Intensive Exercise for Perinatal Stroke

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

18 Participants Needed

Trial Summary

What is the purpose of this trial?

A prospective, single blind, parallel group, randomized control trial to determine if early, intensive lower extremity activity delivered by a physical therapist and a parent in partnership improves gross motor function more than usual care.

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 data supports the effectiveness of the treatment Intensive Exercise for Perinatal Stroke?

Research shows that high-intensity exercise can improve leg function and walking ability in stroke patients, with no major adverse events reported. This suggests that similar intensive exercise programs might help improve movement in patients with perinatal stroke. ^{1 2 3 4 5}

Is intensive exercise generally safe for humans?

Research on intensive exercise, particularly in children with cerebral palsy, shows it can be safe and beneficial, leading to increased muscle volume and strength without reported adverse effects. ^{6 7 8 9 10}

How does the treatment 'Intensive Exercise for Perinatal Stroke' differ from other treatments for this condition?

This treatment is unique because it focuses on intensive, task-specific leg exercises early on, which is designed to improve motor function by increasing physical activity and engaging the affected limbs more actively, unlike traditional therapies that may not emphasize intensity or task-specificity as much. ^{1 3 4 5 11}

Research Team

Jaynie Yang, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Intensity versus task-specificity after stroke: how important is intensity? [2016]

2. Switzerland 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. [2023]

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

Effects of a high-intensity task-oriented training on gait performance early after stroke: a pilot study. [2022]

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

Intensive treadmill training in the acute phase after ischemic stroke. [2018]

5. Netherlands 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. [2017]

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

Physiological effects of a sports rehabilitation program on cerebral palsied and post-poliomyelitic adolescents. [2019]

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

A randomized clinical trial of strength training in young people with cerebral palsy. [2022]

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

Increases in muscle volume after plantarflexor strength training in children with spastic cerebral palsy. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The Influence of a Constraint and Bimanual Training Program Using a Variety of Modalities, on Upper Extremity Functions and Gait Parameters Among Children with Hemiparetic Cerebral Palsy: A Case Series. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Contributing factors to muscle weakness in children with cerebral palsy. [2022]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of Task-Specific Lower Extremity Training on Cognitive and Gait Function in Stroke Patients: A Prospective Randomized Controlled Trial. [2020]