Telerehabilitation for Core Stability and Strength in Hereditary Ataxia

NCT07200505 | Not Yet Recruiting

• 1 other identifier: 25
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Hereditary Ataxia

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (11)

• 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).

• Lower limb functional strength

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

• Transfer ability

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

• Upper limb functionality

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

• Walking Speed

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

Study Arms (2)

Intervention group. TR mixed mode

EXPERIMENTAL

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.

Other: TR Mixed CORE Exercices

Control group: Asynchronous mode

ACTIVE COMPARATOR

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.

Other: TR Asyncronous CORE Exercices

Interventions

TR Mixed CORE Exercices OTHER

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.

Intervention group. TR mixed mode

TR Asyncronous CORE Exercices OTHER

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.

Control group: Asynchronous mode

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universitat de Lleida: lead

Study Sites (1)

University of Lleida

Lleida, Lleida, 25008, Spain

Location

MeSH Terms

Conditions

Spinocerebellar Degenerations

Condition Hierarchy (Ancestors)

Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Maria Masbernat-Almenara

  Universitat de Lleida

  PRINCIPAL INVESTIGATOR

• Selma Pelàez Hervàs

  Hospital Clinic of Barcelona

  STUDY CHAIR

• Helena Fernández Lago

  Universitat de Lleida

  STUDY CHAIR

Central Study Contacts

Maria Masbernat-Almenara

CONTACT

+34 973 70 24 50; maria.masbernat@udl.cat

Selma Pelàez-Hervás

CONTACT

spelaez@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will remain blinded to group allocation. Due to the nature of the intervention, participants and physiotherapists cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 1, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): December 21, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available within 12 months after publication of the main study results and will remain accessible for at least 5 years.
• Access Criteria: Access will be granted to researchers upon reasonable request through the CORA platform. Requests must include a short proposal describing the intended use of the data and will be reviewed by the study's principal investigator and steering committee. Data will only be used for scientific purposes aligned with the consent provided by participants. Data sheets will be openly accessible through the CORA platform without restriction.

Locations

ES (1)