Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2021-05-20
2023-01-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Given the fact that drug interventions are rare in degenerative diseases and limited to only specific type of diseases and symptoms, physiotherapy is a major cornerstone in current therapy of ataxic gait. Core stability exercises training could be included as an adjunct to conventional balance training in improving dynamic balance and gait. Due to the nature of the interventions, the study will have a single blind design.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Telerehabilitation, Core Stability Exercises and Hereditary Ataxia (TRCore-ataxia)
NCT06152133
Telerehabilitation for Core Stability and Strength in Hereditary Ataxia
NCT07200505
Aerobic Exercise, Balance Training, and Ataxia
NCT03745248
Ataxia and Exercise Disease Using MRI and Gait Analysis
NCT03701776
Training in Ataxia - Individuals With Degenerative Cerebellar Diseases
NCT05002218
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Clinical manifestations of hereditary ataxia are poor coordination of movement and a wide-based, uncoordinated, unsteady gait. Poor coordination of the limbs and of speech (dysarthria) are often present. Ataxia patients perceive impairments in balance, coordination and speech as the symptoms with greatest impact, as well as fatigue.
Postural disorders in cerebellar ataxia constitute a major cause of poor balance. Local stability of the trunk during gait in patients with cerebellar degenerative ataxia is lower than that in controls. To compensate for this instability, walkers increase the width of the base of support, take smaller steps and increase the duration of foot contact to the floor, sacrificing swing phase. They progress forward slower, with a lower cadence and preferred walking pace. This lack of stability is in turn correlated with the history of falls. Local stability of the trunk may thus be useful when planning gait and balance rehabilitation in patients with ataxia. Developing core strength is essential for everyday health and well-being, as a strong core protects the spine, reduces back pain, enhances movement patterns, and improves balance, stability and posture. However, while motor training programs have been shown to be beneficial in other neurodegenerative diseases (e.g., Parkinson's disease or stroke, their effectiveness remains controversial in the field of degenerative hereditary ataxias.
There's emerging evidence that rehabilitation may improve function, mobility, ataxia and balance in genetic degenerative ataxia. Although these conclusions are based primarily on moderate to low-quality studies, the consistency of positive effects verifies that rehabilitation is beneficial. Intensive rehabilitation (with balance and coordination exercises) improves the patients' functional abilities (level of proof: moderate). Although techniques such as virtual reality, biofeedback, treadmill exercises with supported body weight and torso weighting appear to be of value, their specific efficacy has yet to be characterized. This body of literature is limited by the wide range of underlying conditions studied and methodological weaknesses (small sample sizes, poorly described rehabilitation protocols, etc.
The aim of this study is that a program of core stability exercises could improve sitting and standing balance and gait in hereditary ataxia patients. Secondary objectives are activities of daily living, lower limb strength and health status of quality of life. After giving informed consent, participants will be randomly assigned (at a ratio 1:1) to core stability group or control group. Concealed treatment allocation will be performed via opaque envelopes.
The study will be carried out in accordance with the principles enunciated in the current version of the Declaration of Helsinki and the requirements of Spanish law and the Spanish regulatory authority.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Core stability exercises group
30 minutes of core stability exercises program at a light intensity and take a rest breaks if is necessary. They will be instructed in the use of the 4-5 points of the Borg 10 Rating of Perceived Exertion for self-monitoring of exercise intensity. The exercises will performed twice a day for 5 days a week during 5 weeks. A physiotherapist conducted an initial home visit to ensure correct execution of the exercises. He or she will teach the exercises and then the patient will perform them alone in your home. Once a week the physiotherapist will phone the patient and will ask her/him for doubts.
Therapeutic core stability 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.
Control group
The patients to continue as normal and not change their routine in terms of exercise and physical activity during the period of study.
Usual care
Usual routine as walking and activities of daily living.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Therapeutic core stability 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.
