Cerebrovascular AccidentPhase 1NCT02990650
Outcomes Associated With Progressive Balance And Gait Training Using The KineAssist® Robot
A Phase 1 study testing Balance Task Training with therapist guarding support, Balance task training with robotic guarding support and Challneged balance task training with robotic guarding support in people with Cerebrovascular Accident, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Balance Task Training with therapist guarding support, Balance task training with robotic guarding support and Challneged balance task training with robotic guarding support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 6 months post-stroke
- post-stroke hemiparesis
- 1.0 m/sec or slower walking speed
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Balance Task Training with therapist guarding support, Balance task training with robotic guarding support, Challneged balance task training with robotic guarding support
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance Task Training with therapist guarding supportBehavioural
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
Balance task training with robotic guarding supportBehavioural
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
Challneged balance task training with robotic guarding supportBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Standard physical therapist | Active comparator | A combination of nine balance training tasks where the physical therapist provides guarding against loss of balance Receives: Behavioral: Balance Task Training with therapist guarding support |
| standard robotic guarding | Experimental | A combination of nine balance training tasks where the robotic system provides guarding against loss of balance Receives: Behavioral: Balance task training with robotic guarding support |
| challenge based robotic guarding | Experimental | 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 Receives: Behavioral: Challneged balance task training with robotic guarding support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time of 10 meter walk test at baseline
Measured: baseline
Mean time of 10 meter walk test at 3 weeks post baseline
Measured: 3 weeks post baseline
Mean time of 10 meter walk test at 6 weeks at end of training
Measured: 6 weeks post baseline
Mean time of 10 meter walk test at 6 months post training
Measured: 6 months post end of training
Mean time of 6 minute walk test at baseline
Measured: baseline
Mean time of 6 minute walk test at 3 weeks post baseline
Measured: 3 weeks post baseline
Mean time of 6 minute walk test at 6 weeks post baseline (end of training)
Measured: 6 weeks post baseline (end of training)
Mean time of 6 minute walk test at 6 months post training
Measured: 6 months post end of training (7.5 months post baseline)
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.
Measured: baseline
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.
Measured: 3 weeks post baseline
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.
Measured: 6 weeks post baseline
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.
Measured: 6 months post end of training (7.5 months post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startOct 2008
- Primary completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990650
- Sponsor's protocol ID
- STU00001977
- Status last verified
- Oct 2016
- First submitted
- 16 Oct 2016
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Associated With Progressive Balance And Gait Training Using The KineAssist® Robot
- ClinicalTrials.gov ID
- NCT02990650
- Acronym / sponsor ID
- STU00001977
- Conditions
- Cerebrovascular Accident
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Study start
- Oct 2008
- Primary completion
- Sep 2013 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard physical therapist | Active comparator | Behavioral: Balance Task Training with therapist guarding supportA combination of nine balance training tasks where the physical therapist provides guarding against loss of balance |
| standard robotic guarding | Experimental | Behavioral: Balance task training with robotic guarding supportA combination of nine balance training tasks where the robotic system provides guarding against loss of balance |
| challenge based robotic guarding | Experimental | Behavioral: Challneged balance task training with robotic guarding supportA 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 6 months post-stroke
- post-stroke hemiparesis
- 1.0 m/sec or slower walking speed
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance Task Training with therapist guarding supportNine 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 | Behavioural | Standard physical therapist |
| Balance task training with robotic guarding supportNine 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 | Behavioural | standard robotic guarding |
| Challneged balance task training with robotic guarding supportNine 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 | Behavioural | challenge based robotic guarding |
Primary outcome
Mean time of 10 meter walk test at baseline
Time frame: baseline
Mean time of 10 meter walk test at 3 weeks post baseline
Time frame: 3 weeks post baseline
Mean time of 10 meter walk test at 6 weeks at end of training
Time frame: 6 weeks post baseline
Mean time of 10 meter walk test at 6 months post training
Time frame: 6 months post end of training
Mean time of 6 minute walk test at baseline
Time frame: baseline
Mean time of 6 minute walk test at 3 weeks post baseline
Time frame: 3 weeks post baseline
Mean time of 6 minute walk test at 6 weeks post baseline (end of training)
Time frame: 6 weeks post baseline (end of training)
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)
Mean Berg Balance Scale score at baseline
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Balance Task Training with therapist guarding support, Balance task training with robotic guarding support and Challneged balance task training with robotic guarding support in people with Cerebrovascular Accident, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean time of 10 meter walk test at baseline (time frame: baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2017.