Robotic Gait Training + Physical Therapy for Cerebral Palsy

Recruiting at 2 trial locations

Overseen By Lesley Wiart, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must not be taking: Botulinum toxin

Disqualifiers: Severe spasticity, Hip instability, others

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

Compensation: Varies

Number of Visits: 17

Duration: 8-10 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different approaches to improve walking skills in children with cerebral palsy. It compares four therapies: one using a robotic device called Lokomat, one focusing on gait-focused physical therapy exercises, one combining both methods, and a regular maintenance therapy. The goal is to determine which method best enhances walking abilities, balance, fitness, and overall quality of life. Children with cerebral palsy who can walk, follow instructions, and participate in therapy sessions may be good candidates for this study.

As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could significantly improve therapeutic approaches for children with cerebral palsy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, regular physical therapy and other gross motor mobility therapies must be discontinued during the trial, except for home programs like stretching and light exercise.

What prior data suggests that robotic gait training and physical therapy are safe for children with cerebral palsy?

Research has shown that both the Lokomat and gait-focused physical therapy are generally safe for children with cerebral palsy. The Lokomat, a robotic device that aids in walking practice, has been found safe for children to use, allowing them to practice walking skills without reported safety issues.

Gait-focused physical therapy is also supported by research as safe, with no reports of problems like pain or tiredness during sessions. This therapy improves walking by focusing on exercises that enhance balance and coordination.

When used together, the Lokomat and physical therapy remain safe and well-tolerated by children, according to multiple studies. Promising evidence suggests these treatments can improve walking ability without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for cerebral palsy because they offer innovative approaches to improving mobility. The Lokomat (LOK) robotic gait training stands out due to its use of a robotic exoskeleton that provides a goal-based method to enhance walking skills, encouraging dual-tasking and improving posture through motor imagery practice. Meanwhile, the gait-focused physical therapy (fPT) emphasizes motor learning by allowing children to practice motor skills through diverse activities without relying on techniques that change body structure. These approaches are different from traditional physical therapies, which may not incorporate advanced robotic technology or a strong focus on motor learning principles.

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

Research has shown that Lokomat therapy, a treatment in this trial, can improve walking skills in children with cerebral palsy. Studies have found it to be as effective as traditional physical therapy, though not necessarily superior. Gait-focused physical therapy, another treatment arm in this trial, aims to increase walking speed, as reviews of multiple studies have suggested. Both Lokomat therapy and gait-focused physical therapy aim to enhance the walking abilities of children with cerebral palsy. While each method works well independently, participants in this trial may receive a combination of both, potentially offering additional benefits by combining their strengths. ^{1 2 6 7 8}

Who Is on the Research Team?

Lesley Wiart, PhD

Principal Investigator

University of Alberta

Virginia Wright, PhD

Principal Investigator

Holland Bloorview Kids Rehabilitation Hospital

Are You a Good Fit for This Trial?

This trial is for children and youth aged 5-18 with Cerebral Palsy, specifically those who can follow instructions for a walking test and participate in active physical therapy. They should be able to communicate discomfort and have certain levels of hip and knee flexibility. Participants must commit to multiple sessions over several weeks but cannot receive other mobility therapies during the study.

Inclusion Criteria

Parent agrees to contact of their primary PT (if not already involved by parent in the screening process) and their paediatrician or physiatrist to confirm eligibility

I can follow physical therapy instructions and do at least 30 minutes of active PT.

I agree to stop regular physical therapy for 8-10 weeks during the study, but can do home exercises.

Exclusion Criteria

My seizures are fully controlled with medication, and I haven't had a seizure in the last year.

If you have severe muscle stiffness, you may not be able to participate after a special test called L-FORCE assessment.

