Intensive Exercise for Perinatal Stroke

Not currently recruiting at 3 trial locations

Overseen By Michelle Barnes

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must not be taking: Botulinum toxin

Disqualifiers: Bilateral motor impairment, Epileptic seizures, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether early, intensive exercise can improve movement skills in children who have experienced a perinatal stroke, which affects the brain around birth and can lead to movement issues. The trial includes two groups: one begins exercising immediately, while the other waits six months before starting the same exercise program. The researchers aim to determine if starting exercise earlier enhances motor skills more effectively than waiting. Children aged 8 months to 3 years with movement difficulties on one side of the body (hemiparesis) and whose parents agree to follow the schedule may be eligible to join. As an unphased trial, this study provides a unique opportunity to contribute to understanding how early intervention might benefit children with movement challenges.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this intensive exercise is safe for perinatal stroke patients?

Research has shown that intensive exercise is safe for young children who experienced a stroke around the time of birth. Studies found that high-intensity exercise improved their leg function and walking ability. Importantly, no major negative effects were reported, indicating that the children tolerated the treatment well. Intensive exercise appears to be a promising and safe method to assist children with mobility issues due to perinatal stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for intensive exercise as a treatment for perinatal stroke because it explores a non-pharmacological approach to enhancing recovery. Unlike standard treatments, which often focus on medical management and rehabilitation therapies that may not be intensive, this trial investigates whether a concentrated exercise regimen can significantly improve outcomes. The unique feature here is the timing and intensity of the intervention, which is delivered over 12 weeks and is hypothesized to potentially accelerate recovery and improve motor skills. This could open up new pathways for treating perinatal stroke that go beyond traditional methods.

What evidence suggests that intensive exercise is effective for improving gross motor function in perinatal stroke?

This trial will compare two groups: the Immediate Group, which will undergo intensive exercise over 12 weeks starting upon admission to the study, and the Delay Group, which will initially have no intervention for 6 months before having the opportunity to receive the same intensive exercise. Research has shown that early, intensive exercise for children who have experienced a stroke around the time of birth can enhance their movement abilities. This exercise strengthens the connection between the brain and the legs, aiding in walking and leg use. One study found that this exercise plan is not only feasible but also beneficial in the short term for improving these skills. Importantly, no major side effects were reported, suggesting it is a safe option. These findings strongly support that intensive exercise can effectively improve movement skills in young children after a perinatal stroke. ^{1 3 4 6 7}

Who Is on the Research Team?

Jaynie Yang, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for children aged 8 months to 3 years who have had a perinatal stroke, leading to weakness in the arms and/or legs. Parents must commit to the training schedule and be able to communicate in English or French. Children with seizures affecting training, bilateral motor issues, recent leg treatments like Botox or surgery, or conditions causing regression can't join.

Inclusion Criteria

I had a stroke around the time I was born.

I have weakness on one side of my body.

Parental agreement to adhere to the training and testing schedule

Exclusion Criteria

I cannot communicate in English or French.

I have movement difficulties in both sides of my body.

I will be wearing a cast during the treatment phase.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention (Immediate Group)

Participants receive intensive exercise intervention for 12 weeks

12 weeks

2 visits per week (in-person), 2 sessions per week (home-based)

Follow-up (Immediate Group)

Participants are monitored for 9 months post-intervention

9 months

Waitlist-Control (Delay Group)

Participants are followed for 6 months with no intervention

6 months

Intervention (Delay Group)

Participants receive intensive exercise intervention after 6 months

12 weeks

2 visits per week (in-person), 2 sessions per week (home-based)

Follow-up (Delay Group)

Participants are monitored for 3 months post-intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Intensive exercise

Trial Overview The study tests if early intensive exercise for young children's legs, guided by physical therapists and parents together, improves movement more than standard care does. It's a controlled test where some kids get this new method while others continue usual treatment routines.

How Is the Trial Designed?

Group I: Immediate Group Experimental Treatment 1 Intervention

The intervention is intensive exercise, delivered over 12 weeks beginning on admission to the study. The group will then be followed for 9 months post intervention.

Group II: Delay Group Active Control 1 Intervention

The group will be followed for 6 months with no intervention. After 6 months the group will be given the opportunity to receive the same intensive exercise intervention as the Immediate group. The group will be followed for 3 months following the intervention.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Brain Canada

Collaborator

Trials

22

Recruited

6,100+

Published Research Related to This Trial

A high-intensity task-oriented training program significantly improved gait speed and walking capacity in patients with subacute stroke compared to a low-intensity physiotherapy program, as shown by results from the 10-metre timed walking test and the six-minute walk test.

