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Hereditary AtaxiaTRCORE-AH2NCT07200505

Telerehabilitation for Core Stability and Strength in Hereditary Ataxia

A study testing TR Mixed CORE Exercices and TR Asyncronous CORE Exercices in people with Hereditary Ataxia, run by Universitat de Lleida at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hereditary Ataxia
What is being tested?
TR Mixed CORE Exercices and TR Asyncronous CORE Exercices
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSpain
Study dates
9 Feb 2026to 21 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maria Masbernat-Almenara contact

+34 973 70 24 50

maria.masbernat@udl.cat

Selma Pelàez-Hervás contact

spelaez@clinic.cat

Spain1 site
  • University of Lleida

    Lleida, Lleida, 25008

    Maria Masbernat-Almenara, +34 973 70 24 50, maria.masbernat@udl.cat

Other trials in Spain

About this study

Official title: A Telerehabilitation Intervention Targeting Core Stability and Muscular Strength in Individuals With Moderate-to-Advanced Hereditary Ataxia: A Pilot Study

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).

Read the 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.

Being tested
TR Mixed CORE Exercices, TR Asyncronous CORE Exercices
Medical subject headings
Spinocerebellar Degenerations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TR Mixed CORE ExercicesOther

    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 will only receive basic materials and follow-up phone calls. If needed, family members will be trained to provide occasional assistance with exercise performance.

  • TR Asyncronous CORE ExercicesOther

    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 group will only receive basic materials and follow-up phone calls. If needed, family members will be trained to provide occasional assistance with exercise performance.

Study groups in NCT07200505
Study groupRoleWhat they receive
Intervention group. TR mixed modeExperimentalIntervention 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.
Receives: Other: TR Mixed CORE Exercices
Control group: Asynchronous modeActive comparatorControl 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.
Receives: Other: TR Asyncronous CORE Exercices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dynamic sitting balance and coordination

    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.

    Measured: Baseline (T0) , post-intervention (up to 12 weeks), (T1), and follow-ups at 3 months (T2) and 6 months (T3).

Secondary outcomes (11)
  1. Static sitting and standing balance

    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.

    Measured: Baseline (T0), post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).

  2. Lower limb functional strength

    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.

    Measured: Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).

  3. Transfer ability

    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.

    Measured: Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).

  4. Upper limb functionality

    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.

    Measured: Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).

  5. Walking Speed

    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.

    Measured: Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).

  6. Gait Performance

    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.

    Measured: Baseline (T0), post-intervention (up to 12 weeks) (T1), and follow-ups at 3 months (T2) and 6 months (T3)

  7. Functional mobility and fall risk

    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.

    Measured: Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).

  8. Disease severity

    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.

    Measured: Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).

  9. Program Compliance

    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.

    Measured: Post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).

  10. Exercise Adherence

    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.

    Measured: Post-intervention (up to 12 weeks) (T1), and follow-ups at 3 months (T2) and 6 months (T3).

  11. Satisfaction, perceived benefits, risks, and acceptability

    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.

    Measured: Post-intervention (up to 12 weeks)(T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2025
  2. Study start9 Feb 2026 (estimated)
  3. Primary completion12 Jun 2026 (estimated)
  4. Study completion21 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07200505
Sponsor's protocol ID
25
Acronym
TRCORE-AH2
Status last verified
Sep 2025
First submitted
12 Sep 2025
Last updated
1 Oct 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be made available in open access at the Catalan Open Research Area (CORA) repository, in accordance with the FAIR data principles and current data protection regulations (EU GDPR and Spanish Organic Law 3/2018). De-identified datasets will be deposited after publication of the main study results and will be accessible to other researchers upon reasonable request through the CORA platform.

Questions about this trial

What is this clinical trial studying?

A study testing TR Mixed CORE Exercices and TR Asyncronous CORE Exercices in people with Hereditary Ataxia, run by Universitat de Lleida at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria Masbernat-Almenara (+34 973 70 24 50, maria.masbernat@udl.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.

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