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

NCT ID: NCT02990650

Last Updated: 2017-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31

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.

Conditions

Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard physical therapist

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

Group Type: ACTIVE_COMPARATOR

Balance Task Training with therapist guarding support

Intervention Type: BEHAVIORAL

Nine balance tasks:

1. long forward step

2. forward reach

3. push forward

4. push backward

5. step over hurdle

6. step up on foam surface

7. step up on solid surface

8. sit-to-stand

9. step onto slippery surface The therapist will provide guarding support

standard robotic guarding

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

Group Type: EXPERIMENTAL

Balance task training with robotic guarding support

Intervention Type: BEHAVIORAL

Nine balance tasks:

1. long forward step

2. forward reach

3. push forward

4. push backward

5. step over hurdle

6. step up on foam surface

7. step up on solid surface

8. sit-to-stand

9. step onto slippery surface The guarding support will be provided by a robot

challenge based robotic guarding

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

Group Type: EXPERIMENTAL

Challneged balance task training with robotic guarding support

Intervention Type: BEHAVIORAL

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

1. long forward step

2. forward reach

3. push forward

4. push backward

5. step over hurdle

6. step up on foam surface

7. step up on solid surface

8. sit-to-stand

9. step onto slippery surface The guarding support will be provided by a robot

Interventions

Balance Task Training with therapist guarding support

Nine balance tasks:

1. long forward step

2. forward reach

3. push forward

4. push backward

5. step over hurdle

6. step up on foam surface

7. step up on solid surface

8. sit-to-stand

9. step onto slippery surface The therapist will provide guarding support

Intervention Type: BEHAVIORAL

Balance task training with robotic guarding support

Nine balance tasks:

1. long forward step

2. forward reach

3. push forward

4. push backward

5. step over hurdle

6. step up on foam surface

7. step up on solid surface

8. sit-to-stand

9. step onto slippery surface The guarding support will be provided by a robot

Intervention Type: BEHAVIORAL

Challneged balance task training with robotic guarding support

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

1. long forward step

2. forward reach

3. push forward

4. push backward

5. step over hurdle

6. step up on foam surface

7. step up on solid surface

8. sit-to-stand

9. step onto slippery surface The guarding support will be provided by a robot

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Locomotor Control Lab

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

STU00001977

Identifier Type: -

Identifier Source: org_study_id