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Motion Sensor and Feedback System Efficacy to Refine Movements After Injury

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ClinicalTrials.gov Identifier: NCT05032378
Recruitment Status : Enrolling by invitation
First Posted : September 2, 2021
Last Update Posted : March 29, 2023
Sponsor:
Collaborator:
Quality Living, Inc.
Information provided by (Responsible Party):
PantherTec

Tracking Information
First Submitted Date August 26, 2021
First Posted Date September 2, 2021
Last Update Posted Date March 29, 2023
Actual Study Start Date December 17, 2021
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2021)
  • Goal Attainment Scaling (GAS) in rehabilitation [ Time Frame: completion of 8-week treatment period ]
    The GAS uses a 5-point rating scale to describe the extent of a participant's goal achievement. Scores for each attainment goal range from -2 (much worse than expected) to +2 (much better than expected). The composite GAS (the sum of attainment levels x the relative weight for each goal) is transformed into a standardized measure or T score with a mean of 50 and standard deviation of 10.
  • System Usability Scale (SUS) [ Time Frame: completion of 8-week treatment provision period ]
    The SUS is a feasibility rating scale for that will be used by professional participants to evaluate the KAT device. It includes 10 items with 5 response options ranging from 1 (strongly disagree) to 5 (strongly agree). Scores for odd-numbered items on the scale are calculated by subtracting 1 from the user's rating; scores for even-numbered items on the scale are calculated by subtracting the user's response from 5. This scales all values from 0 to 4, with four being the most positive response. Summing the converted scores and multiplying by 2.5 yields a score between 0 and 100, with 100 being the most positive score.
Original Primary Outcome Measures
 (submitted: August 26, 2021)
  • Goal Attainment Scale [ Time Frame: completion of 8-week treatment period ]
    5-point rating scale for use by people with movement disorders to describe their extent of goal achievement
  • System User Satisfaction Rating Scale [ Time Frame: completion of 8-week treatment provision period ]
    Feasibility rating scale for use by professionals to evaluate the KAT device
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Motion Sensor and Feedback System Efficacy to Refine Movements After Injury
Official Title Efficacy of a Motion Sensor and Feedback System to Refine Movements of People With Acquired Neurological Injury: A Series of Case Studies
Brief Summary The purpose of these case studies is to determine the efficacy of the Kinesthetic Awareness Training (KAT) device in facilitating the restoration of desired movement patterns when people with acquired central nervous system damage perform functional activities such as walking, transitioning from one position to another, or reaching with the arms.
Detailed Description

People with acquired neurological disorders often exhibit impaired movement patterns when performing functional activities such as walking, standing up from a seated position, and reaching for objects. Re-establishing normal movement patterns is an essential part of rehabilitation; however, achievement of this typically requires thousands of accurate movement repetitions. Only through this repetition can a person benefit from the inherent neuroplasticity of the nervous system to make restored patterns habitual.

Sensory and/or proprioceptive problems may limit a person's awareness of ways in which abnormal movement patterns differ from desired ones. Because of these problems, provision of external feedback in the form of verbal comments, physical repositioning of the limbs by another person, or other auditory or haptic cues is critical. As a general rule, a person benefits most when provided with precise feedback about the position of body parts when he/she is actively engaged in performing a desired movement. As such, the linking of motion sensors programmed to detect achievement of a target position with immediate auditory (i.e., beeps) and/or haptic (i.e., vibrations) feedback has the potential to be a powerful treatment tool.

The Kinesthetic Awareness Training (KAT) device developed by PantherTec is a wearable, motion capture system that can be programmed to detect and provide immediate auditory and/or haptic feedback when a person moves a specified body part to a target position during performance of a functional sequence of movements. Each time a person replicates the desired movement, the device either begins emitting or ceases emitting beeps and/or vibrations-as specified during programming-to indicate achievement of the correct position. Adjustment of the sensitivity (i.e., margin of error per target value) allows for specification of how close a performed movement must be to the target position to elicit feedback.

PantherTec has made a prototype of the KAT device available to Quality Living, Inc. (QLI) for feasibility testing and exploration of possible applications with people with movement impairments resulting from acquired neurological injury. The purpose of the proposed case studies is to determine the efficacy of the KAT device in facilitating the restoration of desired movement patterns when people with acquired central nervous system damage perform functional activities such as walking, transitioning from one position to another, or reaching with the arms.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Current residents of Quality Living, Inc., who are receiving treatment for an acquired movement disorder.

Current staff of Quality Living, Inc., who are providing physical or occupational therapy treatment to a participant with an acquired movement disorder.

Condition
  • Spinal Cord Injuries
  • Stroke
  • Acquired Brain Injury
  • Movement Disorders
Intervention
  • Behavioral: Kinesthetic Awareness Training
    One physical or occupational therapy session per week for 8 weeks during which the participant with disordered movement will attempt to perform desired movements while wearing the KAT device
    Other Name: KAT
  • Behavioral: Provision of KAT-assisted physical or occupational therapy
    Physical or occupational therapy professionals will provide one KAT-assisted therapy session per week for 8 weeks to one or more participants with movement disorder.
Study Groups/Cohorts
  • People with movement disorders
    Adults with acquired movement disorders secondary to neurological injury.
    Intervention: Behavioral: Kinesthetic Awareness Training
  • Professionals
    Professionals providing physical or occupational therapy to participants with acquired movements disorders.
    Intervention: Behavioral: Provision of KAT-assisted physical or occupational therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: August 26, 2021)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2024
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • For participants with movement disorders:

    • Between 16 and 70 years of age
    • Has an acquired movement disorder secondary to neurological injury
    • Understands English sufficiently to follow simple commands
    • Is a current resident of Quality Living, Inc.
  • For professionals:

    • Over 19 years of age
    • A physical therapy or occupational therapy staff member employed by Quality Living, Inc.
    • Has used the KAT device to provide treatment to a participant with a movement disorder

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05032378
Other Study ID Numbers KAT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party PantherTec
Original Responsible Party Same as current
Current Study Sponsor PantherTec
Original Study Sponsor Same as current
Collaborators Quality Living, Inc.
Investigators
Principal Investigator: Karen Hux, Ph.D. Quality Living, Inc.
PRS Account PantherTec
Verification Date March 2023