Cerebellar AtaxiaNCT02903290
Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait in Patients With Cerebellar Ataxia Gene
A study testing Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait and walking track GAITRite,manual dynamometer, and treadmill in people with Cerebellar Ataxia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Genetic cerebellar ataxias involves progressive degeneration of the cerebellum. Their overall prevalence is estimated at 2-4 cases per 100 000 people. These diseases are manifested by a static and kinetic cerebellar syndrome characterized by impaired balance, coordination, and an ataxic gait. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cerebellar Ataxia
- What is being tested?
- Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait and walking track GAITRite,manual dynamometer, and treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2017to 31 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient aged 18 to 60;
- Patient with cerebellar syndrome genetically determined or evidence of inheritance;
- Patient walking more than 50 meters independently, with or without technical assistance;
- Patient likely to be followed regularly for at least one year;
- Patient has given written informed consent;
- Patient affiliated to Social Security.
Who cannot join
- Patient with any other injuries not attributable to the pathology and can influence the running tests according to physician judgment;
- Patient with any disease or condition incompatible to the success of the study according to the doctor's judgment;
- Patient not strolling or sauntering only with a third person to help;
- Major person under guardianship;
- People hospitalized without his consent and not protected by law;
- Nobody deprived of liberty;
- Patients speakers.
Trial locations and contacts
1 site in 1 country.
About this study
Genetic cerebellar ataxias involves progressive degeneration of the cerebellum. Their overall prevalence is estimated at 2-4 cases per 100 000 people. These diseases are manifested by a static and kinetic cerebellar syndrome characterized by impaired balance, coordination, and an ataxic gait. To date, no therapy is available for patients and physical therapy is essential and recommended. The evolution of the pathology causes a degradation of walking, increased instability and risk of falling. In one year, between 74% and 93% of patients reported having fallen at least once. Falls prevention by understanding the mechanisms affecting stability is a major issue in the management of these patients physiotherapy. The analysis of the literature, we assume that there exists a trio "fatigue - instability - energy expenditure" in which the three parameters would influence each other. To date, we do not have data to characterize these interrelationships and their evolution over time.
STUDY OBJECTIVES: The main objective is to study the relationship between changes in energy expenditure and changes in instability when walking at one year in patients with cerebellar ataxia gene. The secondary objectives are to study, after one year of development, the relationship between fatigue, instability, energy consumption, the number of falls, the severity of ataxia and quality of life.
CONDUCT OF THE STUDY: This is a pilot, multicenter, interventional. The projected duration of patient recruitment will be 12 months and the total number of patients will be included in 15. The duration of participation in this study is 12 months for each patient. The anticipated duration of the study is 30 months. Development of the study: Patients included will perform two sets (S1 and S2) tests a year apart including the evaluation of ataxia according Scale for the assessment and rating of ataxia (SARA); measuring the quality of life through SF36 (The Short Form (36)) Questionnaire; quantifying the severity of fatigue perceived by FSS questionnaire quantifying the severity of physical tiredness by VAS before and after physical activity; quantified analysis of walking on walking track GAITRite® (with score calculation FAP and GVI) before and after physical activity; physical activity like walking on a treadmill (with measurement of maximal voluntary quadriceps by manual dynamometer before and after physical activity to ensure the induction of fatigue). Patients will be provided with a portable device for analyzing gas exchange FitMateMED® (COSMED, Rome, Italy) during walking analyzes GAITRite®.
- Conditions
- Cerebellar Ataxia
- Being tested
- Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait, walking track GAITRite,manual dynamometer, and treadmill
- Medical subject headings
- Cerebellar Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During GaitOther
Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait
walking track GAITRite,manual dynamometer, and treadmillOther
walking track GAITRite,manual dynamometer, and treadmill
| Study group | Role | What they receive |
|---|---|---|
| cerebellar ataxia | Other | Evaluation ataxia according SARAs; measuring the quality of life through SF36 Questionnaire; quantifying the severity of fatigue perceived by FSS questionnaire quantifying the severity of physical tiredness by VAS before and after physical activity; quantified analysis of walking on walking track GAITRite® (with score calculation FAP and GVI) before and after physical activity; physical activity like walking on a treadmill (with measurement of maximal voluntary quadriceps by manual dynamometer before and after physical activity to ensure the induction of fatigue). Patients will be provided with a portable device for analyzing gas exchange FitMateMED® (COSMED, Rome, Italy) during walking analyzes GAITRite® Receives: Other: Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait; Other: walking track GAITRite,manual dynamometer, and treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre physical activity scores (Gilette Gait Index (GVI)) to pre exercise walking
The main objective is to investigate the relationship between changes in energy expenditure and changes in instability when walking at one year in patients with cerebellar ataxia gene.
Measured: At one year
Oxygen consumption to pre exercise walking
The main objective is to investigate the relationship between changes in energy expenditure and changes in instability when walking at one year in patients with cerebellar ataxia gene.
Measured: At one year
Pre physical activity scores (Functional Ambulation Performance Score (FAPS)) to pre exercise walking
The main objective is to investigate the relationship between changes in energy expenditure and changes in instability when walking at one year in patients with cerebellar ataxia gene.
Measured: At one year
Secondary outcomes (2)
Functional Systems Scores (FSS) score
Study, after one year of development, the relationship between fatigue, instability, energy consumption, the number of falls, the severity of ataxia and quality of life.
Measured: At one year
Visual Analog Scale (VAS) tiredness
Study, after one year of development, the relationship between fatigue, instability, energy consumption, the number of falls, the severity of ataxia and quality of life.
Measured: At one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start25 Jan 2017
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar AtaxiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SACCONI Sabrina, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903290
- Sponsor's protocol ID
- 15-AOI-10
- Status last verified
- Mar 2025
- First submitted
- 22 Jul 2016
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait in Patients With Cerebellar Ataxia Gene
- ClinicalTrials.gov ID
- NCT02903290
- Acronym / sponsor ID
- 15-AOI-10
- Conditions
- Cerebellar Ataxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 16 Sep 2016 (estimated)
- 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.
Genetic cerebellar ataxias involves progressive degeneration of the cerebellum. Their overall prevalence is estimated at 2-4 cases per 100 000 people. These diseases are manifested by a static and kinetic cerebellar syndrome characterized by impaired balance, coordination, and an ataxic gait. To date, no therapy is available for patients and physical therapy is essential and recommended. The evolution of the pathology causes a degradation of walking, increased instability and risk of falling. In one year, between 74% and 93% of patients reported having fallen at least once. Falls prevention by understanding the mechanisms affecting stability is a major issue in the management of these patients physiotherapy. The analysis of the literature, we assume that there exists a trio "fatigue - instability - energy expenditure" in which the three parameters would influence each other. To date, we do not have data to characterize these interrelationships and their evolution over time.
STUDY OBJECTIVES: The main objective is to study the relationship between changes in energy expenditure and changes in instability when walking at one year in patients with cerebellar ataxia gene. The secondary objectives are to study, after one year of development, the relationship between fatigue, instability, energy consumption, the number of falls, the severity of ataxia and quality of life.
CONDUCT OF THE STUDY: This is a pilot, multicenter, interventional. The projected duration of patient recruitment will be 12 months and the total number of patients will be included in 15. The duration of participation in this study is 12 months for each patient. The anticipated duration of the study is 30 months. Development of the study: Patients included will perform two sets (S1 and S2) tests a year apart including the evaluation of ataxia according Scale for the assessment and rating of ataxia (SARA); measuring the quality of life through SF36 (The Short Form (36)) Questionnaire; quantifying the severity of fatigue perceived by FSS questionnaire quantifying the severity of physical tiredness by VAS before and after physical activity; quantified analysis of walking on walking track GAITRite® (with score calculation FAP and GVI) before and after physical activity; physical activity like walking on a treadmill (with measurement of maximal voluntary quadriceps by manual dynamometer before and after physical activity to ensure the induction of fatigue). Patients will be provided with a portable device for analyzing gas exchange FitMateMED® (COSMED, Rome, Italy) during walking analyzes GAITRite®.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cerebellar ataxia | Other | Other: Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait, Other: walking track GAITRite,manual dynamometer, and treadmillEvaluation ataxia according SARAs; measuring the quality of life through SF36 Questionnaire; quantifying the severity of fatigue perceived by FSS questionnaire quantifying the severity of physical tiredness by VAS before and after physical activity; quantified analysis of walking on walking track GAITRite® (with score calculation FAP and GVI) before and after physical activity; physical activity like walking on a treadmill (with measurement of maximal voluntary quadriceps by manual dynamometer before and after physical activity to ensure the induction of fatigue). Patients will be provided with a portable device for analyzing gas exchange FitMateMED® (COSMED, Rome, Italy) during walking analyzes GAITRite® |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient aged 18 to 60;
- Patient with cerebellar syndrome genetically determined or evidence of inheritance;
- Patient walking more than 50 meters independently, with or without technical assistance;
- Patient likely to be followed regularly for at least one year;
- Patient has given written informed consent;
Key exclusion criteria (7 listed)
- Patient with any other injuries not attributable to the pathology and can influence the running tests according to physician judgment;
- Patient with any disease or condition incompatible to the success of the study according to the doctor's judgment;
- Patient not strolling or sauntering only with a third person to help;
- Major person under guardianship;
- People hospitalized without his consent and not protected by law;
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 |
|---|---|---|
| Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During GaitLongitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait | Other | cerebellar ataxia |
| walking track GAITRite,manual dynamometer, and treadmillwalking track GAITRite,manual dynamometer, and treadmill | Other | cerebellar ataxia |
Primary outcome
Pre physical activity scores (Gilette Gait Index (GVI)) to pre exercise walking
Time frame: At one year
The main objective is to investigate the relationship between changes in energy expenditure and changes in instability when walking at one year in patients with cerebellar ataxia gene.
Oxygen consumption to pre exercise walking
Time frame: At one year
The main objective is to investigate the relationship between changes in energy expenditure and changes in instability when walking at one year in patients with cerebellar ataxia gene.
Pre physical activity scores (Functional Ambulation Performance Score (FAPS)) to pre exercise walking
Time frame: At one year
The main objective is to investigate the relationship between changes in energy expenditure and changes in instability when walking at one year in patients with cerebellar ataxia gene.
2 secondary outcomes
Functional Systems Scores (FSS) score
Time frame: At one year
Visual Analog Scale (VAS) tiredness
Time frame: At one year
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 19 Mar 2025.
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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.
SACCONI Sabrina principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait and walking track GAITRite,manual dynamometer, and treadmill in people with Cerebellar Ataxia, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 6 inclusion and 7 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 19 Mar 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 France. 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?
Pre physical activity scores (Gilette Gait Index (GVI)) to pre exercise walking (time frame: At one year). 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 19 Mar 2025.