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

NCT02391324 | Completed DMC

• 1 other identifier: RES0022460
• Study Type: interventional
• Target: 68
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Change in gross motor abilities using the Gross Motor Function Measure (GMFM-66) from 0-8 and 0-20 weeks

  A standardized measure of gross motor function for children with cerebral palsy

  Baseline, 8 weeks, 20 weeks

Secondary Outcomes (13)

• Change in walking distance using the 6-Minute walk test from 0-8 and 0-20 weeks

  Baseline, 8 weeks, 20 weeks

• Change in individual goal attainment using the Canadian Occupational Performance Measure (COPM) performance ratings from 0-8 and 0-20 weeks

  Baseline, 8 weeks, 20 weeks

• Change in individual goal attainment using Goal Attainment Scaling (GAS) from 0-8 and 0-20 weeks

  Baseline, 8 weeks, 20 weeks

• Change in anaerobic capacity using the Adapted Shuttle Run Test from 0-8 and 0-20 weeks

  Baseline, 8 weeks, 20 weeks

• Change in Pediatric Berg Balance Scale from 0-8 and 0-20 weeks

  Baseline, 8 weeks, 20 weeks

Study Arms (4)

Lokomat (LOK)

EXPERIMENTAL

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)

Gait focused physical therapy (fPT)

EXPERIMENTAL

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)

LOK + fPT

EXPERIMENTAL

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

Maintenance therapy

NO INTERVENTION

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.

Interventions

Lokomat (LOK) PROCEDURE

Physical therapy provided using a robotic gait training system (Lokomat).

Also known as: Robotic Gait Training

Lokomat (LOK)

Gait focused physical therapy (fPT) PROCEDURE

Overground physical therapy focussed on enhancing gait related motor skills

Gait focused physical therapy (fPT)

LOK + fPT PROCEDURE

A combination of robotic gait training and gait focussed functional physical therapy.

LOK + fPT

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• University of Alberta: lead
• Holland Bloorview Kids Rehabilitation Hospital: collaborator
• Shirley Ryan AbilityLab: collaborator
• Northeastern University: collaborator

Study Sites (3)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

University of Alberta

Edmonton, Alberta, T6G 2G4, Canada

Location

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

Related Publications (1)

• Wiart L, Rosychuk RJ, Wright FV. Evaluation of the effectiveness of robotic gait training and gait-focused physical therapy programs for children and youth with cerebral palsy: a mixed methods RCT. BMC Neurol. 2016 Jun 2;16:86. doi: 10.1186/s12883-016-0582-7.

  PMID: 27255908 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Virginia Wright, PhD

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

• Lesley Wiart, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 18, 2015
• Study Start: January 1, 2016
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1); CA (2)