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Functional Trunk Training in Ataxia Patients

Primary Purpose

Ataxia, Spinocerebellar, Ataxias, Hereditary

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Functional training
Routine training
Sponsored by
Hasan Kalyoncu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ataxia, Spinocerebellar focused on measuring ataxia,rehabilitation,trunk,disabilities

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hasan kalyoncu üniversitesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Study

Arm Description

Routine training; mat exercises and perturbation training

Trunk training; Functional training, mat exercises and perturbation training

Outcomes

Primary Outcome Measures

The Functional Independence
The Functional Independence Scale for Children (WeeFIM) was used determine to independence level.
Trunk impairment
The Trunk Disorder Scale (TIS) was used to assess static and dynamic sitting balance and trunk coordination
The severity of ataxia
The International Ataxia Rating Scale (ICARS) was used to determine the severity
The quality of life
The Children's Quality of Life Scale (PedsQL) was used determine to quality of life level.

Secondary Outcome Measures

Upper extremity functional performance
The 9-Hole Peg test was used to evaluate upper extremity performance
Functional Reach Test
Functional Reach Test was used determine to dynamic trunk balance

Full Information

First Posted
February 2, 2021
Last Updated
March 1, 2023
Sponsor
Hasan Kalyoncu University
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1. Study Identification

Unique Protocol Identification Number
NCT04740359
Brief Title
Functional Trunk Training in Ataxia Patients
Official Title
The Effect of Functional Trunk Training on Trunk Control and Upper Extremity Functions in Hereditary Ataxia Patients With Autosomal Recessive
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
September 12, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ataxia, Spinocerebellar, Ataxias, Hereditary
Keywords
ataxia,rehabilitation,trunk,disabilities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were divided in two groups. Two groups will get two different intervention.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Routine training; mat exercises and perturbation training
Arm Title
Study
Arm Type
Experimental
Arm Description
Trunk training; Functional training, mat exercises and perturbation training
Intervention Type
Other
Intervention Name(s)
Functional training
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Routine training
Intervention Description
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.).
Primary Outcome Measure Information:
Title
The Functional Independence
Description
The Functional Independence Scale for Children (WeeFIM) was used determine to independence level.
Time Frame
through of te study, average 8 weeks
Title
Trunk impairment
Description
The Trunk Disorder Scale (TIS) was used to assess static and dynamic sitting balance and trunk coordination
Time Frame
through of te study, average 8 weeks
Title
The severity of ataxia
Description
The International Ataxia Rating Scale (ICARS) was used to determine the severity
Time Frame
through of te study, average 8 weeks
Title
The quality of life
Description
The Children's Quality of Life Scale (PedsQL) was used determine to quality of life level.
Time Frame
through of te study, average 8 weeks
Secondary Outcome Measure Information:
Title
Upper extremity functional performance
Description
The 9-Hole Peg test was used to evaluate upper extremity performance
Time Frame
through of te study, average 8 weeks
Title
Functional Reach Test
Description
Functional Reach Test was used determine to dynamic trunk balance
Time Frame
through of te study, average 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hasan kalyoncu üniversitesi
City
Gaziantep
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
27100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20649489
Citation
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.
Results Reference
background
PubMed Identifier
15838852
Citation
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.
Results Reference
background
PubMed Identifier
19823893
Citation
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.
Results Reference
background
PubMed Identifier
27372366
Citation
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.
Results Reference
background

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Functional Trunk Training in Ataxia Patients

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