Condition category
Nervous System Diseases
Date applied
09/05/2018
Date assigned
12/05/2018
Last edited
11/05/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Non-ambulatory (not able to walk) children with cerebral palsy (CP) are not physically active and have a lot of sedentary time which has significant health risks. The standard care for those children in Sweden includes static standing training (StS) in standing frames for 45-90 minutes daily. Parents of non-ambulatory children with CP performing dynamic standing (DyS) in an upright weight-bearing position with the motorised medical device Innowalk report effects not seen during StS. Therefore, the aim of this study is to see whether there are any differences in the response to one acute bout of StS and DyS in metabolic response, blood pressure, temperature, spasticity and Passive Range of Motion in the extremities among non-ambulatory children with CP.

Who can participate?
Non-ambulatory children with CP aged 2-17

What does the study involve?
Each child performs 30 minutes of static standing and 30 minutes of dynamic standing on two separate occasions at the Health Sciences Lab, Lund University, Sweden, with 5 days in between. Assessments and measurements of metabolic response, blood pressure, temperature, spasticity and passive range of motion in the legs are performed before, during and/or after the standing exercise.

What are the possible benefits and risks of participating?
Benefits include the knowledge gained about different types of standing. The study visits took time from both children and their parents. There might be inconvenience for the children when the metabolic response or the blood pressure are measured. The parents could end their participation in the study at any time.

Where is the study run from?
Lund University (Sweden)

When is the study starting and how long is it expected to run for?
January to September 2016

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
1. Dr Katarina Lauruschkus
katarina.lauruschkus@med.lu.se
2. Prof. Åsa Tornberg

Trial website

Contact information

Type

Scientific

Primary contact

Dr Katarina Lauruschkus

ORCID ID

http://orcid.org/0000-0002-1801-8503

Contact details

Lund University
Box 157
Lund
22100
Sweden
+46 (0)707 51 98 88
katarina.lauruschkus@med.lu.se

Type

Scientific

Additional contact

Prof Åsa Tornberg

ORCID ID

Contact details

Box 157
Lund
22100
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Physiological responses from static and dynamic supported standing among non-ambulatory children with cerebral palsy: a pilot study

Acronym

Study hypothesis

The study hypothesis are that there are differences in the response to one acute exercise bout of Static Standing and Dynamic Standing in metabolic response, blood pressure, temperature, spasticity and Passive Range Of Motion (PROM) in the hips, knee and ankle joints among non-ambulatory children with cerebral palsy.

Ethics approval

Regional Ethical Review Board at Lund University, Sweden, 07/06/2016, ref: LU-Dnr 2016/374

Study design

Clinical controlled study, where the children were their own controls with a cross-over design

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Non-ambulatory children with cerebral palsy (CP), who cannot walk or sit without support

Intervention

The standard care in Sweden for non-ambulatory children with CP includes daily static standing. The standing exercise training in standing frames is a static standing (StS) exercise where the child is fixated in an individually casted frame. No movements in the lower body can be achieved but making standing in an upright position possible. The motorised medical device Innowalk gives an opportunity to experience walking movements in an upright weight-bearing position, making dynamic standing (DyS) possible. 30 minutes of standing in StS and DyS were performed at two separate occasions, at the Health Sciences Lab, Lund University, Sweden, with five days in between. Questionnaires and personal data were collected. Assessments of spasticity and passive range of motion (PROM) were performed and thereafter, capillary blood sample was taken and heart rate belt and blood pressure cuff were put on. The child was positioned in either the standing frame or in the Innowalk. If the Innowalk was to be used it was individually adjusted to the child. When the child was in an upright position the airtight mask covering mouth and nose was put on. The indirect caloric assessment in a standing position was performed for 30 minutes. Blood pressure and. temperature of the arms and legs were measured every 10th minute during standing. After 30 minutes of standing the child was lifted down on a mat and a capillary blood sample was taken and assessments of spasticity and PROM were performed once more. Finally the feasibility and evaluation questionnaires were filled in by the parents.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Metabolic response: capillary blood samples were taken from a fingertip for blood glucose and blood lactate analysis before and after the Static Standing (StS) in the standing frame compared to the Dynamic Standing (DyS) in the Innowalk

Secondary outcome measures

1. Respiratory gas exchange measured with an airtight mask covering the mouth and nose while standing for 30 minutes in StS or DyS
2. Heart rate monitored with a Polar belt while standing for 30 minutes in StS or DyS
3. Spasticity in hip flexors and extenders, adductors, hamstrings, knee extenders and gastrocnemius assessed by the Modified Ashworth Scale before and after Sts and DyS
4. Passive Range Of Motion (PROM) in the hips, knee and ankle joints measured by goniometry before and after Sts and DyS
5. Blood pressure assessed at the upper arm (model, country) at rest before standing, 1 minute before the test started, at 10, 20 and 30 minutes of standing and at rest after standing
6. Body temperature assessed using infrared thermometer at both forearms, hands, shanks and feet at rest before standing, 1 minute before the test started, at 10, 20 and 30 minutes of standing and at rest after standing

Overall trial start date

15/01/2016

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children aged 2-17 years
2. Cerebral palsy, GMFCS level IV and V (non-ambulatory)
3. Boys and girls
4. Living in the Skane county, in Southern Sweden

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

The target number was 6-8 children

Participant exclusion criteria

1. Children younger than 2 years of age
2. Young people older than 17 years

Recruitment start date

15/05/2016

Recruitment end date

15/06/2016

Locations

Countries of recruitment

Sweden

Trial participating centre

Lund University
Department of Health Sciences Faculty of Medicine Box 157
Lund
22100
Sweden

Sponsor information

Organisation

Lund University, Faculty of Medicine

Sponsor details

Box 117
Lund
22100
Sweden
+46 (0)46 222 00 00
info@med.lu.se

Sponsor type

University/education

Website

https://www.med.lu.se/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol will be available on request, 1 scientific paper, presentation at conferences

IPD sharing statement
Participant level data will be available on request from Dr Katarina Lauruschkus (katarina.lauruschkus@med.lu.se) from June 2018 to May 2028. Consent from the participants' parents as their legal guardians was obtained. All data presented are anonymised, and there is a code list locked in at Lund University.

Intention to publish date

30/06/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes