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Contact Information:

Dr Yi Shiau Ng
+44 (0)191 208 3084
yi.ng@newcastle.ac.uk


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Be Part of Research - Trial Details - Friedreich ataxia: balance and gait study
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Friedreich ataxia: balance and gait study

Recruiting

Open to: All Genders

Age: Mixed

Newcastle upon Tyne

Medical Conditions

Friedreich ataxia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Friedreich’s ataxia (FA) is an inherited genetic condition. FA affects the part of the brain that controls movement and balance (the cerebellum). It also affects the nerves which carry signals from the brain to the rest of the body. People with FA experience symptoms that get worse over time. These include movement and balance difficulties, speech and swallowing issues, and muscle weakness. Other symptoms can include diabetes mellitus and heart problems. Many people with FA live with significant physical disability and reduced life expectancy. Currently, there is no cure for FA, and more research on this rare condition is needed. Performing clinical trials in rare conditions like FA is challenging. Current clinical rating scales and many outcome measures are subjective. The results may differ depending on who performs the assessment. Often, assessments are not sensitive enough to detect changes over a short time frame. Instrumented assessments of gait and balance, may be useful as alternative outcome measures. They are already used to assess gait and balance issues (ataxia) in some conditions. They are less subjective than current measures and may be better at detecting changes. This study will investigate instrumented assessments of gait and balance in FA. This will be in a specialist gait laboratory and via wearable sensors. It will investigate if these assessments show a consistent pattern. It will also check if these assessments are sensitive enough to measure changes in FA over a year compared to current outcome measures.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Nov 2023 31 Aug 2025

Participants will attend the study centre in Newcastle upon Tyne for three visits over 12 months. These will take place at baseline (the start), month 6 and month 12.

Visit assessments will include clinical assessments including physical examination and review of medical history, standard clinical rating tools for FA and tests of upper limb coordination. Participants will also complete questionnaires about ataxia, quality of life and fatigue. Assessments of balance and gait will be performed in a gait laboratory and using wearable sensors. Following each visit, participants will continue wearing a wearable sensor for seven days at home.

Data collected in this study will be combined for analyses with data collected via a separate protocol (under separate approvals and governance) undertaken at the Hertie Institute for Clinical Brain Research and Centre for Integrative Neuroscience, in Germany (Tübingen).


People aged 14 to 65 years, years and above with a confirmed diagnosis of FA

You can take part if:



You may not be able to take part if:


1. Lacking the capacity to provide informed consent2. Enrolled in interfering therapy or clinical drug trial currently or within last 3 months3. Pregnancy at the time of enrolment4. Any other reason, which in the opinion of the recruiting investigator would preclude involvement in the study


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • NIHR Newcastle Clinical Ageing Research Unit (CARU)
    Freeman Hospital Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN

There will be no direct benefits to individual participants. The study will provide data on the severity and progression of FA. It will investigate new methods for measuring ataxia in FA and will inform the design of future research.
The study involves tests of balance and walking and there may be a risk of falling or becoming tired. The assessments are delivered in an area designed for this type of activity. All staff are trained and experienced in delivering these assessments. Opportunities for regular breaks will be provided.
Study questionnaires include questions on quality of life and well-being. These questions may be distressing for some participants. Participants can contact study staff at any point if they are worried or have difficulty with a questionnaire.

Dr Yi Shiau Ng
+44 (0)191 208 3084
yi.ng@newcastle.ac.uk



The study is sponsored by Newcastle University and funded by l'Association Française de l'Ataxie de Friedreich (AFAF).



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Read full details for Trial ID: ISRCTN40092306

Or CPMS 57586

Last updated 13 August 2024

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