Plain English Summary
Background and study aims
Cerebral palsy (CP) is a term for a number of conditions that affect movement and co-ordination. It occurs when there is a problem in the parts of the brain responsible for controlling muscles. This can be due to abnormal development of the brain or damage caused before, during or after birth. CP leads to a range of symptoms, including muscle stiffness or weakness, random and uncontrolled body movements and balance and coordination problems. Problems with walking (gait) are the most common problems seen in children with CP. Robotics are being used more and more to help people who have problems with movement. The CPWalker rehabilitation platform is a robotic device made up of a walker and an exoskeleton (device worn on the outside of the body), which provides support and guidance to patients while they can experiment with walking techniques. The device can tprovide body weight support and the exoskeleton allows different control modes in order to adapt the therapy to the patient's needs. The aim of this study is to find out if therapy involving robot-based walking sessions can help children with CP to improve their gait (walking ability).
Who can participate?
Children aged 11 to 18 years who have cerebral palsy.
What does the study involve?
All the participants receive 16 robot-based walking sessions of 70 minutes each, distributed over two months with training on two non-consecutive days per week. The patients are free to also take part in other conventional rehabilitation therapies while they are taking part in the study. The first eight sessions focus mainly on general control of movement and strength training exercises, and the second eight sessions focus on increasing independence. At the start of the study and then after eight and 16 weeks, participants undergo a range of assessments to find out if their gait and wellbeing has changed.
What are the possible benefits and risks of participating?
Participants may benefit from improving their gait (walking ability) function and speed, which could improve their quality of life. There is a small risk of muscle pain and tiredness after the therapy sessions with the robot.
Where is the study run from?
Hospital Infantil Universitario Niño Jesús (Spain)
When is the study starting and how long is it expected to run for?
August 2016 to February 2017
Who is funding the study?
Ministry of Economy and Competitiveness (Spain)
Who is the main contact?
Dr Eduardo Racon
sarah.payneriches@phc.ox.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R-0032/12
Study information
Scientific title
Assessment evolution of a defined over-ground robot-based therapy in four children with Cerebral Palsy using the CPWalker robotic platform
Acronym
Study hypothesis
The implementation of strength and power robot-based exercises at the same time than overground walking guidance, and performing in parallel an active head-trunk control therapy, will boost the rehabilitation of children with Cerebral Palsy.
Ethics approval
Local Ethical Committee of the “Hospital Infantil Universitario Niño Jesús”, 26/06/2012, ref: R-0032/12
Study design
Single-centre non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cerebral Palsy
Intervention
Four children with CP are recruited to train with a robotic platform (CPWalker) two non-consecutive days per week for eight weeks (16 total sessions). The sessions consist of a 10-15 minutes warm-up and 60 minutes of over-ground exercise with CPWalker, including 3 minutes of independent gait as a cool-down phase. The first eight sessions correspond with general motor control and strength exercises, where the robot imposed a gait trajectory tracking. Sessions 9 to 16 are related to muscle power performance through levels of AAN strategies, where self-activity was required.
All children undergo assessments at baseline, after 8 weeks and after 16 weeks.
Intervention type
Device
Phase
Drug names
Primary outcome measures
Gait function is measured using 3D gait analysis at baseline, 8 and 16 weeks.
Secondary outcome measures
1. Gait-speed is measured using 10-meter walking test at baseline, 8 and 16 weeks
2. Global responses involved and endurance is measured using 6-minutes walking test at baseline, 8 and 16 weeks
3. Maximum isometric strength is measured using a hand-held dynamometer v
4. Selective voluntary motor control is measured using the Selective Control Assessment of Lower Extremity (SCALE) at baseline, 8 and 16 weeks
5. The changes in gross motor function are measured using the Gross Motor Function Measure (GMFM-88) dimensions D (standing) and E (walking) at baseline, 8 and 16 weeks
6. Psychological influence of fear and pain is measured using a personal kinesiophobia assessment at baseline, 8 and 16 weeks
7. Users' satisfaction is measured using the Gillette Functional Assessment Questionnaire (FAQ) at baseline, 8 and 16 weeks
Overall trial start date
01/08/2016
Overall trial end date
01/02/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children aged 11 to 18 years suffering from spastic diplegia
2. Gross Motor Function Classification System (GMFCS) levels I to IV
3. Maximum weight 75 kg
4. Anthropometric measures of lower limbs according to the exoskeleton of CPWalker
5. Capable of understanding the proposed exercises
6. Able to signal pain or discomfort
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
4
Participant exclusion criteria
1. Patients who experimented concomitant treatments 3-months prior study (e.g. orthopedic surgery or botulinum toxin)
2. Children with muscle-skeletal deformities or unhealed skin lesions in the lower limbs that could prevent the use of the exoskeleton
3. Patients with critical alterations of motor control as dystonia, choreoathetosis or ataxia
4. Aggressive or self-harming behaviors
5. Severe cognitive impairment
Recruitment start date
20/10/2016
Recruitment end date
20/12/2016
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Infantil Universitario Niño Jesús
Av. de Menéndez Pelayo, 65
Madrid
28009
Spain
Sponsor information
Organisation
Centre for Robotics and Automation, Spanish National Research Council
Sponsor details
Ctra. Campo Real
km 0.200
La Poveda - Arganda del Rey
Madrid
28500
Spain
Sponsor type
Research council
Website
Funders
Funder type
Not defined
Funder name
Ministry of Economy and Competitiveness (Ministerio de Economía y Competitividad)
Alternative name(s)
Ministry of Economy and Competitiveness, MINECO
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Spain
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal as soon as possible.
IPD Sharing plan:
The patient dataset is not expected to be made available to ensure the privacy of patients. The data will be held by the Analysis Movement Laboratory of the Hospital Niño Jesús (Spain) and by the Neural and Cognitive Engineering group of the Spanish Research Council.
Intention to publish date
31/12/2017
Participant level data
Not expected to be available
Results - basic reporting
Publication summary