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

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Balance Task Training with therapist guarding support
Balance task training with robotic guarding support
Challneged balance task training with robotic guarding support
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Locomotor Control Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard physical therapist

standard robotic guarding

challenge based robotic guarding

Arm Description

A combination of nine balance training tasks where the physical therapist provides guarding against loss of balance

A combination of nine balance training tasks where the robotic system provides guarding against loss of balance

A combination of nine balance training tasks where the robotic system provides guarding against loss of balance while the participant works at a level greater than their current balance capability

Outcomes

Primary Outcome Measures

Mean time of 10 meter walk test at baseline
Mean time of 10 meter walk test at 3 weeks post baseline
Mean time of 10 meter walk test at 6 weeks at end of training
Mean time of 10 meter walk test at 6 months post training
Mean time of 6 minute walk test at baseline
Mean time of 6 minute walk test at 3 weeks post baseline
Mean time of 6 minute walk test at 6 weeks post baseline (end of training)
Mean time of 6 minute walk test at 6 months post training
Mean Berg Balance Scale score at 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.
Mean Berg Balance Scale score at 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.
Mean Berg Balance Scale score at 6 weeks post baseline (end of training)
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.
Mean Berg Balance Scale score at 6 months post end of training
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.

Secondary Outcome Measures

Full Information

First Posted
October 16, 2016
Last Updated
January 18, 2017
Sponsor
University of Alabama at Birmingham
Collaborators
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT02990650
Brief Title
Outcomes Associated With Progressive Balance And Gait Training Using The KineAssist® Robot
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Shirley Ryan AbilityLab

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard physical therapist
Arm Type
Active Comparator
Arm Description
A combination of nine balance training tasks where the physical therapist provides guarding against loss of balance
Arm Title
standard robotic guarding
Arm Type
Experimental
Arm Description
A combination of nine balance training tasks where the robotic system provides guarding against loss of balance
Arm Title
challenge based robotic guarding
Arm Type
Experimental
Arm Description
A combination of nine balance training tasks where the robotic system provides guarding against loss of balance while the participant works at a level greater than their current balance capability
Intervention Type
Behavioral
Intervention Name(s)
Balance Task Training with therapist guarding support
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Balance task training with robotic guarding support
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Challneged balance task training with robotic guarding support
Intervention Description
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 Outcome Measure Information:
Title
Mean time of 10 meter walk test at baseline
Time Frame
baseline
Title
Mean time of 10 meter walk test at 3 weeks post baseline
Time Frame
3 weeks post baseline
Title
Mean time of 10 meter walk test at 6 weeks at end of training
Time Frame
6 weeks post baseline
Title
Mean time of 10 meter walk test at 6 months post training
Time Frame
6 months post end of training
Title
Mean time of 6 minute walk test at baseline
Time Frame
baseline
Title
Mean time of 6 minute walk test at 3 weeks post baseline
Time Frame
3 weeks post baseline
Title
Mean time of 6 minute walk test at 6 weeks post baseline (end of training)
Time Frame
6 weeks post baseline (end of training)
Title
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)
Title
Mean Berg Balance Scale score at baseline
Description
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.
Time Frame
baseline
Title
Mean Berg Balance Scale score at 3 weeks post baseline
Description
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.
Time Frame
3 weeks post baseline
Title
Mean Berg Balance Scale score at 6 weeks post baseline (end of training)
Description
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.
Time Frame
6 weeks post baseline
Title
Mean Berg Balance Scale score at 6 months post end of training
Description
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.
Time Frame
6 months post end of training (7.5 months post baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Locomotor Control Lab
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35210
Country
United States

12. IPD Sharing Statement

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

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