I cannot comfortably fit or stay in the required position for the treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either LOK, fPT, or LOK+fPT interventions, consisting of two 50-minute sessions per week over 8 to 10 weeks

8-10 weeks

16-20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 months post-intervention

12 weeks

1 visit (in-person)

Qualitative Interviews

Interviews with children and parents to gather insights on experiences and outcomes

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Gait focused physical therapy
• Lokomat
• Regular Maintenance Therapy

Trial Overview The study tests four approaches: robotic device-assisted walking training (LOK), functional physical therapy (fPT) focusing on balance and motor skills, a combination of both LOK+fPT, and regular maintenance therapy. The goal is to see which method best improves walking-related motor skills over eight to ten weeks.

How Is the Trial Designed?

Group I: Lokomat (LOK) Experimental Treatment 1 Intervention

Two 50-minute sessions per week. The manualized LOK walking protocol provides methods for progressing/tracking including a 5-minute overground walking session after the LOK to facilitate transfer of motor learning from the LOK to usual walking devices. The goal-based LOK program uses a standardized approach to progressing LOK body weight and guidance support and includes upper body activities while walking to encourage dual tasking and improved posture, and motor imagery practice.

Group II: LOK + fPT Experimental Treatment 1 Intervention

Two 50-minute sessions per week. Children will receive both the LOK and the fPT protocols (content as described above for each) for the duration of the 8 to 10 week intervention phase. These will be given as two sessions of LOK one week alternating with two sessions of fPT the next week. The fPT will build on motor learning principles because the activities will allow the child to practice motor skills in a variety of different activities. Techniques focusing on body structure changes will be prohibited.

Group III: Gait focused physical therapy (fPT) Experimental Treatment 1 Intervention

Two 50-minute sessions per week. Each weekly fPT session consists of 50 minutes of active treatment, a 'dose' equivalent to time spent in active treatment in the LOK arm. Techniques that focus on body structure changes will be not be permitted (e.g., inhibitive casting, kinesiotaping, functional electrical stimulation).

Group IV: Maintenance therapy Active Control 1 Intervention

Consists of maintenance therapy and a weekly email from the centre's research assistant to monitor any co-interventions. Maintenance may include range of motion/stretching and basic isometric strength home program as well as up to 10 minutes per day of exercise bicycle or treadmill or general walking practice.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

Holland Bloorview Kids Rehabilitation Hospital

Collaborator

Trials

69

Recruited

14,100+

Shirley Ryan AbilityLab

Collaborator

Trials

212

Recruited

17,900+

Published Research Related to This Trial

Children with cerebral palsy had mixed feelings about robotic gait training with the Lokomat, often feeling uncertain about what to expect and sometimes anxious about participating, indicating a need for better engagement strategies in rehabilitation.

Despite the potential benefits of robotic training, children did not express a strong desire to achieve 'normal' walking patterns, suggesting that rehabilitation goals should align more closely with children's personal expectations and experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is it like to walk with the help of a robot? Children's perspectives on robotic gait training technology. Phelan, SK., Gibson, BE., Wright, FV.[2018]

Robotic-assisted gait training using the Lokomat® Pediatric significantly improved locomotor parameters and balance control in children with Cerebral Palsy, as shown by a study involving 14 treated children compared to 16 control children.

The therapy resulted in a more appropriate timing between the Center of Mass and Center of Pressure trajectories, indicating enhanced gait mechanics after 20 sessions of rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of robotic-assisted gait rehabilitation on dynamic equilibrium control in the gait of children with cerebral palsy. Wallard, L., Dietrich, G., Kerlirzin, Y., et al.[2018]

In a study involving 10 children with cerebral palsy, walking on the Lokomat exoskeleton resulted in lower muscle activity compared to treadmill walking, indicating that the Lokomat may not fully engage the muscles as effectively during gait training.

Adjusting training parameters like speed can increase muscle activity in the Lokomat, suggesting that to enhance training effectiveness, it may be beneficial to encourage higher speeds or provide specific instructions to promote active contributions from the children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amplitude and stride-to-stride variability of muscle activity during Lokomat guided walking and treadmill walking in children with cerebral palsy. van Kammen, K., Reinders-Messelink, HA., Elsinghorst, AL., et al.[2021]

A scoping review of 208 studies on Lokomat therapy for gait rehabilitation found that less than one-third of the studies reported the specific therapy parameters used, indicating poor reporting quality.

While there is some evidence that Lokomat therapy parameters may influence treatment effectiveness, the lack of detailed reporting limits the ability to make specific recommendations for clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Settings matter: a scoping review on parameters in robot-assisted gait therapy identifies the importance of reporting standards. van Dellen, F., Labruyère, R.[2022]

This study is a randomized controlled trial comparing robotic-assisted gait training (RAGT) to traditional physiotherapy (PT) in children with cerebral palsy, aiming to assess improvements in gross motor function and walking endurance over 16 weeks with twice-weekly sessions.

The trial will evaluate key outcomes such as gross motor functional ability and walking distance, providing valuable insights into the effectiveness of RAGT compared to standard PT, which could influence rehabilitation practices for children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial. Hilderley, AJ., Fehlings, D., Lee, GW., et al.[2022]

Robot-assisted gait therapy (RAGT) significantly improves gait speed, walking distance, and overall mobility skills (walking, running, and jumping) in children with cerebral palsy compared to conventional therapy (CT), based on a systematic review of 15 controlled clinical trials involving 413 participants.

While RAGT shows clear benefits over CT, it does not demonstrate significant differences in other measures when compared to treadmill therapy (TT), indicating that while RAGT is effective, it may not be superior to all forms of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Robot-Assisted Gait Therapy Compared to Conventional Therapy or Treadmill Training in Children with Cerebral Palsy: A Systematic Review with Meta-Analysis. Cortés-Pérez, I., González-González, N., Peinado-Rubia, AB., et al.[2022]

Robotic-assisted gait training therapy (RAGT) significantly improves dynamic balance control and locomotor functions in children with bilateral spastic cerebral palsy, as evidenced by kinematic data and Gross Motor Function Measure test results after 20 sessions of treatment.

Children receiving RAGT demonstrated enhanced upper body control and improved lower limb movement strategies compared to a control group that only received standard physiotherapy, highlighting the effectiveness of RAGT in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted gait training improves walking abilities in diplegic children with cerebral palsy. Wallard, L., Dietrich, G., Kerlirzin, Y., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5131187/

Effectiveness of Rehabilitation Interventions to Improve ... The results of the meta-analysis suggest that interventions focused on gait training were the most effective in improving gait speed for children with CP. In ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4890515/

Evaluation of the effectiveness of robotic gait training and gait ... Participants improved equally on the GMFM Stand and Walk Dimensions (i.e., mean gains about 5 points in each after 12 sessions given over 3 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02391324

NCT02391324 | Effectiveness of Robotic Gait Training and ... Robot assisted gait training is seen as a promising intervention for improving the walking abilities of children with cerebral palsy, but research to ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.1005485/full

Which gait training intervention can most effectively ... This study suggested that BWSTT was optimal in increasing the gait velocity and RAGT was optimal in optimizing GMFM in persons with CP.

5. e-jer.org e-jer.org/journal/view.php?number=2013600776

Effectiveness of treadmill training on gait function ... These findings suggested that treadmill training on cerebral palsy was effective for gait endurance, gait speed and limb support time than cadence and step ...

6. journals.lww.com journals.lww.com/md-journal/fulltext/2020/01100/efficacy_and_safety_of_core_stability_training_on.30.aspx

Efficacy and safety of core stability training on gait of... The study will evaluate the effect of CST on gait of children with CP from multiple outcomes, including walking speed, endurance, stride length, and safety.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2821278

Overground Gait Training With a Wearable Robot in ... No safety issues were reported, and the experimental group experienced no adverse effects, such as skin lesions, pain, or fatigue, during RAGT.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dmcn.13708

The efficacy of functional gait training in children and ... There is promising evidence that functional gait training is a safe, feasible, and effective intervention to target improved walking ability in children and ...