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

NCT02196298 | Completed Phase 2 DMC

• 1 other identifier: 12-293
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Cerebral Palsy

Keywords

physical therapy; gait; pediatric rehabilitation; gross motor function; participation

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (10)

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

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

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

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

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

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

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

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

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

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

Other Outcomes (3)

• Assessment of mastery motivation using the Dimensions of Mastery Questionnaire at the first baseline

  Baseline 1 only

• Monitoring of range of motion (ROM) of hip, knee and ankle

  baseline, 4 weeks, 8 weeks (repeated in same manner after crossover)

• Body pain

  participants will be followed at each treatment session for the duration of the study, an expected average of 16 weeks (8 weeks in the Lokomat arm and 8 weeks in the PT arm)

Study Arms (2)

Lokomat

EXPERIMENTAL

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.

Device: Lokomat

Physiotherapy

ACTIVE COMPARATOR

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

Other: Physiotherapy

Interventions

Lokomat DEVICE

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.

Also known as: Lokomat®Pro Pediatric Orthoses

Lokomat

Physiotherapy OTHER

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

Physiotherapy

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• CIBC Children's Foundation: collaborator

Study Sites (1)

Holland Bloorview Kids Rehabiltation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

Related Publications (3)

• 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.

  PMID: 27843743 BACKGROUND

• 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.

  PMID: 25856202 BACKGROUND

• 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.

  PMID: 25529412 BACKGROUND

Related Links

• Website of facility where trial is occurring. Investigators' lab sites are also on that website

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Virginia Wright, PT, PhD

  Holland Bloorview Kids Rehabiltation Hospital

  PRINCIPAL INVESTIGATOR

• Darcy Fehlings, MD, MSc

  Holland Bloorview Kids Rehabiltation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: July 22, 2014
• Study Start: October 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: January 30, 2017
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

CA (1)