Harness Support During Walking for Cerebral Palsy

Overseen By Marissa Thill, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Baclofen, Botulinum toxin, Phenol

Disqualifiers: Surgery, Baclofen pump, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore why walking can be so energy-draining for kids with cerebral palsy (CP). Researchers will use harnesses to provide varying levels of support while walking to observe the effects on energy use. The trial involves two groups: children with CP and children without CP, serving as a comparison group. Children aged 8-17 with CP, who have undergone gait analysis at Gillette Children's Specialty Healthcare and have not had certain recent surgeries or treatments, may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to understanding and potentially improving mobility for children with CP.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that participants should not have had a baclofen pump or certain injections in the last 2 months.

What prior data suggests that harness-assisted walking is safe for children with cerebral palsy?

Research has shown that using a harness for support while walking is safe for children with cerebral palsy. Studies suggest that these supportive aids improve walking ability without causing harm. Children often feel comfortable and secure because the harness supports their weight and prevents falls. This support allows them to focus on relearning skills like standing and walking.

Overall, harness-assisted walking has been well-received, with no major problems reported in studies. This evidence suggests that harness support is a safe option for helping children with cerebral palsy improve their mobility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using varying levels of harness support during walking for children with cerebral palsy because it offers a unique, non-invasive approach to improving mobility. Unlike standard treatments like physical therapy or medication, which often require long-term commitment and can have limited effects, harness systems can provide immediate support and feedback. This technique aims to enhance motor control and confidence in walking, potentially leading to better long-term outcomes for children with cerebral palsy. By adjusting the level of support, this method can be tailored to each child's specific needs, offering a personalized approach that isn't typically possible with other treatments.

What evidence suggests that varying levels of harness support during walking are effective for cerebral palsy?

Studies have shown that harness support while walking can help children with cerebral palsy. This trial will test varying levels of harness support to assess their impact on walking speed and practice opportunities, which can improve walking skills. Some research suggests these aids make children feel happier and more confident, leading to greater independence. Other findings indicate that harness-assisted walking is safe for children with cerebral palsy. Overall, different levels of harness support might make walking easier and more efficient for these children. ^{1 2 4 6 7}

Who Is on the Research Team?

Michael Schwartz, PhD

Principal Investigator

Gillette Children's Specialty Healthcare

Katherine M Steele, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for children aged 8-17 with bilateral cerebral palsy, specifically those who can walk and have a certain level of motor function. They should not have had recent surgery or muscle spasm treatments and must be able to understand instructions.

Inclusion Criteria

I haven't had botulinum toxin or phenol injections in the past 2 months.

I haven't had surgery in the last 9 months.

Ability to follow instruction

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Research Visit

Participants undergo a one-time research visit to measure net nondimensional oxygen consumption, gait kinematics, gait kinetics, passive joint range of motion, spasticity, selective motor control, and lower extremity strength

1 hour 45 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the research visit

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Varying levels of harness support during walking

Trial Overview The study tests how different levels of harness support affect the energy used by children with CP while walking. It aims to understand why walking consumes more energy for them and will measure oxygen use during various walking tasks.

How Is the Trial Designed?

Group I: Typically Developing Children (Controls) Experimental Treatment 1 Intervention

Children meeting inclusion/exclusion criteria without a diagnosis of cerebral palsy or other condition.

Group II: Children with Cerebral Palsy (Cases) Experimental Treatment 1 Intervention

Children meeting inclusion/exclusion criteria with a diagnosis of cerebral palsy.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Gillette Children's Specialty Healthcare

Collaborator

Trials

31

Recruited

8,100+

Published Research Related to This Trial

A 17-year-old male with spastic cerebral palsy showed significant improvements in walking ability after 12 sessions of gait training using the Hybrid Assistive Limb over 4 weeks, including increased gait speed and step length.

These improvements were sustained for 7 months post-intervention, indicating that Hybrid Assistive Limb training can be an effective long-term solution for enhancing mobility in patients with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement and sustainability of walking ability with hybrid assistive limb training in a patient with cerebral palsy after puberty: a case report. Nakagawa, S., Mutsuzaki, H., Mataki, Y., et al.[2020]

The new walking aid with axillary support (WAAS) significantly increased muscle activation in the quadriceps and hamstrings during walking in children with cerebral palsy, indicating improved muscle function.

Using the WAAS helped reduce the coactivation of opposing muscles, particularly during the swing phase of walking, which may enhance walking ability and promote greater independence and quality of life for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new walking aid with axillary support for children with cerebral palsy: electromyographic evaluation. Botega, R., Medola, FO., Santos, CB., et al.[2013]

Dynamic suit orthoses (DSO) can positively impact spatio-temporal gait parameters in children with Cerebral Palsy, particularly improving walking speed, cadence, stride length, and step length symmetry, based on a review of 12 studies.

To achieve optimal results, a training program combined with DSO intervention is recommended, with a suggested range of 18 to 60 sessions, although the evidence remains limited and further research is needed to comprehensively assess all gait parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Dynamic Suit Orthoses on the Spatio-Temporal Gait Parameters in Children with Cerebral Palsy: A Systematic Review. Belizón-Bravo, N., Romero-Galisteo, RP., Cano-Bravo, F., et al.[2021]

Using Lofstrand forearm crutches significantly decreased back muscle activity and improved lower back mobility in adolescents with spastic diplegia, suggesting a reduction in muscular demands during walking.

The study found that walking with crutches led to slower walking speed and changes in body posture, which may help in managing and preventing chronic back pain in individuals with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinematic and electromyographic studies on unaided, unilateral and bilateral crutch walking in adolescents with spastic diplegia. Yeung, EH., Chow, DH., Su, IY.[2013]

A systematic review of 41 studies on ankle-foot orthoses (AFOs) for children with cerebral palsy revealed significant variability in the reporting quality, making it difficult to compare outcomes across studies.

The review led to the development of best practice guidelines for future research, emphasizing the need for detailed descriptions of participant characteristics and orthosis designs to improve the reliability and replicability of findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review to determine best practice reporting guidelines for AFO interventions in studies involving children with cerebral palsy. Ridgewell, E., Dobson, F., Bach, T., et al.[2022]

A clinical feasibility study involving five individuals with cerebral palsy demonstrated that using a novel untethered ankle exoskeleton significantly improved gait mechanics, including a clinically meaningful 14.4° improvement in lower-extremity flexion deformity.

The powered ankle assistance not only enhanced biological function, leading to a 19% reduction in metabolic cost of transport, but also increased ankle power by 44%, suggesting it could be a valuable tool for improving mobility in individuals with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Battery-Powered Ankle Exoskeleton Improves Gait Mechanics in a Feasibility Study of Individuals with Cerebral Palsy. Lerner, ZF., Harvey, TA., Lawson, JL.[2019]

An international expert consensus was achieved on 47 out of 48 joint patterns during gait for children with cerebral palsy, based on a Delphi survey involving 13 experts from eight gait laboratories.

The identified joint patterns, particularly for the knee, can aid in clinical decision-making and treatment strategies for children with cerebral palsy, highlighting the need for further automation in classification and additional feature incorporation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of joint patterns during gait in children with cerebral palsy: a Delphi consensus study. Nieuwenhuys, A., Õunpuu, S., Van Campenhout, A., et al.[2022]

The pilot study involving three children with bilateral spastic cerebral palsy demonstrated that overground robot-assisted gait training (RAGT) using a torque-assisted exoskeleton significantly improved gross motor function and walking performance after 17-20 training sessions.

All participants showed positive outcomes, including increased walking speed and endurance, with one child achieving independent walking with a platform walker, indicating that this intervention is both safe and effective even for those with severe motor impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overground Robot-Assisted Gait Training for Pediatric Cerebral Palsy. Kim, SK., Park, D., Yoo, B., et al.[2021]

The study successfully tested a robotic walker with five participants aged 13-22 years with cerebral palsy, where four were able to walk independently, highlighting the device's potential to enhance mobility and independence for individuals with severe motor limitations.

Participants reported physical benefits like hands-free walking and improved fitness, as well as social advantages such as increased peer engagement, although challenges like device size and limited terrain adaptability were noted, leading to recommendations for design improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a robotic walker for individuals with cerebral palsy. Alazem, H., McCormick, A., Nicholls, SG., et al.[2021]

A qualitative study involving eight participants (parents, educators, and physical therapists) highlighted that low-cost support walkers significantly enhance emotional welfare, physical wellbeing, and social enjoyment for children with Cerebral Palsy (CP).

The use of support walkers not only boosts children's happiness and self-confidence but also encourages greater participation in physical and social activities, promoting their overall autonomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of a Low-Cost Walking Device in Children with Cerebral Palsy: A Qualitative Study. Rodríguez-Costa, I., De la Cruz-López, I., Fernández-Zárate, I., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-cerebral-palsy-7-2021-46e65

Harness Support During Walking for Cerebral Palsy The studies suggest that using supportive walking aids, like harness-assisted walking, is safe for children with cerebral palsy. These aids help improve ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8092676/

Mechanically assisted walking training for ... - PubMed Central Mechanically assisted walking training can be provided with or without body weight support to enable children with cerebral palsy to perform repetitive practice ...

3. cochrane.org cochrane.org/evidence/CD013114_mechanically-assisted-walking-training-children-cerebral-palsy

Mechanically assisted walking training for children with ... Compared with no walking, mechanically assisted walking training probably results in small increases in walking speed (with or without body ...

4. researchgate.net researchgate.net/publication/349977816_Benefits_of_a_Low-Cost_Walking_Device_in_Children_with_Cerebral_Palsy_A_Qualitative_Study

(PDF) Benefits of a Low-Cost Walking Device in Children ... To conclude, the use of a support walker in children with CP makes them feel happier, improves their self-confidence and autonomy, and promotes participation.

5. secondstepinc.com secondstepinc.com/gait-harness-research/

Research, Gait Harness System | Second Step, Inc ... The GHS provides a chance for individuals with a variety of neurological and musculoskeletal illnesses or injuries to restore a sense of independence.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6698473/

Newly developed hybrid assistive limb for pediatric patients ... The newly developed hybrid assistive limb has the potential to immediately improve walking ability even among young children with cerebral palsy.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06593886?term=AREA%5BBasicSearch%5D(diane%20damiano)&rank=2

Promoting Upright Mobility in Infants With Cerebral Palsy ... The harness helps support the infant s weight; it also slows any falls and catches the body before it hits the floor. BabyG can be adjusted to support 5% to 50% ...