Neurologic DisorderNCT05313295
Physical Therapy Treatment on Children and Adolescents With Neurological Pathologies
A study testing Home-based physiotherapy and Usual Physiotherapy in people with Neurologic Disorder and Duchenne, run by Universidad de Almeria at 1 site in Spain.
Trial summary
To evaluate the positive effects of a home-based physical therapy intervention added to the usual physical therapy programs performed in children with neurological pathologies that induce sensorimotor impairments that affect their quality of life and the importance of the implications of their families in their… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Neurologic Disorder, Duchenne, Pediatric Disorder
- What is being tested?
- Home-based physiotherapy and Usual Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2018to 10 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Parents agree to include their children on the study
- Affiliated to the Duchenne Parents Project Association (Spain)
- Between 3-18 years old
Who cannot join
- Other pathological conditions
- Parents refuse the participation on the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Physical Therapy Treatment on Children and Adolescents With Chronic and Neurological Pathologies Affecting Their Sensorimotor Abilities.
To evaluate the positive effects of a home-based physical therapy intervention added to the usual physical therapy programs performed in children with neurological pathologies that induce sensorimotor impairments that affect their quality of life and the importance of the implications of their families in their treatment.
- Being tested
- Home-based physiotherapy, Usual Physiotherapy
- Keywords
- Childhood, Neurologic disorder, Duchenne
- Medical subject headings
- Nervous System Diseases, Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based physiotherapyOther
Manual Therapy, passive and active mobilizations, stretching, respiratory techniques
Usual PhysiotherapyOther
Usual care provided for the management of neurological disorders in children
| Study group | Role | What they receive |
|---|---|---|
| Home-based Physiotherapy | Experimental | Two days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques) + 3 hours extra of home-based physiotherapy (stretching, active mobilizations) Receives: Other: Home-based physiotherapy |
| Usual physiotherapy | Active comparator | Two days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques) Receives: Other: Usual Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Function Measure
Measurement scale for motor function applied to neuromuscular diseases (MFM): It was created in France in order to perform a better evaluation of global motor function in patients with Duchenne's muscular dystrophy (DMD), both for ambulatory and non-ambulatory patients. It has two versions, MFM 20 for children under 6 years of age and MFM 32 for children over 6 years of age. The scale considers three dimensions: (D1) standing station and transfers; (D2) axial and proximal motor skills and (D3) distal motor skills. The sum of the three results in a global percentage that provides an updated overview of the patient's functional diagnosis. (Trundell et al., 2020)
Measured: One Year
Secondary outcomes (4)
Brooke Upper Extremity Scale
It is a scale of levels from 1 to 5 for the motor functional classification of the upper limbs. (Brooke et al., 1989) It is graded according to the motor ability of the child evaluated in the following categories: (1) bring the arms towards the ceiling (2) raises arms above head but bends elbows (3) cannot raise hands above head, but can bring glass of water to mouth (4) holds pen or picks up coin and ( 5) It does not have any useful function with the hand. The lower the score, the better the upper extremity motor function. (Mayhew et al., 2013) In addition, this scale is frequently used in the DMD population and its intraclass correlation coefficient (ICC) is .99 .(Lue et al., 2006)
Measured: One Year
Vignos Scale
It is a functional classification that scores from 1 to 10, where the highest number represents the most intense progressive condition of DMD reflected in the patient's ambulation. The possible categories are: (1) walks and climbs stairs without assistance (2) walks and climbs stairs with assistance or handrails (3) walks and climbs stairs slowly with the assistance of handrails (4) walks without assistance and gets up from a chair but does not climb stairs (5) walks without assistance but cannot get up from a chair or climb stairs (6) walks only with the aid of long orthoses (7) walks with long orthoses but needs help to maintain balance (8) stands upright with orthoses but unable to walk or with assistance, (9) in a wheelchair and (10) confined to bed.(Fernandes et al., 2014; Martini et al., 2015)
Measured: One Year
Timed Up and Go Test
Determines the patient's risk of falling. The test is performed under a stopwatch, asking the patient to get up from a chair (with or without support), stand up, walk 3 meters, turn around and come back to sit on the chair again. If the patient takes more than 20 seconds to perform, they have a high risk of falling; and between 10 and 20 seconds will indicate fragility. (Alkan et al., 2017)
Measured: One Year
Six Minutes Walk Distance
It consists of quantifying in meters the distance traveled in 6 minutes by the patient. The more meters walked, the less impairment.(Mcdonald et al., 2013) Individualized periodic assessment of 6 Minutes Walking Distance (6MWD) is the most widely accepted primary clinical endpoint in Duchenne's muscular dystrophy (DMD) clinical trials(Goemans et al., 2016); and provides a better prognosis than those based solely on age. After analyzing its test-retest reliability in DMD, its ICC is 0.92. (Mcdonald et al., 2013)
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Nov 2018
- Primary completion30 Nov 2022
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María del Mar Sánchez Joya, Universidad de Almeria
- Investigators
- María del Mar Sánchez-Joya, PhD, Study chair, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313295
- Sponsor's protocol ID
- FiNeuro
- Status last verified
- May 2023
- First submitted
- 27 Feb 2022
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Publications
Alemdaroglu I, Karaduman A, Yilmaz OT, Topaloglu H. Different types of upper extremity exercise training in Duchenne muscular dystrophy: effects on functional performance, strength, endurance, and ambulation. Muscle Nerve. 2015 May;51(5):697-705. doi: 10.1002/mus.24451. Epub 2015 Mar 5.
PubMed 25196721Alkan H, Mutlu A, Firat T, Bulut N, Karaduman AA, Yilmaz OT. Effects of functional level on balance in children with Duchenne Muscular Dystrophy. Eur J Paediatr Neurol. 2017 Jul;21(4):635-638. doi: 10.1016/j.ejpn.2017.02.005. Epub 2017 Feb 20.
PubMed 28259452Hind D, Parkin J, Whitworth V, Rex S, Young T, Hampson L, Sheehan J, Maguire C, Cantrill H, Scott E, Epps H, Main M, Geary M, McMurchie H, Pallant L, Woods D, Freeman J, Lee E, Eagle M, Willis T, Muntoni F, Baxter P. Aquatic therapy for children with Duchenne muscular dystrophy: a pilot feasibility randomised controlled trial and mixed-methods process evaluation. Health Technol Assess. 2017 May;21(27):1-120. doi: 10.3310/hta21270.
PubMed 28627356Goemans N, Vanden Hauwe M, Signorovitch J, Swallow E, Song J; Collaborative Trajectory Analysis Project (cTAP). Individualized Prediction of Changes in 6-Minute Walk Distance for Patients with Duchenne Muscular Dystrophy. PLoS One. 2016 Oct 13;11(10):e0164684. doi: 10.1371/journal.pone.0164684. eCollection 2016.
PubMed 27737016Jansen M, van Alfen N, Geurts AC, de Groot IJ. Assisted bicycle training delays functional deterioration in boys with Duchenne muscular dystrophy: the randomized controlled trial "no use is disuse". Neurorehabil Neural Repair. 2013 Nov-Dec;27(9):816-27. doi: 10.1177/1545968313496326. Epub 2013 Jul 24.
PubMed 23884013
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Physical Therapy Treatment on Children and Adolescents With Chronic and Neurological Pathologies Affecting Their Sensorimotor Abilities.
- ClinicalTrials.gov ID
- NCT05313295
- Acronym / sponsor ID
- FiNeuro
- Keywords
- Childhood, Neurologic disorder, Duchenne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the positive effects of a home-based physical therapy intervention added to the usual physical therapy programs performed in children with neurological pathologies that induce sensorimotor impairments that affect their quality of life and the importance of the implications of their families in their treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based Physiotherapy | Experimental | Other: Home-based physiotherapyTwo days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques) + 3 hours extra of home-based physiotherapy (stretching, active mobilizations) |
| Usual physiotherapy | Active comparator | Other: Usual PhysiotherapyTwo days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques) |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Parents agree to include their children on the study
- Affiliated to the Duchenne Parents Project Association (Spain)
- Between 3-18 years old
Key exclusion criteria (2 listed)
- Other pathological conditions
- Parents refuse the participation on the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based physiotherapyManual Therapy, passive and active mobilizations, stretching, respiratory techniques | Other | Home-based Physiotherapy |
| Usual PhysiotherapyUsual care provided for the management of neurological disorders in children | Other | Usual physiotherapy |
Primary outcome
Motor Function Measure
Time frame: One Year
Measurement scale for motor function applied to neuromuscular diseases (MFM): It was created in France in order to perform a better evaluation of global motor function in patients with Duchenne's muscular dystrophy (DMD), both for ambulatory and non-ambulatory patients. It has two versions, MFM 20 for children under 6 years of age and MFM 32 for children over 6 years of age. The scale considers three dimensions: (D1) standing station and transfers; (D2) axial and proximal motor skills and (D3) distal motor skills. The sum of the three results in a global percentage that provides an updated overview of the patient's functional diagnosis. (Trundell et al., 2020)
4 secondary outcomes
Brooke Upper Extremity Scale
Time frame: One Year
Vignos Scale
Time frame: One Year
Timed Up and Go Test
Time frame: One Year
Six Minutes Walk Distance
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Background: PubMed 25196721Alemdaroglu I, Karaduman A, Yilmaz OT, Topaloglu H. Different types of upper extremity exercise training in Duchenne muscular dystrophy: effects on functional performance, strength, endurance, and ambulation. Muscle Nerve. 2015 May;51(5):697-705. doi: 10.1002/mus.24451. Epub 2015 Mar 5.
- Background: PubMed 28259452Alkan H, Mutlu A, Firat T, Bulut N, Karaduman AA, Yilmaz OT. Effects of functional level on balance in children with Duchenne Muscular Dystrophy. Eur J Paediatr Neurol. 2017 Jul;21(4):635-638. doi: 10.1016/j.ejpn.2017.02.005. Epub 2017 Feb 20.
- Background: PubMed 28627356Hind D, Parkin J, Whitworth V, Rex S, Young T, Hampson L, Sheehan J, Maguire C, Cantrill H, Scott E, Epps H, Main M, Geary M, McMurchie H, Pallant L, Woods D, Freeman J, Lee E, Eagle M, Willis T, Muntoni F, Baxter P. Aquatic therapy for children with Duchenne muscular dystrophy: a pilot feasibility randomised controlled trial and mixed-methods process evaluation. Health Technol Assess. 2017 May;21(27):1-120. doi: 10.3310/hta21270.
- Background: PubMed 27737016Goemans N, Vanden Hauwe M, Signorovitch J, Swallow E, Song J; Collaborative Trajectory Analysis Project (cTAP). Individualized Prediction of Changes in 6-Minute Walk Distance for Patients with Duchenne Muscular Dystrophy. PLoS One. 2016 Oct 13;11(10):e0164684. doi: 10.1371/journal.pone.0164684. eCollection 2016.
- Background: PubMed 23884013Jansen M, van Alfen N, Geurts AC, de Groot IJ. Assisted bicycle training delays functional deterioration in boys with Duchenne muscular dystrophy: the randomized controlled trial "no use is disuse". Neurorehabil Neural Repair. 2013 Nov-Dec;27(9):816-27. doi: 10.1177/1545968313496326. Epub 2013 Jul 24.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María del Mar Sánchez-Joya, PhD study chair
Universidad de Almeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based physiotherapy and Usual Physiotherapy in people with Neurologic Disorder and Duchenne, run by Universidad de Almeria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Function Measure (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05313295, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.