Impact and Feasibility of a Dual Joint Visual Feedback Design in Pediatrics With Hemiplegic Cerebral Palsy: A Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Hip flexion angle at initial contact without feedback
研究概览
简要总结
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.
详细描述
Participant characteristics
This study will recruit 8 pediatric participants with hemiplegic gait secondary to CP, in accordance with the inclusion and exclusion criteria.
Dual Joint Visual Feedback System (DJVF)
The DJVF system uses four inertial measurement unit (IMU) sensors (MTW Devkit, Xsens Technologies BV, Enschede, Netherlands) which are placed on the pelvis, shank, thigh, and foot, to measure three-dimensional segment accelerations and orientations during gait. The software application has been developed by our study team using the MATLAB (Mathworks, Natick, MA) programming language and the application programming interface supplied with the Xsens system. Sensor data is relayed back to a controlling PC for processing and feedback display formulation in real-time. The primary feedback is in the form of a cursor representing the position of the foot ahead of or behind the body. Relative foot position is calculated using the segmental angle and lengths of the paretic thigh and shank. The feedback is designed to reward a more anterior foot placement at the initial contact phase of gait by awarding points according to target screen zones that the cursor enters. The zone reached is highlighted and the instantaneous score is displayed.
FBC vs FBCS: addition of cumulative scoring:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •understand and follow instructions for equipment setup, testing and task performance
- •answer questions related to effort and preference
- •be able to understand consent document and provide informed consent
排除标准
- •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.
结局指标
主要结局
Hip flexion angle at initial contact without feedback
时间窗: 1 day (At single time point)
Measurement of how flexed the hip is when the foot touches the ground at the end of the swing phase without feedback
Knee flexion angle at initial contact without feedback
时间窗: 1 day (At single time point)
Measurement of how bent the knee is when the foot touches the ground at the end of the swing phase without feedback
Hip flexion angle at initial contact during FBC exposure
时间窗: 1 day (At single time point)
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
Hip flexion angle at initial contact during FBCS exposure
时间窗: 1 day (At single time point)
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
Participant questionnaire responses
时间窗: 1 day (At single time point)
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.
Knee flexion angle at initial contact during FBCS exposure
时间窗: 1 day (At single time point)
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
Knee flexion angle at initial contact during FBC exposure
时间窗: 1 day (At single time point)
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
次要结局
未报告次要终点