The effect of gait training in adults with cerebral palsy on ankle joint stiffness and kinematics

ISRCTN	ISRCTN15203895
DOI	https://doi.org/10.1186/ISRCTN15203895
Secondary identifying numbers	N/A

Submission date: 08/04/2015
Registration date: 22/04/2015
Last edited: 29/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Jakob Lorentzen
Scientific

Geelsskovej 9
Virum
2830
Denmark

ORCID ID	0000-0002-7634-0218
Phone	004531521131
Email	jlo@elsasscenter.dk

Study information

Study design	Randomized controlled clinical training study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Home
Study type	Treatment
Participant information sheet	This material is only available in Danish
Scientific title	Randomized controlled clinical trial of the effect of gait training in adults with cerebral palsy on ankle joint stiffness and kinematics
Study objectives	We wanted to evaluate the effect of intensive daily gait treadmill training on passive and active ankle stiffness and gait ability.
Ethics approval(s)	Ethics committee of Copenhagen, Denmark (Videnskabsetisk komite, Region hovedstaden), ref: H-2-2014-028
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2014
Completion date	01/02/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	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.
Total final enrolment	32
Key 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)
Key exclusion criteria	Severe cognitive and physical disability that made training impossible
Date of first enrolment	01/03/2014
Date of final enrolment	01/01/2015

Locations

Countries of recruitment

Denmark

Study participating centres

Helene Elsass Center

Holmegaardsvej 28
Charlottenlund
2920
Denmark

University of Copenhagen, Institute of Sports and Nutrition

Nørre Alle
Copenhagen
2200
Denmark

Sponsor information

Institute of Sports and Nutrition
University/education

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

Phone	0045 28 75 73 1
Email	jbnielsen@nexs.ku.dk
"ROR"	https://ror.org/035b05819

Funders

Funder type

Research organisation

Ludvig and Sara Elsass Foundation (Denmark)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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. 2015 abstract in: https://doi.org/10.1111/dmcn.39_12886 (added 29/05/2020)
IPD sharing plan

Editorial Notes

29/05/2020: Publication reference and total final enrolment number added.