Hereditary AtaxiaTRCore-ataxiaNCT06152133
Telerehabilitation, Core Stability Exercises and Hereditary Ataxia (TRCore-ataxia)
A study testing Therapeutic core stability exercises in people with Hereditary Ataxia and Spinocerebellar Degenerations, run by Universitat de Lleida at 1 site in Spain.
Trial summary
Hereditary ataxias (HA) are a heterogeneous group of degenerative diseases of the cerebellum, brain stem and spinal cord. People who suffer from AH, among other symptoms, present deficiencies in the stability of the trunk, which leads to an alteration in postural control, with a strongly influential factor in the loss… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Ataxia, Spinocerebellar Degenerations, Cerebellar Ataxia
- What is being tested?
- Therapeutic core stability exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Suffer from degenerative HA at any stage of the disease (Spinocerebellar ataxia, Friedreich's ataxia, sporadic idiopathic cerebellar ataxia and neurodegenerative diseases where ataxia is the dominant symptom).
- Adults over 18 years of age.
- Be able to use a computer or mobile phone (It will be evaluated using the DILE scale)
- Have an internet connection.
Who cannot join
- Suffer from other neurological diseases and inability to follow simple instructions. -
- Suffering from a musculoskeletal injury that prevents you from performing the exercises.
- Being unable to maintain standing for more than 10 seconds without support (assessed with item 2 on the SARA scale).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Telerehabilitation Program of Central Stability Exercises to Improve Balance and Gait in Hereditary Ataxia. A Randomized Controlled Pilot Study.
Hereditary ataxias (HA) are a heterogeneous group of degenerative diseases of the cerebellum, brain stem and spinal cord. People who suffer from AH, among other symptoms, present deficiencies in the stability of the trunk, which leads to an alteration in postural control, with a strongly influential factor in the loss of balance and gait disorders. Improving the functionality of these physical aspects can help reduce the rate of falls, increase autonomy and quality of life for people with HA.
Evidence suggests that rehabilitation strategies based on core stability exercises (CSE) are effective in improving balance and postural control in several neurological diseases, such as stroke. However, there is little evidence with people with HA. In a previous study carried out by researchers of this project, in which an EEC exercise program was piloted at home, low adherence to treatment was perceived due to the little follow-up that was given to the participants. Therefore, including telerehabilitation in these programs would increase follow-up and could influence adherence.
- Being tested
- Therapeutic core stability exercises
- Keywords
- Spinocerebellar Degenerations, Telerehabilitation, Exercise
- Medical subject headings
- Spinocerebellar Degenerations, Cerebellar Ataxia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic core stability exercisesOther
Also called trunk exercises
exercises focused on trunk muscle strengthening, proprioception, selective movements of the trunk and pelvis muscle, and coordination, and will be carried out in supine, sitting on a stable surface and sitting on an unstable surface (ball). The exercise involves changes in the position of the body with or without resistance, aiming to improve strength, endurance, proprioception and coordination. Training is determined by the patient's ability to undertake easy exercises and progress to more challenging exercises.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Core stability exercises group | Experimental | Not described Receives: Other: Therapeutic core stability exercises |
| Core stability exercises group | Active comparator | Not described Receives: Other: Therapeutic core stability exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dynamic sitting balance and trunk coordination
panish-version of Trunk Impairment Scale 2.0. Each item will be performed three times and the highest score counts. Otherwise, no practice session allowed. The patient can be corrected between attempts. The tests are verbally explained to the patient and can be demonstrated if needed. There are two subscales: dynamic sitting balance and coordination. The first have 10 items and second 6. The highest possible total score is consequently 16 points, which indicates a good dynamic sitting balance and correct trunk control and sitting coordination. If the patient cannot maintain a sitting position for 10 seconds without back and arm support, with hands on thighs, feet in contact with the ground and knees bent at 90° (starting position), the total score for the scale is 0 points.
Measured: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Static sitting balance and Standing balance
Static sitting balance will be recorded with the sitting section of SARA, standing balance will be recorded with the standing section of SARA as well, as well as walking.
Measured: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Walking Speed
The walking speed will be determined with the 4 meter walking test.
Measured: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Secondary outcomes (7)
ADLs
ADLs will be assessed with the Activities-specific Balance Confidence (ABC)
Measured: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Lower extremity strength
Lower extremity strength will be assessed with the 30 s Sit-to-stand test.
Measured: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Adherence to treatment
Adherence to treatment will be asses with the Exercise Adherence Rating Scale (EARS) (Newman-Beinart 2017).
Measured: T1: 7 weeks and T0: follow up 7 weeks
Risk of falls
The risk of falls with the Timed Up and GO scale
Measured: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Severity of ataxia
The severity of ataxia will be evaluated with the SARA scale
Measured: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Treatment compliance
treatment compliance measured as the rate of sessions performed/prescribed (Capecci 2023), we will obtain the % compliance for each participant with the calculation Total number of minutes performed by the patient / Total number of minutes that should have been done (1400 minutes) x 100. Or with the calculation Total number of exercises per session performed by the patient / Total number of exercises that should have been done (23 per session) x 100
Measured: T1: 7 weeks and T0: follow up 7 weeks
Program satisfaction
A questionnaire will be administered to participants to evaluate both their experience and satisfaction with the program, as well as its adverse effects.
