Motion Sensor and Feedback System Efficacy to Refine Movements After Injury

• ClinicalTrials.gov Identifier: NCT05032378
• Recruitment Status: Enrolling by invitation
• First Posted: September 2, 2021
• Last Update Posted: March 29, 2023
• Sponsor: PantherTec
• 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

• 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

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

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