Recruiting

Visual Feedback Gait Retraining

Sponsor:

Kessler Foundation

Code:

NCT05011201

Conditions

Hemiplegic Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

Dual Joint Visual Feedback without Scoring

Dual Joint Visual Feedback with Scoring

Study Details

Brief summary:

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.

Conditions

Hemiplegic Cerebral Palsy

Study ID

NCT05011201

Start date

Nov 19, 2021

Status verified date

Jan, 2022

Completion date

Aug, 2022

Anticipated

Primary completion date

May, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. understand and follow instructions for equipment setup, testing and task performance
2. answer questions related to effort and preference
3. be able to understand consent document and provide informed consent

Exclusion Criteria:

  • 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.

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Experimental Group

Participants will undergo a single testing session of gait retraining using two variants of the dual joint visual feedback system (DJVF). The DJVF system uses IMU sensors to measure knee and hip joint motions and calculates the users foot position, relative to their pelvis. The relative foot position is represented in real time on a screen in front of the user with feedback designed to elicit increases in anteriorly located foot positions.

Interventions

Dual Joint Visual Feedback without Scoring

Participants will walk on the treadmill while given instantaneous anterior and posterior foot position and immediate scoring information using the DJVF interface. A pediatric physical therapist will provide (1) verbal encouragement and redirection of attention to the task as needed (2) verbal cueing to assist if difficulty in interpreting the feedback and appropriate modification is noted.

Dual Joint Visual Feedback with Scoring

Participants will walk on the treadmill using the same DJFB with additional visual cumulative scoring on their performance. A pediatric physical therapist will provide (1) verbal encouragement and redirection of attention to the task as needed (2) verbal cueing to assist if difficulty in interpreting the feedback and appropriate modification is noted.

Primary outcome measure

  • Knee flexion angle at initial contact without feedback [ Time Frame: 1 day (At single time point) ]
  • Knee flexion angle at initial contact during FBC exposure [ Time Frame: 1 day (At single time point) ]
  • Knee flexion angle at initial contact during FBCS exposure [ Time Frame: 1 day (At single time point) ]
  • Hip flexion angle at initial contact without feedback [ Time Frame: 1 day (At single time point) ]
  • Hip flexion angle at initial contact during FBC exposure [ Time Frame: 1 day (At single time point) ]
  • Hip flexion angle at initial contact during FBCS exposure [ Time Frame: 1 day (At single time point) ]
  • Participant questionnaire responses [ Time Frame: 1 day (At single time point) ]

Central Contacts and Locations

Central contacts

Peter J Barrance, PhD

9733243550pbarrance@kesslerfoundation.org

Erik Hummer, PhD

973 965 6624ehummer@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Peter J Barrance, PhD

973-324-3550PBarrance@KesslerFoundation.org

Principal Investigator:

Peter J Barrance, PhD

More Information

Sponsor

Kessler Foundation

Last update posted

Jan 19, 2022

Last verified

Jan, 2022

Keywords

  • 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 2022-01-19.