Measured: T1: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Mar 2024
- Primary completion30 Sep 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary AtaxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Randomized Controlled Pilot
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat de Lleida
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Internacional de Catalunya, Hospital Clinic of Barcelona, Universidad Europea de Madrid
- Responsible party
- Principal investigator, Maria Masbernat-Almenara, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152133
- Sponsor's protocol ID
- 01
- Acronym
- TRCore-ataxia
- Status last verified
- Apr 2025
- First submitted
- 21 Nov 2023
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Telerehabilitation Program of Central Stability Exercises to Improve Balance and Gait in Hereditary Ataxia. A Randomized Controlled Pilot Study.
- ClinicalTrials.gov ID
- NCT06152133
- Acronym / sponsor ID
- TRCore-ataxia / 01
- Keywords
- Spinocerebellar Degenerations, Telerehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universitat de LleidaUniversity, hospital or other
- Collaborators
- Universitat Internacional de Catalunya, Hospital Clinic of Barcelona, Universidad Europea de Madrid
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hereditary ataxias (HA) are a heterogeneous group of degenerative diseases of the cerebellum, brain stem and spinal cord. People who suffer from AH, among other symptoms, present deficiencies in the stability of the trunk, which leads to an alteration in postural control, with a strongly influential factor in the loss of balance and gait disorders. Improving the functionality of these physical aspects can help reduce the rate of falls, increase autonomy and quality of life for people with HA.
Evidence suggests that rehabilitation strategies based on core stability exercises (CSE) are effective in improving balance and postural control in several neurological diseases, such as stroke. However, there is little evidence with people with HA. In a previous study carried out by researchers of this project, in which an EEC exercise program was piloted at home, low adherence to treatment was perceived due to the little follow-up that was given to the participants. Therefore, including telerehabilitation in these programs would increase follow-up and could influence adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Pilot
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Core stability exercises group | Experimental | Other: Therapeutic core stability exercises |
| Core stability exercises group | Active comparator | Other: Therapeutic core stability exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Suffer from degenerative HA at any stage of the disease (Spinocerebellar ataxia, Friedreich's ataxia, sporadic idiopathic cerebellar ataxia and neurodegenerative diseases where ataxia is the dominant symptom).
- Adults over 18 years of age.
- Be able to use a computer or mobile phone (It will be evaluated using the DILE scale)
- Have an internet connection.
Key exclusion criteria (3 listed)
- Suffer from other neurological diseases and inability to follow simple instructions. -
- Suffering from a musculoskeletal injury that prevents you from performing the exercises.
- Being unable to maintain standing for more than 10 seconds without support (assessed with item 2 on the SARA scale).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic core stability exercisesAlso: trunk exercisesexercises focused on trunk muscle strengthening, proprioception, selective movements of the trunk and pelvis muscle, and coordination, and will be carried out in supine, sitting on a stable surface and sitting on an unstable surface (ball). The exercise involves changes in the position of the body with or without resistance, aiming to improve strength, endurance, proprioception and coordination. Training is determined by the patient's ability to undertake easy exercises and progress to more challenging exercises. | Other | Core stability exercises group, Telerehabilitation Core stability exercises group |
Primary outcome
Rate of dynamic sitting balance and trunk coordination
Time frame: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
panish-version of Trunk Impairment Scale 2.0. Each item will be performed three times and the highest score counts. Otherwise, no practice session allowed. The patient can be corrected between attempts. The tests are verbally explained to the patient and can be demonstrated if needed. There are two subscales: dynamic sitting balance and coordination. The first have 10 items and second 6. The highest possible total score is consequently 16 points, which indicates a good dynamic sitting balance and correct trunk control and sitting coordination. If the patient cannot maintain a sitting position for 10 seconds without back and arm support, with hands on thighs, feet in contact with the ground and knees bent at 90° (starting position), the total score for the scale is 0 points.
Static sitting balance and Standing balance
Time frame: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Static sitting balance will be recorded with the sitting section of SARA, standing balance will be recorded with the standing section of SARA as well, as well as walking.
Walking Speed
Time frame: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
The walking speed will be determined with the 4 meter walking test.
7 secondary outcomes
ADLs
Time frame: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Lower extremity strength
Time frame: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Adherence to treatment
Time frame: T1: 7 weeks and T0: follow up 7 weeks
Risk of falls
Time frame: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Severity of ataxia
Time frame: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks
Treatment compliance
Time frame: T1: 7 weeks and T0: follow up 7 weeks
Program satisfaction
Time frame: T1: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic core stability exercises in people with Hereditary Ataxia and Spinocerebellar Degenerations, 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 4 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: finished, as of the sponsor's last update on 6 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of dynamic sitting balance and trunk coordination (time frame: T0: Baseline, T1: 7 weeks and T0: follow up 7 weeks). The study lists 3 primary outcomes in all. 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 6 Apr 2025.