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Completed

NCT Number: NCT05335798

Reinforcing CP Robotic Training With Auditory Feedback

The purpose of this study is to create a platform to prolong the adaption obtained from the cable-actuated gait training and encourage the individuals with CP to provide self-care at home.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo, South Campus, Kimball 115

Buffalo, New York, 14260-4200, United States

About this study

The experiment protocol involves a maximum of ten sessions and will take two or three hours for each session. Baseline data will be collected before the first session for both overground and treadmill walking. During this session, the sound level will be adjusted based on the feedback received from the users. The researcher will ask the comfortable sound level to the participant before starting the experiment. Training will be conducted on the treadmill with the cable-actuated device for about 20 minutes. When the cables were removed, participants walked on the treadmill for 4 minutes during the post-training session. During training and post-training, participants will be exposed to feedback while walking on the treadmill. After treadmill walking, CP participants will be asked to take a ten-minute break and then practice overground walking for two minutes with auditory feedback (type A) and without it (type B). Effects of 3 different types of auditory feedback will be explored namely, rhythmic sounds, movement sonification, and sound notifying erroneous gait. Group A participants will be further divided into groups depending on the type of auditory feedback that will be provided. Participants will participate in a maximum of 10 sessions, two or three times a week. Before the first and after the last training, participants will be evaluated for functional gait assessment, 6-min-walk, leg strength using a dynamometer, and Modified Ashworth test by a physical therapist.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with cerebral palsy (18-65 years old)
  • Ambulation of a distance of 100 feet with or without the use of assistive devices.

Exclusion criteria

  • Severe Equinovarus foot or Genu recurvatum of the knee
  • Surgery within 6 months will be excluded.
  • Individuals with pregnancy
  • Lower limb prosthetics
  • Severe respiratory problems such as chronic obstructive pulmonary disease, heart disease, a loss of sensation, uncontrolled blood pressure,
  • Seizure disorder
  • Severe arthritis

Treatment and study plan

Bodyweight augment system

Device

Motorized cables will be providing downward force on the participant's pelvis

Smart insole

Device

Insole provided auditory feedback when heel strike or toe-off events happen

Primary outcomes

  1. Change of 10m walk between pre/post evaluation and 6 Training sessions

    Time frame: through study completion, an average of 5 weeks

    Timing in seconds during 10 m over ground walking. Lower score means faster (better) walking speed

  2. Change of 6 min walk between Pre/post evaluation

    Time frame: through study completion, an average of 5 weeks

    Measure distance in meter over 6 min walk. Increased distance shows better walking endurance

  3. Change of Ground reaction force between 6 Training sessions

    Time frame: through study completion, an average of 5 weeks

    Bertec Force instrumented treadmill will use to measure vertical ground reaction force in Newton. We will identify whether we can see a distict heel strike and strong push

  4. Change of Kinematics between Pre/post evaluation and 6 Training sessions

    Time frame: through study completion, an average of 5 weeks

    Motion capture data. We will measure hip, knee, and ankle joint angles in degrees. We expect to see If the knees is more extended and dorsiflexion is observed at heel strike the gait is improved

  5. Change of surface electromyography between Pre/post evaluation and 6 Training sessions

    Time frame: through study completion, an average of 5 weeks

    Surface electromyography will be measured for the lower limb. Unit is in mV. We are expecting to measure the peak semg during each gait cycle.

Other outcomes

  1. Change of Muscle tone between Pre/post evaluation

    Time frame: through study completion, an average of 5 weeks

    Modified Ashworth Scale a clinical measure of muscle spasticity. Rated from 0(no increase in muscle tone) to 4(affected part rigid in flexion or extension). Lower score means better muscle tone.

  2. Usability questionnaire of Post evaluation

    Time frame: through study completion, an average of 5 weeks

    Questionnaires were made to understand the the perceived improvement (increased steps and walking speed ) or dose of the intervention (more session and frequency of the intervention). It is rated from 1 very likely to 5 unlikely.

  3. Exit interview after completion of the sessions of Post evaluation

    Time frame: through study completion, an average of 5 weeks

    This is designed for any improvement of future study design. We will ask questions on potential improvement of the intervention

  4. Change of strength of Post evaluation between Pre/post evaluation

    Time frame: through study completion, an average of 5 weeks

    Measure the strength with Dynamometer in N. Higher number means stronger limb.

  5. Change of functional gait assessment between Pre/post evaluation

    Time frame: through study completion, an average of 5 weeks

    Measure different aspects of gait. It is rated from 0 to 3. Higher score means improved improved walking during gait with level surface, change in speed, gait with head turns, step over obstacle, gait with eyes closed, steps.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2022
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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