Functional Trunk Training in Ataxia Patients

• ClinicalTrials.gov Identifier: NCT04740359
• Recruitment Status: Active, not recruiting
• First Posted: February 5, 2021
• Last Update Posted: February 5, 2021
• Sponsor: Hasan Kalyoncu University
• Information provided by (Responsible Party): Sedat Yiğit, Hasan Kalyoncu University

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.

Condition or disease	Intervention/treatment	Phase
Ataxia, Spinocerebellar; Ataxias, Hereditary	Other: Functional training; Other: Routine training	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants were divided in two groups. Two groups will get two different intervention.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Functional Trunk Training on Trunk Control and Upper Extremity Functions in Hereditary Ataxia Patients With Autosomal Recessive
• Actual Study Start Date: January 12, 2021
• Estimated Primary Completion Date: January 12, 2022
• Estimated Study Completion Date: January 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Control; Routine training; mat exercises and perturbation training	Other: Routine training; 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.).
Experimental: Study; Trunk training; Functional training, mat exercises and perturbation training	Other: Functional training; 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).

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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
3. 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
4. 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.

Secondary Outcome Measures :

1. Upper extremity functional performance [ Time Frame: through of te study, average 8 weeks ]
   The 9-Hole Peg test was used to evaluate upper extremity performance
2. Functional Reach Test [ Time Frame: through of te study, average 8 weeks ]
   Functional Reach Test was used determine to dynamic trunk balance

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Turkey

Hasan kalyoncu üniversitesi

Gaziantep, Eyalet/Yerleşke, Turkey, 27100

Sponsors and Collaborators

Hasan Kalyoncu University

More Information

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.

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.

• Responsible Party: Sedat Yiğit, Res Asst, Hasan Kalyoncu University
• ClinicalTrials.gov Identifier: NCT04740359
• Other Study ID Numbers: 2020/107
• First Posted: February 5, 2021
• Last Update Posted: February 5, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sedat Yiğit, Hasan Kalyoncu University:

ataxia,rehabilitation,trunk,disabilities

Additional relevant MeSH terms:

Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn