Spinal Cord InjuriesPROPEL-SCINCT06176833
Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury
A study testing Body Weight Supported Treadmill Training in people with Spinal Cord Injuries, run by Milap Sandhu at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate if a specific type of additional walking therapy, called body weight supported treadmill training (BWSTT) affects walking ability following a traumatic spinal cord injury. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Body Weight Supported Treadmill Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Mar 2024to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of Acute and Traumatic SCI with AIS classification of B, C, or D between the neurological levels of C5 and T12
- Between the ages of 16-74
- Weight bearing as tolerated in bilateral lower extremities
- Able to tolerate a harness
- Ability to provide informed consent. For minors, consent of parents or primary caregivers/guardians and assent of the minor
- Able to provide informed consent within 60 days of injury onset
- Able to participate in all study related activities, including 1-year follow up
Who cannot join
- Orthopedic injuries, fractures, surgeries, or other conditions affecting locomotor function or weight bearing
- A weight over 250lbs and if so a BMI greater than 30, or deemed clinically inappropriate due to body habitus
- Moderate to sever traumatic brain injury of other neurological conditions at a severity which impairs cognition
- Presence of uncontrolled orthostatic hypotension that limits active participation in intense physical rehabilitation program.
- Other medical complications such as severe heart failure or large/deep pelvic or lower abdominal wounds that may limit the ability to safely don and doff a harness for ambulation
- Pregnancy, as confirmed by blood draw
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Milap Sandhu, Phd, 312-238-6529, msandhu@sralab.org
Alexander Barry, MS, CCRC, 312-238-1435, abarry@sralab.org
- Not yet recruiting
Baylor Scott and White Institute for Rehabilitation
Fort Worth, Texas, 76132
Faith Meza, MPH, 214-820-9409, faith.meza@bswhealth.org
Chad Swank, PhD
About this study
Official title: Critical Time Window for Rehabilitation After Incomplete Spinal Cord Injury: Early vs Late Locomotor Training
The purpose of this study is to evaluate if a specific type of additional walking therapy, called body weight supported treadmill training (BWSTT) affects walking ability following a traumatic spinal cord injury. Specifically, the study will look at whether starting BWSTT, which uses a body harness to support body weight while walking on a treadmill at different times within the first 6 months after the injury, makes a difference in how effective this therapy may be, While we know that the brain re-learns patterns following an injury, there has not been a lot of prior research evaluating how starting this type of walking therapy at specific times within the first 6 months after injury may impact any effectiveness of the additional therapy.
The study will randomize participants into four groups: those who start this therapy within 60 days, within 3 months, within 6 months or who do not receive this additional research therapy. Randomization means that which group you will be in as part of this study is determined by chance, like the flip of a coin. The additional walking therapy for this research study, if you are randomized for one of the three groups who receives the additional therapy, will be given on top of (meaning in addition to) any standard of care therapies that you may be receiving at that time point after your injury.
- Conditions
- Spinal Cord Injuries
- Being tested
- Body Weight Supported Treadmill Training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Weight Supported Treadmill TrainingProcedure or surgery
Also called BWSTT
For these training sessions, participants will undergo walking training sessions that consist of wearing a harness for either body weight support or as a safety precaution while walking on a treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention | Active comparator | Additional training will begin no more than 60 days following spinal cord injury Receives: Procedure: Body Weight Supported Treadmill Training |
| Sub-acute Intervention | Active comparator | Additional training will occur 3 months following spinal cord injury Receives: Procedure: Body Weight Supported Treadmill Training |
| Chronic Intervention | Active comparator | Additional training will occur 6-12 months following SCI Receives: Procedure: Body Weight Supported Treadmill Training |
| Standard of Care | No intervention | This group only receives standard of care treatment but is assessed at the same time points as the other groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 Meter walk test
Used to assess walking speed, time taken to walk 10 meters at fastest pace
Measured: 1-5 days Following Intervention
Secondary outcomes (4)
6 Minute Walk test
Used to assess distance traveled during a 6 minute walking test at a self selected pace
Measured: 1-5 days Following Intervention
Walking Index for spinal cord injury
Assessment to determine the physical assistance and assistive devices needed to walk 10 meters
Measured: 1-5 days following intervention
Daily step counts
Step counts from a waist worn activity tracker
Measured: 2 weeks following 3-, 6-, 9-, and 12- month assessments
Gait Deviation idex
A measure of gait quality by quantifying joint angles during a gait cycle. This data is recorded via a marker-less motion capture system
Measured: Baseline, 3-, 6-, 9-, and 12- month assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start21 Mar 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomized into one of 4 intervention groups, based around if and when additional walking training is given following injury
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milap Sandhu
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor Scott and White Health, University of Florida, Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor-investigator, Milap Sandhu, Shirley Ryan AbilityLab
- Investigators
- Milap Sandhu, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176833
- Sponsor's protocol ID
- STU00219541
- Other IDs
- CDMRP- SC220241
- Acronym
- PROPEL-SCI
- Status last verified
- Jul 2026
- First submitted
- 11 Dec 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not currently planning to make individual participant data available to other researchers
Publications
Henry M, Coxe RC, Barry A, O'Donnell A, Kessler A, Shan G, Swank C, Rymer WZ, Sandhu MS. A research protocol to study the critical time window for rehabilitation after incomplete spinal cord injury: early vs. late locomotor training. BMC Neurol. 2024 Dec 19;24(1):482. doi: 10.1186/s12883-024-03980-x.
