Dual Joint Visual Feedback Gait Retraining in Pediatric Hemiplegic Cerebral Palsy

NCT05011201 | Unknown

• 1 other identifier: R-1151-21
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

gait; biofeedback

Outcome Measures

Primary Outcomes (7)

• Knee flexion angle at initial contact without feedback

  Measurement of how bent the knee is when the foot touches the ground at the end of the swing phase without feedback

  1 day (At single time point)

• Knee flexion angle at initial contact during FBC exposure

  Measurement of how bent the knee is when the foot touches the ground at the end of the swing phase during exposure to FBC visual feedback

  1 day (At single time point)

• Knee flexion angle at initial contact during FBCS exposure

  Measurement of how bent the knee is when the foot touches the ground at the end of the swing phase during exposure to FBCS visual feedback

  1 day (At single time point)

• Hip flexion angle at initial contact without feedback

  Measurement of how flexed the hip is when the foot touches the ground at the end of the swing phase without feedback

  1 day (At single time point)

• Hip flexion angle at initial contact during FBC exposure

  Measurement of how flexed the hip is when the foot touches the ground at the end of the swing phase during exposure to FBC visual feedback

  1 day (At single time point)

• Hip flexion angle at initial contact during FBCS exposure

  Measurement of how flexed the hip is when the foot touches the ground at the end of the swing phase during exposure to FBCS visual feedback

  1 day (At single time point)

• Participant questionnaire responses

  Participant responses to a five-point ordinal scale detailing 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.

  1 day (At single time point)

Study Arms (1)

Experimental Group

EXPERIMENTAL

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.

Device: Dual Joint Visual Feedback without Scoring; Device: Dual Joint Visual Feedback with Scoring

Interventions

Dual Joint Visual Feedback without Scoring DEVICE

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.

Experimental Group

Dual Joint Visual Feedback with Scoring DEVICE

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.

Experimental Group

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• understand and follow instructions for equipment setup, testing and task performance
• answer questions related to effort and preference
• be able to understand consent document and provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

Study Officials

• Peter J Barrance, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter J Barrance, PhD

CONTACT

9733243550; pbarrance@kesslerfoundation.org

Erik Hummer, PhD

CONTACT

973 965 6624; ehummer@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will take part in the same interventional model. Participants will undergo several gait retraining bouts using two variants of the DJVF system. The order of bouts during the gait retraining will be block randomized.

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 18, 2021
• Study Start: November 19, 2021
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)