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

Sponsor

Universitat de Lleida (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06152133

Collaborator

Universitat Internacional de Catalunya (Other), Hospital Clinic of Barcelona (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hereditary Ataxia Spinocerebellar Degenerations Cerebellar Ataxia	Other: Therapeutic core stability exercises	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Controlled PilotRandomized Controlled Pilot

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

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

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

Other Names:

trunk exercises

Outcome Measures

Primary Outcome Measures

Rate of dynamic sitting balance and trunk coordination [T1: Baseline, T2: 7 weeks and T3: 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).