Innovative Robotic Gait Trainer Use to Enable Walking in Children With Cerebral Palsy GMFCS III and IV

Children's Hospital of Eastern Ontario

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Behavioral: Functional Clinical Therapy; Device: Robotic Gait Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05378243

20200502

Details and patient eligibility

About

Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.

Full description

Exploration to optimize mixed quantitative and qualitative methodology using multiple outcome measures in a randomized, cross-over trial structure comparing the effect of robotic gait training (RGT) group, and functional clinical therapy (FCT) using each subject as their own control.

The primary objective is to assess feasibility of the study design and device tolerability. Specifically:

• Recruitment success (number screened, number eligible, number enrolled) where 80% of the recruitment target is reached.
• Attrition rates of less than 10% (i.e. ≥90% of participant's successfully complete assessments).
• Adherence for each participant: 80% of participants who complete assessments achieve the minimum target dose (i.e. approx. ≥30 hours of therapy in both study groups).
• Qualitative feedback from clinicians and patients/caregivers on device tolerability and study participation.

Secondary objectives will evaluate the distance a child can walk in two minutes using the Two Minute Walk Test (2MWT, 18) and will examine a more global impact of the use of this technology. Data collected will include quality of gait, child or proxy chosen individualized goals, hypertonicity, contractures, and bone health.

Enrollment: 10 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis of cerebral palsy
• GMFCS Levels III and IV
• Ages ≥2 to ≤12 years
• Ability to take steps with and/or without assistance
• Meet the Trexo Plus device size requirements
• Ability to follow instructions and signal pain, fear, or discomfort
• Ability to safely use the device at home as determined by the study team

Exclusion criteria

• Lower limb or orthopedic surgery within 9 months prior to enrollment
• Botulinum toxin injections within 4 months prior to enrollment
• Serial casting within 3 months prior to enrollment
• Knee flexion contracture > 20°
• Knee valgus > 40°
• Hip subluxation > 40 % migration percentage
• Uncontrolled movements that prevent transfer in and/or out of device
• Weight bearing restrictions
• Uncontrolled seizures
• Skin lesions in areas where the device straps would be attached
• Significant language barrier with parents and/or caregivers Note: children with severe contractures will be unable to fit in the device and are therefore excluded from the study

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Robotic Gait Training

Experimental group

Description:

8 weeks of therapy with the robotic gait training device 4-5 times a week for 1 hour each session

Treatment:

Device: Robotic Gait Training

Functional Clinical Therapy

Experimental group

Description:

8 weeks of therapy with a custom designed therapy program for the participant's needs 4-5 times a week for 1 hour each session

Treatment:

Behavioral: Functional Clinical Therapy