Condition category
Nervous System Diseases
Date applied
23/06/2020
Date assigned
24/06/2020
Last edited
24/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cerebral palsy (CP) is caused by an injury to the immature brain that disturbs typical development. People with CP often have reduced muscle strength and difficulties in learning motor (movement) activities. This may impact their ability to perform activities such as standing, walking, running and participation in everyday life. Traditional treatment consists of physiotherapy and efforts to normalize movements. People with CP are often treated with antispastic treatment, but this medication may cause inactivity because of side effects such as drowsiness, muscle weakness and impaired motor learning. There is very little research regarding physical interventions in adults with CP, especially the severy affected. This study therefore aims to investigate if adults who are severely affected by CP are able to improve their motor function through tailored training supported by a reduction in their antispastic medication.

Who can participate?
Adults aged over 18 with CP

What does the study involve?
Participants are assigned to three different groups. The first group receives a 3-month physical intervention (3-5 times per week over 12 weeks) and discontinued antispastic medication (oral bachlofen or dantrolene). The second group receives an intervention including standard care and discontinued antispastic medication. The third group functions as a control group including standard care and no changes to medication. Participants' functional ability is measured at the start of the study, immediately after the 4-week drug discontinuation, immediately after the 12-week active intervention, and at follow-up 1 month after finishing the intervention.

What are the possible benefits and risks of participating?
Participants in the intervention group may benefit from better physical function and health. No risks are expected, except for occasionally muscle soreness. Participants whose antispastic medication is reduced may experience fewer side effects. Reduction of medication is evaluated individually and an experienced physician will oversee the process. Information obtained from this study may benefit future rehabilitation approaches and individualized training methods for adults with severe brain damage.

Where is the study run from?
Jonstrupvang Bebyggelsen (Denmark)

When is the study starting and how long is it expected to run for?
September 2018 to September 2022

Who is funding the study?
The Elsass Foundation (Denmark)

Who is the main contact?
Helle Hüche Larsen
hhl@elsassfonden.dk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Helle Hüche Larsen

ORCID ID

Contact details

Panum Institute 33.3
Blegdamsvej 3
Copenhagen
2200
Denmark
+45 (0)26573438
hhl@elsassfonden.dk

Type

Public

Additional contact

Miss Helle Hüche Larsen

ORCID ID

Contact details

Panum Institute 33.3
Blegdamsvej 3
Copenhagen
2200
Denmark
+45 (0)26573438
hhl@elsassfonden.dk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1A

Study information

Scientific title

Effect of motor learning-based activities combined with discontinuation of antispastic medication on functional ability in adults with severe cerebral palsy

Acronym

Study hypothesis

Gross motor function in adults with severe cerebral palsy can be optimized by daily motor-learning based activities combined with discontinuation in antispastic medication.

Ethics approval

Approved 07/09/2018, Center For Sundhed (Regionsgården, Kongens Vænge 2, 3400 Hillerød; +45 (0)38666395; vek@regionh.dk), ref: H-18029151

Study design

Open-label non-randomized pragmatic clinical pilot study with a two-group design

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 to request a participant information sheet

Condition

Gross motor function in cerebral palsy

Intervention

Adults with severe CP (Gross Motor Function Classification Scale III-V) are recruited through convenience sampling and assigned to three different groups:
1. The first group receives a 3-month physical intervention including activities based on motor learning principles and discontinued antispastic medication (oral bachlofen or dantrolene)
2. The second group receives an intervention including standard care and discontinued antispastic medication
3. The third group functions as a control group including standard care and no changes to medication

The physical intervention is planned based on science-based neurorehabilitation and motor learning principles and adjusted individually to each participant. The dose will be 3-5 times per week in 12 weeks.

Participants will be reduced in bachlofen or dantrolene dose by 25% per week during a 4-week period. In this period participants are closely followed by an experienced physician.

Participants will be enrolled through convenience sampling and are distinguished by their willingness to participate and therefore not randomly assigned to groups.

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Functional ability measured by Gross Motor Function Measure (GMFM-88) at baseline; immediately following 4-week drug discontinuation and prior to starting the 12-week active intervention; immediately following the intervention; and at follow-up 1 month after finishing the intervention

Secondary outcome measures

Neurological screening including Modified Ashworth's Scale (MAS), Range of Motion (ROM), tendon reflex testing and 0-5 strength scale at baseline; immediately following 4-week drug discontinuation and prior to starting the 12-week active intervention; immediately following the intervention; and at follow-up 1 month after finishing the intervention

Overall trial start date

01/09/2018

Overall trial end date

01/09/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosed with cerebral palsy
2. GMFCS level between III-V
3. >18 years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Total final enrolment

16

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

12/09/2018

Recruitment end date

08/03/2020

Locations

Countries of recruitment

Denmark

Trial participating centre

Jonstrupvang Bebyggelsen
Chr. Hauchs Alle 11
Værløse
3500
Denmark

Sponsor information

Organisation

University of Copenhagen

Sponsor details

Panum Institute 33.3
Blegdamsvej 3
Copenhagen
2200
Denmark
+45 (0)26573438
hellel1@hotmail.com

Sponsor type

University/education

Website

http://www.ku.dk/english/

Funders

Funder type

Charity

Funder name

Elsass Fonden

Alternative name(s)

Elsass Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

Denmark

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Helle Hüche Larsen (hhl@elsassfonden.dk). Participants gave written informed consent to the study, which was approved by the local ethics committee of Copenhagen region and performed in accordance with the Helsinki Declaration. All personal data are anonymized. Files containing personal data are stored on a separate hard drive and stored securely according to the guidelines provided by The Danish Data Protection Agency. Raw data will be available in anonymized form on request for statistical or scientific purposes of significant meaning according to the guidelines provided by The Danish Data Protection Agency.

Intention to publish date

01/01/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/06/2020: Trial's existence confirmed by Center For Sundhed.