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The purpose of this study is to create a platform to prolong the adaption obtained from the cable-actuated gait training and encourage the individuals with CP to provide self-care at home.
The experiment protocol involves a maximum of ten sessions and will take two or three hours for each session. Baseline data will be collected before the first session for both overground and treadmill walking. During this session, the sound level will be adjusted based on the feedback received from the users. The researcher will ask the comfortable sound level to the participant before starting the experiment. Training will be conducted on the treadmill with the cable-actuated device for about 20 minutes. When the cables were removed, participants walked on the treadmill for 4 minutes during the post-training session. During training and post-training, participants will be exposed to feedback while walking on the treadmill. After treadmill walking, CP participants will be asked to take a ten-minute break and then practice overground walking for two minutes with auditory feedback (type A) and without it (type B). Effects of 3 different types of auditory feedback will be explored namely, rhythmic sounds, movement sonification, and sound notifying erroneous gait. Group A participants will be further divided into groups depending on the type of auditory feedback that will be provided. Participants will participate in a maximum of 10 sessions, two or three times a week. Before the first and after the last training, participants will be evaluated for functional gait assessment, 6-min-walk, leg strength using a dynamometer, and Modified Ashworth test by a physical therapist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with Cerebral Palsy | Experimental | Adults with Cerebral Palsy who are able to be self-ambulatory for minimum 100 feet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bodyweight augment system | Device | Motorized cables will be providing downward force on the participant's pelvis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of 10m walk between pre/post evaluation and 6 Training sessions | Timing in seconds during 10 m over ground walking. Lower score means faster (better) walking speed | through study completion, an average of 5 weeks |
| Change of 6 min walk between Pre/post evaluation | Measure distance in meter over 6 min walk. Increased distance shows better walking endurance | through study completion, an average of 5 weeks |
| Change of Ground reaction force between 6 Training sessions | 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 | through study completion, an average of 5 weeks |
| Change of Kinematics between Pre/post evaluation and 6 Training sessions | 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 | through study completion, an average of 5 weeks |
| Change of surface electromyography between Pre/post evaluation and 6 Training sessions | 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. | through study completion, an average of 5 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of Muscle tone between Pre/post evaluation | 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. | through study completion, an average of 5 weeks |
| Usability questionnaire of Post evaluation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiyeon Kang | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo, South Campus, Kimball 115 | Buffalo | New York | 14260-4200 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33351772 | Background | Chen D, Asaeikheybari G, Chen H, Xu W, Huang MC. Ubiquitous Fall Hazard Identification With Smart Insole. IEEE J Biomed Health Inform. 2021 Jul;25(7):2768-2776. doi: 10.1109/JBHI.2020.3046701. Epub 2021 Jul 27. | |
| 33157884 | Result | Kang J, Martelli D, Vashista V, Martinez-Hernandez I, Kim H, Agrawal SK. Robot-driven downward pelvic pull to improve crouch gait in children with cerebral palsy. Sci Robot. 2017 Jul 26;2(8):eaan2634. doi: 10.1126/scirobotics.aan2634. Epub 2017 Jul 26. |
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The de-identified data will be shared upon request to PI.
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After the study is completed
The personnel who is requesting the data needs to explain how the data will be used in their research.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2022 | Apr 4, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 7, 2022 | Apr 4, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Smart insole | Device | Insole provided auditory feedback when heel strike or toe-off events happen |
|
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. |
| through study completion, an average of 5 weeks |
| Exit interview after completion of the sessions of Post evaluation | This is designed for any improvement of future study design. We will ask questions on potential improvement of the intervention | through study completion, an average of 5 weeks |
| Change of strength of Post evaluation between Pre/post evaluation | Measure the strength with Dynamometer in N. Higher number means stronger limb. | through study completion, an average of 5 weeks |
| Change of functional gait assessment between Pre/post evaluation | 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. | through study completion, an average of 5 weeks |