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
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