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BALTiC Study: A Feasibility Analysis of Home Based BALance Training in People With Charcot-Marie-Tooth Disease (BALTiC)

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ClinicalTrials.gov Identifier: NCT02982343
Recruitment Status : Completed
First Posted : December 5, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
Charcot Marie Tooth United Kingdom
Kingston University
Information provided by (Responsible Party):
Gita Ramdharry, University College London Hospitals

Brief Summary:
Charcot Marie Tooth (CMT) is the most common inherited neuropathy. It affects the nerves of the hands and feet first, slowly progressing towards the centre of the body. It causes varying degrees of weakness and reduced feeling, usually affecting the feet and ankles first. High incidence of falls and knock on effects in quality of life are common. This is a lifelong condition which, though not life limiting, does not have a cure. Research into the effect of balance rehabilitation in people with CMT has been limited to traditional exercises, which do not address the complex nature of balance impairments in this condition. Multi-sensory rehabilitation has proved beneficial in improving balance in people with sensory neuropathy. Research shows that strengthening trunk muscles can improve balance in older people. Trunk and muscles close to it are largely unaffected in people with CMT, therefore these muscles could be strengthened in these patients. This study proposes to assess the feasibility of multi-sensory balance training, strength training with a focus on the trunk and muscles close to the trunk, and falls management education. This comprehensive approach is reflective of a clinical physiotherapy programme. Though a life-long condition, many people with CMT lead full lives. A home based programme is proposed to so that patients can fit it into their lives without having to travel for treatment. Therapists will use self-management principles within treatment. Measurements will be taken prior to and following treatment including physical measures, questionnaires and interviews. The physiotherapy interventions will be taught home and data collection will be at the National Hospital for Neurology and Neurosurgery, University College London Hospitals (UCLH).

Condition or disease Intervention/treatment Phase
Charcot-Marie-Tooth Disease, Type IA Behavioral: Falls management plus exercise training Behavioral: Falls management only Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: BALTiC Study: A Feasibility Analysis of Home Based BALance Training in People With Charcot-Marie-Tooth Disease
Actual Study Start Date : December 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2018


Arm Intervention/treatment
Experimental: Falls management plus exercise training
Falls management and education session. Home proximal lower limb strength training and multi-sensory balance training.
Behavioral: Falls management plus exercise training
Participants will undergo a session of falls management and education followed by 12 weeks of strength and balance training. Strength training will be performed 4 times per week. Resistance training of the proximal muscles will be prescribed progressing to loads of 60% of 1 repetition maximum, 8-12 repetitions. Weaker muscles will be trained using 2 sets of 8-12 repetitions against gravity. They will also give a selection of exercises targeting balance to challenge stability and sensory feedback using equipment such as foam cushions, though will be individual based on participants' limitations and abilities. Participants will be asked to perform balance exercises daily.

Active Comparator: Falls management only
Falls management and education session only.
Behavioral: Falls management only
Participants will undergo a session of falls management and education.




Primary Outcome Measures :
  1. Balance performance [ Time Frame: 12 weeks ]
    Balance performance will be measured using laboratory measures of postural stability during static and dynamic tasks. Centre of pressure excursion and velocity will be the main variables


Secondary Outcome Measures :
  1. Recruitment rate [ Time Frame: 1 year ]
    For this feasibility study, recruitment rate data will be gathered

  2. Falls monitoring [ Time Frame: 20 weeks ]
    Falls monitoring will be done one month before, during the 12 week invention/control period and one month afterwards using postcards or a web based app, depending on participant preference.

  3. Bruininks Oseretsky Test (BOT) [ Time Frame: 12 weeks ]
    Clinician rated measure of functional balance performance.

  4. Berg Balance test [ Time Frame: 12 weeks ]
    Clinician rated measure of functional balance performance.

  5. BESTest [ Time Frame: 12 weeks ]
    Clinician rated measure of functional balance performance.

  6. 10 minute timed walk [ Time Frame: 12 weeks ]
    Walking speed test

  7. Quantitative lower limb muscle strength testing [ Time Frame: 12 weeks ]
    Hand-held myometry protocol performed by rater for the major lower limb muscle groups.

  8. CMTES: Charcot Marie Tooth Examination Score [ Time Frame: 12 weeks ]
    Clinician rated disease severity scale

  9. Falls Self Efficacy Scale [ Time Frame: 12 weeks ]
    Patient reported outcome measure of balance confidence. Questionnaire.

  10. Walk-12 [ Time Frame: 12 weeks ]
    Patient reported outcome measure of walking function. Questionnaire.

  11. IPAQ: International Physical Activity Questionnaire [ Time Frame: 12 weeks ]
    Patient reported outcome measure of physical activity. Questionnaire.

  12. SF36: Short Form 36 [ Time Frame: 12 weeks ]
    Patient reported outcome measure of health related quality of life. Questionnaire.

  13. Hospital Anxiety and Depression Score [ Time Frame: 12 weeks ]
    Patient reported outcome measure of depression and anxiety symptoms. Questionnaire.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Genetically confirmed diagnosis of CMT1a
  2. History of falls
  3. Mixed sensory and motor presentation
  4. Over 18 years
  5. Able to stand unsupported for five minutes
  6. Able to walk for 50m with or without a walking stick or orthotic devices

Exclusion Criteria:

  1. Presence of other significant neurological disorders (such as multiple sclerosis, cerebrovascular diseases, epilepsy, movement disorders), or major comorbidities (e.g. vestibular dysfunction, use of medication which may affect balance, cognitive impairment, presence of medical conditions in which exercise training may be detrimental).
  2. Presence of peripheral neuropathy caused by a condition other then CMT.
  3. Limb surgery during the six months prior to screening (or planned before final assessment).
  4. Participation in any other concurrent intervention trial, or less than six months after cessation of an intervention trial.
  5. Women of child-bearing age if they are pregnant, planning a pregnancy during their time in the study or in the 12 weeks following giving birth. This is due to the effects of pregnancy on balance.

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): NCT02982343


Locations
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United Kingdom
National Hospital for Neurology and Neurosurgery, UCLH
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
University College London Hospitals
Charcot Marie Tooth United Kingdom
Kingston University
Investigators
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Principal Investigator: Gita M Ramdharry, PhD University College London Hosptials NHS Trust

Publications:
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Responsible Party: Gita Ramdharry, Principle Investigator, University College London Hospitals
ClinicalTrials.gov Identifier: NCT02982343     History of Changes
Other Study ID Numbers: 16/LO/0720
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Tooth Diseases
Stomatognathic Diseases
Nervous System Malformations
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn