Structural Validity and Inter-rater Reliabitiliy of the Ataxia Trunk, Lower And Upper Extremity Scale (ATLAS)

NCT07079332 | Not Yet Recruiting

• 3 other identifiers: ATLAS_0116-M252025-01498
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ataxia is a neurological disorder affecting coordination, caused by damage to the cerebellum, brainstem, or related pathways. It can be hereditary (e.g., Friedreich's ataxia) or acquired (e.g., multiple sclerosis, stroke). Though rare, ataxia significantly impacts quality of life and independence. Treatments are limited and mainly focus on multidisciplinary rehabilitation. Accurate assessment is essential, yet current tools like Scale for the Assessment and Rating of Ataxia (SARA) have limitations. This study aims to validate a new scale, named the Ataxia Trunk, Lower And upper extremity Scale (ATLAS), through Rasch analysis, to develop a shorter, reliable version. It will assess internal consistency, construct validity, and inter-rater reliability. For the valitdity part, statistics will be used (1) to see if the different items of the scale are indeed different and complementary to each other, and (2) to compare the results of this scale with other scales already known and valid (SARA, Trunk Impairment Scale (TIS) and Functional Impairment Measurement(FIM)). Secondly, the investigators would like to know whether ATLAS is reliable. In this particular case, the reliability being assessed is inter-rater reliability, i.e. whether all raters give the same score on the items performed by the patient. To carry out such a study, 64 people will be needed to achieve these goals. Each person will complete the 20 items of the ATLAS scale, those of a trunk motor capacity assessment (TIS), and will evaluate his or her functional independence (FIM).

Conditions

Ataxia, Cerebellar; Ataxia, Gait; Ataxia, Motor; Ataxia; Ataxia, Spinocerebellar; Ataxias, Hereditary; Ataxia - Other

Keywords

Ataxia; Scale; Validity Study; reliability study; new scale

Outcome Measures

Primary Outcomes (1)

• Ataxia Trunk, Lower And upper extremity Scale scores (ATLAS)

  The Ataxia Trunk, Lower And upper extremity Scale (ATLAS) includes 20 items: 14 related to the trunk, 3 to the lower limbs (LL), and 3 to the upper limbs (UL). Each item is rated using an ordinal scale ranging from 2 to 4. A maximum total score of 64 indicates severe ataxia, while a score of 0 reflects the absence of ataxia. The maximum subscore for the trunk is 28, for the lower limbs 18, and for the upper limbs 18, with each side assessed separately.

  Once, at day 1

Secondary Outcomes (3)

• Functional Independence Measure (FIM)

  Once, at day 1

• Trunk Impairment Scale 2.0 (TIS 2.0)

  Once, at day 1

• Scale for the Assessment and Rating of Ataxia (SARA)

  Once, at day 1

Study Arms (1)

Ataxia patient

Presenting motor symtpoms of ataxia

Other: New Scale to evaluate ataxia motor symptoms

Interventions

New Scale to evaluate ataxia motor symptoms OTHER

The Ataxia Trunk, Lower And upper extremity Scale (ATLAS) is a new scale. It differs from other Ataxia Scale by focusing on the assessment of coordination abilities of specific body segments: the trunk, lower limbs, and upper limbs.

Ataxia patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population of the study consists of individuals with motor impairments of cerebellar origin. These individuals are expected to exhibit typical symptoms of cerebellar dysfunction and, as such, will be found among those with hereditary or genetic ataxia, as well as individuals who have experienced a pontine or cerebellar stroke.

You may qualify if:

• Be adults
• Be able to provide written informed consent
• Be able to understand and follow simple physical instructions
• Have a diagnosis of genetic or hereditary ataxia, or a cerebellar or pontine stroke (either hemorrhagic or ischemic), confirmed by a neurologist

You may not qualify if:

• Muscle group strength \< 3 on the Medical Research Council (MRC) scale
• Spasticity \> 2 in any muscle on the Modified Ashworth Scale
• Pain \> 5 on the Visual Analogue Scale (VAS) in any part of the body

Sponsors & Collaborators

• Haute Ecole de Santé Vaud: lead

MeSH Terms

Conditions

Cerebellar Ataxia; Gait Ataxia; Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations

Condition Hierarchy (Ancestors)

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

Study Officials

• Sylvie Ferchichi-Barbey, Master

  HESAV School of Health Sciences - Vaud, HES-SO University of Applied Sciences and Arts Western Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie Ferchichi-Barbey Sylvie, F, PT, Msc, Master

CONTACT

+41 21 556 63 13; sylvie.ferchichi-barbey@hesav.ch

Simone C Gafner, PhD

CONTACT

+41 79 292 09 09; simone.gafner@hevs.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 23, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 13, 2025

Record last verified: 2025-08