Usual care
Usual routine as walking and activities of daily living.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universitat de Lleida
OTHER
Universitat Internacional de Catalunya
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rosa Cabanas Valdés
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rosa C Cabanas-Valdés, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitat Internacional de Catalunya
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rosa Cabanas Valdés
Cardedeu, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chen DH, Latimer C, Yagi M, Ndugga-Kabuye MK, Heigham E, Jayadev S, Meabon JS, Gomez CM, Keene CD, Cook DG, Raskind WH, Bird TD. Heterozygous STUB1 missense variants cause ataxia, cognitive decline, and STUB1 mislocalization. Neurol Genet. 2020 Feb 10;6(2):1-13. doi: 10.1212/NXG.0000000000000397. eCollection 2020 Apr.
Ruano L, Melo C, Silva MC, Coutinho P. The global epidemiology of hereditary ataxia and spastic paraplegia: a systematic review of prevalence studies. Neuroepidemiology. 2014;42(3):174-83. doi: 10.1159/000358801. Epub 2014 Mar 5.
OVERTON, Caroline E.; O'BRIEN, Kate. Guidelines on the Diagnosis and Management of Miscarriage. Early Pregnancy, 2017, 129.
Marquer A, Barbieri G, Perennou D. The assessment and treatment of postural disorders in cerebellar ataxia: a systematic review. Ann Phys Rehabil Med. 2014 Mar;57(2):67-78. doi: 10.1016/j.rehab.2014.01.002. Epub 2014 Feb 6.
Chini G, Ranavolo A, Draicchio F, Casali C, Conte C, Martino G, Leonardi L, Padua L, Coppola G, Pierelli F, Serrao M. Local Stability of the Trunk in Patients with Degenerative Cerebellar Ataxia During Walking. Cerebellum. 2017 Feb;16(1):26-33. doi: 10.1007/s12311-016-0760-6.
Park J, Gong J, Yim J. Effects of a sitting boxing program on upper limb function, balance, gait, and quality of life in stroke patients. NeuroRehabilitation. 2017;40(1):77-86. doi: 10.3233/NRE-161392.
Cabanas-Valdes R, Urrutia G, Bagur-Calafat C, Caballero-Gomez FM, German-Romero A, Girabent-Farres M. Validation of the Spanish version of the Trunk Impairment Scale Version 2.0 (TIS 2.0) to assess dynamic sitting balance and coordination in post-stroke adult patients. Top Stroke Rehabil. 2016 Aug;23(4):225-32. doi: 10.1080/10749357.2016.1151662. Epub 2016 Mar 11.
Haruyama K, Kawakami M, Otsuka T. Effect of Core Stability Training on Trunk Function, Standing Balance, and Mobility in Stroke Patients. Neurorehabil Neural Repair. 2017 Mar;31(3):240-249. doi: 10.1177/1545968316675431. Epub 2016 Nov 9.
Cabrera-Martos I, Jimenez-Martin AT, Lopez-Lopez L, Rodriguez-Torres J, Ortiz-Rubio A, Valenza MC. Effects of a core stabilization training program on balance ability in persons with Parkinson's disease: a randomized controlled trial. Clin Rehabil. 2020 Jun;34(6):764-772. doi: 10.1177/0269215520918631. Epub 2020 Apr 29.
Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, Hernandez-Valino M, Urrutia Cuchi G. The effect of additional core stability exercises on improving dynamic sitting balance and trunk control for subacute stroke patients: a randomized controlled trial. Clin Rehabil. 2016 Oct;30(10):1024-1033. doi: 10.1177/0269215515609414. Epub 2015 Oct 8.
Synofzik M, Ilg W. Motor training in degenerative spinocerebellar disease: ataxia-specific improvements by intensive physiotherapy and exergames. Biomed Res Int. 2014;2014:583507. doi: 10.1155/2014/583507. Epub 2014 Apr 27.
