How training and reduction of antispastic medication affects adults with severe cerebral palsy
| ISRCTN | ISRCTN66528622 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66528622 |
| Secondary identifying numbers | 1A |
- Submission date
- 23/06/2020
- Registration date
- 24/06/2020
- Last edited
- 20/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
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
Contact information
Scientific
Panum Institute 33.3
Blegdamsvej 3
Copenhagen
2200
Denmark
| Phone | +45 (0)26573438 |
|---|---|
| hhl@elsassfonden.dk |
Public
Panum Institute 33.3
Blegdamsvej 3
Copenhagen
2200
Denmark
| Phone | +45 (0)26573438 |
|---|---|
| hhl@elsassfonden.dk |
Study information
| 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 |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effect of motor learning-based activities combined with discontinuation of antispastic medication on functional ability in adults with severe cerebral palsy |
| Study objectives | 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(s) | Approved 07/09/2018, Center For Sundhed (Regionsgården, Kongens Vænge 2, 3400 Hillerød; +45 (0)38666395; vek@regionh.dk), ref: H-18029151 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2018 |
| Completion date | 01/09/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 16 |
| Key inclusion criteria | 1. Diagnosed with cerebral palsy 2. GMFCS level between III-V 3. >18 years of age |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 12/09/2018 |
| Date of final enrolment | 08/03/2020 |
Locations
Countries of recruitment
- Denmark
Study participating centre
Værløse
3500
Denmark
Sponsor information
University/education
Panum Institute 33.3
Blegdamsvej 3
Copenhagen
2200
Denmark
| Phone | +45 (0)26573438 |
|---|---|
| hellel1@hotmail.com | |
| Website | http://www.ku.dk/english/ |
"ROR" |
https://ror.org/035b05819 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Elsass Foundation
- Location
- Denmark
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/04/2021 | 20/07/2021 | Yes | No |
Editorial Notes
20/07/2021: Publication reference added.
24/06/2020: Trial's existence confirmed by Center For Sundhed.
