Hereditary AtaxiaCore-ataxiaNCT04750850
Core Stability Exercises and Hereditary Ataxia
A study testing Therapeutic core stability exercises in people with Hereditary Ataxia and Spinocerebellar Degenerations, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The hereditary ataxias are a group of genetic disorders characterized by slowly progressive incoordination of gait and balance impairments in sitting and standing. Trunk local stability during gait is lower in patients with degenerative ataxia than that in healthy adult population. 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
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2021to 10 Jan 2023
- 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
- Inclusion criteria: suffer a degenerative hereditary ataxia. spinocerebellar ataxia (SCA), Friedreich's ataxia (FRDA), idiopathic sporadic cerebellar ataxia, and specific neurodegenerative disorders in which ataxia is the dominant symptom (e.g. cerebellar variant of multiple systems atrophy (MSA-C). Both sexes and age ≥ 18 years old. •Ability to understand and execute simple instructions.
- Exclusion Criteria: Concurrent neurologic disorder (e. g. Parkinson's disease) or major orthopedic problem (e. g. amputation) that hamper sitting balance, relevant psychiatric disorders that may prevent from following instructions, Other treatments that could influence the effects of the interventions, Contraindication to physical activity (e.g., heart failure).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Core Stability Exercises to Improve Balance and Gait in Hereditary Ataxias. Pilot Study
The hereditary ataxias are a group of genetic disorders characterized by slowly progressive incoordination of gait and balance impairments in sitting and standing. Trunk local stability during gait is lower in patients with degenerative ataxia than that in healthy adult population.
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.
Read the detailed description
The hereditary ataxias are a group of genetic disorders characterized by slowly progressive incoordination of gait and often associated with poor coordination of hands, speech, and eye movements. Prevalence of the autosomal dominant cerebellar ataxias (ADCAs) is estimated to be approximately 1-5:100,000 populations. Hereditary ataxia may result from: dysfunction of the cerebellum and its associated system, lesions in the spinal cord and/or peripheral sensory loss.
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.
- Being tested
- Therapeutic core stability exercises, Usual care
- Keywords
- ataxia, balance, gait ataxia, activities of daily living, core stability exercises, postural balance
- Medical subject headings
- Spinocerebellar Degenerations, Cerebellar Ataxia, Ataxia, Gait Ataxia
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.
Usual careOther
Also called Conventional physiotherapy
Usual routine as walking and activities of daily living.
| Study group | Role | What they receive |
|---|---|---|
| Core stability exercises group | Experimental | 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. Receives: Other: Therapeutic core stability exercises |
| Control group | Active comparator | The patients to continue as normal and not change their routine in terms of exercise and physical activity during the period of study. Receives: Other: Usual care |
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
Spanish-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: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of static sitting balance
Sitting section of Scale for the assessment and rating of ataxia (SARA). Patient is asked to sit on an examination bed without support of feet, eyes open and arms outstretched to the front. 0 Normal, no difficulties sitting >10 seconds, 1 Slight difficulties, intermittent sway, 2 Constant sway, but able to sit > 10 s without support, 3 Able to sit for > 10 s only with intermittent support, 4 Unable to sit for >10 s without continuous support
Measured: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of ataxia severity
Scale for the Assessment and Rating of Ataxia (SARA). The scale is made up of 8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating
Measured: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Secondary outcomes (8)
Rate of standing balance
Standing section of Scale for the assessment and rating of ataxia (SARA). Patient is asked to stand (1) in natural position, (2) with feet together in parallel (big toes touching each other) and (3) in tandem (both feet on one line, no space between heel and toe). Proband does not wear shoes, eyes are open. For each condition, three trials are allowed. Best trial is rated. 0 Normal, able to stand in tandem for > 10 seconds 1 Able to stand with feet together without sway, but not in tandem for > 10s, 2 Able to stand with feet together for > 10 s, but only with sway, 3 Able to stand for > 10 s without support in natural, position, but not with feet together, 4 Able to stand for >10 s in natural position only with intermittent support, 5 Able to stand >10 s in natural position only with constant support of one arm, 6 Unable to stand for >10 s even with constant support of one arm.
Measured: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of gait ability
Gait section of Scale for the assessment and rating of ataxia (SARA). Patient is asked (1) to walk at a safe distance parallel to a wall including a half-turn (turn around to face the opposite direction of gait) and (2) to walk in tandem (heels to toes) without support. Scoring items from 0 to 8: 0 Normal, no difficulties in walking, turning and walking tandem (up to one misstep allowed) and 8 Unable to walk, even supported.
Gait speed by 4 meters walking test (meters per second) . The individual walks without assistance for 6 meters, with the time measured for the intermediate 4 meters to allow for acceleration and deceleration.
Measured: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of balance confidence
Activities-specific Balance Confidence (ABC). Larger typeset should be used for self-administration, while an enlarged version of the rating scale on an index card will facilitate in-person interviews. The ABC is an 11-point scale and ratings should consist of whole numbers (0-100) for each item. Total the ratings (possible range = 0 - 1600) and divide by 16 to get each subject's ABC score. If a subject qualifies his/her response to items #2, #9, #11, #14 or #15 (different ratings for "up" vs. "down" or "onto" vs. "off"), solicit separate ratings and use the lowest confidence of the two (as this will limit the entire activity, for instance the likelihood of using the stairs.) • 80% = high level of physical functioning
- 50-80% = moderate level of physical functioning • < 50% = low level of physical, functioning . < 67% = older adults at risk for falling; predictive of future fall.
