An interventional study of Bodyweight augment system and Smart insole in Cerebral Palsy, sponsored by State University of New York at Buffalo. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by State University of New York at Buffalo · Not applicable, Interventional, and Treatment
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.
1,853 studies on the registry are indexed under Cerebral Palsy; 433 are open to participants now.
This study's enrollment of 5 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Exclusion Criteria:
Adults with Cerebral Palsy who are able to be self-ambulatory for minimum 100 feet
Device: Bodyweight augment system · Device: Smart insole
Motorized cables will be providing downward force on the participant's pelvis
Insole provided auditory feedback when heel strike or toe-off events happen
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: through study completion, an average of 5 weeks
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.
Time frame: through study completion, an average of 5 weeks
Usability questionnaire of Post evaluation
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 5 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The de-identified data will be shared upon request to PI.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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State University of New York at Buffalo