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

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebellar Ataxia; Spinocerebellar Degenerations; Hereditary Ataxia
• Intervention / Treatment: Other: Therapeutic core stability exercises

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Lleida, Spain, 25198
    • University of Lleida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation Core stability exercises group	Other: Therapeutic core stability exercises; 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
Active Comparator: Core stability exercises group	Other: Therapeutic core stability exercises; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADLs	ADLs will be assessed with the Activities-specific Balance Confidence (ABC)	T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Lower extremity strength	Lower extremity strength will be assessed with the 30 s Sit-to-stand test.	T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Adherence to treatment	Adherence to treatment will be asses with the Exercise Adherence Rating Scale (EARS) (Newman-Beinart 2017).	T1: 7 weeks and T0: follow up 7 weeks
Risk of falls	The risk of falls with the Timed Up and GO scale	T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Severity of ataxia	The severity of ataxia will be evaluated with the SARA scale	T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Treatment compliance	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	T1: 7 weeks and T0: follow up 7 weeks
Program satisfaction	A questionnaire will be administered to participants to evaluate both their experience and satisfaction with the program, as well as its adverse effects.	T1: 7 weeks

Collaborators and Investigators

• Sponsor: Universitat de Lleida
• Collaborators: Hospital Clinic of Barcelona; Universidad Europea de Madrid; Universitat Internacional de Catalunya

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Telerehabilitation; Spinocerebellar Degenerations
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Spinal Cord Diseases; Dyskinesias; Cerebellar Diseases; Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations
• Other Study ID Numbers: 01 (Miami VAHS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No