Recruiting

Biofeedback Gait Retraining

Sponsor:

Kessler Foundation

Code:

NCT05105763

Conditions

Brain Injury

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

Interventions

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

Feedback training on the knee alone (Condition B)

Study Details

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

Study ID

NCT05105763

Start date

Oct 30, 2021

Status verified date

Mar, 2022

Completion date

Sep 29, 2022

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: feedback training on single joint first

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

other: sequential feedback training on multi-joint first

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

Interventions

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

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 the knee alone (Condition B)

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.

Primary outcome measure

  • Root mean square error of the knee flexion angle [ Time Frame: immediate after the first training session ]
  • Root mean square error of the knee flexion angle [ Time Frame: immediate after the second training session ]
  • Peak knee flexion angle [ Time Frame: immediate after the first training session ]
  • Peak knee flexion angle [ Time Frame: immediate after the second training session ]
  • Peak hip flexion angle [ Time Frame: immediate after the first training session ]
  • Peak hip flexion angle [ Time Frame: immediate after the second training session ]
  • Minimum relative phase angle between hip and knee [ Time Frame: immediate after the first training session ]
  • Minimum relative phase angle between hip and knee [ Time Frame: immediate after the second training session ]
  • Symmetry ratio of the stance phase [ Time Frame: immediate after the first training session ]
  • Symmetry ratio of the stance phase [ Time Frame: immediate after the second training session ]

Central Contacts and Locations

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

More Information

Sponsor

Kessler Foundation

Last update posted

Mar 31, 2022

Last verified

Mar, 2022

Keywords

  • stiff knee gait
  • biofeedback

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2022-03-31.