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Completed

NCT Number: NCT06152133

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lleida

Lleida, 25198, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Other names: trunk exercises

Primary outcomes

  1. Rate of dynamic sitting balance and trunk coordination

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

    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.

  2. Static sitting balance and Standing balance

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

    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.

  3. Walking Speed

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

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

Secondary outcomes

  1. ADLs

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

    ADLs will be assessed with the Activities-specific Balance Confidence (ABC)

  2. Lower extremity strength

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

    Lower extremity strength will be assessed with the 30 s Sit-to-stand test.

  3. Adherence to treatment

    Time frame: T1: 7 weeks and T0: follow up 7 weeks

    Adherence to treatment will be asses with the Exercise Adherence Rating Scale (EARS) (Newman-Beinart 2017).

  4. Risk of falls

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

    The risk of falls with the Timed Up and GO scale

  5. Severity of ataxia

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

    The severity of ataxia will be evaluated with the SARA scale

  6. Treatment compliance

    Time frame: T1: 7 weeks and T0: follow up 7 weeks

    treatment compliance measured as the rate of sessions performed/prescribed (Capecci 2023), we will obtain the % compliance for each participant with the calculation Total number of minutes performed by the patient / Total number of minutes that should have been done (1400 minutes) x 100. Or with the calculation Total number of exercises per session performed by the patient / Total number of exercises that should have been done (23 per session) x 100

  7. Program satisfaction

    Time frame: T1: 7 weeks

    A questionnaire will be administered to participants to evaluate both their experience and satisfaction with the program, as well as its adverse effects.

Sponsors and collaborators

Lead sponsor

Universitat de Lleida

Other

Collaborators

  • Hospital Clinic of Barcelona
  • Universidad Europea de Madrid
  • Universitat Internacional de Catalunya

Registry information

Official study title

Effects of a Telerehabilitation Program of Central Stability Exercises to Improve Balance and Gait in Hereditary Ataxia. A Randomized Controlled Pilot Study.

Acronym: TRCore-ataxia

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 30, 2023
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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