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Trial record 1 of 1 for:    TresPE
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Treadmill, Stretching and Proprioceptive Exercise (TreSPE) Rehabilitation Program for Charcot-Marie-Tooth Neuropathy Type 1A (CMT1A) (TreSPE)

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ClinicalTrials.gov Identifier: NCT01289704
Recruitment Status : Unknown
Verified October 2010 by University of Genova.
Recruitment status was:  Not yet recruiting
First Posted : February 4, 2011
Last Update Posted : February 4, 2011
Sponsor:
Information provided by:
University of Genova

Study Description
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Brief Summary:
Charcot-Marie-Tooth neuropathy type 1A (CMT1A) is one of the most common inherited neurological disorders. The study will evaluate the efficacy and safety of an innovative rehabilitation protocol constituted by exercises at the treadmill and by a stretching and proprioceptive approach. A total of 92 patients will be enrolled in the study and treated in a controlled, randomized, single blind, way. To recruit a high number of patients with CMT1A the study will be multicentric and will comprehend four of the most active clinical centers in the field of CMT, in Italy. People with CMT1A are very motivated in entering rehabilitation protocols because to date there is no effective therapy for this disease. Therefore, the investigators expect a high compliance by the patients. With the present project the investigators plan to clarify several unanswered questions: 1) the efficacy and safety of treadmill over a more conventional protocol; 2) the duration and frequency of any rehabilitation treatment; 3) the most sensitive outcome measures to evaluate the efficacy of rehabilitation approach in patients with CMT.

Condition or disease Intervention/treatment Phase
Charcot-Marie-Tooth Disease Charcot-Marie-Tooth Disease Type 1A Other: TreSPE Other: SPE Phase 2 Phase 3

Detailed Description:

A multicentre, prospective, randomised, controlled, single blind study to evaluate the impact of aerobic exercise, based on a tightly controlled program at the treadmill, on the rehabilitation therapy of CMT 1A neuropathy.

Comparing aerobic training at the treadmill combined with respiratory physiotherapy, stretching and proprioceptive exercises (TreSPE- treated group) with a more conventional treatment only composed by respiratory physiotherapy, stretching and proprioceptive exercises (SPE- control group) will provide information on the impact of Treadmill in CMT1A.

92 patients (23 per centre) will be enrolled and randomly assigned to TreSPE (n = 46) or to SPE (n = 46). Both groups will be treated for three months and followed up for six months.

No serious side effects are expected with TreSPE, as also suggested by our preliminary results. For safety reasons blood pressure (BP), heart rate (HR) and an electrocardiogram will be recorded during the rehabilitation treatment when the treating physician considers it necessary. The patients will be allowed, if needed, to hold at the parallel bars of the treadmill during exercise. According to the American Thoracic Society (ATS) guidelines the cardiopulmonary exercise test will be interrupted if BP raises at 240/120 and/or HR to 220-patients age.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Study to Evaluate the Effects on Charcot-Marie-Tooth Neuropathy Type 1A of a Composite Treadmill, Stretching and Proprioceptive Exercise (TreSPE) Rehabilitation Program.
Study Start Date : February 2011
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : January 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: TreSPE
Treatment with treadmill, proprioceptive and stretching exercises
 Other: TreSPE
  1. treadmill: 5'warm up, 20'aerobic exercise (gradually incremented to 30', from session to session, if possible), 5'warm down, controlling hearth rate, blood pressure and SaO2.
  2. Respiratory Physiotherapy: positive Expiratory Pressure (PEP) bottle for 10' (in various postures), and postural training, for the other 10'.
  3. Stretching for 20', of the triceps surae, tibialis posterior, extensor and flexors digitorum longus and brevis, both at the bed and in a static position.
  4. Proprioceptive and postural kinesitherapy according to the Perfetti method.
  5. Balance Exercising consists of exercises carried on by basculating bars with improving difficulties in the instruments utilized and in the tasks with therapist supervision and near a handbar preventing falls.
Other Name: SPE
Active Comparator: SPE
Proprioceptive and stretching exercises
 Other: TreSPE
  1. treadmill: 5'warm up, 20'aerobic exercise (gradually incremented to 30', from session to session, if possible), 5'warm down, controlling hearth rate, blood pressure and SaO2.
  2. Respiratory Physiotherapy: positive Expiratory Pressure (PEP) bottle for 10' (in various postures), and postural training, for the other 10'.
  3. Stretching for 20', of the triceps surae, tibialis posterior, extensor and flexors digitorum longus and brevis, both at the bed and in a static position.
  4. Proprioceptive and postural kinesitherapy according to the Perfetti method.
  5. Balance Exercising consists of exercises carried on by basculating bars with improving difficulties in the instruments utilized and in the tasks with therapist supervision and near a handbar preventing falls.
Other Name: SPE

Other: SPE
  1. Respiratory Physiotherapy for 20', consisting of Positive Expiratory Pressure (PEP) bottle for 10' (in various postures), and postural training according to the Mèzières technique, for the other 10'.
  2. Stretching for 20', of the triceps surae, tibialis posterior, extensor and flexors longus and brevis, both at the bed and in a static position.
  3. Proprioceptive and postural kinesitherapy according to the neurocognitive method.
  4. Balance Exercising consists of exercises carried on by moving bars with improving difficulties in the instruments utilized and in the tasks with therapist supervision and near a handlebar preventing falls.


Outcome Measures
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Primary Outcome Measures :
  1. Walking ability of patients will be evaluated as the time needed to walk for 10 meters at normal speed for the patients [ Time Frame: Baseline: 1 day before the rehabilitative protocol starts (T1) ]
    The walking ability of patients will be evaluated through the "10 meters timed walk test" which will be performed at baseline (T1 or day-1), at the end of the three months of treatment (T2 or day90) and at the end of the three months of follow up (T3 or day180).

  2. Walking ability of patients will be evaluated after finishing the treatment as the time needed to walk for 10 meters at normal speed for the patients [ Time Frame: at the end of treatment: day 90 (T2) ]
    The walking ability of patients will be evaluated through the "10 meters timed walk test" which will be performed at baseline (T1 or day-1), at the end of the three months of treatment (T2 or day90) and at the end of the three months of follow up (T3 or day180).

  3. Walking ability of patients will be evaluated after finishing the treatment as the time needed to walk for 10 meters at normal speed for the patients [ Time Frame: at the end of follow up: day 180 (T3) ]
    The walking ability of patients will be evaluated through the "10 meters timed walk test" which will be performed at baseline (T1 or day-1), at the end of the three months of treatment (T2 or day90) and at the end of the three months of follow up (T3 or day180).


Secondary Outcome Measures :
  1. Balance will be evaluated through the Berg Scale [ Time Frame: Baseline: 1 day before the rehabilitative protocol starts ]
    The Berg scale is a tool to evaluate balance and ranges from 0 to 36 points being 36 normal

  2. Balance will be evaluated through the Berg Scale [ Time Frame: at the end of treatment: day 90 (T2) ]
    The Berg scale is a tool to evaluate balance and ranges from 0 to 36 points being 36 normal

  3. balance will be evaluted through the Berg scale [ Time Frame: at the end of follow up: day 180 (T3) ]
    The Berg scale is a tool to evaluate balance and ranges from 0 to 36 points being 36 normal

  4. Quality of life will be evaluated through the SF - 36 questionnaire [ Time Frame: Baseline: 1 day before the rehabilitative protocol starts (T1) ]
    The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.

  5. Quality of life will be evaluated through the SF - 36 questionnaire [ Time Frame: at the end of treatment: day 90 (T2) ]
    The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.

  6. Quality of life will be evaluated through the SF - 36 questionnaire [ Time Frame: at the end of follow up: day 180 (T3) ]
    The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinical diagnosis of CMT1A
  • Genetic confirmation (17p112 chromosome duplication)
  • Age 18 - 70 years old
  • Ability to accomplish the primary outcome measure (10 meter walking test) without support, with or without ankle foot orthoses (AFO)
  • Ability to walk on a treadmill on a horizontal plane for 20 minutes at a speed of 1.5 km/h with or without support at the bars
  • Score at the Mobility Scale between 2 and 11
  • Signed written informed consent to participate

Exclusion Criteria:

  • Diagnosis of Hereditary Neuropathy with Liability to Pressure Palsies (HNPP) or any other type of CMT
  • Other associated causes of neuropathy
  • Vestibular affections, psychiatric, cardiovascular and lung disorders or severe arthropathic changes in the lower limbs
  • Non ambulating patients or patients always requiring even monolateral support to walk
  • Other neurological disorders
Contacts and Locations
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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): NCT01289704


Contacts
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Contact: Margherita A Monti Bragadin, MD 0039-010-3537040 margherita.montibragadin@gmail.com

Locations
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Italy
University of Genoa
Genoa, Italy, 16132
Contact: Angelo Schenone, Professor    +39 010 353 7040    aschenone@neurologia.unige.it   
I.R.C.C.S. Foundation, Besta Institute
Milan, Italy, 20133
Contact: Davide Pareyson, MD    +39 02 23943001    dpareyson@istituto-besta.it   
Don Carlo Gnocchi Foundation
Rome, Italy, 00194
Contact: Luca Padua, MD    +39 06 33086231    lpadua@rm.unicatt.it   
Departement of Neurological and Visual Sciences, University of Verona
Verona, Italy, 37134
Contact: Gian Maria Fabrizi, MD    +39 045 8124461    gianmaria.fabrizi@univr.it   
Sponsors and Collaborators
University of Genova
Investigators
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Principal Investigator: Angelo E Schenone, MD University of Genova
More Information
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Additional Information:

Publications:

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Responsible Party: Gianluigi Mancardi, Neuroscience, Ophtalmology and Genetic Departement
ClinicalTrials.gov Identifier: NCT01289704    
Other Study ID Numbers: GUP09013
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: February 4, 2011
Last Verified: October 2010
Keywords provided by University of Genova:
Charcot-Marie-Tooth disease,
CMT1A,
rehabilitation,
treadmill,
 stretching,
proprioception,
Randomised Controlled Trial.
Additional relevant MeSH terms:
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Tooth Diseases
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
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