Condition category
Nervous System Diseases
Date applied
08/04/2015
Date assigned
22/04/2015
Last edited
20/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cerebral palsy (CP) is the general term to describe a number of conditions that affect muscle control, movement and co-ordination. It can happen of the brain develops abnormally or is damaged before, during or shortly after birth. People with cerebral palsy (CP) often develop contractors in their lower limbs (that is, muscles shortening leading to loss of range of movement), especially in the ankle joints. This often contributes significantly to their disability. Treatment has often been focused on passive stretching even though no evidence of any clinical benefit has been found. However, intensive gait training has been shown to reduce muscle stiffness in children with CP. Here, we are going to investigate whether intensive gait training can reduce ankle stiffness in adults CP sufferers as well.

Who can participate?
Adults (age 18-60) with CP and increased ankle stiffness.

What does the study involve?
The study involves two tests days (one before and one after the intervention, or treatment) that includes assessing each participants degree of ankle stiffness with the use of dynamometers and EMG, neurological examination, a functional gait test including 3D kinematic evaluation and ultrasound of the muscles in the lower limbs (legs and ankles). The participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are given gait training on a treadmill for 30 minutes every day for 6 weeks. This is in addition to their normal activities. Those in group 2 (control group) go about their usual activities.

What are the possible benefits and risks of participating?
The participants may possibly improve their walking abilities and general fitness level due to the intervention. There are no risk involved in participation of this study.

Where is the study run from?
Helene Elsass Center and University of Copenhagen (Denmark)

When is the study starting and how long is it expected to run for?
January 2014 to February 2015.

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

Who is the main contact?
Dr Jakob Lorentzen
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

Geelsskovej 9
Virum
2830
Denmark
004531521131
jlo@elsasscenter.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomized controlled clinical trial of the effect of gait training in adults with cerebral palsy on ankle joint stiffness and kinematics

Acronym

Study hypothesis

We wanted to evaluate the effect of intensive daily gait treadmill training on passive and active ankle stiffness and gait ability.

Ethics approval

Ethics committee of Copenhagen, Denmark (Videnskabsetisk komite, Region hovedstaden), ref: H-2-2014-028

Study design

Randomized controlled clinical training study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient information sheet

This material is only available in Danish

Condition

Cerebral palsy (CP)

Intervention

32 adults with CP (GMFCS 1, n=10; 2, n=7; 3, n=15) aged 38.1 years +/-12 (SD) years old were recruited for the study. The participants were randomly allocated to either a training group (n=16) where gait training on a treadmill was performed daily for 30 min for six weeks in addition to their usual activities or a control group (n=16) that performed their usual activities.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Evaluation of muscle stiffness and gait ability was made twice on all participants before and after the six week of training or control period
2. Measurement of passive and reflex stiffness in the ankle joint plantar flexors was made by a dynamometer which applied stretches below and above the stretch reflex threshold
3. Gait kinematics was recorded by 3D video analysis during treadmill walking with a velocity chosen by the participant at the first evaluation
4. Foot pressure was measured by force sensitive foot soles during treadmill and over ground walking

Secondary outcome measures

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

Overall trial start date

01/01/2014

Overall trial end date

01/02/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults, both genders
2. Aged 18-60 years
3. with CP and increased ankle stiffness and reduced ankle ROM (range of motion)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32 adults with CP (GMFCS 1, n=10; 2, n=7; 3, n=15) aged 38.1 years +/-12 (SD) years old were recruited for the study.

Participant exclusion criteria

Severe cognitive and physical disability that made training impossible

Recruitment start date

01/03/2014

Recruitment end date

01/01/2015

Locations

Countries of recruitment

Denmark

Trial participating centre

Helene Elsass Center
Holmegaardsvej 28
Charlottenlund
2920
Denmark

Trial participating centre

University of Copenhagen, Institute of Sports and Nutrition
Nørre Alle
Copenhagen
2200
Denmark

Sponsor information

Organisation

Institute of Sports and Nutrition

Sponsor details

University of Copenhagen
Panum Instituttet 33,3
Nørre Alle
Copenhagen
2200
Denmark
0045 28 75 73 1
jbnielsen@nexs.ku.dk

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

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 or three research papers. One paper that describes the changes in ankle stiffness in the intervention group and control group and one paper that describes the changes in gaitability including kinematic measures.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes