Ataxia, SpinocerebellarNCT04740359
Functional Trunk Training in Ataxia Patients
A study testing Functional training and Routine training in people with Ataxia, Spinocerebellar and Ataxias, Hereditary, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The study is to examine the effect of functional trunk training on trunk control and upper extremity functions in patients with autosomal recessive ataxia. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Ataxia, Spinocerebellar, Ataxias, Hereditary
- What is being tested?
- Functional training and Routine training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2021to 1 Nov 2021
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Without any communication impairment (seeing, hearing, hearing),
- Have not had surgery for the upper and lower extremities in the last 6 months,
- Between the ages of 5 and 18,
- The mental level determined by the pediatrician is sufficient,
Who cannot join
- Patients who want to leave the study at any stage of the study
- Patients who do not attend regular training
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hasan kalyoncu üniversitesi
Gaziantep, Eyalet/Yerleşke, 27100
About this study
Official title: The Effect of Functional Trunk Training on Trunk Control and Upper Extremity Functions in Hereditary Ataxia Patients With Autosomal Recessive
The study is to examine the effect of functional trunk training on trunk control and upper extremity functions in patients with autosomal recessive ataxia.
Read the detailed description
Hereditary ataxias are a group of genetic diseases characterized by slow progressive gait disturbance. In addition, coordination disorders can be seen in extremities, speech and eye movements. Atrophy is common in the cerebellum. Friedreich's ataxia, ataxia telangiectasia, ataxia with vitamin E deficiency, infantile-onset spinocerebellar atrophy and Marinesco-Sjögren syndrome are autosomal recessive hereditary ataxias. The constant main sign of autosomal recessive ataxia is progressive ataxia.
The trunk has an important role on dynamic stabilization for postural reactions and limb movements. A good trunk support enables movements in other parts of the body to occur more regularly. Trunk stabilization is important to support upper and lower extremity movements, to meet the loads, and to protect the spinal cord. The relationship between upper extremity function, daily living activities and trunk functions has been emphasized in many studies but comparative studies about the rehabilitation were very less.
This study is to evaluate the effect o functional trunk training in patients with autosomal recessive ataxia.
- Conditions
- Ataxia, Spinocerebellar, Ataxias, Hereditary
- Being tested
- Functional training, Routine training
- Keywords
- ataxia,rehabilitation,trunk,disabilities
- Medical subject headings
- Spinocerebellar Ataxias, Spinocerebellar Degenerations, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional trainingOther
The therapy program was planned for 8 weeks and the sessions were performed in 45 minutes (min) for 3 days a week. The functional reach (forward-lateral-cross), trunk rotation exercises were performed in the sitting positions.(25min) Facilitation of trunk extension and elongation in the prone position (10 min). Thoracic mobilization on exercise ball (10min).
Routine trainingOther
The therapy program was planned for 8 weeks and the sessions were performed in 45 minutes (min) for 3 days a week. The strengthening exercises were applied on the mat (3x10 for the first 4 weeks and 3x15 repetition for the last 4 weeks). Eyes open-closed perturbation training was performed for trunk control in sitting and standing positions (10 min.).
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Routine training; mat exercises and perturbation training Receives: Other: Routine training |
| Study | Experimental | Trunk training; Functional training, mat exercises and perturbation training Receives: Other: Functional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Functional Independence
The Functional Independence Scale for Children (WeeFIM) was used determine to independence level.
Measured: through of te study, average 8 weeks
Trunk impairment
The Trunk Disorder Scale (TIS) was used to assess static and dynamic sitting balance and trunk coordination
Measured: through of te study, average 8 weeks
The severity of ataxia
The International Ataxia Rating Scale (ICARS) was used to determine the severity
Measured: through of te study, average 8 weeks
The quality of life
The Children's Quality of Life Scale (PedsQL) was used determine to quality of life level.
Measured: through of te study, average 8 weeks
Secondary outcomes (2)
Upper extremity functional performance
The 9-Hole Peg test was used to evaluate upper extremity performance
Measured: through of te study, average 8 weeks
Functional Reach Test
Functional Reach Test was used determine to dynamic trunk balance
Measured: through of te study, average 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start12 Feb 2021
- Primary completion12 Sep 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ataxia, SpinocerebellarStudies 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
- Model description
- Participants were divided in two groups. Two groups will get two different intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sedat Yiğit, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740359
- Sponsor's protocol ID
- 2020/107
- Status last verified
- Mar 2023
- First submitted
- 2 Feb 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Freund JE, Stetts DM. Use of trunk stabilization and locomotor training in an adult with cerebellar ataxia: a single system design. Physiother Theory Pract. 2010 Oct;26(7):447-58. doi: 10.3109/09593980903532234.
PubMed 20649489Van de Warrenburg BP, Bakker M, Kremer BP, Bloem BR, Allum JH. Trunk sway in patients with spinocerebellar ataxia. Mov Disord. 2005 Aug;20(8):1006-13. doi: 10.1002/mds.20486.
PubMed 15838852Corben LA, Tai G, Wilson C, Collins V, Churchyard AJ, Delatycki MB. A comparison of three measures of upper limb function in Friedreich ataxia. J Neurol. 2010 Apr;257(4):518-23. doi: 10.1007/s00415-009-5352-7. Epub 2009 Oct 13.
