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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if body weight supported treadmill training (BWSTT) can improve walking after a traumatic spinal cord injury. BWSTT involves using a harness to support body weight while walking on a treadmill. The study will assess whether starting this therapy at different times within the first six months after injury affects outcomes. Participants will begin therapy early, mid-way, later, or not at all, while continuing their usual treatments. This trial suits those who can walk with support, have had a recent spinal cord injury, and can wear a harness. As an unphased trial, it offers a unique opportunity to contribute to understanding the optimal timing for BWSTT therapy, potentially benefiting future patients.

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 prior data suggests that body weight supported treadmill training is safe for spinal cord injury patients?

Research shows that Body Weight Supported Treadmill Training (BWSTT) has been studied for aiding people with spinal cord injuries. Some studies suggest this training can improve cardiovascular health. Evidence also indicates it might help reduce muscle loss, though it does not prevent bone loss after an injury.

The safety of BWSTT remains unclear. One review noted insufficient information to fully understand its safety as an exercise therapy. Since this trial is "Not Applicable" for phase, the focus may be more on assessing the treatment's effectiveness rather than proving its safety. However, previous studies have used BWSTT, suggesting it has been tried with people before. This offers some reassurance about its general use, despite the lack of detailed safety data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of body weight supported treadmill training to improve recovery after spinal cord injury (SCI). Unlike standard rehabilitation, which may include physical therapy and occupational therapy, this technique involves walking on a treadmill while a harness supports part of the patient's body weight, allowing them to practice walking sooner and more safely. The trial investigates different timings for starting this training: early, sub-acute, and chronic phases post-injury. By determining the best time to begin treadmill training, researchers hope to maximize recovery and improve outcomes for those with SCI.

What evidence suggests that body weight supported treadmill training is effective for improving walking ability after a spinal cord injury?

Research has shown that Body Weight Supported Treadmill Training (BWSTT) can help people with spinal cord injuries improve their walking and balance. In this trial, participants will join different intervention arms to assess the timing of BWSTT. One study found that this therapy can increase walking duration, although it might not enhance walking speed. BWSTT also supports heart and lung health, which are crucial for overall recovery. Another study found that this therapy might help reduce muscle loss after an injury. However, results can vary, and not everyone may experience the same benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

Milap Sandhu, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

Citations

1. journals.lww.com journals.lww.com/jnpt/fulltext/2009/03000/a_systematic_review_of_the_effectiveness_of.4.aspx

A Systematic Review of the Effectiveness of Treadmill... Lower level evidence (nonrandomized studies) did show some support for body weight–supported treadmill training (BWSTT) in chronic SCI by showing that these ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6907034/

Effect of Body Weight–Supported Treadmill Training on ... There is some evidence that the use of BWSTT as an exercise in individuals with SCI has positive effects on cardiovascular and pulmonary health.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00006429

NCT00006429 | Treadmill Training for Spinal Cord Injury This is a trial to test whether treadmill training can be used to improve the "walking" of patients with partial spinal cord injury. While on the treadmill, ...

4. mdpi.com mdpi.com/2077-0383/13/4/1105

Effectiveness of Body Weight-Supported Gait Training on ... Body weight-supported gait training with robotic assistance does improve walking functionality, walking endurance, and balance, but not walking speed.

5. nature.com nature.com/articles/3101774

Body weight supported treadmill training in acute spinal ... Twice-weekly BWSTT appeared to partially reverse muscle atrophy after SCI, but did not prevent bone loss.

6. research.iscrr.com.au research.iscrr.com.au/__data/assets/pdf_file/0011/297794/Body-Weight-Supported-Treadmill-Training-for-Spinal-Cord-Service.pdf

Body Weight Supported Treadmill Training for Spinal Cord ... What are the risks associated with use of this intervention? Safety of exercise: insufficient evidence to determine the effect of BWSTT on safety of exercise.