Clinical trial NCT02990650: Outcomes Associated With Progressive Balance And Gait Training Using The KineAssist® Robot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cerebrovascular Accident
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Shirley Ryan AbilityLab
First posted: 2016-12-13
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean time of 10 meter walk test at baseline
timeFrame: baseline
measure: Mean time of 10 meter walk test at 3 weeks post baseline
timeFrame: 3 weeks post baseline
measure: Mean time of 10 meter walk test at 6 weeks at end of training
timeFrame: 6 weeks post baseline
measure: Mean time of 10 meter walk test at 6 months post training
timeFrame: 6 months post end of training
measure: Mean time of 6 minute walk test at baseline
timeFrame: baseline
measure: Mean time of 6 minute walk test at 3 weeks post baseline
timeFrame: 3 weeks post baseline
measure: Mean time of 6 minute walk test at 6 weeks post baseline (end of training)
timeFrame: 6 weeks post baseline (end of training)
measure: Mean time of 6 minute walk test at 6 months post training
timeFrame: 6 months post end of training (7.5 months post baseline)
measure: Mean Berg Balance Scale score at baseline
timeFrame: baseline
measure: Mean Berg Balance Scale score at 3 weeks post baseline
timeFrame: 3 weeks post baseline
measure: Mean Berg Balance Scale score at 6 weeks post baseline (end of training)
timeFrame: 6 weeks post baseline
measure: Mean Berg Balance Scale score at 6 months post end of training
timeFrame: 6 months post end of training (7.5 months post baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Locomotor Control Lab
state: Alabama
Study officials:
References: