StrokeNCT06169657
Comparison of Gait Training Methods in Sub-acute Stroke and Spinal Cord Injury
An observational study of Stroke and Incomplete Spinal Cord Injury, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The purpose of the project is to compare intensity (minutes in target heart rate zone) and steps per session across three gait training modalities, including body-weight supported treadmill training (BWSTT), overground gait training with body weight-support (BWS), and overground gait training utilizing a lower… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Incomplete Spinal Cord Injury
- What is being tested?
- Body-weight-supported treadmill training (BWSTT), EksoNR exoskeleton gait training and Overground gait training
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 31 Dec 2025
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals poststroke or post-iSCI that are inpatients at Shirley Ryan AbilityLab
Who may be able to join
- Age 18-75 years old, inclusive
- Medical clearance from primary medical team (signed Medical Clearance form)
- Adequate cognitive function as determined by the NIH scale: score ≤1 on question 1b and score =0 on question 1c
- Gait speed between 0-0.79 m/s
- Informed consent provided by participant or POA
- English speaking
Show all 12Show fewer
- Additional Inclusion Criteria for patients post-stroke:
- First stroke, ischemic or hemorrhagic, within the past six months
- Unilateral, supratentorial stroke
- Additional Inclusion Criteria for patients iSCI:
- ASIA C or D
- Traumatic iSCI, within past six months
Who cannot join
- Severe aphasia limiting ability to express needs or discomfort verbally or nonverbally
- History of or concurrent neurologic condition (i.e., stroke, SCI, PD, TBI, MS, etc.)
- History of peripheral nerve injury
- Severe knee, hip, or ankle osteoarthritis
- Severe osteoporosis as indicated by physician medical clearance
- Open wounds on skin surfaces in contact with exoskeleton or harness
Show all 31Show fewer
- Unstable spine or unhealed fractures
- Weight bearing precautions
- Unresolved deep vein thrombosis (DVT)
- Pregnancy
- Prisoners
- Additional Exclusion criteria for EksoNR13:
- Weight >220 lbs (100 kg)
- Height below 60 inches or above 76 inches
- Standing hip width of approximately 18 inches or more
- Joint contractures or range of motion deficits that limit normal range of motion during ambulation:
- Knee flexion contracture greater than 12°
- Hip flexion contracture greater than 17°
- Inability to achieve 0° neutral ankle dorsiflexion with knee flexion up to 12°
- Bilateral hip flexion less than 110°
- Significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
- Leg length discrepancy:
- Greater than 0.5 in. (1.27 cm) for upper legs
- Greater than 0.75 in. (1.91 cm) for lower legs
- Active heterotopic ossification
- Significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
- High anxiety or claustrophobia
- Clostridium difficile or other gastrointestinal isolation precautions
- Colostomy
- Uncontrolled autonomic dysreflexia
- Lower limb prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intensity and Step Count of Gait Training Modalities in the Inpatient Rehabilitation Setting in Sub-acute Central Nervous System Injury
The purpose of the project is to compare intensity (minutes in target heart rate zone) and steps per session across three gait training modalities, including body-weight supported treadmill training (BWSTT), overground gait training with body weight-support (BWS), and overground gait training utilizing a lower extremity exoskeleton, between patients presenting with varying functional ambulation capacities in the inpatient setting. Additionally, the researchers will compare physical therapist (PT) burden across these modalities and patient functional presentation levels.
Read the detailed description
Aim 1 of this study is to measure stepping repetition and intensity via heart rate of three gait-training modalities utilized with patients in the subacute phase of stroke and iSCI during inpatient rehabilitation in order to guide therapists through clinical decision-making of selecting the optimal intervention for patients based on functional presentation. Aim 2 of this study is to measure therapist burden across each gait training modalities, as this is an additional factor that contributes to the number of steps taken and intensity experienced by the patient.
The gait training modalities assessed will include BWSTT, overground gait training with a lower extremity exoskeleton, and overground gait training with BWS. The participants' functional level will be classified by gait speed obtained via the 10 meter walk test (10MWT), a standardized assessment commonly used in rehabilitation. These functional classification categories include household ambulator (low level) and limited community ambulator (high level), determined by Fritz et al. 2009.
The researchers hypothesize that low functioning/household ambulators will achieve more minutes in high-intensity training zones utilizing the exoskeleton due to the enhanced participation and increased weight-bearing the device supports compared to the other modalities. In addition, a greater number steps will be achieved in this mode due to the exoskeleton's ability to decrease overall therapist burden compared to BWSTT and overground with BWS. In contrast, the researchers anticipate that steps per session and overall intensity will be decreased in high functioning/limited community ambulators due the unnecessary support the exoskeleton provides at this functional level. The researchers believe that high functioning/ limited community ambulators will achieve the highest number of steps and intensity during BWSTT due to the ability to increase challenges via treadmill parameters such as speed and incline while utilizing a harness for safety and bodyweight support only as necessary. In contrast, the researchers believe the amount of BWS and assistance a PT must provide relative to the patient's contribution to practice successful stepping during BWSTT will result in a lower intensity and number of steps achieved in low functioning/household ambulators.
- Conditions
- Stroke, Incomplete Spinal Cord Injury
- Being tested
- Body-weight-supported treadmill training (BWSTT), EksoNR exoskeleton gait training, Overground gait training
- Keywords
- Stroke, Incomplete Spinal Cord Injury, Gait Rehabilitation, Exoskeleton, Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body-weight-supported treadmill training (BWSTT)Device
Walking on a treadmill in a harness with body weight support as needed
EksoNR exoskeleton gait trainingDevice
Walking in the EksoNR exoskeleton
Overground gait trainingDevice
Walking overground in a harness with body weight support as needed
| Study group | Role | What they receive |
|---|---|---|
| Inpatients Post-stroke, low level ambulators | Individuals post acute or subacute stroke that that are inpatients at the Shirley Ryan AbilityLab ages 18-75 with initial gait speed 0.0-0.39 m/s Receives: Device: Body-weight-supported treadmill training (BWSTT); Device: EksoNR exoskeleton gait training; Device: Overground gait training | |
| Inpatients Post-stroke, high level ambulators | Individuals post acute or subacute stroke that that are inpatients at the Shirley Ryan AbilityLab ages 18-75 with initial gait speed 0.4-0.79 m/s Receives: Device: Body-weight-supported treadmill training (BWSTT); Device: EksoNR exoskeleton gait training; Device: Overground gait training | |
| Inpatients with iSCI, low level ambulators | Individuals post-SCI or subacute that that are inpatients at the Shirley Ryan AbilityLab ages 18-75 with initial gait speed 0.0-0.39 m/s Receives: Device: Body-weight-supported treadmill training (BWSTT); Device: EksoNR exoskeleton gait training; Device: Overground gait training | |
| Inpatients with iSCI, high level ambulators | Individuals post-SCI or subacute that that are inpatients at the Shirley Ryan AbilityLab ages 18-75 with initial gait speed 0.4-0.79 m/s Receives: Device: Body-weight-supported treadmill training (BWSTT); Device: EksoNR exoskeleton gait training; Device: Overground gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of Step count
The number of steps taken during each session will be measured using activity monitors/pedometers. These devices are small accelerometers that can be worn on a belt and/or on the ankle to record steps and Kcals during an activity. The therapist leading the intervention session will apply the ActiGraph at the beginning of each intervention session and remove it upon completion. A higher step count is a better outcome.
Measured: Each session through completion of study, up to 10 days
Observation of Time spent in age-predicted maximum high-intensity target heart rate zone
The target range of 70-85% of age-predicted maximum heart rate will be calculated for each participant utilizing HR max = 208 - [0.7 × age] as developed by Tanka et al in 2001. The target range of 70-85% of age-predicted maximum heart rate will be calculated for each participant. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. More time spent in the maximum intensity zone target zone is a better outcome.
Measured: Each session through completion of study, up to 10 days
Observation of Time spent in age-predicted moderate-intensity target heart rate zone
The target range of 50-70% of age-predicted maximum heart rate will be calculated for each participant utilizing HR max = 208 - [0.7 × age] as developed by Tanka et al in 2001. The target range of 50-70% of age-predicted maximum heart rate will be calculated for each participant. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. Less time spent in the moderate intensity pre-calculated target zone is a better outcome as the more minutes in the high intensity zone is the best outcome.
Measured: Each session through completion of study, up to 10 days
Observation of Time spent in age-predicted low-intensity target heart rate zone
The target range of 50% of age-predicted maximum heart rate will be calculated for each participant utilizing HR max = 208 - [0.7 × age] as developed by Tanka et al in 2001. Low intensity equals 50% or less of age-predicted maximum heart rate and will be calculated for each participant. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. Less time spent in the low intensity zone is better as the goal is to achieve more minutes in high-intensity zone.
Measured: Each session through completion of study, up to 10 days
Secondary outcomes (8)
Observation of Minutes spent in equipment setup per session
Total time in minutes spent applying and removing equipment. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. Less time would be considered better as that indicates more time spent walking.
Measured: Each session through completion of study, up to 10 days
Observation of Minutes spent in rest breaks per session
Total time in minutes the participant spends resting (not walking or applying/ removing equipment) between walking bouts. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. Less time would be considered better as that indicates more time spent walking.
Measured: Each session through completion of study, up to 10 days
Observation of Minutes spent stepping
Total time in minutes the participant spends walking (not including rest breaks or applying/ removing equipment) during a session. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. Less time would be considered better as that indicates more time spent walking.
Measured: Each session through completion of study, up to 10 days
Observation of Patient Borg Rating of perceived exertion (RPE)
The Borg Rating of Perceived Exertion is a tool to measure the subjective report of effort, exertion, and fatigue during physical work. It consists of a 15-point scale from 6-20, in which 6=no exertion and 20=absolute maximum exertion. It is presented to the participant in written format with descriptors to standardize the report of perceived exertion across tasks. An optimal score is between 14-20 as this indicates higher perceived walking intensity for the participant.
Measured: Each session through completion of study, up to 10 days
Observation of Patient Intrinsic Motivation Inventory (IMI)
The Intrinsic Motivation Inventory (IMI) is a multidimensional measurement that measures participants' subjective experience related to a target activity in laboratory experiments. The instrument consists of seven subscale scores related to interest/enjoyment, perceived competence, effort/importance, felt pressure/tension, perceived choice, value/usefulness and relatedness while performing a given activity. 29 items, adapted from the standardized instrument, are addressed on a 7 point scale, 1-7, in which one indicates not at all and seven indicates very true. A higher score is better.
Measured: Each session through completion of study, up to 10 days
Observation of therapist maximum heart rate
Therapist heart rate will be measured throughout each session as an indicator of burden. There is no standard minimum or maximum value, however a higher heart rate indicates increased therapist burden.
Measured: Each session through completion of study, up to 10 days
Observation of therapist maximum Borg Rating of perceived exertion (RPE)
The Borg Rating of Perceived Exertion is a tool to measure the subjective report of effort, exertion, and fatigue during physical work. It consists of a 15-point scale from 6-20, in which 6=no exertion and 20=absolute maximum exertion. It is presented to the participant in written format with descriptors to standardize the report of perceived exertion across tasks. A lower score is better, indicating less burden on the therapist.
Measured: Each session through completion of study, up to 10 days
Observation of therapist Numerical Pain Rating Scale (NPRS)
The NPRS is used to measure the subjective report of pain intensity. It consists of an 11-point scale, 0-10, in which zero indicates no pain and ten indicates the most intense pain imaginable. A lower score is better, indicating less pain.
Measured: Each session through completion of study, up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start1 Sep 2024 (estimated)
- Primary completion25 Nov 2024
- Study completion31 Dec 2025 (estimated)
Why it stopped: The study team had been practicing running the study interventions, but the core study team members left the organization before any subjects could be enrolled. There is now insufficient personnel time dedication to this study, so it is being closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Pons, Shirley Ryan AbilityLab
- Investigators
- Jose L Pons, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169657
- Sponsor's protocol ID
- STU00219486
- Status last verified
- May 2025
- First submitted
- 5 Dec 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intensity and Step Count of Gait Training Modalities in the Inpatient Rehabilitation Setting in Sub-acute Central Nervous System Injury
- ClinicalTrials.gov ID
- NCT06169657
- Acronym / sponsor ID
- STU00219486
- Conditions
- Stroke, Incomplete Spinal Cord Injury
- Keywords
- Stroke, Incomplete Spinal Cord Injury, Gait Rehabilitation, Exoskeleton, Balance
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study team had been practicing running the study interventions, but the core study team members left the organization before any subjects could be enrolled. There is now insufficient personnel time dedication to this study, so it is being closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Dec 2023 (actual)
- 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.
The purpose of the project is to compare intensity (minutes in target heart rate zone) and steps per session across three gait training modalities, including body-weight supported treadmill training (BWSTT), overground gait training with body weight-support (BWS), and overground gait training utilizing a lower extremity exoskeleton, between patients presenting with varying functional ambulation capacities in the inpatient setting. Additionally, the researchers will compare physical therapist (PT) burden across these modalities and patient functional presentation levels.
Detailed description
Aim 1 of this study is to measure stepping repetition and intensity via heart rate of three gait-training modalities utilized with patients in the subacute phase of stroke and iSCI during inpatient rehabilitation in order to guide therapists through clinical decision-making of selecting the optimal intervention for patients based on functional presentation. Aim 2 of this study is to measure therapist burden across each gait training modalities, as this is an additional factor that contributes to the number of steps taken and intensity experienced by the patient.
The gait training modalities assessed will include BWSTT, overground gait training with a lower extremity exoskeleton, and overground gait training with BWS. The participants' functional level will be classified by gait speed obtained via the 10 meter walk test (10MWT), a standardized assessment commonly used in rehabilitation. These functional classification categories include household ambulator (low level) and limited community ambulator (high level), determined by Fritz et al. 2009.
The researchers hypothesize that low functioning/household ambulators will achieve more minutes in high-intensity training zones utilizing the exoskeleton due to the enhanced participation and increased weight-bearing the device supports compared to the other modalities. In addition, a greater number steps will be achieved in this mode due to the exoskeleton's ability to decrease overall therapist burden compared to BWSTT and overground with BWS. In contrast, the researchers anticipate that steps per session and overall intensity will be decreased in high functioning/limited community ambulators due the unnecessary support the exoskeleton provides at this functional level. The researchers believe that high functioning/ limited community ambulators will achieve the highest number of steps and intensity during BWSTT due to the ability to increase challenges via treadmill parameters such as speed and incline while utilizing a harness for safety and bodyweight support only as necessary. In contrast, the researchers believe the amount of BWS and assistance a PT must provide relative to the patient's contribution to practice successful stepping during BWSTT will result in a lower intensity and number of steps achieved in low functioning/household ambulators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inpatients Post-stroke, low level ambulators | – | Device: Body-weight-supported treadmill training (BWSTT), Device: EksoNR exoskeleton gait training, Device: Overground gait trainingIndividuals post acute or subacute stroke that that are inpatients at the Shirley Ryan AbilityLab ages 18-75 with initial gait speed 0.0-0.39 m/s |
| Inpatients Post-stroke, high level ambulators | – | Device: Body-weight-supported treadmill training (BWSTT), Device: EksoNR exoskeleton gait training, Device: Overground gait trainingIndividuals post acute or subacute stroke that that are inpatients at the Shirley Ryan AbilityLab ages 18-75 with initial gait speed 0.4-0.79 m/s |
| Inpatients with iSCI, low level ambulators | – | Device: Body-weight-supported treadmill training (BWSTT), Device: EksoNR exoskeleton gait training, Device: Overground gait trainingIndividuals post-SCI or subacute that that are inpatients at the Shirley Ryan AbilityLab ages 18-75 with initial gait speed 0.0-0.39 m/s |
| Inpatients with iSCI, high level ambulators | – | Device: Body-weight-supported treadmill training (BWSTT), Device: EksoNR exoskeleton gait training, Device: Overground gait trainingIndividuals post-SCI or subacute that that are inpatients at the Shirley Ryan AbilityLab ages 18-75 with initial gait speed 0.4-0.79 m/s |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals poststroke or post-iSCI that are inpatients at Shirley Ryan AbilityLab
Key inclusion criteria (12 listed)
- Age 18-75 years old, inclusive
- Medical clearance from primary medical team (signed Medical Clearance form)
- Adequate cognitive function as determined by the NIH scale: score ≤1 on question 1b and score =0 on question 1c
- Gait speed between 0-0.79 m/s
- Informed consent provided by participant or POA
Key exclusion criteria (31 listed)
- Severe aphasia limiting ability to express needs or discomfort verbally or nonverbally
- History of or concurrent neurologic condition (i.e., stroke, SCI, PD, TBI, MS, etc.)
- History of peripheral nerve injury
- Severe knee, hip, or ankle osteoarthritis
- Severe osteoporosis as indicated by physician medical clearance
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 |
|---|---|---|
| Body-weight-supported treadmill training (BWSTT)Walking on a treadmill in a harness with body weight support as needed | Device | Inpatients Post-stroke, high level ambulators, Inpatients Post-stroke, low level ambulators, Inpatients with iSCI, high level ambulators, Inpatients with iSCI, low level ambulators |
| EksoNR exoskeleton gait trainingWalking in the EksoNR exoskeleton | Device | Inpatients Post-stroke, high level ambulators, Inpatients Post-stroke, low level ambulators, Inpatients with iSCI, high level ambulators, Inpatients with iSCI, low level ambulators |
| Overground gait trainingWalking overground in a harness with body weight support as needed | Device | Inpatients Post-stroke, high level ambulators, Inpatients Post-stroke, low level ambulators, Inpatients with iSCI, high level ambulators, Inpatients with iSCI, low level ambulators |
Primary outcome
Observation of Step count
Time frame: Each session through completion of study, up to 10 days
The number of steps taken during each session will be measured using activity monitors/pedometers. These devices are small accelerometers that can be worn on a belt and/or on the ankle to record steps and Kcals during an activity. The therapist leading the intervention session will apply the ActiGraph at the beginning of each intervention session and remove it upon completion. A higher step count is a better outcome.
Observation of Time spent in age-predicted maximum high-intensity target heart rate zone
Time frame: Each session through completion of study, up to 10 days
The target range of 70-85% of age-predicted maximum heart rate will be calculated for each participant utilizing HR max = 208 - [0.7 × age] as developed by Tanka et al in 2001. The target range of 70-85% of age-predicted maximum heart rate will be calculated for each participant. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. More time spent in the maximum intensity zone target zone is a better outcome.
Observation of Time spent in age-predicted moderate-intensity target heart rate zone
Time frame: Each session through completion of study, up to 10 days
The target range of 50-70% of age-predicted maximum heart rate will be calculated for each participant utilizing HR max = 208 - [0.7 × age] as developed by Tanka et al in 2001. The target range of 50-70% of age-predicted maximum heart rate will be calculated for each participant. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. Less time spent in the moderate intensity pre-calculated target zone is a better outcome as the more minutes in the high intensity zone is the best outcome.
Observation of Time spent in age-predicted low-intensity target heart rate zone
Time frame: Each session through completion of study, up to 10 days
The target range of 50% of age-predicted maximum heart rate will be calculated for each participant utilizing HR max = 208 - [0.7 × age] as developed by Tanka et al in 2001. Low intensity equals 50% or less of age-predicted maximum heart rate and will be calculated for each participant. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training. The minimum amount of time would be 0 minutes and the maximum amount of time would be 60 minutes as this would be the total time of the session. Less time spent in the low intensity zone is better as the goal is to achieve more minutes in high-intensity zone.
8 secondary outcomes
Observation of Minutes spent in equipment setup per session
Time frame: Each session through completion of study, up to 10 days
Observation of Minutes spent in rest breaks per session
Time frame: Each session through completion of study, up to 10 days
Observation of Minutes spent stepping
Time frame: Each session through completion of study, up to 10 days
Observation of Patient Borg Rating of perceived exertion (RPE)
Time frame: Each session through completion of study, up to 10 days
Observation of Patient Intrinsic Motivation Inventory (IMI)
Time frame: Each session through completion of study, up to 10 days
Observation of therapist maximum heart rate
Time frame: Each session through completion of study, up to 10 days
Observation of therapist maximum Borg Rating of perceived exertion (RPE)
Time frame: Each session through completion of study, up to 10 days
Observation of therapist Numerical Pain Rating Scale (NPRS)
Time frame: Each session through completion of study, up to 10 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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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.
Jose L Pons, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Incomplete Spinal Cord Injury, run by Shirley Ryan AbilityLab 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 12 inclusion and 31 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: withdrawn, as of the sponsor's last update on 25 May 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Observation of Step count (time frame: Each session through completion of study, up to 10 days). The study lists 4 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 25 May 2025.