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Completed

NCT Number: NCT04740359

Functional Trunk Training in Ataxia Patients

The study is to examine the effect of functional trunk training on trunk control and upper extremity functions in patients with autosomal recessive ataxia.

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Key information

Conditions

Ataxia, Spinocerebellar Ataxia Ataxias, Hereditary Brain Diseases Central Nervous System Diseases Cerebellar Ataxia Cerebellar Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinocerebellar Ataxias Spinocerebellar Degenerations

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasan kalyoncu üniversitesi

Gaziantep, Eyalet/Yerleşke, 27100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Training

Other

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 training

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hasan Kalyoncu University

Other

Registry information

Official study title

The Effect of Functional Trunk Training on Trunk Control and Upper Extremity Functions in Hereditary Ataxia Patients With Autosomal Recessive

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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