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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 accordin

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Nice

Current 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.
• 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.

Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Nice

Dates:
Date Received: July 22, 2016
Date Started: May 2016
Date Completion: August 2018
Last Updated: September 12, 2016
Last Verified: July 2016