NCT04740359

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

February 12, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

February 2, 2021

Last Update Submit

March 1, 2023

Conditions

Keywords

ataxia,rehabilitation,trunk,disabilities

Outcome Measures

Primary Outcomes (4)

  • The Functional Independence

    The Functional Independence Scale for Children (WeeFIM) was used determine to independence level.

    through of te study, average 8 weeks

  • 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

  • The severity of ataxia

    The International Ataxia Rating Scale (ICARS) was used to determine the severity

    through of te study, average 8 weeks

  • 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 Outcomes (2)

  • Upper extremity functional performance

    through of te study, average 8 weeks

  • Functional Reach Test

    through of te study, average 8 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

Routine training; mat exercises and perturbation training

Other: Routine training

Study

EXPERIMENTAL

Trunk training; Functional training, mat exercises and perturbation training

Other: Functional training

Interventions

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).

Study

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.).

Control

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • Patients who want to leave the study at any stage of the study
  • Patients who do not attend regular training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan kalyoncu üniversitesi

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

Location

Related Publications (4)

  • 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.

    PMID: 20649489BACKGROUND
  • 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.

    PMID: 15838852BACKGROUND
  • 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.

    PMID: 19823893BACKGROUND
  • 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.

    PMID: 27372366BACKGROUND

MeSH Terms

Conditions

Spinocerebellar AtaxiasSpinocerebellar DegenerationsAtaxia

Condition Hierarchy (Ancestors)

Cerebellar AtaxiaCerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were divided in two groups. Two groups will get two different intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Res Asst

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 5, 2021

Study Start

February 12, 2021

Primary Completion

September 12, 2021

Study Completion

November 1, 2021

Last Updated

March 2, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations