SCIP system allows for tSCS intensity (mA) at two electrodes to be independently adjusted in 1 mA increments. Other stimulation parameters such as pulse frequency (30 Hz), overlap frequency (10 kHz), pulse width (1 ms), and waveform (biphasic) are constant on the SCiP device. To target sensorimotor function of lower-extremity muscle groups within the spinal cord, the two electrodes are positioned over the spinous process at T11 and L1 with grounding electrodes placed on the pelvis. The tSCS intensity will be set to each individual's maximum tolerable stimulation intensity.
This study will recruit 20 individuals with CP to attend two in-lab visits. One visit will include treadmill walking with tSCS and the other will include treadmill walking without tSCS. The visit order will be pseudo-randomized and balanced across participants. Participants will be consented at the initial visit and will also conduct 3 trials of the 10-Meter Walk Test to evaluate self-selected walking speed. The average speed from these trials will be used to set treadmill speed. At the beginning of each visit, participants will complete a physical exam to characterize range of motion and spasticity via the Modified Tardieu Scale. Participants will complete a 5-minute treadmill familiarization at their self-selected speed to ensure it is comfortable. The tSCS intensity will gradually increase during treadmill familiarization until participants report discomfort. The tSCS intensity will be set at 1 mA below the level of discomfort if the visit calls for tSCS. During the treadmill walking, participants will walk at their self-selected walking speed for 10 - 20 minutes with either (1) no stimulation or (2) tSCS at their maximum tolerable stimulation intensity.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Katherine Steele, PhD
- Telefonnummer: 206-685-2390
- E-post: kmsteele@uw.edu
Studer Kontakt Backup
- Navn: Katie Landwehr, MS
- Telefonnummer: 206-543-0116
- E-post: klandweh@uw.edu
Studiesteder
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Washington
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Seattle, Washington, Forente stater, 98195
- Rekruttering
- University of Washington
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Ta kontakt med:
- Katie Landwehr, MS
- Telefonnummer: 206-543-0116
- E-post: klandweh@uw.edu
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Individuals who:
- have a diagnosis of spastic cerebral palsy or high likelihood of CP diagnosis
- are 4-65 years of age
- have spasticity in lower-extremity muscles
- are at a functional Gross Motor Function Classification System (GMFCS) Level I-III
- can walk for at least 10 minutes with/without support
- can understand and follow simple directions
- have a stable medical condition, as reported by the caregiver/parent
Exclusion Criteria:
Individuals who:
- who have had lower-extremity surgery or injury in the prior 12 months
- have had botulinum toxin injections in the prior 3 months
- have had selective dorsal rhizotomy (SDR) in the past
- have uncontrolled seizures
- have significant cardiovascular or musculoskeletal disease that would prevent full participation
- are dependent on ventilation support
- have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump)
- have established osteoporosis and taking medication for osteoporosis treatment.
- have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
- have active cancer
- have received stem cell injections into the spinal cord
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Spinal Stimulation First (AB Arm)
Participants randomized into this arm will complete two visits.
The first visit will use spinal stimulation while walking on a treadmill, and the second visit will be treadmill walking without stimulation.
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A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).
Andre navn:
Participant will walk on a treadmill.
|
|
Eksperimentell: No Spinal Stimulation First (BA Arm)
Participants randomized into this arm will complete two visits.
The first visit will involve walking on a treadmill without stimulation, while the second visit will be treadmill walking with stimulation.
|
A stimulator will be used non-invasively stimulate the spine at the neck and/or lower back (cervical and/or lumbar).
Andre navn:
Participant will walk on a treadmill.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Modified Tardieu Scale of Spasticity
Tidsramme: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
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Change in quality of muscle reaction of the gastrocnemius assessed by the score on the Tardieu assessment.
Lower score indicates less spasticity.
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End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Step Length
Tidsramme: End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
|
From quantitative gait analysis step length is quantified as the average during the final minute of walking using gait analysis and markers on the foot.
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End of treadmill walking during visit, anticipated average 20 minutes, relative to baseline at start of visit.
|
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Gait Deviation Index (GDI)
Tidsramme: Last 5 minutes of treadmill walking during visit relative to baseline at start of walking.
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A multivariate metric derived from quantitative gait analysis that quantifies how much a gait cycle deviates from normative data.
Average GDI calculated at the last 5 minutes of walking.
Higher GDI indicates more normative walking.
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Last 5 minutes of treadmill walking during visit relative to baseline at start of walking.
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Katherine Steele, PHD, University of Washington
- Hovedetterforsker: Heather Feldner, PhD, University of Washington
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00014877-A
- R21HD121135 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
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