Cerebrovascular Accident
Conditions
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.
Interventions
BEHAVIORALBalance 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
BEHAVIORALBalance 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
BEHAVIORALChallneged 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
Sponsors
Shirley Ryan AbilityLab
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean time of 6 minute walk test at 6 weeks post baseline (end of training) | 6 weeks post baseline (end of training) | — |
| Mean time of 6 minute walk test at 6 months post training | 6 months post end of training (7.5 months post baseline) | — |
| Mean time of 6 minute walk test at baseline | baseline | — |
| Mean time of 6 minute walk test at 3 weeks post baseline | 3 weeks post baseline | — |
| Mean time of 10 meter walk test at baseline | baseline | — |
| Mean time of 10 meter walk test at 3 weeks post baseline | 3 weeks post baseline | — |
| Mean time of 10 meter walk test at 6 weeks at end of training | 6 weeks post baseline | — |
| Mean time of 10 meter walk test at 6 months post training | 6 months post end of training | — |
| Mean Berg Balance Scale score at baseline | 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 | 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) | 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. |
| Mean Berg Balance Scale score at 6 months post end of training | 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. |
Countries
United States
Outcome results
None listed