Intensive Leg Exercise for Spastic Diplegia

Recruiting at 1 trial location

Overseen By Donna Livingstone, BScPT

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must not be taking: Botulinum toxin-A

Disqualifiers: Uncontrolled epilepsy, Cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether intensive leg exercises can improve movement abilities in young children with spastic diplegia, a condition affecting muscle control. It compares intensive exercise to regular physiotherapy over three months. The trial includes two groups: one begins exercises immediately, while the other waits six months. Children who have difficulty moving their legs due to early brain injury, can stand with some support, and have not received recent muscle injections are suitable candidates. As an unphased trial, this study offers children a unique opportunity to potentially enhance their mobility through innovative exercise routines.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had Botulinum toxin-A injections in the legs in the last 6 months, you cannot participate.

What prior data suggests that intensive leg exercise is safe for young children with spastic diplegia?

Research has shown that intensive leg exercise is safe for children with spastic diplegia. Studies have not identified any negative effects from this type of exercise program, indicating that children tolerate it well. Typically, children exercise for 1 hour a day, 4 days a week, for 3 months. Although the exercises are challenging, the reviewed studies provide no evidence of harm. This information should help participants feel more confident about the safety of this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intensive leg exercise for spastic diplegia because it offers a non-invasive approach that directly targets muscle control and movement. Unlike standard treatments, which often include medications like baclofen or botulinum toxin to reduce spasticity, this method focuses on enhancing motor skills through physical activity. The hope is that this exercise regimen will lead to long-term improvements in mobility without the side effects associated with medication, offering a potentially transformative way to manage spastic diplegia in children.

What evidence suggests that intensive leg exercise is effective for improving gross motor function in children with spastic diplegia?

Research has shown that intensive leg exercise, which participants in this trial will receive, can greatly improve movement skills in children with spastic diplegia, a condition affecting muscle control. One study found that a 6-week strength training program focusing on the hips and knees led to noticeable improvements in 40 children. Another study discovered that starting intensive lower-body exercises early helped improve motor skills in children who had a stroke around the time of birth. These findings suggest that intensive exercise can effectively enhance movement abilities in young children with these conditions. ^{1 2 3 4 6}

Who Is on the Research Team?

Jaynie Yang, Phd

Principal Investigator

Universtiy of Alberta

Are You a Good Fit for This Trial?

This trial is for young children with spastic diplegia, a form of cerebral palsy affecting the legs. Participants must have bilateral motor impairment and be able to stand with support but not have severe upper limb involvement, recent leg injections (BTX-A), uncontrolled epilepsy, or conditions that make intensive exercise unsafe.

Inclusion Criteria

I can stand up if I have something to lean on.

I have brain damage from premature birth complications.

I have difficulty moving both of my legs.

Exclusion Criteria

I have received BTX-A injections in my legs within the last 6 months.

I have heart or muscle issues that prevent me from doing intense exercise.

I have significant difficulty using my hands and arms for daily tasks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Delay Period

Children in the Delay Group are assessed for 6 months with no intervention

6 months

Regular assessments

Treatment

Children participate in intensive exercise intervention for 3 months

3 months

Guided by physical therapists

Follow-up

Participants are monitored for long-term benefits until they turn 4 years old

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Intensive exercise

Trial Overview The study tests whether 3 months of early intensive leg exercises can improve walking better than standard physiotherapy in children with spastic diplegia resulting from periventricular leukomalacia.

How Is the Trial Designed?

Group I: Immediate training group Experimental Treatment 1 Intervention

Children will participate in intensive exercise intervention for 3 months and will be followed for 9 months following the intervention

Group II: Delay training group Active Control 1 Intervention

Children will be assessed for 6 months with no intervention. After the 6 month period children will be given the same intervention as the immediate group and followed for 3 months after the intervention.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

In a study of 10 stroke patients, exercising the non-involved leg (isometric knee flexion) significantly increased muscle activity in the paretic rectus femoris and tibialis anterior muscles compared to voluntary movements on the affected side.

This suggests that non-involved-side exercises could be an effective rehabilitation strategy to enhance muscle function in the affected leg of patients with severe hemiplegia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of non-paretic leg movement on muscle action in the paretic leg of hemiplegic patients. Fujiwara, T., Hara, Y., Chino, N.[2019]

Bilateral lower limb strengthening exercises significantly improve balance and walking in stroke patients, as shown by enhanced scores in functional reach, balance, and mobility tests.

Patients who underwent bilateral therapy (training both legs) showed greater improvements in balance (FRT and BBS scores) compared to those who trained only the affected leg, indicating the benefits of a more comprehensive strengthening approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of bilateral lower limb strengthening exercise on balance and walking in hemiparetic patients after stroke: a randomized controlled trial. Jeon, HJ., Hwang, BY.[2020]

Functional stretching exercises significantly improved rehabilitation outcomes in 30 ambulant spastic diplegic children aged 5 to 8, compared to traditional passive stretching over a 3-month period.

The study group showed reductions in the H∖M ratio, increases in the popliteal angle, and improvements in gait parameters, indicating the effectiveness of functional stretching in enhancing mobility and flexibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional stretching exercise submitted for spastic diplegic children: a randomized control study. Elshafey, MA., Abd-Elaziem, A., Gouda, RE.[2021]

A 10-week progressive strength training program significantly improved muscle strength and walking ability in adults with spastic diplegia, with notable gains in hip and knee strength and walking speed.

Importantly, the training did not increase spasticity, suggesting it is a safe intervention for enhancing mobility in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adults with cerebral palsy: walking ability after progressive strength training. Andersson, C., Grooten, W., Hellsten, M., et al.[2019]

A 6-week strength training program targeting hip and knee extensors significantly improved gross motor function in 40 children with spastic diplegic cerebral palsy, as measured by the Gross Motor Function Measure (GMFM).

The program, consisting of 45-minute sessions three times a week, effectively increased muscle strength and motor skills, indicating that such training can be a beneficial intervention for enhancing mobility in affected children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of strength training program on hip extensors and knee extensors strength of lower limb in children with spastic diplegic cerebral palsy. Aye, T., Thein, S., Hlaing, T.[2020]

In a study of 40 children with spastic diplegia, it was found that the affected lower limb had significantly poorer selective voluntary motor control compared to the unaffected limb, indicating a clear bilateral difference in motor control.

There was a significant inverse correlation between selective voluntary motor control and maximum knee extensor strength, suggesting that better motor control is associated with greater strength in the knee extensors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relation of selective voluntary motor control of the lower extremity and extensor strength of the knee joint in children with spastic diplegia. Kusumoto, Y., Takaki, K., Matsuda, T., et al.[2020]

A single session of ischemic conditioning (IC) significantly increased knee extensor strength in chronic stroke survivors by an average of 10.6 Nm, compared to only 1.3 Nm in the sham group, indicating its efficacy as a rehabilitation strategy.

IC also enhanced muscle activation, evidenced by a 31% increase in EMG magnitude during maximal contractions and a reduction in motor unit recruitment thresholds, suggesting improved neuromuscular function in the affected leg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ischemic conditioning increases strength and volitional activation of paretic muscle in chronic stroke: a pilot study. Hyngstrom, AS., Murphy, SA., Nguyen, J., et al.[2023]

After multi-level orthopedic surgery in children with spastic diplegia, there was a significant reduction in lower limb muscle strength at 6 months post-operation, despite improvements in gait and motor function.

Intensive physiotherapy, particularly resistance strengthening exercises, led to significant improvements in muscle strength and functional recovery, although muscle strength did not fully return to pre-operative levels by 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery of muscle strength following multi-level orthopaedic surgery in diplegic cerebral palsy. Seniorou, M., Thompson, N., Harrington, M., et al.[2022]

In a study of 23 children with spastic diplegia, different knee movement patterns were identified, with the crouch pattern showing increased activation of the rectus femoris muscle, indicating a potential target for therapeutic interventions.

The kinetic analysis revealed that children with the jump pattern exhibited abnormal power generation at the knee and ankle, which did not support normal movement but instead assisted in upward motion, highlighting the need for tailored management strategies based on individual movement patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common abnormal kinetic patterns of the knee in gait in spastic diplegia of cerebral palsy. Lin, CJ., Guo, LY., Su, FC., et al.[2022]

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03166293

Early Intensive Exercise to Improve Walking in Children ... Children will participate in intensive leg training with a physical therapist after the 3 month delay period. Training will be 1 hour/day, 4 days/week for 12 ...

2. withpower.com withpower.com/trial/phase-leukomalacia-periventricular-2019-22cb9

Intensive Leg Exercise for Spastic Diplegia A 6-week strength training program targeting hip and knee extensors significantly improved gross motor function in 40 children with spastic diplegic cerebral ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03672877/randomized-controlled-trial-of-early-intensive-leg-exercise-to-improve-walking-in-children-with-diplegia

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 ...

4. 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.

5. 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10686296/

Engaging the Lower Extremity via Active Therapy Early ... Participants showed an increase in GMFM-66 score of 2.4–7.5 points (min–max) over the 3-month intervention phase, as compared to a decrease of ...