PubMed 19823893Freund JE, Stetts DM, Vallabhajosula S. Relationships between trunk performance, gait and postural control in persons with multiple sclerosis. NeuroRehabilitation. 2016 Jun 30;39(2):305-17. doi: 10.3233/NRE-161362.
PubMed 27372366
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Trunk Training on Trunk Control and Upper Extremity Functions in Hereditary Ataxia Patients With Autosomal Recessive
- ClinicalTrials.gov ID
- NCT04740359
- Acronym / sponsor ID
- 2020/107
- Conditions
- Ataxia, Spinocerebellar, Ataxias, Hereditary
- Keywords
- ataxia,rehabilitation,trunk,disabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 12 Sep 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 5 Feb 2021 (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.
The study is to examine the effect of functional trunk training on trunk control and upper extremity functions in patients with autosomal recessive ataxia.
Detailed description
Hereditary ataxias are a group of genetic diseases characterized by slow progressive gait disturbance. In addition, coordination disorders can be seen in extremities, speech and eye movements. Atrophy is common in the cerebellum. Friedreich's ataxia, ataxia telangiectasia, ataxia with vitamin E deficiency, infantile-onset spinocerebellar atrophy and Marinesco-Sjögren syndrome are autosomal recessive hereditary ataxias. The constant main sign of autosomal recessive ataxia is progressive ataxia.
The trunk has an important role on dynamic stabilization for postural reactions and limb movements. A good trunk support enables movements in other parts of the body to occur more regularly. Trunk stabilization is important to support upper and lower extremity movements, to meet the loads, and to protect the spinal cord. The relationship between upper extremity function, daily living activities and trunk functions has been emphasized in many studies but comparative studies about the rehabilitation were very less.
This study is to evaluate the effect o functional trunk training in patients with autosomal recessive ataxia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were divided in two groups. Two groups will get two different intervention.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Routine trainingRoutine training; mat exercises and perturbation training |
| Study | Experimental | Other: Functional trainingTrunk training; Functional training, mat exercises and perturbation training |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Without any communication impairment (seeing, hearing, hearing),
- Have not had surgery for the upper and lower extremities in the last 6 months,
- Between the ages of 5 and 18,
- The mental level determined by the pediatrician is sufficient,
Key exclusion criteria (2 listed)
- Patients who want to leave the study at any stage of the study
- Patients who do not attend regular training
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 |
|---|---|---|
| Functional trainingThe therapy program was planned for 8 weeks and the sessions were performed in 45 minutes (min) for 3 days a week. The functional reach (forward-lateral-cross), trunk rotation exercises were performed in the sitting positions.(25min) Facilitation of trunk extension and elongation in the prone position (10 min). Thoracic mobilization on exercise ball (10min). | Other | Study |
| Routine trainingThe therapy program was planned for 8 weeks and the sessions were performed in 45 minutes (min) for 3 days a week. The strengthening exercises were applied on the mat (3x10 for the first 4 weeks and 3x15 repetition for the last 4 weeks). Eyes open-closed perturbation training was performed for trunk control in sitting and standing positions (10 min.). | Other | Control |
Primary outcome
The Functional Independence
Time frame: through of te study, average 8 weeks
The Functional Independence Scale for Children (WeeFIM) was used determine to independence level.
Trunk impairment
Time frame: through of te study, average 8 weeks
The Trunk Disorder Scale (TIS) was used to assess static and dynamic sitting balance and trunk coordination
The severity of ataxia
Time frame: through of te study, average 8 weeks
The International Ataxia Rating Scale (ICARS) was used to determine the severity
The quality of life
Time frame: through of te study, average 8 weeks
The Children's Quality of Life Scale (PedsQL) was used determine to quality of life level.
2 secondary outcomes
Upper extremity functional performance
Time frame: through of te study, average 8 weeks
Functional Reach Test
Time frame: through of te study, average 8 weeks
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 2 Mar 2023.
- Background: PubMed 20649489Freund JE, Stetts DM. Use of trunk stabilization and locomotor training in an adult with cerebellar ataxia: a single system design. Physiother Theory Pract. 2010 Oct;26(7):447-58. doi: 10.3109/09593980903532234.
- Background: PubMed 15838852Van de Warrenburg BP, Bakker M, Kremer BP, Bloem BR, Allum JH. Trunk sway in patients with spinocerebellar ataxia. Mov Disord. 2005 Aug;20(8):1006-13. doi: 10.1002/mds.20486.
- Background: PubMed 19823893Corben LA, Tai G, Wilson C, Collins V, Churchyard AJ, Delatycki MB. A comparison of three measures of upper limb function in Friedreich ataxia. J Neurol. 2010 Apr;257(4):518-23. doi: 10.1007/s00415-009-5352-7. Epub 2009 Oct 13.
- Background: PubMed 27372366Freund JE, Stetts DM, Vallabhajosula S. Relationships between trunk performance, gait and postural control in persons with multiple sclerosis. NeuroRehabilitation. 2016 Jun 30;39(2):305-17. doi: 10.3233/NRE-161362.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional training and Routine training in people with Ataxia, Spinocerebellar and Ataxias, Hereditary, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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 4 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 2 Mar 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 Turkey (Türkiye). 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?
The Functional Independence (time frame: through of te study, average 8 weeks). The study lists 4 primary outcomes in all. 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 NCT04740359, which also lists 4 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 2 Mar 2023.