The study involved 44 stroke patients and demonstrated that while the high-intensity training was feasible and effective for improving gait, it did not show significant differences in balance measures, suggesting that future research should also assess physical fitness and energy expenditure during walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. Outermans, JC., van Peppen, RP., Wittink, H., et al.[2022]

High-intensity exercise (HIE) significantly improves lower limb function in acute and subacute stroke patients, particularly enhancing performance in the 6-minute walk test and gait speed, based on a systematic review of seven randomized controlled trials.

The review found no major adverse events associated with HIE, suggesting it is a safe intervention for stroke rehabilitation, and supports its implementation over lower intensity exercises for better functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence of High-Intensity Exercise on Lower Limb Functional Outcomes and Safety in Acute and Subacute Stroke Population: A Systematic Review. Mah, SM., Goodwill, AM., Seow, HC., et al.[2023]

Intensive treadmill training is feasible for patients with acute ischemic stroke, with 196 out of 224 training sessions completed and only nonserious adverse events reported in 14.7% of sessions.

The training significantly increased leg activity over time, with a 133% increase in activity counts by day 5 compared to day 1, indicating that such training can greatly enhance overall physical activity in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive treadmill training in the acute phase after ischemic stroke. Strømmen, AM., Christensen, T., Jensen, K.[2018]

In a study involving 10 stroke patients, partial body weight support treadmill training (PBWSTT) at faster speeds (up to 2.0 mph) significantly improved stride characteristics and muscle activation in the affected limbs, indicating enhanced motor recovery during the acute phase post-stroke.

Training at the fastest speed resulted in greater perceived exertion and a more optimal gait pattern, suggesting that higher intensity training may be beneficial for improving walking ability after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partial body weight support treadmill training speed influences paretic and non-paretic leg muscle activation, stride characteristics, and ratings of perceived exertion during acute stroke rehabilitation. Burnfield, JM., Buster, TW., Goldman, AJ., et al.[2017]

A six-week home-based strength-training program significantly improved lower limb strength in 11 young people with spastic diplegic cerebral palsy, with effects lasting up to 12 weeks after the program ended.

Participants also showed trends towards improved gross motor function, including better standing, running, jumping, and faster stair climbing, indicating that this training can enhance daily activities for those with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of strength training in young people with cerebral palsy. Dodd, KJ., Taylor, NF., Graham, HK.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28789469/

Early Intensive Leg Training to Enhance Walking in ... The study hypothesis was that intensive, early, child-initiated activity during the critical period will enhance connectivity of motor pathways to the legs and ...

2. academic.oup.com academic.oup.com/ptj/article/97/8/818/3803379

Early Intensive Leg Training to Enhance Walking in Children ... Early intensive leg training to enhance walking in children with perinatal stroke: protocol for a randomized controlled trial.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9127938/

Early, Intensive, Lower Extremity Rehabilitation Shows ... Early, activity-intensive lower extremity therapy for young children with perinatal stroke is feasible and improves gross motor function in the short term.

4. researchgate.net researchgate.net/publication/316982995_Early_Intensive_Leg_Training_to_Enhance_Walking_in_Children_With_Perinatal_Stroke_Protocol_for_a_Randomized_Controlled_Trial?_tp=eyJjb250ZXh0Ijp7InBhZ2UiOiJzY2llbnRpZmljQ29udHJpYnV0aW9ucyIsInByZXZpb3VzUGFnZSI6bnVsbCwic3ViUGFnZSI6bnVsbH19

Early Intensive Leg Training to Enhance Walking in ... Early, Intensive, Lower Extremity Rehabilitation Shows Preliminary Efficacy After Perinatal Stroke: Results of a Pilot Randomized Controlled ...

5. withpower.com withpower.com/trial/phase-stroke-1-2019-5c64a

Intensive Exercise for Perinatal Stroke · Info for Participants Research shows that high-intensity exercise can improve leg function and walking ability in stroke patients, with no major adverse events reported. This ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35427191/

Early, Intensive, Lower Extremity Rehabilitation Shows ... Early, activity-intensive lower extremity therapy for young children with perinatal stroke is feasible and improves gross motor function in the short term.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03672877?term=AREA%5BConditionSearch%5D(Periventricular%20Leukomalacia)%20AND%20AREA%5BStdAge%5D(CHILD)&rank=3

Randomized Controlled Trial of Early Intensive Leg ... This is a randomized controlled trial, comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of gross motor function ...