BALTiC Study: A Feasibility Analysis of Home Based BALance Training in People With Charcot-Marie-Tooth Disease (BALTiC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02982343|
Recruitment Status : Completed
First Posted : December 5, 2016
Last Update Posted : May 3, 2018
|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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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
- Recruitment rate [ Time Frame: 1 year ]For this feasibility study, recruitment rate data will be gathered
- 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.
- Bruininks Oseretsky Test (BOT) [ Time Frame: 12 weeks ]Clinician rated measure of functional balance performance.
- Berg Balance test [ Time Frame: 12 weeks ]Clinician rated measure of functional balance performance.
- BESTest [ Time Frame: 12 weeks ]Clinician rated measure of functional balance performance.
- 10 minute timed walk [ Time Frame: 12 weeks ]Walking speed test
- Quantitative lower limb muscle strength testing [ Time Frame: 12 weeks ]Hand-held myometry protocol performed by rater for the major lower limb muscle groups.
- CMTES: Charcot Marie Tooth Examination Score [ Time Frame: 12 weeks ]Clinician rated disease severity scale
- Falls Self Efficacy Scale [ Time Frame: 12 weeks ]Patient reported outcome measure of balance confidence. Questionnaire.
- Walk-12 [ Time Frame: 12 weeks ]Patient reported outcome measure of walking function. Questionnaire.
- IPAQ: International Physical Activity Questionnaire [ Time Frame: 12 weeks ]Patient reported outcome measure of physical activity. Questionnaire.
- SF36: Short Form 36 [ Time Frame: 12 weeks ]Patient reported outcome measure of health related quality of life. Questionnaire.
- Hospital Anxiety and Depression Score [ Time Frame: 12 weeks ]Patient reported outcome measure of depression and anxiety symptoms. Questionnaire.
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
|National Hospital for Neurology and Neurosurgery, UCLH|
|London, United Kingdom, WC1N 3BG|
|Principal Investigator:||Gita M Ramdharry, PhD||University College London Hosptials NHS Trust|