Telerehabilitation for Core Stability and Strength in Hereditary Ataxia
NCT07200505 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-10-01
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
Interventions
- OTHER
-
TR Mixed CORE Exercices
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.
- OTHER
-
TR Asyncronous CORE Exercices
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.
Sponsors & Collaborators
-
Universitat de Lleida
lead OTHER
Principal Investigators
-
Maria Masbernat-Almenara · Universitat de Lleida
-
Selma Pelàez Hervàs · Hospital Clinic of Barcelona
-
Helena Fernández Lago · Universitat de Lleida
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-09
- Primary Completion
- 2026-06-12
- Completion
- 2026-12-21
Countries
- Spain
Study Locations
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