Biofeedback Gait Retraining for Stiff Knee Gait Correction

NCT05105763 | Unknown

• 1 other identifier: R-1084-19
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Injury

Keywords

stiff knee gait; biofeedback

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

feedback training on single joint first

OTHER

Participants in Subgroup 1 will first undergo Condition B in the first visit and then Condition A in the second visit.

Other: Sequential switched feedback training on the knee and the hip (Condition A); Other: Feedback training on the knee alone (Condition B)

sequential feedback training on multi-joint first

OTHER

Participants in Subgroup 2 will start with Condition A in the first visit and then undergo Condition B in the second visit.

Other: Sequential switched feedback training on the knee and the hip (Condition A); Other: Feedback training on the knee alone (Condition B)

Interventions

Sequential switched feedback training on the knee and the hip (Condition A) OTHER

Condition A will include four 6-mins training blocks: 2-mins knee joint feedback-on, 2-mins hip joint feedback-on, and 2-mins feedback-off. Training with feedback on will occur as follows: The subject will walk on the treadmill and try to achieve the target hip and/or knee flexion pattern shown on the feedback interface. Training with feedback off will occur as follows: The subject will walk on the treadmill and try to maintain the pattern without any form of visual or verbal feedback.

feedback training on single joint first; sequential feedback training on multi-joint first

Feedback training on the knee alone (Condition B) OTHER

Condition B will include four 6-mins training blocks: 4-mins knee joint feedback-on and 2-mins feedback-off. Training with feedback on will occur as follows: The subject will walk on the treadmill and try to achieve the target hip and/or knee flexion pattern shown on the feedback interface. Training with feedback off will occur as follows: The subject will walk on the treadmill and try to maintain the pattern without any form of visual or verbal feedback.

feedback training on single joint first; sequential feedback training on multi-joint first

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Botulinum toxin treatment less than 16 weeks before initiation of the study
• Recent or concurrent treatment that might interfere with the study.

Sponsors & Collaborators

• Kessler Foundation: lead
• Children's Specialized Hospital: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Xuan Liu, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuan Liu, PhD

CONTACT

973-324-3561; XLiu@kesslerfoundation.org

Peter Barrance, PhD

CONTACT

973-324-3550; PBarrance@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A counterbalanced repeated measures design will be used in this study to examine the adaptation of children and young adults with brain injury who have SKG to two types of feedback training: feedback training on the knee alone (Condition B) and sequential switched feedback training on the knee and the hip (Condition A). The participants will participate in treadmill training twice with a 2-weeks washout period between the two visits and will receive the two training conditions in different orders. Ten participants will be alternately allocated to two subgroups according to the sequence they are recruited to the study. In the end, the investigators will have five participants in Subgroup 1 and the other five participants in Subgroup 2. Participants in Subgroup 1 will first undergo Condition B in the first visit and then Condition A in the second visit, while participants in Subgroup 2 will start with Condition A in the first visit and then undergo Condition B in the second visit.

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: November 3, 2021
• Study Start: October 30, 2021
• Primary Completion: June 30, 2022
• Study Completion: September 29, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)