Telerehabilitation, Core Stability Exercises and Hereditary Ataxia (TRCore-ataxia)

NCT06152133 | Completed

• 1 other identifier: 01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Hereditary ataxias (HA) are a heterogeneous group of degenerative diseases of the cerebellum, brain stem and spinal cord. People who suffer from AH, among other symptoms, present deficiencies in the stability of the trunk, which leads to an alteration in postural control, with a strongly influential factor in the loss of balance and gait disorders. Improving the functionality of these physical aspects can help reduce the rate of falls, increase autonomy and quality of life for people with HA. Evidence suggests that rehabilitation strategies based on core stability exercises (CSE) are effective in improving balance and postural control in several neurological diseases, such as stroke. However, there is little evidence with people with HA. In a previous study carried out by researchers of this project, in which an EEC exercise program was piloted at home, low adherence to treatment was perceived due to the little follow-up that was given to the participants. Therefore, including telerehabilitation in these programs would increase follow-up and could influence adherence.

Conditions

Hereditary Ataxia; Spinocerebellar Degenerations; Cerebellar Ataxia

Keywords

Spinocerebellar Degenerations; Telerehabilitation; Exercise

Outcome Measures

Primary Outcomes (3)

• Rate of dynamic sitting balance and trunk coordination

  panish-version of Trunk Impairment Scale 2.0. Each item will be performed three times and the highest score counts. Otherwise, no practice session allowed. The patient can be corrected between attempts. The tests are verbally explained to the patient and can be demonstrated if needed. There are two subscales: dynamic sitting balance and coordination. The first have 10 items and second 6. The highest possible total score is consequently 16 points, which indicates a good dynamic sitting balance and correct trunk control and sitting coordination. If the patient cannot maintain a sitting position for 10 seconds without back and arm support, with hands on thighs, feet in contact with the ground and knees bent at 90° (starting position), the total score for the scale is 0 points.

  T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks

• Static sitting balance and Standing balance

  Static sitting balance will be recorded with the sitting section of SARA, standing balance will be recorded with the standing section of SARA as well, as well as walking.

  T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks

• Walking Speed

  The walking speed will be determined with the 4 meter walking test.

  T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks

Secondary Outcomes (7)

• ADLs

  T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks

• Lower extremity strength

  T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks

• Adherence to treatment

  T1: 7 weeks and T0: follow up 7 weeks

• Risk of falls

  T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks

• Severity of ataxia

  T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks

Study Arms (2)

Telerehabilitation Core stability exercises group

EXPERIMENTAL

Other: Therapeutic core stability exercises

Core stability exercises group

ACTIVE COMPARATOR

Other: Therapeutic core stability exercises

Interventions

Therapeutic core stability exercises OTHER

exercises focused on trunk muscle strengthening, proprioception, selective movements of the trunk and pelvis muscle, and coordination, and will be carried out in supine, sitting on a stable surface and sitting on an unstable surface (ball). The exercise involves changes in the position of the body with or without resistance, aiming to improve strength, endurance, proprioception and coordination. Training is determined by the patient's ability to undertake easy exercises and progress to more challenging exercises.

Also known as: trunk exercises

Core stability exercises group; Telerehabilitation Core stability exercises group

Eligibility Criteria

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

You may qualify if:

• Suffer from degenerative HA at any stage of the disease (Spinocerebellar ataxia, Friedreich's ataxia, sporadic idiopathic cerebellar ataxia and neurodegenerative diseases where ataxia is the dominant symptom).
• Adults over 18 years of age.
• Be able to use a computer or mobile phone (It will be evaluated using the DILE scale)
• Have an internet connection.

You may not qualify if:

• Suffer from other neurological diseases and inability to follow simple instructions. -
• Suffering from a musculoskeletal injury that prevents you from performing the exercises.
• Being unable to maintain standing for more than 10 seconds without support (assessed with item 2 on the SARA scale).

Sponsors & Collaborators

• Universitat de Lleida: lead
• Universitat Internacional de Catalunya: collaborator
• Hospital Clinic of Barcelona: collaborator
• Universidad Europea de Madrid: collaborator

Study Sites (1)

University of Lleida

Lleida, Lleida, 25198, Spain

Location

MeSH Terms

Conditions

Spinocerebellar Degenerations; Cerebellar Ataxia; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Pilot

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: March 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)