StrokeNCT00125619
Internally Versus Externally Guided Body Weight-Supported Treadmill Training (BWSTT) for Locomotor Recovery Post-stroke
A study testing Locomotor training in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The overriding goal of this proposal is to identify the critical physiological and biomechanical effects of BWSTT for promoting improved locomotor function in persons with post-stroke hemiparesis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Locomotor training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of cerebrovascular accident
- Single event
- Unilateral hemiplegia
- Locomotor disability
- Ability to walk independently 25' on level ground (may use an assistive device [cane or walker]; may NOT use a brace)
- Cognitive ability to follow 3-step commands
Who cannot join
- Unstable or uncontrolled blood pressure
- Uncontrolled seizures
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
About this study
Official title: Internally v. Externally Guided BWSTT for Locomotor Recovery Post-stroke
The overriding goal of this proposal is to identify the critical physiological and biomechanical effects of BWSTT for promoting improved locomotor function in persons with post-stroke hemiparesis.
Read the detailed description
In this pilot study, we tested two forms of locomotor training for gait rehabilitation in persons post-stroke: traditional locomotor training (partial body-weight support and manual assistance of therapists) vs. robotic-assisted locomotor training (partial body-weight support and robotic guidance with the Lokomat). We enrolled 16 persons with chronic (>6 months) hemiparesis post-stroke who were randomized to traditional/manual or robotic locomotor training. All individuals received 12 sessions (thrice weekly for four weeks) of training. Each session involved 30 minutes of stepping.
The complete study results are published.
- Conditions
- Stroke
- Being tested
- Locomotor training
- Keywords
- biomechanics, stroke, electromyography, Gait disability stroke, locomotor therapy, muscular weakness, reflex variability stroke
- Medical subject headings
- Stroke, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locomotor trainingBehavioural
Also called partial body-weight supported treadmill training, body-weight supported treadmill training
This study compares two forms of Iocomotor training: 1) standard or manual - in which an individual is provided partial body weight support while walking on a treadmill with assistance of 1-3 therapists to move the legs and stabilize the trunk/pelvis and 2) robotic-guided - in which an exoskeleton robot (Lokomat) guides movement of the walking pattern. Partial body-weight support, treadmill walking and treadmill speed are consistent between the study arms.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Therapist assisted | Active comparator | Therapist assisted locomotor training (partial body-weight supported) Receives: Behavioral: Locomotor training |
| Arm 2: Robot-assisted | Experimental | Robot-assisted locomotor training (partial body-weight supported) Receives: Behavioral: Locomotor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-selected Overground Walking Speed
Overground walking speed determined as rate of walking over a 10 meter distance.
Measured: 4 weeks (s/p 12 sessions of locomotor training)
Secondary outcomes (6)
Fast Walking Speed
Fastest comfortable walking speed measured while walking overground
Measured: 4 weeks (s/p 12 training sessions)
Six Minute Walk
distance, in meters, walked overground over a six minute interval.
Measured: 4 weeks
Step Length Ratio (Abs)
measure of step length symmetry, calculated as = ABS [1 - (Pstep length / NPstep length)]
Measured: 4 weeks
Lower Extremity Fugl-Meyer Motor Assessment
Standardized clinical measure of motor impairment. The lower extremity (leg) sub-scale ranges from 0 - 35 points, where less impairment corresponds with scores approaching 35 and worse impairment corresponds with scores approaching 0.
Measured: 4 weeks
Short Physical Performance Battery
Standardized clinical measure of physical function involving tests of: walking speed, strength (repeated chair rise), and balance. The scale ranges from 0 - 12 points with better physical function as the score approaches 12 points and worse physical function as the score approaches 0 points.
Measured: 4 weeks
Berg Balance Scale
Clinical measure of balance
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Carolynn Patten, PhD, Principal investigator, North Florida/South Georgia Veterans Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125619
- Sponsor's protocol ID
- B4032-I
- Status last verified
- Dec 2016
- First submitted
- 28 Jul 2005
- Last updated
- 17 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Westlake KP, Patten C. Pilot study of Lokomat versus manual-assisted treadmill training for locomotor recovery post-stroke. J Neuroeng Rehabil. 2009 Jun 12;6:18. doi: 10.1186/1743-0003-6-18.
PubMed 19523207Spiess MR, Jaramillo JP, Behrman AL, Teraoka JK, Patten C. Unexpected recovery after robotic locomotor training at physiologic stepping speed: a single-case design. Arch Phys Med Rehabil. 2012 Aug;93(8):1476-84. doi: 10.1016/j.apmr.2012.02.030. Epub 2012 Mar 23.
PubMed 22446153
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internally v. Externally Guided BWSTT for Locomotor Recovery Post-stroke
- ClinicalTrials.gov ID
- NCT00125619
- Acronym / sponsor ID
- B4032-I
- Conditions
- Stroke
- Keywords
- biomechanics, stroke, electromyography, Gait disability stroke, locomotor therapy, muscular weakness, reflex variability stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Sep 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 1 Aug 2005 (estimated)
- Results
- Posted 17 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overriding goal of this proposal is to identify the critical physiological and biomechanical effects of BWSTT for promoting improved locomotor function in persons with post-stroke hemiparesis.
Detailed description
In this pilot study, we tested two forms of locomotor training for gait rehabilitation in persons post-stroke: traditional locomotor training (partial body-weight support and manual assistance of therapists) vs. robotic-assisted locomotor training (partial body-weight support and robotic guidance with the Lokomat). We enrolled 16 persons with chronic (>6 months) hemiparesis post-stroke who were randomized to traditional/manual or robotic locomotor training. All individuals received 12 sessions (thrice weekly for four weeks) of training. Each session involved 30 minutes of stepping.
The complete study results are published.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Therapist assisted | Active comparator | Behavioral: Locomotor trainingTherapist assisted locomotor training (partial body-weight supported) |
| Arm 2: Robot-assisted | Experimental | Behavioral: Locomotor trainingRobot-assisted locomotor training (partial body-weight supported) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of cerebrovascular accident
- Single event
- Unilateral hemiplegia
- Locomotor disability
- Ability to walk independently 25' on level ground (may use an assistive device [cane or walker]; may NOT use a brace)
Key exclusion criteria (3 listed)
- Unstable or uncontrolled blood pressure
- Uncontrolled seizures
- Severe cognitive impairment
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 |
|---|---|---|
| Locomotor trainingAlso: partial body-weight supported treadmill training, body-weight supported treadmill trainingThis study compares two forms of Iocomotor training: 1) standard or manual - in which an individual is provided partial body weight support while walking on a treadmill with assistance of 1-3 therapists to move the legs and stabilize the trunk/pelvis and 2) robotic-guided - in which an exoskeleton robot (Lokomat) guides movement of the walking pattern. Partial body-weight support, treadmill walking and treadmill speed are consistent between the study arms. | Behavioural | Arm 1: Therapist assisted, Arm 2: Robot-assisted |
Primary outcome
Self-selected Overground Walking Speed
Time frame: 4 weeks (s/p 12 sessions of locomotor training)
Overground walking speed determined as rate of walking over a 10 meter distance.
6 secondary outcomes
Fast Walking Speed
Time frame: 4 weeks (s/p 12 training sessions)
Six Minute Walk
Time frame: 4 weeks
Step Length Ratio (Abs)
Time frame: 4 weeks
Lower Extremity Fugl-Meyer Motor Assessment
Time frame: 4 weeks
Short Physical Performance Battery
Time frame: 4 weeks
Berg Balance Scale
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19523207Westlake KP, Patten C. Pilot study of Lokomat versus manual-assisted treadmill training for locomotor recovery post-stroke. J Neuroeng Rehabil. 2009 Jun 12;6:18. doi: 10.1186/1743-0003-6-18.
- Results publication: PubMed 22446153Spiess MR, Jaramillo JP, Behrman AL, Teraoka JK, Patten C. Unexpected recovery after robotic locomotor training at physiologic stepping speed: a single-case design. Arch Phys Med Rehabil. 2012 Aug;93(8):1476-84. doi: 10.1016/j.apmr.2012.02.030. Epub 2012 Mar 23.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Carolynn Patten, PhD principal investigator
North Florida/South Georgia Veterans Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locomotor training in people with Stroke, run by VA Office of Research and Development 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 6 inclusion and 3 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 17 Feb 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-selected Overground Walking Speed (time frame: 4 weeks (s/p 12 sessions of locomotor training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00125619, which also lists 2 linked publications.
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 17 Feb 2017.