Brain Injury Clinical Trial
Official title:
Biofeedback Gait Retraining for Stiff Knee Gait Correction: Multi-joint Adaptation in Children and Young Adults With Brain Injury
The research team has developed a visual kinematic biofeedback system which is designed to help children with hemiplegic cerebral palsy (CP) correct a pattern of reduced knee extension in terminal swing and early stance. The system provides real-time feedback on the knee angle pattern during walking on a treadmill. From a pilot study on children with CP, the investigators observed that when the system was used in children who have stiff knee gait (SKG), training with knee feedback alone could lead to an increase in hip flexion which in turn led to limited normalization of the knee pattern through the whole gait cycle. This study, funded by the NIDILRR Switzer grant (PI: X Liu, Ph.D.), seeks to address the question of whether a training design with feedback on both the knee and hip joints would reduce this tendency to generate unintended changes in hip joint motion, and in doing so also improve convergence to the intended knee joint pattern. This study will test ten children and young adults with brain injury who have SKG and examine their short term adaptations to two types of kinematic feedback training: feedback training on the knee alone (condition B) and sequential switched feedback training on the knee and the hip (condition A). An additional sensor placed on the pelvis will be added to the current feedback system for measurement and feedback on the hip joint angle. Software enhancements will also be made with methods that will allow study and description of adaptations in measures of inter-limb symmetry during training. The participants will visit twice with a 2-week washout period between the two visits. Five participants will first undergo condition B in the first visit and then condition A in the second visit, while the other five participants will start with condition A in the first visit and then undergo condition B in the second visit. To compare the effects of the conditions on normalizing the joint angle trajectories, the knee and hip kinematics will be collected and analyzed in both the conditions. To investigate the coordination of lower limb segments under feedback training, relative phase measures will be analyzed on the hip and the knee. To examine whether participants adapt to the feedback retraining in terms of improvement in gait quality, symmetry ratios will be analyzed.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | September 29, 2022 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 21 Years |
Eligibility | Inclusion Criteria: - age 7 to 21; - has SKG - diagnosed with brain injury including but not limited to Cerebral Palsy, Stroke,Traumatic Brain Injury; - ability to walk on a treadmill without assistive devices based on parent/guardian report and/or treatment history; - the cognitive development is at the level needed to: understand and follow instructions, answer questions, be able to understand the purpose of the study and the activities involved. Exclusion Criteria: - Botulinum toxin treatment less than 16 weeks before initiation of the study - Recent or concurrent treatment that might interfere with the study. |
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 | Root mean square error of the knee flexion angle | The root-mean-square error of the knee flexion angle (RMSE_KF) will be calculated between the measured and target knee flexion angles in the last ten strides of the last trial with feedback off in each training session. | immediate after the first training session | |
Primary | Root mean square error of the knee flexion angle | The root-mean-square error of the knee flexion angle (RMSE_KF) will be calculated between the measured and target knee flexion angles in the last ten strides of the last trial with feedback off in each training session. | immediate after the second training session | |
Primary | Peak knee flexion angle | The Peak knee flexion angle (PKF) is the mean maximum knee flexion angles in the last ten strides of the last trial with feedback off. | immediate after the first training session | |
Primary | Peak knee flexion angle | The Peak knee flexion angle (PKF) is the mean maximum knee flexion angles in the last ten strides of the last trial with feedback off. | immediate after the second training session | |
Primary | Peak hip flexion angle | The Peak hip flexion angle (PHF) is the mean maximum knee flexion angles in the last ten strides of the last trial with feedback off. | immediate after the first training session | |
Primary | Peak hip flexion angle | The Peak hip flexion angle (PHF) is the mean maximum knee flexion angles in the last ten strides of the last trial with feedback off. | immediate after the second training session | |
Primary | Minimum relative phase angle between hip and knee | Minimum relative phase angle between hip and knee is the minimum difference in phase angle between hip and knee. Phase angle is computed as the inverse tangent of angular velocity divided by angular displacement. | immediate after the first training session | |
Primary | Minimum relative phase angle between hip and knee | Minimum relative phase angle between hip and knee is the minimum difference in phase angle between hip and knee. Phase angle is computed as the inverse tangent of angular velocity divided by angular displacement. | immediate after the second training session | |
Primary | Symmetry ratio of the stance phase | The symmetry ratio is calculated by dividing the smaller value by the larger value (trained vs. untrained lower limbs) of the stance phase time (% gait cycle). This results in a value between 0.0 and 1.0, with values closer to 1.0 indicating greater symmetry. | immediate after the first training session | |
Primary | Symmetry ratio of the stance phase | The symmetry ratio is calculated by dividing the smaller value by the larger value (trained vs. untrained lower limbs) of the stance phase time (% gait cycle). This results in a value between 0.0 and 1.0, with values closer to 1.0 indicating greater symmetry. | immediate after the second training session |
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