Treadmill Training for Spinal Cord Injury

(PROPEL-SCI Trial)

Recruiting at 1 trial location

Overseen By Alexander Barry, MS, CCRC

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Milap Sandhu

Disqualifiers: Orthopedic injuries, Severe heart failure, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

108 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems that the additional walking therapy is given alongside any standard care therapies you are already receiving.

What data supports the effectiveness of the treatment Body Weight Supported Treadmill Training (BWSTT) for spinal cord injury?

Research suggests that Body Weight Supported Treadmill Training (BWSTT) can improve walking ability and balance in people with spinal cord injuries, although it may not be better than other rehabilitation methods. However, it offers additional benefits like improved overall body exercise and psychological well-being. ^{1 2 3 4 5}

Is body weight supported treadmill training (BWSTT) safe for humans?

The research does not specifically mention safety concerns, suggesting that body weight supported treadmill training (BWSTT) is generally considered safe for humans, as it is widely used for spinal cord injury rehabilitation. ^{1 2 3 4 6}

How does treadmill training differ from other treatments for spinal cord injury?

Treadmill training for spinal cord injury is unique because it uses body weight support to help individuals practice walking, which can improve both physical and psychological outcomes. Unlike other treatments, it focuses on task-specific training and can be adjusted for forward or backward walking, offering a tailored approach to rehabilitation. ^{1 2 3 4 7}

Research Team

Milap Sandhu, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

This trial is for individuals who have experienced a traumatic spinal cord injury. It's designed to see if starting walking therapy at different times within the first 6 months post-injury affects recovery. Participants must be in the early stages of their rehabilitation and will be randomly assigned to one of four groups, with three receiving additional therapy.

Inclusion Criteria

I can put weight on both of my legs as much as I can tolerate.

I have a spinal cord injury between my neck and mid-back that still allows for some movement or sensation.

I can wear a harness comfortably.

Exclusion Criteria

I weigh over 250lbs and have a BMI over 30, or my body shape is not suitable for the trial.

I have severe low blood pressure that prevents me from doing intense physical activities.

I have severe heart issues or large wounds that make it hard for me to use a harness for walking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Intervention

Additional training will begin no more than 60 days following spinal cord injury

2 months

Regular visits for therapy sessions

Sub-acute Intervention

Additional training will occur 3 months following spinal cord injury

3 months

Regular visits for therapy sessions

Chronic Intervention

Additional training will occur 6-12 months following spinal cord injury

6 months

Regular visits for therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 3-, 6-, 9-, and 12-month intervals

Treatment Details

Interventions

• Body Weight Supported Treadmill Training

Trial Overview The study tests body weight supported treadmill training (BWSTT), which helps people walk on a treadmill with the aid of a harness that supports some of their body weight. The goal is to determine if the timing of when this therapy starts after an injury influences its effectiveness.

Participant Groups

Group I: Early Intervention Active Control 1 Intervention

Additional training will begin no more than 60 days following spinal cord injury

Group II: Sub-acute Intervention Active Control 1 Intervention

Additional training will occur 3 months following spinal cord injury

Group III: Chronic Intervention Active Control 1 Intervention

Additional training will occur 6-12 months following SCI

Group IV: Standard of Care Active Control 1 Intervention

This group only receives standard of care treatment but is assessed at the same time points as the other groups

Who Is Running the Clinical Trial?

Milap Sandhu

Lead Sponsor

Trials

1

Recruited

110+

Baylor Scott and White Health

Collaborator

Trials

18

Recruited

61,200+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Findings from Research

Body weight-supported treadmill training (BWSTT) is widely used to help improve walking abilities after spinal cord injury, but it may not be more effective than traditional rehabilitation methods for locomotor improvement.

Despite its labor-intensive nature, BWSTT offers significant physiological and psychological benefits, making it a valuable therapy for both acute and chronic spinal cord injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training after spinal cord injury: it's not just about the walking. Hicks, AL., Ginis, KA.[2019]

Backward walking (BW) training using body weight supported treadmill training (BWSTT) showed greater improvements in the 5-repetition sit-to-stand test compared to forward walking (FW) training in a 57-year-old male with incomplete spinal cord injury, indicating its potential efficacy for enhancing specific functional movements.

