Interval Treadmill Training for Cerebral Palsy

Recruiting at 1 trial location

Overseen By Neil Panlasigui, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Kristie Bjornson

Disqualifiers: Recent surgery, Injection therapy, others

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

Compensation: Varies

Number of Visits: 44

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Ambulatory children with cerebral palsy (CP) walk predominately in low intensity stride rates with little variability, thus limiting their walking activity and ability to participate in daily life. In contrast, typically developing (TD) children engage in short bursts of intense walking activity interspersed with varying intervals of low intensity walking within daily life. In order to optimize motor learning, active participation, task-specific training and multiple repetitions or massed practice is required to learn new motor skills. Short bursts of vigorous intensity locomotor treadmill training (SBLTT) alternating with low/moderate intensity was specifically designed to mimic activity patterns of TD children in a massed practice format. Pilot data suggests that SBLTT is feasible and enhances walking capacity and performance in daily life for children with CP. This project will examine the effect of SBLTT versus an equivalent dosage of traditional locomotor treadmill training (TLTT) on the primary outcomes of walking capacity and performance in children with CP and whether the effects of SBLTT on walking capacity and performance are mediated by improvements in in muscle power generation. The scientific premise is that SBLTT, that approximates the walking intensity patterns of typically developing (TD) children through a home-based massed practice protocol, will be more effective than TLTT in improving walking capacity and performance. We hypothesize that SBLTT strategies for children with CP modeled on walking patterns of TD children, will be positively mediated by muscle power generation and subsequently improve walking capacity and community walking performance and mobility. Specific aims. Aim #1. Determine the immediate and retention effects of short-burst interval LTT (SBLTT) on walking capacity in ambulatory children with CP. Aim #2. Examine the effects of treatment on community-based walking activity performance and mobility. Aim #3. Explore whether the effects of SBLTT on walking capacity and performance are mediated by muscle power generation. The proposed research will be the first step in a continuum of research that is expected to direct locomotor training protocols and rehab strategies across pediatric disabilities and positively effecting the community walking performance and mobility for children with CP.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What safety data exists for interval treadmill training in cerebral palsy?

The pilot study titled 'Short-burst interval treadmill training walking capacity and performance in cerebral palsy' suggests that short-burst interval locomotor treadmill training (SBLTT) has been examined for its effects on walking capacity and performance in individuals with cerebral palsy. Although the study focuses on efficacy, the fact that it was conducted implies a level of safety deemed acceptable for research. Additionally, the study on backward locomotor treadmill training (BLTT) in stroke patients indicates that treadmill training approaches are generally considered safe and feasible across different impairment levels, which may suggest a similar safety profile for cerebral palsy applications. ^{1 2 3 4 5}

Is Short Burst Interval Treadmill Training (SBLTT) a promising treatment for cerebral palsy?

Yes, Short Burst Interval Treadmill Training (SBLTT) is a promising treatment for cerebral palsy. It can improve walking ability and performance, making it easier for people with cerebral palsy to move around. This type of treadmill training focuses on short bursts of activity, which can help build strength and endurance. ^{1 2 6 7 8}

What data supports the idea that Interval Treadmill Training for Cerebral Palsy is an effective treatment?

The available research shows that Interval Treadmill Training, specifically Short-Burst Interval Locomotor Treadmill Training (SBLTT), can improve walking capacity and performance in individuals with cerebral palsy. Additionally, studies on similar treadmill training methods, like Body Weight Supported Treadmill Training (BWSTT), have shown positive outcomes in improving gait and ambulation in children with cerebral palsy. These findings suggest that interval treadmill training is a promising treatment for enhancing mobility in people with cerebral palsy. ^{1 2 6 8 9}

Who Is on the Research Team?

Kristie F Bjornson, PhD, PT

Principal Investigator

Seattle Children's Hospital

Noelle Moreau, PhD, PT

Principal Investigator

Lousianna State University in New Orleans

Are You a Good Fit for This Trial?

