Motion Sensor and Feedback System Efficacy to Refine Movements After Injury

NCT05032378 | Unknown

• 1 other identifier: KAT
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Stroke; Acquired Brain Injury; Movement Disorders

Keywords

efficacy; Treatment

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

People with movement disorders

Adults with acquired movement disorders secondary to neurological injury.

Behavioral: Kinesthetic Awareness Training

Professionals

Professionals providing physical or occupational therapy to participants with acquired movements disorders.

Behavioral: Provision of KAT-assisted physical or occupational therapy

Interventions

Kinesthetic Awareness Training BEHAVIORAL

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

Also known as: KAT

People with movement disorders

Provision of KAT-assisted physical or occupational therapy BEHAVIORAL

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.

Professionals

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• PantherTec: lead
• Quality Living, Inc.: collaborator

Study Sites (1)

Quality Living, Inc.

Omaha, Nebraska, 68104, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Stroke; Brain Injuries; Movement Disorders

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Karen Hux, Ph.D.

  Quality Living, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 2, 2021
• Study Start: December 17, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)