Clincosm LogoSign in Get a demo

Functional Trunk Training in Ataxia Patients

Sponsor
Hasan Kalyoncu University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04740359
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
12.6
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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
  • Other: Functional training
  • Other: Routine training
 N/A

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
Anticipated 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.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 :
Jan 12, 2021
Anticipated Primary Completion Date :
Jan 12, 2022
Anticipated Study Completion Date :
Jan 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 [through of te study, average 8 weeks]

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

  2. Trunk impairment [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 [through of te study, average 8 weeks]

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

  4. The quality of life [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 [through of te study, average 8 weeks]

    The 9-Hole Peg test was used to evaluate upper extremity performance

  2. Functional Reach Test [through of te study, average 8 weeks]

    Functional Reach Test was used determine to dynamic trunk balance

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Hasan kalyoncu üniversitesi Gaziantep Eyalet/Yerleşke Turkey 27100

Sponsors and Collaborators

  • Hasan Kalyoncu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sedat Yiğit, Res Asst, Hasan Kalyoncu University
ClinicalTrials.gov Identifier:
NCT04740359
Other Study ID Numbers:
  • 2020/107
First Posted:
Feb 5, 2021
Last Update Posted:
Feb 5, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
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, Res Asst, Hasan Kalyoncu University
ataxia,rehabilitation,trunk,disabilities
Additional relevant MeSH terms:
Ataxia
Cerebellar Ataxia
Spinocerebellar Ataxias
Spinocerebellar Degenerations

Study Results

No Results Posted as of Feb 5, 2021