He M, Zhang HN, Tang ZC, Gao SG. Balance and coordination training for patients with genetic degenerative ataxia: a systematic review. J Neurol. 2021 Oct;268(10):3690-3705. doi: 10.1007/s00415-020-09938-6. Epub 2020 Jun 24.
Milne SC, Corben LA, Georgiou-Karistianis N, Delatycki MB, Yiu EM. Rehabilitation for Individuals With Genetic Degenerative Ataxia: A Systematic Review. Neurorehabil Neural Repair. 2017 Jul;31(7):609-622. doi: 10.1177/1545968317712469. Epub 2017 Jun 9.
Seco, C. J., et al. Improvements in quality of life in individuals with friedreich's ataxia after participation in a 5-year program of physical activity: an observational study pre-post test design, and two years follow-up. Int J Neurorehabil, 2014, 1.3: 129
Chang YJ, Chou CC, Huang WT, Lu CS, Wong AM, Hsu MJ. Cycling regimen induces spinal circuitry plasticity and improves leg muscle coordination in individuals with spinocerebellar ataxia. Arch Phys Med Rehabil. 2015 Jun;96(6):1006-13. doi: 10.1016/j.apmr.2015.01.021. Epub 2015 Feb 7.
Miyai I, Ito M, Hattori N, Mihara M, Hatakenaka M, Yagura H, Sobue G, Nishizawa M; Cerebellar Ataxia Rehabilitation Trialists Collaboration. Cerebellar ataxia rehabilitation trial in degenerative cerebellar diseases. Neurorehabil Neural Repair. 2012 Jun;26(5):515-22. doi: 10.1177/1545968311425918. Epub 2011 Dec 2.
Bunn LM, Marsden JF, Giunti P, Day BL. Training balance with opto-kinetic stimuli in the home: a randomized controlled feasibility study in people with pure cerebellar disease. Clin Rehabil. 2015 Feb;29(2):143-53. doi: 10.1177/0269215514539336. Epub 2014 Jul 31.
Velazquez-Perez L, Rodriguez-Diaz JC, Rodriguez-Labrada R, Medrano-Montero J, Aguilera Cruz AB, Reynaldo-Cejas L, Gongora-Marrero M, Estupinan-Rodriguez A, Vazquez-Mojena Y, Torres-Vega R. Neurorehabilitation Improves the Motor Features in Prodromal SCA2: A Randomized, Controlled Trial. Mov Disord. 2019 Jul;34(7):1060-1068. doi: 10.1002/mds.27676. Epub 2019 Apr 8.
Rodriguez-Diaz JC, Velazquez-Perez L, Rodriguez Labrada R, Aguilera Rodriguez R, Laffita Perez D, Canales Ochoa N, Medrano Montero J, Estupinan Rodriguez A, Osorio Borjas M, Gongora Marrero M, Reynaldo Cejas L, Gonzalez Zaldivar Y, Almaguer Gotay D. Neurorehabilitation therapy in spinocerebellar ataxia type 2: A 24-week, rater-blinded, randomized, controlled trial. Mov Disord. 2018 Sep;33(9):1481-1487. doi: 10.1002/mds.27437. Epub 2018 Aug 22.
Tabbassum, Khan Neha, et al. Core stability training with conventional balance training improves dynamic balance in progressive degenerative cerebellar ataxia. Indian Journal of Physiotherapy and Occupational Therapy, 2013, 7.1: 136.
Schmitz-Hubsch T, du Montcel ST, Baliko L, Berciano J, Boesch S, Depondt C, Giunti P, Globas C, Infante J, Kang JS, Kremer B, Mariotti C, Melegh B, Pandolfo M, Rakowicz M, Ribai P, Rola R, Schols L, Szymanski S, van de Warrenburg BP, Durr A, Klockgether T, Fancellu R. Scale for the assessment and rating of ataxia: development of a new clinical scale. Neurology. 2006 Jun 13;66(11):1717-20. doi: 10.1212/01.wnl.0000219042.60538.92.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Core protocol 1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.