Promoting Recovery Outcomes Through Precise Early Locomotor Interventions in Persons With Spinal Cord Injury

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Milap Sandhu
Study ID
NCT06176833
Status
Recruiting
Apply to this trial

Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Body Weight Supported Treadmill Training — PROCEDURE
    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 Details

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.

Key Dates

Start date
Mar 21, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Early Intervention
    Additional training will begin no more than 60 days following spinal cord injury
  • Active Comparator: Sub-acute Intervention
    Additional training will occur 3 months following spinal cord injury
  • Active Comparator: Chronic Intervention
    Additional training will occur 6-12 months following SCI
  • No Intervention: Standard of Care
    This group only receives standard of care treatment but is assessed at the same time points as the other groups

Primary Outcome Measure

10 Meter walk test [ Time Frame: 1-5 days Following Intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The Shirley Ryan AbilityLabChicagoIllinois60611
Milap Sandhu, Phd
[email protected]
312-238-6529
Alexander Barry, MS, CCRC
[email protected]
312-238-1435
Milap Sandhu, PhD (PRINCIPAL_INVESTIGATOR)
William Z Rymer, MD, PhD (SUB_INVESTIGATOR)
Baylor Scott and White Institute for RehabilitationFort WorthTexas76132
Faith Meza, MPH
[email protected]
214-820-9409
Chad Swank, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
The Shirley Ryan AbilityLab· Chicago, ILBaylor Scott and White Institute for Rehabilitation· Fort Worth, TX

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