N/A
Completed N=16
Investigating the Effect of Stochastic Resonance Vibration on Gait and Balance and Upper Extremity Function in Children With Cerebral Palsy
Source: ClinicalTrials.gov NCT04388787 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Change in Manual Dexterity — 10.7; 12.4; 14.4 points on assessment — p=0.03
Summary
The purpose of this research study is to determine the effects of wearable vibration devices for children with cerebral palsy and impaired arm function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Manual Dexterity |
10.7; 12.4; 14.4 | 0.03 sig |
| PRIMARY Change in Upper Extremity Functionality |
21.2; 24.2; 30.8; 37.1; 34.4; 48.6 | 0.0008 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with cerebral palsy
- 3 years to 18 years of age
- Able to reliably express pain, discomfort or fear as reported by the parent/guardian
- Manual ability classification scale (MACS) levels I, II or III
Exclusion Criteria
- Any unstable medical condition. An unstable medical condition is a state of imminent threat to life such as shock, acute asthma, respiratory distress, severe infection and sepsis. Any patient in a clinic or therapy center presenting with signs and symptoms of an unstable medical condition will be directed to emergency medical services
- Any medical condition preventing active rehabilitation reported by the parent/guardian such as:
o Thromboembolic disease, acute progressive neurological disorder, cardiovascular or pulmonary contraindications, aggressive behavior, severe cognitive deficits, joint instabilities and compromised bone health, recent or non-consolidated fractures, osteoporosis
- Subjects with cardiac pacemakers, electronic pumps or any other implanted medical devices
- Skin lesions affecting the areas where the device straps will be attached to the body
Data sourced from ClinicalTrials.gov (NCT04388787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.