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
Qualifiers
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
Treatments tested in this trial
- TR Mixed CORE Exercices
- TR Asyncronous CORE Exercices
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov