Telerehabilitation for Core Stability and Strength in Hereditary Ataxia
ConditionHereditary Ataxia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitat de Lleida
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
TR Mixed CORE Exercices
Other interventionThe 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 Exercices
Other interventionThe 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Intervention group. TR mixed modeExperimental treatment 1 intervention
Group B: Control group: Asynchronous modeActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (T0) , post-intervention (up to 12 weeks), (T1), and follow-ups at 3 months (T2) and 6 months (T3).Secondary outcomes
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.
Time frame
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.
Time frame
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.
Time frame
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.
Time frame
Baseline (T0) , post-intervention (up to 12 weeks)(T1), and follow-ups at 3 months (T2) and 6 months (T3).Sponsors and contacts
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Source ClinicalTrials.gov
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