Measured: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of lower limb strength
30 seconds sit-to-stand. The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds rather then the amount of time it takes to complete a pre-determined number of repetitions. That way, it is possible to assess a wide variety of ability levels with scores ranging from 0 for those who can not complete 1 stand to greater then 20 for more fit individuals.
Measured: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of adherence
Adherence to the core stability exercise programme will be determined using exercise diaries, and process evaluation will be conducted via structured interviews with each participant at end of treatment.
Measured: T2: 5 weeks
Rate of health status
Health status by Euroqol 5 dimensions (EQ-5D). EQ-5D is a visual analogue scale for health ranging from 0 (worst possible) to 100 (best possible).
Measured: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of gait speed
4 meters walking test (4-MWT)
Measured: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of quality of life
Quality of life by EQ-5D-5L. The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Measured: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start20 May 2021
- Primary completion30 Nov 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat de Lleida
- Responsible party
- Principal investigator, Rosa Cabanas Valdés, Universitat Internacional de Catalunya
- Investigators
- Rosa C Cabanas-Valdés, PhD, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750850
- Sponsor's protocol ID
- Core protocol 1
- Acronym
- Core-ataxia
- Status last verified
- May 2023
- First submitted
- 10 Feb 2021
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32211513Ruano 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.
PubMed 24603320OVERTON, 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.
PubMed 24582474Chini 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.
PubMed 26811155Park 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.
PubMed 27792020Cabanas-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.
PubMed 26922850Haruyama 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.
PubMed 27821673Cabrera-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.
PubMed 32349543Cabanas-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.
PubMed 26451007Synofzik 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.
PubMed 24877117He 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.
PubMed 32583055Milne 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.
PubMed 28595509Seco, 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.
PubMed 25668777
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Core Stability Exercises to Improve Balance and Gait in Hereditary Ataxias. Pilot Study
- ClinicalTrials.gov ID
- NCT04750850
- Acronym / sponsor ID
- Core-ataxia / Core protocol 1
- Keywords
- ataxia, balance, gait ataxia, activities of daily living, core stability exercises, postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Universitat de Lleida
- Study start
- 20 May 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 11 Feb 2021 (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.
The hereditary ataxias are a group of genetic disorders characterized by slowly progressive incoordination of gait and balance impairments in sitting and standing. Trunk local stability during gait is lower in patients with degenerative ataxia than that in healthy adult population.
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.
Detailed description
The hereditary ataxias are a group of genetic disorders characterized by slowly progressive incoordination of gait and often associated with poor coordination of hands, speech, and eye movements. Prevalence of the autosomal dominant cerebellar ataxias (ADCAs) is estimated to be approximately 1-5:100,000 populations. Hereditary ataxia may result from: dysfunction of the cerebellum and its associated system, lesions in the spinal cord and/or peripheral sensory loss.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core stability exercises group | Experimental | Other: Therapeutic core stability exercises30 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. |
| Control group | Active comparator | Other: Usual careThe patients to continue as normal and not change their routine in terms of exercise and physical activity during the period of study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
| Usual careAlso: Conventional physiotherapyUsual routine as walking and activities of daily living. | Other | Control group |
Primary outcome
Rate of dynamic sitting balance and trunk coordination
Time frame: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Spanish-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.
Rate of static sitting balance
Time frame: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Sitting section of Scale for the assessment and rating of ataxia (SARA). Patient is asked to sit on an examination bed without support of feet, eyes open and arms outstretched to the front. 0 Normal, no difficulties sitting >10 seconds, 1 Slight difficulties, intermittent sway, 2 Constant sway, but able to sit > 10 s without support, 3 Able to sit for > 10 s only with intermittent support, 4 Unable to sit for >10 s without continuous support
Rate of ataxia severity
Time frame: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Scale for the Assessment and Rating of Ataxia (SARA). The scale is made up of 8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating
8 secondary outcomes
Rate of standing balance
Time frame: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of gait ability
Time frame: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of balance confidence
Time frame: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of lower limb strength
Time frame: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of adherence
Time frame: T2: 5 weeks
Rate of health status
Time frame: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of gait speed
Time frame: T1: Baseline, T2: 5 weeks and T3: follow up 5 weeks
Rate of quality of life
Time frame: T1: Baseline, T2: 5 weeks and T3: follow up 5 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 May 2023.
- Background: PubMed 32211513Chen 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.
- Background: PubMed 24603320Ruano 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.
- BackgroundOVERTON, Caroline E.; O'BRIEN, Kate. Guidelines on the Diagnosis and Management of Miscarriage. Early Pregnancy, 2017, 129.
- Background: PubMed 24582474Marquer 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.
- Background: PubMed 26811155Chini 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.
- Background: PubMed 27792020Park 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.
- Background: PubMed 26922850Cabanas-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.
- Background: PubMed 27821673Haruyama 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.
- Background: PubMed 32349543Cabrera-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.
- Background: PubMed 26451007Cabanas-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.
- Background: PubMed 24877117Synofzik 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.
- Background: PubMed 32583055He 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.
- Individual participant dataSharing planned: No
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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.
Rosa C Cabanas-Valdés, PhD principal investigator
Universitat Internacional de Catalunya
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 Internacional de Catalunya 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?
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 May 2023. 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: T1: Baseline, T2: 5 weeks and T3: follow up 5 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?
On the ClinicalTrials.gov record for NCT04750850, which also lists 21 linked publications.
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 May 2023.