Telerehabilitation for Core Stability and Strength in Hereditary Ataxia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TR Mixed CORE Exercices, TR Asyncronous CORE Exercices.
- Who it may be relevant to
- Registry conditions: Hereditary Ataxia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Telerehabilitation Intervention Targeting Core Stability and Muscular Strength in Individuals With Moderate-to-Advanced Hereditary Ataxia: A Pilot Study
Overview
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).
Detailed 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.
Interventions
- Other TR Mixed CORE Exercices
The intervention will last 12 weeks, with five weekly sessions. Prior to starting, all participants will attend three educational sessions and an initial in-person session, during which the physiotherapist will explain and personalise the exercises, ensure proper use of the platform, and provide necessary materials. Participants will then perform the exercises autonomously. he intervention group will receive support through the platform and weekly synchronous supervision, while the control group - Other TR Asyncronous CORE Exercices
The intervention will last 12 weeks, with five weekly sessions. Prior to starting, all participants will attend three educational sessions and an initial in-person session, during which the physiotherapist will explain and personalize the exercises, ensure proper use of the platform, and provide necessary materials. Participants will then perform the exercises autonomously. The intervention group will receive support through the platform and weekly synchronous supervision, while the control gro
Primary outcome measures
- Dynamic sitting balance and coordination [Time frame: Baseline (T0) , post-intervention (up to 12 weeks), (T1), and follow-ups at 3 months (T2) and 6 months (T3).]
Secondary outcome measures (11)
- Static sitting and standing balance [Time frame: Baseline (T0), post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).]
- Lower limb functional strength [Time frame: Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).]
- Transfer ability [Time frame: Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).]
- Upper limb functionality [Time frame: Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).]
- Walking Speed [Time frame: Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).]
- Gait Performance [Time frame: Baseline (T0), post-intervention (up to 12 weeks) (T1), and follow-ups at 3 months (T2) and 6 months (T3)]
- Functional mobility and fall risk [Time frame: Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).]
- Disease severity [Time frame: Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).]
- Program Compliance [Time frame: Post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).]
- Exercise Adherence [Time frame: Post-intervention (up to 12 weeks) (T1), and follow-ups at 3 months (T2) and 6 months (T3).]
- Satisfaction, perceived benefits, risks, and acceptability [Time frame: Post-intervention (up to 12 weeks)(T1)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- University of Lleida — Lleida
Identifiers
NCT: NCT07200505 · 25