Telerehabilitation for Core Stability and Strength in Hereditary Ataxia (TRCORE-AH2)

Universitat de Lleida

Status: Begins enrollment this month

Conditions: Hereditary Ataxia

Treatments: Other: TR Mixed CORE Exercices; Other: TR Asyncronous CORE Exercices

Study type: Interventional

Funder types: Other

Identifiers

NCT07200505

25

Details and patient eligibility

About

This is a two-arm, controlled clinical trial with a parallel design. Participants will be randomly assigned to an intervention or control group. The study is single-blind, as outcome assessors will be blinded to group allocation, while participants and physiotherapists cannot be blinded due to the nature of the intervention. Consecutive sampling will be applied.

For the evaluation of intervention effects (primary and secondary outcomes), the study will follow the Consolidated Standards of Reporting Trials (CONSORT) for non-pharmacological interventions. For the assessment of satisfaction and adherence, a qualitative study will be conducted following the COREQ EQUATOR 17 guidelines to ensure methodological rigor.

The intervention will consist of a 12-week home-based exercise program supervised via mixed telerehabilitation (TR). The control group will perform the same program but receive only telephone follow-up. Four assessments will be conducted: baseline (T0), post-intervention (T1), three months follow-up (T2), and six months follow-up (T3).

Full description

This study is a two-arm, controlled, parallel-group clinical trial designed to evaluate the effectiveness, adherence, and satisfaction of a telerehabilitation (TR) program combining core stability and strength exercises with an educational component for people with moderate hereditary ataxia.

Participants will be consecutively recruited through the Catalan Association of Hereditary Ataxias (ACAH), the CSUR Centre for Ataxias and Hereditary Spastic Paraparesis at Hospital Clínic de Barcelona. Eligible participants must have a diagnosis of hereditary spinocerebellar ataxia, moderate severity according to the SARA scale (10-20 points), internet access, basic digital literacy, and provide informed consent.

Participants will be randomly allocated to an intervention or control group. The intervention group will receive three preliminary online educational sessions and then follow a 12-week home-based exercise program delivered through a dedicated telerehabilitation platform. The platform includes pre-recorded videos, weekly synchronous physiotherapy sessions, automated reminders, personal diaries, and interactive features to promote adherence and engagement.

The control group will complete the same 12-week exercise program using printed materials and videos hosted in a cloud repository, supported only by periodic telephone follow-up, without educational sessions or access to the platform.

All participants will undergo four assessments: baseline (T0), post-intervention (T1), and follow-ups at three months (T2) and six months (T3).

The primary outcome is trunk control and sitting balance assessed with the Spanish version of the Trunk Impairment Scale (TIS 2.0). Secondary outcomes include lower limb strength (5x Sit-to-Stand Test), transfer ability (Transfer Assessment Instrument 4.0), upper limb function (Upper Extremity Functional Index), walking speed (4MWT), functional mobility (Timed Up and Go), disease severity (SARA), activities of daily living, health status, falls, adherence (Exercise Adherence Rating Scale and session completion rate), and satisfaction.

Quantitative analyses will follow CONSORT guidelines for non-pharmacological trials, while qualitative data on adherence, satisfaction, perceived risks and benefits, and acceptability will be collected through semi-structured interviews and analyzed thematically according to the COREQ EQUATOR 17 guidelines.

This study will provide evidence on the feasibility, effectiveness, and acceptability of a digital home-based rehabilitation approach for a population with limited access to specialized services, aiming to promote functional autonomy and quality of life while reducing healthcare disparities.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of spinocerebellar hereditary ataxia.

• Moderate severity defined by the SARA scale (10-20 points, Traschütz et al., 2023).

• Stable internet access and suitable electronic devices.

  • Basic digital literacy.
  • Signed informed consent.

Exclusion criteria

• Mild (<10) or severe (>20) scores on the SARA scale.
• Severe comorbidities preventing safe exercise participation.
• Severe cognitive impairment that would preclude program adherence.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Intervention group. TR mixed mode

Experimental group

Description:

Intervention group: Participants will perform the 12-week exercise program with access to a specially developed telerehabilitation platform. The platform will include videos, questionnaires, a personal diary, automatic reminders, a social chat, and one weekly synchronous supervision session with a physiotherapist to correct technique and adjust progression.

Treatment:

Other: TR Mixed CORE Exercices

Control group: Asynchronous mode

Active Comparator group

Description:

Control group: Participants will perform the same exercise program at home but will only receive printed material and videos uploaded to a cloud repository, along with telephone follow-up. They will not have access to the telerehabilitation platform or synchronous sessions.

Treatment:

Other: TR Asyncronous CORE Exercices