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.
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: Two feedback conditions representing two variants will be tested. The first (FBC) is as above, with only instantaneous scoring. The FBCS condition will be the same as the FBC condition with the following addition: game context cues of the cumulative score will be provided as visual numerical count displayed to the right of the main feedback interface. Study Protocol Researchers will place inertial sensors on the pelvis, thigh, shank, and shoe of the paretic limb, using elastic wraps and medical tape. Researchers will place surface EMG sensors on the participant's lower extremity paretic side. If any sensors cannot be placed due to the presence of orthotics or other complicating factors, data for that sensor will not be collected. Researchers will check the signal of each sensor, by having participants perform some easy activities such as flexing their knee, squatting, going on their toes, and raising their toes. Following setup, participants will first walk on the study treadmill at a self-selected comfortable speed while baseline (BAS) gait patterns are recorded. After the baseline trial, practice, and orientation to the feedback, including the FBC and FBCS variants, will occur. The order of these training blocks will be randomized prior to participant arrival. Between training blocks, participants will be allotted rest periods to reduce fatigue. Following testing, participants will complete a questionnaire with items on a five-point ordinal scale describing 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04635930 -
Taping and Traditional Exercises in Upper Limb Function in Hemiplegic
|
N/A | |
Terminated |
NCT03811275 -
Task or Virtual Reality Intervention for Improving UE Function
|
N/A | |
Completed |
NCT05068596 -
Effect of Loaded Functional Training on Hemiplegic Cerebral Palsy
|
N/A | |
Completed |
NCT03626077 -
Biofeedback Training and Physical Therapy Program Improves Visual-motor Integration in Children With Cerebral Palsy
|
N/A | |
Terminated |
NCT04009031 -
Video Game for Home-based Rehabilitation for Children With Hemiplegia
|
N/A | |
Completed |
NCT01973426 -
Evaluating Human-Machine Interfaces in a Robotic Thumb Orthosis
|
||
Recruiting |
NCT03361930 -
Changes in Muscle Activity of Children With Spastic Unilat Cerebral Palsy Using 2 Types of Ankle-foot Orthoses to Walk
|
N/A | |
Completed |
NCT03691506 -
Comparison of CIMT and Its Modified Form on Upper Motor Function Outcomes in Hemiplegic Cerebral Palsy.
|
N/A | |
Completed |
NCT05062122 -
The Effects of Vibration and Kinesiology Tape Applications in Children With Hemiplegic Cerebral Palsy
|
||
Not yet recruiting |
NCT04177186 -
Strength Training in Children With Spastic Diplegic and Hemiplegic Cerebral Palsy Receiving Botulinum Toxin
|
N/A | |
Completed |
NCT06021899 -
Effects of Classic and Modified CIMT on Quality of Life of Children With Hemiplegic CP
|
N/A | |
Recruiting |
NCT05559320 -
Use of Joystick-operated Ride-on-toys to Improve Affected Arm Use and Function in Children With Hemiplegic Cerebral Palsy
|
N/A | |
Recruiting |
NCT06040619 -
Implementation of Therapy Together
|
N/A | |
Completed |
NCT06330831 -
Intensive Group Based CIMT for Young Children
|
N/A | |
Recruiting |
NCT05931640 -
Effects of Plyometric Training Versus Virtual Reality Among Hemiplegic Cerebral Palsy
|
N/A | |
Recruiting |
NCT06001983 -
Effect of Imaginary Resisted Therapy Versus Physical Resisted Therapy on Hemiplegic Cerebral Palsy
|
N/A | |
Completed |
NCT04894812 -
Vestibular and Motor Functions in Children With Hemiplegic Cerebral Palsy
|
N/A | |
Completed |
NCT05396053 -
Mirror Therapy Versus CIMT on Hand Function in Cerebral Palsy
|
N/A | |
Completed |
NCT05380011 -
Bimanual Task Training and Constraint-Induced Movement Therapy in Hemiplegic Cerebral Palsy Children
|
N/A | |
Completed |
NCT05490758 -
Sensorimotor Training and Constraint Induced Movement Therapy on Upper Extremity Function in Children With Hemiplegic CP
|
N/A |