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Trial record 8 of 190 for:    "autosomal recessive cerebellar ataxia type 1" OR "Cerebellar Ataxia"

Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait in Patients With Cerebellar Ataxia Gene

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ClinicalTrials.gov Identifier: NCT02903290
Recruitment Status : Recruiting
First Posted : September 16, 2016
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Brief 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. 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®.


Condition or disease Intervention/treatment Phase
Cerebellar Ataxia Other: Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait Other: walking track GAITRite,manual dynamometer, and treadmill Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait in Patients With Cerebellar Ataxia Gene
Actual Study Start Date : January 2017
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
cerebellar ataxia
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®
Other: Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait
Other: walking track GAITRite,manual dynamometer, and treadmill



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Functional Systems Scores (FSS) score [ Time Frame: At one year ]
    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.

  2. Visual Analog Scale (VAS) tiredness [ Time Frame: At one year ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903290


Contacts
Contact: GARCIA JEREMY garcia.j@chu-nice.fr
Contact: SACCONI Sabrina sacconi.s@chu-nice.fr

Locations
France
CHU de Nice Recruiting
Nice, France
Contact: GARCIA JEREMY       garcia.j@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: SACCONI Sabrina CHU de Nice

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT02903290     History of Changes
Other Study ID Numbers: 15-AOI-10
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Fatigue
Ataxia
Cerebellar Ataxia
Signs and Symptoms
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases