Condition category
Nervous System Diseases
Date applied
01/03/2017
Date assigned
23/03/2017
Last edited
23/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Eduardo Rocon

ORCID ID

Contact details

Neural and Cognitive Engineering group (g-nec.com)
CAR
UPM-CSIC
Ctra. Campo Real
km 0.200
La Poveda-Arganda del Rey
Madrid
28500
Spain

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

http://www.car.upm-csic.es/

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

Publication citations

Additional files

Editorial Notes