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Robot vs. therapist: which helps kids with CP walk better?

NCT ID NCT02391324

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether robotic gait training (using a device called Lokomat) or standard physical therapy, or a mix of both, helps children with cerebral palsy walk better. 68 children aged 5-18 participated in 16 sessions over 8-10 weeks. Researchers measured changes in motor skills, walking distance, and quality of life. The goal is to provide clear evidence on which approach works best.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Robotic gait training (Lokomat) and gait-focused physical therapy
What this could lead to
If successful, this could show which therapy best improves walking and mobility in children with cerebral palsy, helping families choose the right treatment.
What could go wrong
This is a completed small trial (68 participants) comparing existing therapies, not a new breakthrough. Results may not apply to all children with CP.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

68 people

The number who actually took part.

Started

Jan 2016

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of CP (any type), GMFCS Levels II and III * Able to follow GMFM testing instructions, and to participate in a minimum of 30 minutes of active PT (as judged by the child's PT or physician if not followed by a PT) * Able to reliably signal pain, fear and discomfort using verbal or nonverbal signals * Passive range of motion (ROM) of hips and knees within minimum range requirement for LOK (hip and knee flexion contracture \< 10 degrees, and knee valgus \< 40 degrees). * Parent/child agrees to attend 16 study intervention sessions (given within two 10-week periods), a LOK fitting/acclimatization session or fPT acclimatization session and the three assessment sessions during the course of the study. * 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. * Parent agrees that regular PT (and other gross motor mobility therapies such as conductive education and MEDEK) will be discontinued from the time of the baseline assessment through the 8 to 10 weeks of the active intervention or control group. Note that home programs such as stretching and strengthening and treadmill and exercise bike riding (no more than 10 minutes total per day) will be permitted in all groups. Exclusion Criteria: * Botulinum Toxin injection within the past 4 months or planned within the next 6 months * Fixed knee contracture \> 10 degrees, knee valgus \>40 degrees such that orthosis will not be adaptable to lower limbs. * Hip instability/subluxation as demonstrated by a migration percentage \> 45% * Orthopaedic surgery (soft tissue releases) within the last 9 months, or lower limb bony surgery within the last 18 months * Severe spasticity may be a contraindication as determined in Lokomat trial session using L-FORCE assessment. * Any weightbearing restrictions. * Seizure disorder unless fully controlled by medication and no evidence of seizure in the last 12 months and physician provides singed approval to enter the study * Open skin lesions or vascular disorder of lower extremities * Not able to co-operate or be positioned adequately within the LOK as shown during the fitting/acclimatisation session. -

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Holland Bloorview Kids Rehabilitation Hospital

    Toronto, Ontario, M4G 1R8, Canada

  • Shirley Ryan AbilityLab

    Chicago, Illinois, 60611, United States

  • University of Alberta

    Edmonton, Alberta, T6G 2G4, Canada

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