Condition category
Nervous System Diseases
Date applied
20/11/2014
Date assigned
04/12/2014
Last edited
04/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cerebral palsy in a term used to describe a number of neurological conditions that effect movement and co-ordination. It can result in stiff or floppy muscles, muscle weakness, random or uncontrolled movements and balance and co-ordination problems. Treatment can include physiotherapy to strengthen muscles and improve balance and co-ordination. Home-based training (treatment) is becoming more important with increasing demands on public health systems. We investigated whether individually tailored and supervised interactive home-based training delivered through the internet improves functional abilities in children with cerebral palsy.

Who can participate?
Children with cerebral palsy aged between 7 -16.

What does the study involve?
Children are allocated into one of two groups. Those in the interventional group are given access to the home-based training system, which includes training modules to train cognitive, perceptual and motor abilities. The training consists of 30 minutes daily home-based training for 20 weeks. Those children in the control group are not given access to the training system. Each participant’s motor skills and functional strength are evaluated before and after the 20 week training period.

What are the possible benefits and risks of participating?
The training is likely to lead to improvements in arm and leg function and general improvement in motor skills.

Where is the study run from?
1. Helene Elsass Center, Charlottenlund (Denmark)
2. Institute of Sport and Nutrition, University of Copenhagen (Denmark)

When is the study starting and how long is it expected to run for?
January 2009 to January 2011

Who is funding the study?
Ludvig and Sara Elsass Foundation (Denmark)

Who is the main contact?
Jakob Lorentzen PT, MHSc, PhD
jlo@elsasscenter.dk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jakob Lorentzen

ORCID ID

http://orcid.org/0000-0002-7634-0218

Contact details

Helene Elsass Center
Charlottenlund
2920
Denmark
004531521131
jlo@elsasscenter.dk

Type

Public

Additional contact

OT Line Petersen

ORCID ID

Contact details

Helene Elsass Center
Charlottenlund
2920
Denmark

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Twenty weeks of home-based interactive training of children with cerebral palsy improves functional abilities: an interventional trial

Acronym

Study hypothesis

Home-based training is becoming ever more important with increasing demands on the public health systems. We investigated whether individualized and supervised interactive home-based training delivered through the internet improves functional abilities in children with cerebral palsy (CP).

Ethics approval

Ethics committee of Copenhagen, Denmark (Videnskabsetisk komite, Region hovedstaden), 18/06/2009, ref: H-B-2009-017

Study design

Non-randomized controlled clinical training study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Home

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 (CP)

Intervention

34 children with CP were included in this non-randomized controlled clinical training study. 12 children were allocated to a control group in which measurements were performed with 20 weeks interval without any intervening training.

The intervention consisted of training of the children that took place in their own home over a 20 week period. The training program was delivered to the children and ensured that they trained 30 minutes per day every day during the whole period. The training was delivered through the internet and consisted of a server-based interactive training-system using flash-technology. The system has been developed through collaboration between The Helene Elsass Center, a private software development company (Head-fitted; Århus, Denmark) and the University of Copenhagen. It has now been made commercially available through collaboration between the Helene Elsass center and the Ministry of Research under the name Mitii (Move It To Improve It; Mitii developments, Charlottenlund, Denmark). The training-system is designed to combine cognitive and motor challenges in order to train cognitive, perceptual and motor abilities at the same time. It consists of a number of training modules in which the child has to analyse visual information, solve a cognitive problem (i.e. mathematical question or similar) and respond with a motor act to objects presented on the screen (i.e. bend to pick up needle and blow up balloon with the right answer). The core of the system is that the computer program identifies the movements of the child from video images sampled from a simple web-camera attached to the computer.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Daily activities - tested by AMPS (Assessment of motor and process skills
2. Functional abilities of upper- and lower limbs. Upper limb function was tested by AHA (Assisting Hand Assessment) test. Functional Strength of lower limbs was tested by the Sit-to-stand test and Half kneeling-standing test.

All evaluated before, immediately after training and 12 weeks after training. The training consisted of 30 minutes daily home-based training for 20 weeks delivered through the internet.

Secondary outcome measures

Balance - tested by Romberg 30 seconds, eyes open test.

Overall trial start date

01/01/2008

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children (both girls and boys) with cerebral palsy
2. Age range from 7 to 16

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

34 children with CP (aged 9-16; mean age 10.9+2.4) (GMFCS I-II; MACS I-II) were included in this non-randomized controlled clinical training study. 12 children with CP (aged 7-16 years, mean age: 11.3+/-0.9 years) were allocated to a control group (non intervention)

Participant exclusion criteria

Severe cognitive and physical disability that made training impossible

Recruitment start date

01/01/2009

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Denmark

Trial participating centre

Helene Elsass Center
Holmegaardsvej 28
Charlottenlund
2920
Denmark

Sponsor information

Organisation

Institute of Sports and Nutrition, University of Copenhagen

Sponsor details

University of Copenhagen
Panum Instituttet 33,3
Nørre Alle
Copenhagen
2200
Denmark

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Ludvig and Sara Elsass Foundation (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Two research papers. One paper that describes the pilot phase and one paper that describes the results of the controlled study.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes