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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 1

Conditions: Cerebrovascular Accident

Treatments: Behavioral: Challneged balance task training with robotic guarding support; Behavioral: Balance Task Training with therapist guarding support; Behavioral: Balance task training with robotic guarding support

Study type: Interventional

Funder types: Other

Identifiers

NCT02990650

STU00001977

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

36 participants in 3 patient groups

Standard physical therapist

Active Comparator group

Description:

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

Treatment:

Behavioral: Balance Task Training with therapist guarding support

standard robotic guarding

Experimental group

Description:

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

Treatment:

Behavioral: Balance task training with robotic guarding support

challenge based robotic guarding

Experimental group

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

Treatment:

Behavioral: Challneged balance task training with robotic guarding support