Reinforcing CP Robotic Training With Auditory Feedback
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|ClinicalTrials.gov Identifier: NCT05335798|
Recruitment Status : Recruiting
First Posted : April 19, 2022
Last Update Posted : April 19, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Device: Bodyweight augment system Device: Smart insole||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reinforcing CP Robotic Training With Auditory Feedback|
|Actual Study Start Date :||December 7, 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
Experimental: Adults with Cerebral Palsy
Adults with Cerebral Palsy who are able to be self-ambulatory for minimum 100 feet
Device: Bodyweight augment system
Motorized cables will be providing downward force on the participant's pelvis
Device: Smart insole
Insole provided auditory feedback when heel strike or toe-off events happen
- Change of 10m walk between pre/post evaluation and 6 Training sessions [ Time Frame: through study completion, an average of 5 weeks ]Timing in seconds during 10 m over ground walking. Lower score means faster (better) walking speed
- Change of 6 min walk between Pre/post evaluation [ Time Frame: through study completion, an average of 5 weeks ]Measure distance in meter over 6 min walk. Increased distance shows better walking endurance
- Change of Ground reaction force between 6 Training sessions [ Time Frame: through study completion, an average of 5 weeks ]Bertec Force instrumented treadmill will use to measure vertical ground reaction force in Newton. We will identify whether we can see a distict heel strike and strong push
- Change of Kinematics between Pre/post evaluation and 6 Training sessions [ Time Frame: through study completion, an average of 5 weeks ]Motion capture data. We will measure hip, knee, and ankle joint angles in degrees. We expect to see If the knees is more extended and dorsiflexion is observed at heel strike the gait is improved
- Change of surface electromyography between Pre/post evaluation and 6 Training sessions [ Time Frame: through study completion, an average of 5 weeks ]Surface electromyography will be measured for the lower limb. Unit is in mV. We are expecting to measure the peak semg during each gait cycle.
- Change of Muscle tone between Pre/post evaluation [ Time Frame: through study completion, an average of 5 weeks ]Modified Ashworth Scale a clinical measure of muscle spasticity. Rated from 0(no increase in muscle tone) to 4(affected part rigid in flexion or extension). Lower score means better muscle tone.
- Usability questionnaire of Post evaluation [ Time Frame: through study completion, an average of 5 weeks ]Questionnaires were made to understand the the perceived improvement (increased steps and walking speed ) or dose of the intervention (more session and frequency of the intervention). It is rated from 1 very likely to 5 unlikely.
- Exit interview after completion of the sessions of Post evaluation [ Time Frame: through study completion, an average of 5 weeks ]This is designed for any improvement of future study design. We will ask questions on potential improvement of the intervention
- Change of strength of Post evaluation between Pre/post evaluation [ Time Frame: through study completion, an average of 5 weeks ]Measure the strength with Dynamometer in N. Higher number means stronger limb.
- Change of functional gait assessment between Pre/post evaluation [ Time Frame: through study completion, an average of 5 weeks ]Measure different aspects of gait. It is rated from 0 to 3. Higher score means improved improved walking during gait with level surface, change in speed, gait with head turns, step over obstacle, gait with eyes closed, steps.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Adults with cerebral palsy (18-65 years old)
- Ambulation of a distance of 100 feet with or without the use of assistive devices.
- Severe Equinovarus foot or Genu recurvatum of the knee
- Surgery within 6 months will be excluded.
- Individuals with pregnancy
- Lower limb prosthetics
- Severe respiratory problems such as chronic obstructive pulmonary disease, heart disease, a loss of sensation, uncontrolled blood pressure,
- Seizure disorder
- Severe arthritis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05335798
|Contact: Jiyeon Kangemail@example.com|
|United States, New York|
|University at Buffalo, South Campus, Kimball 115||Recruiting|
|Buffalo, New York, United States, 14260-4200|
|Contact: Jiyeon Kang 716-645-6063 firstname.lastname@example.org|
|Principal Investigator:||Jiyeon Kang||University at Buffalo|
Documents provided by Jiyeon Kang, State University of New York at Buffalo:
|Responsible Party:||Jiyeon Kang, Assistant Professor, State University of New York at Buffalo|
|Other Study ID Numbers:||
|First Posted:||April 19, 2022 Key Record Dates|
|Last Update Posted:||April 19, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||The de-identified data will be shared upon request to PI.|
|Time Frame:||After the study is completed|
|Access Criteria:||The personnel who is requesting the data needs to explain how the data will be used in their research.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Brain Damage, Chronic
Central Nervous System Diseases
Nervous System Diseases