Both BW and FW training resulted in similar improvements in overall gait parameters and aerobic endurance, suggesting that BWSTT can be a beneficial alternative to traditional forward walking training for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of forward versus backward walking using body weight supported treadmill training in an individual with a spinal cord injury: a single subject design. Moriello, G., Pathare, N., Cirone, C., et al.[2022]

A 19-year-old female with an incomplete C6 spinal cord injury showed significant improvements in walking speed, endurance, and gait quality after 28.5 weeks of body weight supported treadmill training (BWSTT) at a very low frequency of 1.16 days per week.

The study highlights that even infrequent BWSTT, when combined with conventional rehabilitation, can lead to meaningful gains in mobility for individuals with spinal cord injuries, suggesting potential for broader applications in rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body weight supported treadmill training at very low treatment frequency for a young adult with incomplete cervical spinal cord injury. Young, DL., Wallmann, HW., Poole, I., et al.[2009]

A six-week body weight-support treadmill training (BWSTT) program significantly improved center-of-mass control in chronic incomplete spinal cord injury (iSCI) patients, as indicated by changes in the instrumented sway test results.

However, the BWSTT program did not lead to improvements in gait independence, as measured by the Walking Index Spinal Cord Injury (WISCI) II test scores, suggesting that while balance may improve, it does not necessarily translate to better walking ability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of body weight-support treadmill training on postural sway and gait independence in patients with chronic spinal cord injury. Covarrubias-Escudero, F., Rivera-Lillo, G., Torres-Castro, R., et al.[2020]

A case report involving a man with an incomplete spinal cord injury showed significant improvements in walking speed and independence after 45 sessions of body-weight-supported locomotor training, increasing from 0.19 m/s to 1.01 m/s.

The training also led to a substantial increase in daily walking activity, from an average of 1,054 steps to 3,924 steps, demonstrating the effectiveness of this rehabilitation approach in enhancing mobility and functional independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locomotor training progression and outcomes after incomplete spinal cord injury. Behrman, AL., Lawless-Dixon, AR., Davis, SB., et al.[2022]

A study involving four men with motor-incomplete spinal cord injury showed that 12 weeks of body weight-supported treadmill training (BWSTT) led to changes in brain activity, indicating potential supraspinal reorganization.

fMRI results revealed increased activation in sensorimotor and cerebellar regions after BWSTT, suggesting that this rehabilitation strategy not only improves locomotion but also enhances brain function related to movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in supraspinal activation patterns following robotic locomotor therapy in motor-incomplete spinal cord injury. Winchester, P., McColl, R., Querry, R., et al.[2022]

Body weight supported treadmill training significantly improves walking cadence, speed, and endurance in individuals with incomplete spinal cord injuries compared to conventional training methods, based on a review of six clinical trials from 2007 to 2019.

While this training method enhances certain aspects of gait, improvements in balance, functionality, and muscle strength are not significantly better than those achieved through conventional rehabilitation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treadmill training with partial body weight support in subjects with incomplete spinal cord injury: a systematic review]. Escribano-Ardura, S., Cuesta-Gómez, A., Fernández-González, P., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treadmill training after spinal cord injury: it's not just about the walking. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Comparison of forward versus backward walking using body weight supported treadmill training in an individual with a spinal cord injury: a single subject design. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Body weight supported treadmill training at very low treatment frequency for a young adult with incomplete cervical spinal cord injury. [2009]

4. England pubmed.ncbi.nlm.nih.gov

Effects of body weight-support treadmill training on postural sway and gait independence in patients with chronic spinal cord injury. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Locomotor training progression and outcomes after incomplete spinal cord injury. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Changes in supraspinal activation patterns following robotic locomotor therapy in motor-incomplete spinal cord injury. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

[Treadmill training with partial body weight support in subjects with incomplete spinal cord injury: a systematic review]. [2021]