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

November 13, 2023 updated by: Centre Hospitalier Universitaire de Nice

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 Overview

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Nice, France
        • CHU de Nice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At one year
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.
At one year
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.
At one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At one year
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.
At one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: SACCONI Sabrina, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

July 22, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimated)

September 16, 2016

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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