Hemiplegic Cerebral Palsy Clinical Trial
Official title:
Impact and Feasibility of a Dual Joint Visual Feedback Design in Pediatrics With Hemiplegic Cerebral Palsy: A Pilot Study
This study aims to assess the feasibility of a visual feedback system designed to augment treadmill-based gait training for children with gait disturbances related to hemiplegic cerebral palsy. The visual feedback uses data from knee and hip joint movements to represent the position of the foot ahead of or behind the body during walking. This study will test eight children with hemiplegic cerebral palsy who have short step lengths related to atypical knee and hip motions when the foot contacts the ground (initial contact). The study will examine walking adaptations in response to the new visual feedback system and compare differences in response and user experience between two variants of the new design. In a single visit, participants will undergo a gait retraining protocol using the dual joint visual feedback (DJVF) system. Hip and knee flexion angles of the paretic (weaker) side will be collected, analyzed, and compared during baseline walking and while responding to the two feedback variants. Muscle firing patterns will be studied using electrodes placed on key lower limb muscles. Study participants will be asked to report their experience and preferences following the gait retraining protocol. The study findings will be used to further refine the DJVF system in preparation for future studies.
Status | Recruiting |
Enrollment | 8 |
Est. completion date | August 2022 |
Est. primary completion date | May 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 17 Years |
Eligibility | Inclusion Criteria: - I1: Diagnosis of hemiplegic cerebral palsy - I2: Gait pattern in hemiplegic limb: deficit of knee extension during late swing phase/initial contact - I3: Age 7 to 17 years - I4: Able to walk on a treadmill without assistive devices - I5: Able to understand spoken English at the level needed to: 1. understand and follow instructions for equipment setup, testing and task performance 2. answer questions related to effort and preference 3. be able to understand consent document and provide informed consent Exclusion Criteria: - E1: Significant injury (such as fracture) in legs or feet that interferes with their ability to walk - E2: Known risk factor for stroke or heart attack while exercising - E3: Lower extremity orthopaedic surgery less than 12 months prior to study start - E4: Other significant health conditions that may interfere with the participant's ability to complete the study or could interfere with interpretation of the study results. |
Country | Name | City | State |
---|---|---|---|
United States | Kessler Foundation | West Orange | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Kessler Foundation | Children's Specialized Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee flexion angle at initial contact without feedback | Measurement of how bent the knee is when the foot touches the ground at the end of the swing phase without feedback | 1 day (At single time point) | |
Primary | Knee flexion angle at initial contact during FBC exposure | Measurement of how bent the knee is when the foot touches the ground at the end of the swing phase during exposure to FBC visual feedback | 1 day (At single time point) | |
Primary | Knee flexion angle at initial contact during FBCS exposure | Measurement of how bent the knee is when the foot touches the ground at the end of the swing phase during exposure to FBCS visual feedback | 1 day (At single time point) | |
Primary | Hip flexion angle at initial contact without feedback | Measurement of how flexed the hip is when the foot touches the ground at the end of the swing phase without feedback | 1 day (At single time point) | |
Primary | Hip flexion angle at initial contact during FBC exposure | Measurement of how flexed the hip is when the foot touches the ground at the end of the swing phase during exposure to FBC visual feedback | 1 day (At single time point) | |
Primary | Hip flexion angle at initial contact during FBCS exposure | Measurement of how flexed the hip is when the foot touches the ground at the end of the swing phase during exposure to FBCS visual feedback | 1 day (At single time point) | |
Primary | Participant questionnaire responses | Participant responses to a five-point ordinal scale detailing their 1) comprehension of the feedback display, 2) self-rating of success, 3) preference of which feedback variant (intervention) they preferred, and 4) effort or exhaustion following training. | 1 day (At single time point) |
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