Interval Treadmill Training for Cerebral Palsy

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help children with cerebral palsy (CP) improve their walking ability and daily mobility. It compares two treadmill training methods: Short Burst Interval Treadmill Training (SBLTT), which involves short bursts of high-speed walking, and Traditional Locomotor Treadmill Training (TLTT), which involves steady walking. The goal is to determine if burst-style training better mimics typical children's walking patterns and boosts muscle power to improve walking. Children with CP who can walk but have limited mobility and haven't had recent major surgeries or treatments might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative training methods that could enhance mobility and quality of life 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 prior data suggests that this interval treadmill training is safe for children with cerebral palsy?

Research has shown that Short Burst Interval Treadmill Training (SBLTT) is safe for children with cerebral palsy (CP). In earlier studies, children with spastic diplegic CP handled SBLTT well, and it significantly improved their walking ability. These studies reported no major safety issues.

Similarly, Traditional Locomotor Treadmill Training (TLTT) has been widely used and studied for children with CP. Past research indicates that TLTT is effective and safe, enhancing walking speed and overall movement skills. It has been successfully used even in young children who have not yet started walking independently.

Both SBLTT and TLTT offer safe options for improving walking in children with CP without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Interval Treadmill Training for cerebral palsy because it explores two distinct treadmill training methods that could enhance mobility. The Short Burst Interval Treadmill Training (SBLTT) is unique because it incorporates short bursts of high-speed walking, alternating with slower speeds, which may improve cardiovascular fitness and muscle strength more effectively than steady-state walking. On the other hand, Traditional Locomotor Treadmill Training (TLTT) offers a consistent pace that might be easier to maintain for some patients. Both approaches provide a home-based, accessible form of therapy that could enhance the quality of life for those with cerebral palsy by improving walking efficiency and endurance.

What evidence suggests that this trial's treatments could be effective for cerebral palsy?

This trial will compare Short Burst Interval Treadmill Training (SBLTT) with Traditional Locomotor Treadmill Training (TLTT) for children with cerebral palsy (CP). Studies have shown that SBLTT can enhance walking ability in children with CP. Early results suggest that SBLTT, which involves alternating short periods of fast walking with slower walking, is feasible and improves daily walking ability. In previous research, children with CP who participated in SBLTT performed better in walking tests, such as the 10-meter walk test and the one-minute walk test, compared to their usual performance. These improvements indicate that SBLTT might strengthen muscles and improve walking skills, similar to the walking patterns of children without CP. This method could provide children with CP a better opportunity to move more easily and participate in daily activities. ^{1 2 3 5 6}

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

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7894036/

Short-burst interval treadmill training walking capacity and ... Average slow speed for SBLTT was 1.4 mph and fast speed was 2.5 mph. Duration of treadmill walking ranged from 15.1 to 31.1 minutes (average = 28.8 minutes).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04026295

Short-Burst Interval Treadmill Training Cerebral Palsy | ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

3. researchgate.net researchgate.net/publication/324553331_Short-burst_interval_treadmill_training_walking_capacity_and_performance_in_cerebral_palsy_a_pilot_study

Short-burst interval treadmill training walking capacity and ... Outcomes included the 10 m walk test, one-minute walk test (1MWT), and timed-up-and go (TUG) (capacity) and StepWatch (performance) collected at ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04026295/short-burst-interval-treadmill-training-cerebral-palsy

Short-Burst Interval Treadmill Training Cerebral Palsy 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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29658831/

Short-burst interval treadmill training walking capacity and ... To examine the effect of short-burst interval locomotor treadmill training (SBLTT) on walking capacity and performance in cerebral palsy (CP).

6. withpower.com withpower.com/trial/phase-cerebral-palsy-10-2019-4f221

Interval Treadmill Training for Cerebral Palsy · Info for Participants Short-burst interval locomotor treadmill training (SBLTT) significantly improved walking capacity in children with spastic diplegic cerebral palsy, as ...