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Completed

NCT Number: NCT02990650

Outcomes Associated With Progressive Balance And Gait Training Using The KineAssist® Robot

Using a randomized controlled research design, compare walking outcomes resulting from gait and balance training with standard physical therapist interaction versus training with the addition of a KineAssist® robotic system that provides for safety and freedom of movement.

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Locomotor Control Lab

Birmingham, Alabama, 35210, United States

About this study

Several studies have investigated the use of balance and gait training and have demonstrated significant improvements in walking speed with trained stroke survivors. The inherent risks associated with balance and gait training requires the therapist to be vigilant with providing safety and support during challenging tasks. As a result, consumers are not challenged to their furthest limits and therapists put an inordinate amount of physical effort into safety control. KineAssist® Design, LLC in collaboration with Rehabilitation Institute of Chicago, developed the KineAssist® Balance and Gait Training System (KineAssist®). The KineAssist® is a novel device that allows full freedom of motion for the trunk and pelvis during gait and balance tasks, with additional postural control to enhance balance stability. These functions are available while the device follows the individual overground with minimal interference. The availability of postural control during complex and omnidirectional movement tasks allows the clinician to guarantee consumer safety and body weight support while at the same time provide graded task challenges to the fullest limits of the consumers capabilities. This KineAssist® is revolutionary in that it is the first device that is fully interactive and responsive to the movements and intentions of both the consumer and the therapist during overground challenging balance and gait activities.

Accordingly, the long-term objective of this research is to test the efficacy of robotically enhanced, progressive gait and balance training for improving walking outcomes post-stroke. The following two aims are designed to test whether the KineAssist® provides a more challenging training environment than is typical with physical therapy, and then compares walking outcomes as a result of long-term (6 weeks) training.

Aim: Using a randomized controlled research design, compare walking outcomes resulting from gait and balance training with standard physical therapist interaction versus training with the addition of a KineAssist®t.

Overall, these studies are an important advance for the development of effective clinical interventions for individuals with impaired locomotor ability post-stroke. This study will provide critical information on physiological effects and clinical outcomes and provide important evidence for the use of this new class of robotic technology that accommodates both the clinician and the consumer in stroke rehabilitation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • > 6 months post-stroke
  • post-stroke hemiparesis
  • 1.0 m/sec or slower walking speed

Exclusion criteria

  • musculoskeletal injury
  • recent history of cardiac event
  • other neurological disease or disorders
  • inability to follow three-step commands
  • uncontrolled diabetes and/or high blood pressure

Treatment and study plan

Balance Task Training with therapist guarding support

Behavioral

Nine balance tasks:

  • long forward step
  • forward reach
  • push forward
  • push backward
  • step over hurdle
  • step up on foam surface
  • step up on solid surface
  • sit-to-stand
  • step onto slippery surface The therapist will provide guarding support

Balance task training with robotic guarding support

Behavioral

Nine balance tasks:

  • long forward step
  • forward reach
  • push forward
  • push backward
  • step over hurdle
  • step up on foam surface
  • step up on solid surface
  • sit-to-stand
  • step onto slippery surface The guarding support will be provided by a robot

Challneged balance task training with robotic guarding support

Behavioral

Nine balance tasks where the subject is challenged to perform at a harder level of difficulty:

  • long forward step
  • forward reach
  • push forward
  • push backward
  • step over hurdle
  • step up on foam surface
  • step up on solid surface
  • sit-to-stand
  • step onto slippery surface The guarding support will be provided by a robot

Primary outcomes

  1. Mean time of 10 meter walk test at baseline

    Time frame: baseline

  2. Mean time of 10 meter walk test at 3 weeks post baseline

    Time frame: 3 weeks post baseline

  3. Mean time of 10 meter walk test at 6 weeks at end of training

    Time frame: 6 weeks post baseline

  4. Mean time of 10 meter walk test at 6 months post training

    Time frame: 6 months post end of training

  5. Mean time of 6 minute walk test at baseline

    Time frame: baseline

  6. Mean time of 6 minute walk test at 3 weeks post baseline

    Time frame: 3 weeks post baseline

  7. Mean time of 6 minute walk test at 6 weeks post baseline (end of training)

    Time frame: 6 weeks post baseline (end of training)

  8. Mean time of 6 minute walk test at 6 months post training

    Time frame: 6 months post end of training (7.5 months post baseline)

  9. Mean Berg Balance Scale score at baseline

    Time frame: baseline

    The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.

  10. Mean Berg Balance Scale score at 3 weeks post baseline

    Time frame: 3 weeks post baseline

    The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.

  11. Mean Berg Balance Scale score at 6 weeks post baseline (end of training)

    Time frame: 6 weeks post baseline

    The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.

  12. Mean Berg Balance Scale score at 6 months post end of training

    Time frame: 6 months post end of training (7.5 months post baseline)

    The Berg Balance Scale has a range of 56 (best) to 14 (worst). There are 14 different balance tasks each with a an assigned rank of 1 - 4 (1, 2, 3, 4). 1 is the worst performance and 4 is the best.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Shirley Ryan AbilityLab

Registry information

Important dates

Study start
2008
Primary completion
2013
First posted
Dec 13, 2016
Registry last updated
Jan 19, 2017

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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