PubMed 39702102
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Time Window for Rehabilitation After Incomplete Spinal Cord Injury: Early vs Late Locomotor Training
- ClinicalTrials.gov ID
- NCT06176833
- Acronym / sponsor ID
- PROPEL-SCI / STU00219541
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Milap SandhuUniversity, hospital or other
- Collaborators
- Baylor Scott and White Health, University of Florida, Congressionally Directed Medical Research Programs
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 20 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 this study is to evaluate if a specific type of additional walking therapy, called body weight supported treadmill training (BWSTT) affects walking ability following a traumatic spinal cord injury. Specifically, the study will look at whether starting BWSTT, which uses a body harness to support body weight while walking on a treadmill at different times within the first 6 months after the injury, makes a difference in how effective this therapy may be, While we know that the brain re-learns patterns following an injury, there has not been a lot of prior research evaluating how starting this type of walking therapy at specific times within the first 6 months after injury may impact any effectiveness of the additional therapy.
The study will randomize participants into four groups: those who start this therapy within 60 days, within 3 months, within 6 months or who do not receive this additional research therapy. Randomization means that which group you will be in as part of this study is determined by chance, like the flip of a coin. The additional walking therapy for this research study, if you are randomized for one of the three groups who receives the additional therapy, will be given on top of (meaning in addition to) any standard of care therapies that you may be receiving at that time point after your injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomized into one of 4 intervention groups, based around if and when additional walking training is given following injury
| Arm | Type | Receives |
|---|---|---|
| Early Intervention | Active comparator | Procedure: Body Weight Supported Treadmill TrainingAdditional training will begin no more than 60 days following spinal cord injury |
| Sub-acute Intervention | Active comparator | Procedure: Body Weight Supported Treadmill TrainingAdditional training will occur 3 months following spinal cord injury |
| Chronic Intervention | Active comparator | Procedure: Body Weight Supported Treadmill TrainingAdditional training will occur 6-12 months following SCI |
| Standard of Care | No intervention | –This group only receives standard of care treatment but is assessed at the same time points as the other groups |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- History of Acute and Traumatic SCI with AIS classification of B, C, or D between the neurological levels of C5 and T12
- Between the ages of 16-74
- Weight bearing as tolerated in bilateral lower extremities
- Able to tolerate a harness
- Ability to provide informed consent. For minors, consent of parents or primary caregivers/guardians and assent of the minor
Key exclusion criteria (6 listed)
- Orthopedic injuries, fractures, surgeries, or other conditions affecting locomotor function or weight bearing
- A weight over 250lbs and if so a BMI greater than 30, or deemed clinically inappropriate due to body habitus
- Moderate to sever traumatic brain injury of other neurological conditions at a severity which impairs cognition
- Presence of uncontrolled orthostatic hypotension that limits active participation in intense physical rehabilitation program.
- Other medical complications such as severe heart failure or large/deep pelvic or lower abdominal wounds that may limit the ability to safely don and doff a harness for ambulation
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 TrainingAlso: BWSTTFor these training sessions, participants will undergo walking training sessions that consist of wearing a harness for either body weight support or as a safety precaution while walking on a treadmill. | Procedure or surgery | Chronic Intervention, Early Intervention, Sub-acute Intervention |
Primary outcome
10 Meter walk test
Time frame: 1-5 days Following Intervention
Used to assess walking speed, time taken to walk 10 meters at fastest pace
4 secondary outcomes
6 Minute Walk test
Time frame: 1-5 days Following Intervention
Walking Index for spinal cord injury
Time frame: 1-5 days following intervention
Daily step counts
Time frame: 2 weeks following 3-, 6-, 9-, and 12- month assessments
Gait Deviation idex
Time frame: Baseline, 3-, 6-, 9-, and 12- month assessments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 39702102Henry M, Coxe RC, Barry A, O'Donnell A, Kessler A, Shan G, Swank C, Rymer WZ, Sandhu MS. A research protocol to study the critical time window for rehabilitation after incomplete spinal cord injury: early vs. late locomotor training. BMC Neurol. 2024 Dec 19;24(1):482. doi: 10.1186/s12883-024-03980-x.
- Individual participant dataSharing planned: No. We are not currently planning to make individual participant data available to other researchers
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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.
Milap Sandhu, PhD principal investigator
Shirley Ryan AbilityLab
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Weight Supported Treadmill Training in people with Spinal Cord Injuries, run by Milap Sandhu at 2 sites 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Barry, MS, CCRC (3122381435, abarry@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10 Meter walk test (time frame: 1-5 days Following Intervention). 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 NCT06176833, which also lists 1 linked publication.
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 6 Jul 2026.