This trial is for children aged 6 to less than 11 years with bilateral spastic cerebral palsy at certain levels of motor function (Levels II & III). They shouldn't have had orthopedic or neurosurgery in the last 9 months or injection therapies like Botox in the last 3 months.

Inclusion Criteria

My mobility is moderately affected.

I have bilateral spastic cerebral palsy.

I am between 6 and 10 years old.

Exclusion Criteria

I have not had injection therapy like Botox or Phenol in the last 3 months.

I have not had orthopedic or brain surgery in the last 9 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Short-burst Interval Treadmill Training (SBLTT) or Traditional Locomotor Treadmill Training (TLTT) for 40 sessions, 5 times a week for 8 weeks

8 weeks

40 home-based sessions

Follow-up

Participants are monitored for retention effects and long-term outcomes

16 weeks

Assessments at 4, 8, and 24 weeks post-training

What Are the Treatments Tested in This Trial?

Interventions

• Short Burst Interval Treadmill Training (SBLTT)
• Traditional Locomotor Treadmill Training (TLTT)

Trial Overview The study compares two types of treadmill training: Short Burst Interval Treadmill Training (SBLTT) and Traditional Locomotor Treadmill Training (TLTT). It aims to see if SBLTT, which mimics typical walking patterns, improves walking capacity and daily mobility more effectively than TLTT.

How Is the Trial Designed?

Group I: Short burst Interval Treadmill Training (SBLTT) Experimental Treatment 1 Intervention

SBLTT will consist of short-bursts (30 seconds) of high speed walking alternating with 30 seconds of low/moderate speed walking. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of SBLTT

Group II: Traditional Locomotor Treadmill Training (TLTT) Active Control 1 Intervention

TLTT will consist of walking at steady-state speeds. Participant will receive 40 home-based sessions (5x/week for 8 weeks) of TLTT

Short Burst Interval Treadmill Training (SBLTT) is already approved in United States for the following indications:

Approved in United States as SBLTT for:

• Cerebral Palsy
• Walking Capacity Improvement
• Muscle Power Generation Enhancement

Who Is Running the Clinical Trial?

Kristie Bjornson

Lead Sponsor

Trials

1

Recruited

70+

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

A home-based body-weight-supported treadmill training (BWSTT) program was implemented for three children with cerebral palsy, showing feasibility and positive family feedback regarding the harness system used.

Two of the three participants demonstrated improvements in functional mobility after 8-12 weeks of BWSTT, indicating potential benefits of this approach for enhancing mobility in children with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A home-based body weight supported treadmill training program for children with cerebral palsy: A case series. Kenyon, LK., Westman, M., Hefferan, A., et al.[2018]

A low-cost body weight support training (BWST) device significantly improved gait and ambulation in 50 individuals with cerebral palsy after surgery, as shown by better scores on the Physician Rating Scale, Dynamic Gait Index, and Functional Mobility Scale after 5 weeks of training.

The positive effects of the BWST device were not only significant immediately after the intervention but were also maintained at a 12-month follow-up, indicating its long-term efficacy in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a low-cost body weight support training device in the rehabilitation of cerebral palsy. Sharan, D., Rajkumar, JS., Balakrishnan, R., et al.[2022]

Short-burst interval locomotor treadmill training (SBLTT) significantly improved walking capacity in children with spastic diplegic cerebral palsy, as evidenced by increased speeds in the 10 m walk test and one-minute walk test after 20 sessions.

The training also enhanced walking performance, with participants showing a substantial increase in daily strides and time spent at higher stride rates, indicating better overall mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-burst interval treadmill training walking capacity and performance in cerebral palsy: a pilot study. Bjornson, KF., Moreau, N., Bodkin, AW.[2021]

Structured speed-dependent treadmill training (STT) significantly improved walking speed, cadence, stride length, and Functional Ambulation Category scores in 60 poststroke patients compared to limited progressive treadmill training (LTT) and conventional gait training (CGT) after 4 weeks of treatment.

The results indicate that STT is a more effective rehabilitation strategy for enhancing gait function in stroke patients, suggesting its potential as a dynamic approach to address gait dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial. Pohl, M., Mehrholz, J., Ritschel, C., et al.[2019]

A case study of a 36-year-old soldier with traumatic brain injury (TBI) showed that body weight-supported treadmill training (BWSTT) combined with goal-directed therapy improved his gait quality, speed, and distance ambulated.

The results suggest that BWSTT may be an effective intervention for improving mobility in TBI patients, but more research is needed to confirm its efficacy and suitability for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait rehabilitation with body weight-supported treadmill training for a blast injury survivor with traumatic brain injury. Scherer, M.[2014]

Backward locomotor treadmill training (BLTT) is a safe and effective rehabilitation method for improving walking ability in stroke survivors, regardless of their initial walking impairment level, as shown in a study of 39 adults over 2 weeks.

Both individuals with severe walking impairment (≤0.4 m/s) and those with mild-moderate impairment (>0.4 m/s) experienced similar improvements in walking metrics, suggesting that BLTT can benefit a wide range of patients, although those with severe impairment may start at a functional disadvantage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Backward Locomotor Treadmill Training Differentially Improves Walking Performance across Stroke Walking Impairment Levels. Awosika, OO., Chan, D., Sucharew, HJ., et al.[2022]

The PROMPT-SCI trial aims to assess the feasibility and potential benefits of early activity-based therapy (in-bed leg cycling) initiated within 48 hours after spinal surgery in 45 patients with severe traumatic spinal cord injury, focusing on safety and recovery outcomes.

The study will evaluate the absence of serious adverse events, session completion rates, and patient outcomes at 6 weeks and 6 months post-injury, comparing results to a historical cohort to determine the effectiveness of early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for rapid onset of mobilisation in patients with traumatic spinal cord injury (PROMPT-SCI) study: a single-arm proof-of-concept trial of early in-bed leg cycling following acute traumatic spinal cord injury. Mac-Thiong, JM., Richard-Denis, A., Petit, Y., et al.[2022]

A study involving 26 children with spastic cerebral palsy compared a supported speed treadmill training exercise program (SSTTEP) to a traditional strengthening exercise program over 12 weeks, focusing on various functional outcomes.

While both groups showed improvements in gait speed and overall physical function, only the SSTTEP group maintained these gains after the intervention ended, suggesting potential long-term benefits of this training method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a supported speed treadmill training exercise program on impairment and function for children with cerebral palsy. Johnston, TE., Watson, KE., Ross, SA., et al.[2011]

Treadmill training, with or without partial body weight support, showed improvements in lower extremity function and gait parameters in children with cerebral palsy, based on a systematic review of 6 studies involving 127 participants.

However, the differences in walking speed and overall effectiveness between treadmill training and control groups were mostly not statistically significant, indicating that while there may be benefits, the evidence is not strong enough to confirm its efficacy definitively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treadmill training with or without partial body weight support in children with cerebral palsy: systematic review and meta-analysis]. Molina-Rueda, F., Aguila-Maturana, AM., Molina-Rueda, MJ., et al.[2018]

Citations

1. England pubmed.ncbi.nlm.nih.gov

A home-based body weight supported treadmill training program for children with cerebral palsy: A case series. [2018]

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

Effectiveness of a low-cost body weight support training device in the rehabilitation of cerebral palsy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Short-burst interval treadmill training walking capacity and performance in cerebral palsy: a pilot study. [2021]

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

Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Gait rehabilitation with body weight-supported treadmill training for a blast injury survivor with traumatic brain injury. [2014]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Backward Locomotor Treadmill Training Differentially Improves Walking Performance across Stroke Walking Impairment Levels. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Protocol for rapid onset of mobilisation in patients with traumatic spinal cord injury (PROMPT-SCI) study: a single-arm proof-of-concept trial of early in-bed leg cycling following acute traumatic spinal cord injury. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effects of a supported speed treadmill training exercise program on impairment and function for children with cerebral palsy. [2011]

9. Spain pubmed.ncbi.nlm.nih.gov

[Treadmill training with or without partial body weight support in children with cerebral palsy: systematic review and meta-analysis]. [2018]