Trunk muscle strength and limitations in functioning in children and youth with spinal muscular atrophy
| ISRCTN | ISRCTN63278972 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63278972 |
| Secondary identifying numbers | 1/2017 |
- Submission date
- 04/04/2017
- Registration date
- 11/04/2017
- Last edited
- 07/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Spinal muscular atrophy (SMA) is a rare inherited condition that causes muscle weakness and progressive (worsening over time) loss of movement. It is caused by deterioration in the nerve cells connecting the brain and spinal cord to the body’s muscles. As the link between the nerves and muscles breaks down, patients gradually lose their ability to move and their muscles waste away (atrophy). The aim of this study is to assess the strength of muscles in the trunk (torso) for rotational activity (twisting) and the level of independent functioning in children and youth with SMA.
Who can participate?
Patients aged 5-18 years who have been diagnosed with SMA and helathy children and youths of the same age.
What does the study involve?
All participants attend a single study visit at which the strength of their trunk (torso) is measured using a handheld measurement device while they are lying on their side. This is done at six points on the body. Following this, participants are asked to complete questionnaires about their daily activities and any limitations they may be facing as well as background information.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.
Where is the study run from?
Center of Functional Rehabilitation ORTHOS (Poland)
When is the study starting and how long is it expected to run for?
December 2016 to December 2017
Who is funding the study?
Józef Piłsudski University of Physical Education (Poland)
Who is the main contact?
Dr Agnieszka Stępień
Contact information
Scientific
Józef Piłsudski University of Physical Education
Marymoncka 34
Warsaw
00-968
Poland
 ORCID ID |
0000-0003-3905-8229 |
|---|
Study information
| Study design | Single-centre case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Strength of trunk rotational muscles and limitations in everyday functioning in children and youth with spinal muscular atrophy |
| Study acronym | SMA |
| Study objectives | 1. Strength of trunk muscles responsible for rotating trunk or pelvis in SMA children and youth is lower than in healthy peers 2. There is a correlation between the strength values of these muscles and limitations in everyday functioning |
| Ethics approval(s) | The Senate Research Ethics Committee at Józef Piłsudski University of Physical Education in Warsaw, Poland, 07/02/2017, ref: SKE 01-03/2017 |
| Health condition(s) or problem(s) studied | Spinal muscular atrophy |
| Intervention | All participants will have a one-time measurement of muscle strength taken in a side-lying position using a handheld MICROFET measurement system. The device will be placed consecutively in three points on the front side of the body (i.e. forehead; trunk – in the shoulder joint area; trunk – in the anterior superior iliac spine area) and later in three points at the back of the body (i.e. posterior middle part of the skull; posterior part of the trunk in the shoulder joint area; pelvis – below iliac crest). 5-10 seconds will be devoted to one measurement during maximal isometric tension. Two series of measurements on each side will be performed in each of the aforementioned points. A higher value will be included in the analysis. Participants will be also asked to complete a questionnaire including questions regarding limitations during everyday activities. Additional information will be collected on age, gender, accompanying illnesses. |
| Intervention type | Other |
| Primary outcome measure | 1. Strength of muscles responsible for trunk rotation is assessed using a handheld MICROFET, in which the value of strength expressed in pounds or Newtons in a pre-set time unit, on the study visit 2. Functioning limitations are measured using a questionnaire designed for the purpose of this study, including questions regarding limitations during everyday activities prepared on the basis of ICF on the study visit |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/12/2016 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | minimum 30 |
| Total final enrolment | 56 |
| Key inclusion criteria | Patients: 1. Spinal muscular atrophy (SMA) diagnosed through clinical and genetic examinations 2. Aged 5-18 years Controls: 1. Healthy 2. Aged 5-18 years 3. Do not practice sport |
| Key exclusion criteria | Patients: 1. No confirmation of SMA in genetic tests 2. Children under 5 3. Children and youth not able to cooperate during an examination Controls: 1. Age under 5 or over 18 2. Children not able to cooperate during an examination. |
| Date of first enrolment | 15/04/2017 |
| Date of final enrolment | 30/09/2017 |
Locations
Countries of recruitment
- Poland
Study participating centre
Warsaw
02-679
Poland
Sponsor information
University/education
Marymoncka 34
Warsaw
00-968
Poland
"ROR" |
https://ror.org/043k6re07 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results will be published in an article in a neurologic, physical therapy or rehabilitation journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Agnieszka Stępień (orthosas@wp.pl) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 30/04/2021 | 07/06/2023 | Yes | No |
Editorial Notes
07/06/2023: Publication reference and total final enrolment added.
