- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04740359
Functional Trunk Training in Ataxia Patients
The Effect of Functional Trunk Training on Trunk Control and Upper Extremity Functions in Hereditary Ataxia Patients With Autosomal Recessive
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Eyalet/Yerleşke
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Gaziantep, Eyalet/Yerleşke, Turkey, 27100
- Hasan Kalyoncu Üniversitesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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,
Exclusion Criteria:
- Patients who want to leave the study at any stage of the study
- Patients who do not attend regular training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Routine training; mat exercises and perturbation training
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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.).
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Experimental: Study
Trunk training; Functional training, mat exercises and perturbation training
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through of te study, average 8 weeks
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Trunk impairment
Time Frame: through of te study, average 8 weeks
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The Trunk Disorder Scale (TIS) was used to assess static and dynamic sitting balance and trunk coordination
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through of te study, average 8 weeks
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The severity of ataxia
Time Frame: through of te study, average 8 weeks
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The International Ataxia Rating Scale (ICARS) was used to determine the severity
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through of te study, average 8 weeks
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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.
|
through of te study, average 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper extremity functional performance
Time Frame: through of te study, average 8 weeks
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The 9-Hole Peg test was used to evaluate upper extremity performance
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through of te study, average 8 weeks
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Functional Reach Test
Time Frame: through of te study, average 8 weeks
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Functional Reach Test was used determine to dynamic trunk balance
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through of te study, average 8 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Van 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.
- Corben 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.
- Freund 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Dyskinesias
- Spinal Cord Diseases
- Heredodegenerative Disorders, Nervous System
- Cerebellar Diseases
- Ataxia
- Cerebellar Ataxia
- Spinocerebellar Ataxias
- Spinocerebellar Degenerations
Other Study ID Numbers
- 2020/107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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