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Cerebral PalsyPhase 2NCT02196298

A Randomized Trial Comparing the Lokomat® With a Gait-related Physiotherapy Program in Children With Cerebral Palsy

A Phase 2 study testing Lokomat and Physiotherapy in people with Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Lokomat is a robotic treadmill gait trainer that is used to help people who have neurologic conditions walk better. Early research with children with cerebral palsy (CP) shows that it may help to improve walking skills. Read more about this study

Who is it for?
Ages 5 to 12 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Lokomat and Physiotherapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteCanada
Study dates
Oct 2012to 30 Jan 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • age 5 to12 years inclusive
  • assessed as GMFCS Levels II or III
  • able to follow testing instructions, and participate in a minimum of 30 minutes of active PT
  • able to reliably signal pain, fear and discomfort
  • have passive range of motion (ROM) of hips and knees within minimum range requirement for Lokomat (hip and knee flexion contracture < 10 degrees, and knee valgus < 40 degrees)
  • client of Child Development Program at Holland Bloorview
  • able to commit to attendance of twice weekly for eight weeks (to support the primary efficacy analysis).

Who cannot join

  • a fixed knee contracture > 10 degrees, knee valgus >40 degrees such that robotic leg orthosis will not be adaptable to lower limbs
  • hip instability/subluxation > 45%
  • orthopaedic surgery within the last 9 months (muscle) or 12 months (bone)
  • Botulinum toxin-A (BTX-A) injections to lower limb in the last 4 months
  • inability to discontinue BTX-A for period of 6 months (during trial) due to concerns about ROM or pain
  • severe spasticity may be a contraindication
Show all 12Show fewer
  • any weightbearing restrictions
  • seizure disorder that is not controlled by medication (if on medication, must not have had a seizure in the last 12 months)
  • open skin lesions or vascular disorder of lower extremities
  • not able to co-operate or be positioned adequately within the Lokomat as shown during the two Lokomat fitting/acclimatisation sessions
  • not prepared or unable to discontinue a regular therapy intervention during the course of the trial
  • involved in another intervention study

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Holland Bloorview Kids Rehabiltation Hospital

    Toronto, Ontario, M4G 1R8

Other trials in Canada

About this study

Official title: A Randomized Cross-over Clinical Trial Comparing the Impact of the Lokomat® Gait Training System With a Gait-related Physiotherapy Program in Children With Cerebral Palsy

The Lokomat is a robotic treadmill gait trainer that is used to help people who have neurologic conditions walk better. Early research with children with cerebral palsy (CP) shows that it may help to improve walking skills. The purpose of this two-group randomized study is to compare Lokomat training to regular physiotherapy (PT) as far as impact on walking abilities and related function. The primary (alternate) hypothesis is that children will improve more with Lokomat training in terms of gross motor skills and walking endurance.

The investigators are enrolling 40 ambulatory children who are ages 5 to 12 years, have CP and are in Gross Motor Function Classification System (GMFCS) Level II (n=20) or III (n=20). In this crossover randomized clinical trial (RCT), whether PT or Lokomat intervention is done first is decided by an independent randomization process that occurs after the first baseline assessment. In the Lokomat phase, children receive 8 to 10 weeks of twice weekly therapy for a maximum of 16 sessions. Each session is 35 minutes plus the time needed for set-up. The 35 minute PT program is also given twice weekly for 8 to 10 weeks for a maximum of 16 sessions, and focuses on a menu-based strength, co-ordination, fitness, walking and balance activities. There is a 6 week break between the Lokomat and PT interventions.

Read more

Each child has four study assessments during their ~6 months in the study. The first assessment is done before starting the Lokomat or physiotherapy phase. The second happens after the first intervention has finished. The child then has a 6-week break period. The third assessment is done at the end of this break, and the fourth occurs after the second intervention. The PT assessor who does these assessments will not be the same as the PT who gives the intervention. The assessor is blinded to the child's intervention phase and previous assessment results. The primary outcome measures are the Gross Motor Function Measure and 6 minute walk test. Secondary measures evaluate gait, functional abilities, participation, health related quality of life and individualized goals.

The randomized aspect of the study lets us look at outcome differences between children for Lokomat and PT within their first intervention phase (n=20/group). The cross-over phase evaluates within-child outcomes across the two phases. A qualitative component is concurrently underway to examine child/parent experiences and their views of Lokomat outcomes.

Read the detailed description

No further information

Conditions
Cerebral Palsy
Being tested
Lokomat, Physiotherapy
Keywords
physical therapy, gait, pediatric rehabilitation, gross motor function, participation
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LokomatDevice

    Also called Lokomat®Pro Pediatric Orthoses

    16 sessions in total, 30 minutes each plus set-up time followed by 5 minutes of overground walking. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.

  • PhysiotherapyOther

    16 sessions, 35 minutes. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.

Study groups in NCT02196298
Study groupRoleWhat they receive
LokomatExperimental16 sessions in total, 30 minutes each plus set-up time followed by 5 minutes of overground walking. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.
Receives: Device: Lokomat
PhysiotherapyActive comparator16 sessions, 35 minutes. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.
Receives: Other: Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in motor function on Gross Motor Function Measure (GMFM-66) at week 8

    Stand and Walk items of the GMFM-66. Gold standard measure of foundational gross motor skills in children with CP.

    Measured: Baseline, 8 weeks (repeated in same manner after crossover)

Secondary outcomes (10)

  1. Change from baseline in walk speed on the Six-minute walk test at week 8

    Used as the co-primary outcome measure. Standardized 6 minute walk test (with shoes, orthoses, walking devices as required) to determine distance covered (capability measure). Well-validated in pediatric CP.

    Measured: Baseline, 8 weeks (repeated in same manner after crossover)

  2. Change from baseline in advanced motor skills on the Challenge Module at week 8

    Just for children in GMFCS Level II. This is a new published measure of advanced motor skills.

    Measured: Baseline, 8 weeks (repeated in same manner after crossover)

  3. Change from baseline in activity and participation on the Activities Scale for Kids at week 8

    Well-validated measure of physical functional ability in children. Child (if 8+ years) or parent-report questionnaire

    Measured: Baseline, 8 weeks (repeated in same manner after crossover)

  4. Change from baseline in quality of life on the KidScreen Questionnaire at week 8

    Measure of health-related quality of life. Questionnaire completed by children 8+ years or parents of younger children.

    Measured: Baseline, 8 weeks (repeated in same manner after crossover)

  5. Change from baseline in participation on the Children's Assessment of Participation and Enjoyment (CAPE) at week 8

    Using the physical activity and sport sections of this parent-report questionnaire to gain picture of areas/extent of participation in these areas.

    Measured: Baseline, 8 weeks (repeated in same manner after crossover)

  6. Change from baseline in gait kinematics as measured on the GaitRite evaluation system at week 8

    Time distance parameters of gait via GaitRite system

    Measured: Baseline, 8 weeks (repeated in same manner after crossover)

  7. Change from baseline in Gait quality as measured on an observational gait scale at week 8

    Gait pattern as evaluated via observational gait scale, rating from video of child's walking

    Measured: Baseline, 8 weeks (repeated in same manner after crossover)

  8. Change from baseline in targeted goal abilities as measured by Goal Attainment Scaling (GAS) at week 8

    Three to five individualized walking-based activity/participation goals set with child/parent/treating PT at baseline 1 and reset at baseline 2. Evaluated by treating PT with child/parent input at post-intervention 1 and 2

    Measured: Baseline, 8 weeks (repeated in same manner after crossover)

  9. Change from baseline in targeted goal abilities and satisfaction with performance as measured by the Canadian Occupational Performance Measure at week 8

    Three to five individualized walking-based activity/participation set at baseline 1 and 2 with assessor and child/parent, and re-evaluated by child/parent at post-intervention assessment 1 and 2. Used by treating PT to formulate GAS goals

    Measured: Baseline, 8 weeks (repeated in same manner after crossover)

  10. Change from baseline in movement quality as measured by the Quality Function Measure (QFM) at week 8

    Companion measure to the GMFM-66 to assess alignment, co-ordination, dissociated movement, stability and weight shift. Rated by PT assessor from GMFM video. Recently validated.

    Measured: Baseline, 8 weeks (repeated in same manner after crossover)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2014 (estimated)
  2. Study startOct 2012
  3. Primary completionNov 2016
  4. Study completion30 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02196298
Sponsor's protocol ID
12-293
Status last verified
Jan 2017
First submitted
9 Apr 2014
Last updated
31 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Hilderley AJ, Fehlings D, Lee GW, Wright FV. 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. Springerplus. 2016 Oct 28;5(1):1886. doi: 10.1186/s40064-016-3535-0. eCollection 2016.

    PubMed 27843743

  • Phelan SK, Gibson BE, Wright FV. What is it like to walk with the help of a robot? Children's perspectives on robotic gait training technology. Disabil Rehabil. 2015;37(24):2272-81. doi: 10.3109/09638288.2015.1019648. Epub 2015 Apr 9.

    PubMed 25856202

  • Beveridge B, Feltracco D, Struyf J, Strauss E, Dang S, Phelan S, Wright FV, Gibson BE. "You gotta try it all": Parents' Experiences with Robotic Gait Training for their Children with Cerebral Palsy. Phys Occup Ther Pediatr. 2015;35(4):327-41. doi: 10.3109/01942638.2014.990547. Epub 2014 Dec 20.

    PubMed 25529412

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lokomat and Physiotherapy in people with Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in motor function on Gross Motor Function Measure (GMFM-66) at week 8 (time frame: Baseline, 8 weeks (repeated in same manner after crossover)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02196298, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.

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