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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05032378
Other study ID # KAT
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 17, 2021
Est. completion date September 2024

Study information

Verified date March 2023
Source PantherTec
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 20
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers
Gender All
Age group 16 Years to 70 Years
Eligibility 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:

Study Design


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
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.

Locations

Country Name City State
United States Quality Living, Inc. Omaha Nebraska

Sponsors (2)

Lead Sponsor Collaborator
PantherTec Quality Living, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Goal Attainment Scaling (GAS) in rehabilitation 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. completion of 8-week treatment period
Primary System Usability Scale (SUS) 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. completion of 8-week treatment provision period
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