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Effectiveness of Robotic Gait Training and Physical Therapy for Children and Youth With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02391324
Recruitment Status : Recruiting
First Posted : March 18, 2015
Last Update Posted : May 22, 2018
Sponsor:
Collaborators:
Holland Bloorview Kids Rehabilitation Hospital
Shirley Ryan AbilityLab
Northeastern University
Information provided by (Responsible Party):
Lesley Wiart, University of Alberta

Brief Summary:
Robot assisted gait training is seen as a promising intervention for improving the walking abilities of children with cerebral palsy, but research to support its effectiveness compared to best practice physical therapy is lacking. This research consists of a randomized controlled trial (RCT) and a qualitative descriptive study that is linked with the RCT. The goal of the RCT is to compare: 1) a walking training program with the Lokomat® robotic device (LOK), 2) a functional physical therapy program (fPT) that includes activities to enhance balance/co-ordination/endurance and advanced motor skills conducted over 'real ground', 3) a combined Lokomat® + functional physical therapy (LOK+fPT) program, and 4) a regular maintenance therapy condition (CONT) for ambulatory children and youth with CP (aged 5- 18 years). The three intervention programs will consist of sixteen 50-minute sessions given twice weekly over 8 to 10 weeks. The primary objective of the RCT is to compare the four groups with respect to walking-related motor skills as measured by the Gross Motor Function Measure. The secondary objectives are to compare each intervention's impact on walking abilities, individualized goals, fitness, balance, physical activity levels, child's belief in ability to do physical activity, participation and quality of life. The investigators will also evaluate the extent of carryover or progress 3 months after the intervention. The qualitative part of the study will consist of interviews of children and parents after they have finished the study intervention. The information from the interviews will assist us with interpretation of the outcome results (areas of impact and amount of change) from the RCT. In particular, the interviews will 1) provide insight into their experiences with the trial interventions, 2) identify the mobility-related outcomes that are important to families and the factors that influence their preferences, and 3) explain the family values, experiences and contextual factors that influenced participation in the study. This research will provide information needed to allow clinicians and families to make informed choices about Lokomat therapy and physical therapy options in relation to their child's functional goals and abilities.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Procedure: Lokomat (LOK) Procedure: Gait focused physical therapy (fPT) Procedure: LOK + fPT Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness of Robotic Gait Training and Gait-focused Physical Therapy Programs for Children and Youth With Cerebral Palsy: A Mixed Methods Randomized Controlled Trial
Actual Study Start Date : January 2016
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lokomat (LOK)
Two 50-minute sessions per week. The manualized LOK walking protocol provides methods for progressing/tracking including a 5-minute overground walking session after the LOK to facilitate transfer of motor learning from the LOK to usual walking devices. The goal-based LOK program uses a standardized approach to progressing LOK body weight and guidance support and includes upper body activities while walking to encourage dual tasking and improved posture, and motor imagery practice.
Procedure: Lokomat (LOK)
Physical therapy provided using a robotic gait training system (Lokomat).
Other Name: Robotic Gait Training

Experimental: Gait focused physical therapy (fPT)
Two 50-minute sessions per week. Each weekly fPT session consists of 50 minutes of active treatment, a 'dose' equivalent to time spent in active treatment in the LOK arm. Techniques that focus on body structure changes will be not be permitted (e.g., inhibitive casting, kinesiotaping, functional electrical stimulation).
Procedure: Gait focused physical therapy (fPT)
Overground physical therapy focussed on enhancing gait related motor skills

Experimental: LOK + fPT
Two 50-minute sessions per week. Children will receive both the LOK and the fPT protocols (content as described above for each) for the duration of the 8 to 10 week intervention phase. These will be given as two sessions of LOK one week alternating with two sessions of fPT the next week. The fPT will build on motor learning principles because the activities will allow the child to practice motor skills in a variety of different activities. Techniques focusing on body structure changes will be prohibited.
Procedure: LOK + fPT
A combination of robotic gait training and gait focussed functional physical therapy.

No Intervention: Maintenance therapy
Consists of maintenance therapy and a weekly email from the centre's research assistant to monitor any co-interventions. Maintenance may include range of motion/stretching and basic isometric strength home program as well as up to 10 minutes per day of exercise bicycle or treadmill or general walking practice.



Primary Outcome Measures :
  1. Change in gross motor abilities using the Gross Motor Function Measure (GMFM-66) from 0-8 and 0-20 weeks [ Time Frame: Baseline, 8 weeks, 20 weeks ]
    A standardized measure of gross motor function for children with cerebral palsy


Secondary Outcome Measures :
  1. Change in walking distance using the 6-Minute walk test from 0-8 and 0-20 weeks [ Time Frame: Baseline, 8 weeks, 20 weeks ]
    Distance walked in 6 minutes

  2. Change in individual goal attainment using the Canadian Occupational Performance Measure (COPM) performance ratings from 0-8 and 0-20 weeks [ Time Frame: Baseline, 8 weeks, 20 weeks ]
    Individualized goal setting tool and outcome measure (ratings of performance and satisfaction with performance)

  3. Change in individual goal attainment using Goal Attainment Scaling (GAS) from 0-8 and 0-20 weeks [ Time Frame: Baseline, 8 weeks, 20 weeks ]
  4. Change in anaerobic capacity using the Adapted Shuttle Run Test from 0-8 and 0-20 weeks [ Time Frame: Baseline, 8 weeks, 20 weeks ]
  5. Change in Pediatric Berg Balance Scale from 0-8 and 0-20 weeks [ Time Frame: Baseline, 8 weeks, 20 weeks ]
  6. Change in Quality FM from 0-8 and 0-20 weeks [ Time Frame: Baseline, 8 weeks, 20 weeks ]
  7. Change in confidence in performing ambulatory abilities as measured by the Activities Balance Confidence Scale from 0-8 and 0-20 weeks [ Time Frame: Baseline, 8 weeks, 20 weeks ]
  8. Change in functional abilities as measured by the PEDI-CAT from 0-8 and 0-20 weeks [ Time Frame: Baseline, 8 weeks, 20 weeks ]
  9. Change in # of steps/day from 0-8 and 0-20 weeks as measured with an accelerometer. [ Time Frame: Baseline, 8 weeks, 20 weeks ]
  10. Change in self-efficacy for physical activity as measured by the Physical Activity Self-efficacy scale [ Time Frame: Baseline, 8 weeks, 20 weeks ]
    Change in Self-efficacy for Physical Activity score from 0-8 and 0-20 weeks

  11. Change in the participation measured using the Participation and Environment Measure for Children and Youth (PEM-CY) from 0-8 and 0-20 weeks [ Time Frame: Baseline, 8 weeks, 20 weeks ]
  12. Change in quality of life using the Kidscreen from 0-8 and 0-20 weeks [ Time Frame: Baseline, 8 weeks, 20 weeks-up ]
  13. Change in quality of life using the Life Satisfaction Scale from 0-8 and 0-20 weeks [ Time Frame: Baseline, 8 weeks, 20 weeks ]


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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391324


Contacts
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Contact: Lesley Wiart, PhD 780-492-2971 lwiart@ualberta.ca

Locations
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United States, Illinois
Shirley Ryan AbilityLab Recruiting
Chicago, Illinois, United States, 60611
Contact: Ariane Garrett    312-238-0947    agarrett@sralab.org   
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2G4
Contact: Ashley McKillop, PhD    780-492-9098    lokomatstudy@ualberta.ca   
Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital Recruiting
Toronto, Ontario, Canada, M4G 1R8
Contact: Gloria Lee    416-425-6220 ext 3342    glee@hollandbloorview.ca   
Sponsors and Collaborators
University of Alberta
Holland Bloorview Kids Rehabilitation Hospital
Shirley Ryan AbilityLab
Northeastern University
Investigators
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Principal Investigator: Virginia Wright, PhD Holland Bloorview Kids Rehabilitation Hospital
Principal Investigator: Lesley Wiart, PhD University of Alberta

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lesley Wiart, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT02391324     History of Changes
Other Study ID Numbers: RES0022460
First Posted: March 18, 2015    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases