Telerehabilitation for Core Stability and Strength in Hereditary Ataxia

Not Applicable

Not yet recruiting

• Conditions: Hereditary Ataxia

• Registration Number: NCT07200505
• Lead Sponsor: Universitat de Lleida

Brief Summary

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-26
• Last Update Submitted: 2025-09-26
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Study Start: 2026-02-09
• Primary Completion: 2026-06-12
• Study Completion: 2026-12-21

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dynamic sitting balance and coordination	Baseline (T0) , post-intervention (up to 12 weeks), (T1), and follow-ups at 3 months (T2) and 6 months (T3).	Dynamic sitting balance and coordination will be assessed using the Spanish version of the Trunk Impairment Scale (S-TIS 2.0).; This scale has a total score range from 0 to 16 points, where higher scores indicate better trunk control, balance, and coordination, and lower scores indicate poorer performance.

Secondary Outcome Measures

Name	Time	Method
Static sitting and standing balance	Baseline (T0), post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).	Static sitting and standing balance will be assessed using items 2 and 3 of the Scale for the Assessment and Rating of Ataxia (SARA); Item 2 (Stance): scored from 0 to 6 points; Item 3 (Sitting): scored from 0 to 4 points; The combined score ranges from 0 to 10 points, where higher scores indicate worse static balance (greater severity of ataxia) and lower scores indicate better balance.
Lower limb functional strength	Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).	Assessed using the 5 Times Sit-to-Stand Test (5xSTS). Time in seconds required to stand up and sit down five consecutive times from a standard chair without using the arms.; Lower scores indicate better performance. Higher scores indicate worse performance.
Transfer ability	Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).	Transfer Ability assessed using Transfer Assessment Instrument version 4.0 (TAI 4.0) The TAI 4.0 has a total score range from 0 to 10 points, where higher scores indicate better quality, safety, and independence during transfers and lower scores indicate poorer performance.
Upper limb functionality	Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).	Assessed using the Upper Extremity Functional Index (UEFI). The UEFI total score ranges from 0 to 80 points, where higher scores indicate better upper limb function and less difficulty performing daily activities.
Walking Speed	Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).	Walking speed, assessed using the 4-Meter Walking Test (4MWT). This test measures the time in seconds needed to walk 4 meters at a comfortable pace. There is no maximum score; shorter times indicate better walking ability, and longer times indicate poorer performance.
Gait Performance	Baseline (T0), post-intervention (up to 12 weeks) (T1), and follow-ups at 3 months (T2) and 6 months (T3)	Gait performance, assessed using Item 1 (Gait) of the Scale for the Assessment and Rating of Ataxia (SARA).; This item is scored from 0 to 8 points, where higher scores indicate worse gait performance (greater severity of ataxia) and lower scores indicate better gait.
Functional mobility and fall risk	Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).	Assessed using the Timed Up and Go Test (TUG). This test measures the time in seconds needed to stand up from a chair, walk 3 meters, turn around, return, and sit down.; There is no maximum score; shorter times indicate better mobility and lower fall risk, and longer times indicate worse mobility and higher fall risk.
Disease severity	Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).	Assessed using Scale for the Assessment and Rating of Ataxia (SARA). The SARA has a total score range from 0 to 40 points, where higher scores indicate greater severity of ataxia and lower scores indicate less severe symptoms.
Program Compliance	Post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).	Program compliance will be assessed using the percentage of completed prescribed sessions, calculated as: (number of minutes or exercises completed / number prescribed) × 100. Higher percentages indicate greater compliance, while lower percentages indicate poorer compliance.
Exercise Adherence	Post-intervention (up to 12 weeks) (T1), and follow-ups at 3 months (T2) and 6 months (T3).	Exercise adherence assessed using Exercise Adherence Rating Scale (EARS) The EARS has a total score range from 0 to 24 points, where higher scores indicate better adherence to the exercise program.
Satisfaction, perceived benefits, risks, and acceptability	Post-intervention (up to 12 weeks)(T1)	Participant satisfaction, perceived benefits, risks, barriers, and overall acceptability of the program will be assessed through semi-structured interviews conducted after completing the intervention. Interviews will last approximately 45 minutes and will be analyzed using thematic content analysis following COREQ guidelines.; This is a qualitative outcome without a numerical score.

Trial Locations

Locations (1)

University of Lleida; 🇪🇸 Lleida, Lleida, Spain