Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04740359
Other study ID # 2020/107
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 12, 2021
Est. completion date November 1, 2021

Study information

Verified date March 2023
Source Hasan Kalyoncu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 1, 2021
Est. primary completion date September 12, 2021
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility 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 Design


Intervention

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).
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.).

Locations

Country Name City State
Turkey Hasan kalyoncu üniversitesi Gaziantep Eyalet/Yerleske

Sponsors (1)

Lead Sponsor Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Functional Independence The Functional Independence Scale for Children (WeeFIM) was used determine to independence level. through of te study, average 8 weeks
Primary Trunk impairment The Trunk Disorder Scale (TIS) was used to assess static and dynamic sitting balance and trunk coordination through of te study, average 8 weeks
Primary The severity of ataxia The International Ataxia Rating Scale (ICARS) was used to determine the severity through of te study, average 8 weeks
Primary The quality of life The Children's Quality of Life Scale (PedsQL) was used determine to quality of life level. through of te study, average 8 weeks
Secondary Upper extremity functional performance The 9-Hole Peg test was used to evaluate upper extremity performance through of te study, average 8 weeks
Secondary Functional Reach Test Functional Reach Test was used determine to dynamic trunk balance through of te study, average 8 weeks
See also
  Status Clinical Trial Phase
Completed NCT05038306 - Chinese Medicine WT for Spinocerebellar Ataxia Type 3 Phase 2
Completed NCT03120013 - Rehabilitative Trial With Cerebello-Spinal tDCS in Neurodegenerative Ataxia N/A