Robotic Gait Training + Physical Therapy for Cerebral Palsy

Recruiting at2 trial locations

Overseen by Virginia Wright, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alberta

Must not be taking: Botulinum toxin

Disqualifiers: Severe spasticity, Hip instability, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Robot assisted gait training is seen as a promising intervention for improving the walking abilities of children with cerebral palsy, but research to support its effectiveness compared to best practice physical therapy is lacking. This research consists of a randomized controlled trial (RCT) and a qualitative descriptive study that is linked with the RCT. The goal of the RCT is to compare: 1) a walking training program with the Lokomat® robotic device (LOK), 2) a functional physical therapy program (fPT) that includes activities to enhance balance/co-ordination/endurance and advanced motor skills conducted over 'real ground', 3) a combined Lokomat® + functional physical therapy (LOK+fPT) program, and 4) a regular maintenance therapy condition (CONT) for ambulatory children and youth with CP (aged 5- 18 years). The three intervention programs will consist of sixteen 50-minute sessions given twice weekly over 8 to 10 weeks. The primary objective of the RCT is to compare the four groups with respect to walking-related motor skills as measured by the Gross Motor Function Measure. The secondary objectives are to compare each intervention's impact on walking abilities, individualized goals, fitness, balance, physical activity levels, child's belief in ability to do physical activity, participation and quality of life. The investigators will also evaluate the extent of carryover or progress 3 months after the intervention. The qualitative part of the study will consist of interviews of children and parents after they have finished the study intervention. The information from the interviews will assist us with interpretation of the outcome results (areas of impact and amount of change) from the RCT. In particular, the interviews will 1) provide insight into their experiences with the trial interventions, 2) identify the mobility-related outcomes that are important to families and the factors that influence their preferences, and 3) explain the family values, experiences and contextual factors that influenced participation in the study. This research will provide information needed to allow clinicians and families to make informed choices about Lokomat therapy and physical therapy options in relation to their child's functional goals and abilities.

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 data supports the effectiveness of the treatment Robotic Gait Training + Physical Therapy for Cerebral Palsy?

Research shows that robotic-assisted gait training, like the Lokomat, can improve balance and walking abilities in children with cerebral palsy by enhancing postural and locomotor functions. Studies have found significant improvements in gait parameters and motor skills after using this treatment, indicating its potential benefits for children with cerebral palsy. ^{1 2 3 4 5}

Is robotic gait training safe for children with cerebral palsy?

The studies reviewed do not report any specific safety concerns related to robotic gait training for children with cerebral palsy, suggesting it is generally safe for use in this population. ^{1 2 4 5 6}

How does robotic gait training with Lokomat differ from other treatments for cerebral palsy?

Robotic gait training with Lokomat is unique because it uses a robotic exoskeleton to help children with cerebral palsy practice walking, allowing for longer and more varied training sessions compared to traditional physical therapy. This approach can improve balance and walking patterns by providing consistent support and guidance, which may not be possible with conventional therapy or treadmill training alone. ^{1 2 3 4 7}

Research Team

Lesley Wiart, PhD

Principal Investigator

University of Alberta

Virginia Wright, PhD

Principal Investigator

Holland Bloorview Kids Rehabilitation Hospital

Eligibility Criteria

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

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

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 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.

Trial Timeline

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

Treatment Details

Interventions

• Gait focused physical therapy (Behavioural Intervention)
• Lokomat (Robotics)
• Regular Maintenance Therapy (Behavioural Intervention)

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.

Participant Groups

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+

Bill Flanagan

University of Alberta

Chief Executive Officer since 2020

LLB from University of Toronto, LLM from Columbia University

Dr. Verna Yiu

University of Alberta

Chief Medical Officer since 2012

MD from University of Alberta, Fellowship in Pediatric Nephrology at Harvard University

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

Jared Auclair

Northeastern University

Chief Executive Officer

PhD in Biomedical Science from the University of Massachusetts Medical School

Anantdeep Kaur

Northeastern University

Chief Medical Officer since 2023

Master’s and Doctorate in Biotechnology from the University of Technology Sydney

Holland Bloorview Kids Rehabilitation Hospital

Collaborator

Trials

69

Recruited

14,100+

Julia Hanigsberg

Holland Bloorview Kids Rehabilitation Hospital

Chief Executive Officer since 2015

Law degrees from McGill University and Columbia Law School

Dr. Golda Milo-Manson

Holland Bloorview Kids Rehabilitation Hospital

Chief Medical Officer since 2010

MD from University of Toronto

Shirley Ryan AbilityLab

Collaborator

Trials

212

Recruited

17,900+

Dr. Pablo Celnik

Shirley Ryan AbilityLab

Chief Executive Officer since 2023

MD from University of Buenos Aires Faculty of Medical Sciences

Dr. James Sliwa

Shirley Ryan AbilityLab

Chief Medical Officer since 2021

DO

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of robotic-assisted gait rehabilitation on dynamic equilibrium control in the gait of children with cerebral palsy. [2018]

2. England 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. [2018]

3. Switzerland 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. [2022]

4. England 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Robotic-assisted gait training improves walking abilities in diplegic children with cerebral palsy. [2018]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Switzerland 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. [2022]